Somebody Turn on the Lights Why Nobody Knows What Anything Costs in Health Care and What Can Be Done About It

MANAGED CareMAY 2019

Somebody Turn on the Lights Why nobody knows what anything costs in health care and what can be done about it. PAGE 24 Real value in RA comes together with Olumiant For adult patients with moderately to severely active RA

Provided Meaningful Demonstrated relief of signss clinical Proven efﬁ cacy in and symptomsms patients who of RA1 response significant have had an efficacy inadequate response to 1 or more TNFis1

Favorable Priced at 60%% pricing Once-daily less than thee oral 2 Available as leading TNFi therapy Cost comparisonss basebasedd a tablet, with a on WAC prices, as of recommended September 1, 2018,18, and do not imply comparablearable dose of 2 mg safety and efﬁ cacy.y. once daily

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Visit olumiant.com/hcp to learn more about adding Olumiant to formulary.

INDICATION Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Use of Olumiant in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include: • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. Treatment for latent infection should be considered prior to Olumiant use. • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Olumiant demonstrated greater ACR20, ACR50, and ACR70 response rates than placebo at weeks 12 and 241,3,4

100 ACR Response Rates *p≤0.05; **p≤0.01; ***p≤0.001. 90 ACR20 is deﬁ ned as achieved a 20% improvement in tender and swollen joint counts and 20% improvement 80 in at least 3 of the 5 remaining ACR components.5 70 From week 16, non-responding patients could be rescued † 60 to receive baricitinib 4 mg once daily. Patients who were rescued or discontinued treatments were considered 50 *** 49 *** non-responders in the analysis. 45 40 Study IV (BEACON) Clinical Trial Design

30 Olumiant was evaluated in a 24-week, randomized, * double-blind, phase 3, placebo-controlled trial in PERCENTAGE OF PATIENTS (NRI) OF PATIENTS PERCENTAGE 27 ** 27 20 23 20 527 patients with moderately to severely active RA *** *** who had an inadequate response to one or more TNF 10 13 13 13 8 2 3 inhibitors. Patients could have had prior treatment 0 with other biologic DMARDs. Patients received Olumiant

ACR20 ACR50 ACR70 ACR20 ACR50 ACR70 2 mg (n=174) or baricitinib 4 mg (n=177) once daily WEEK 12 WEEK 24 or placebo (n=176), added to background cDMARD Placebo + cDMARDs (n=176) Olumiant 2 mg/day + cDMARDs (n=174) treatment. The primary endpoint was the proportion of patients who achieved ACR20 response at week 12. †Baricitinib 4 mg is not an approved dose.

Olumiant demonstrated signiﬁ cant improvement in physical function vs placebo1,3

0 Change in Physical Function (HAQ-DI) ***p≤0.001. HAQ-DI is a patient-reported questionnaire that measures 0.1 the degree of diffi culty experienced in completing activities of daily living, such as dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.6 0.2 From week 16, non-responding patients could be rescued to receive baricitinib 4 mg once daily. 0.3 Missing data were reported as modifi ed last observation carried *** *** forward (mLOCF) except for week 12, which was reported 0.4 as modifi ed baseline observation carried forward (mBOCF). LS MEAN CHANGE FROM BASELINE Primary endpoint was the proportion of patients achieving ACR20 response at week 12. 0.5 0 2 468 1012 14 16 182220 24 RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; WAC=wholesale acquisition cost; ACR20/50/70=American WEEK College of Rheumatology 20%/50%/70% improvement criteria; Placebo + cDMARDs (n=176) Olumiant 2 mg/day + cDMARDs (n=174) NRI=non-responder imputation; cDMARD=conventional disease-modifying antirheumatic drug; LS=least squares; HAQ-DI=Health Assessment Questionnaire-Disability Index.

IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets (cont’d) • Bacterial, viral, and other infections due to opportunistic pathogens. Carefully consider the risks and beneﬁ ts of Olumiant prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant. THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated. Please see the following pages for additional Important Safety Information and Brief Summary of Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis. IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets (cont’d)

WARNINGS AND PRECAUTIONS zoster, interrupt Olumiant treatment until the episode resolves. SERIOUS INFECTIONS: The most common serious infections The impact of Olumiant on chronic viral hepatitis reactivation is reported with Olumiant included pneumonia, herpes zoster, unknown. Screen for viral hepatitis in accordance with clinical and urinary tract infection. Among opportunistic infections, guidelines before initiating Olumiant. tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: cryptococcosis, cytomegalovirus, and BK virus were Malignancies were observed in Olumiant clinical studies. reported with Olumiant. Some patients have presented with Consider the risks and benefi ts of Olumiant prior to initiating disseminated rather than local disease, and were often taking therapy in patients with a known malignancy other than a concomitant immunosuppressants such as methotrexate successfully treated non-melanoma skin cancer (NMSC) or or corticosteroids. Avoid Olumiant in patients with an active, when considering continuing Olumiant in patients who develop serious infection, including localized infections. Consider the a malignancy. NMSCs were reported in patients treated with risks and benefi ts of treatment prior to initiating Olumiant Olumiant. Periodic skin examination is recommended for in patients: patients who are at increased risk for skin cancer. • with chronic or recurrent infection THROMBOSIS: Thrombosis, including DVT and PE, has been • who have been exposed to TB observed at an increased incidence in Olumiant-treated • with a history of a serious or an opportunistic infection patients compared to placebo. In addition, arterial thrombosis • who have resided or traveled in areas of endemic events in the extremities have been reported in clinical studies tuberculosis or endemic mycoses; or with Olumiant. Many of these adverse events were serious and • with underlying conditions that may predispose them some resulted in death. There was no clear relationship between to infection. platelet count elevations and thrombotic events. Use Olumiant Closely monitor patients for infections during and after with caution in patients who may be at increased risk of Olumiant treatment. Interrupt Olumiant if a patient develops a thrombosis. If clinical features of DVT/PE or arterial thrombosis serious infection, an opportunistic infection, or sepsis. Do not occur, evaluate patients promptly and treat appropriately. resume Olumiant until the infection is controlled. GASTROINTESTINAL PERFORATIONS: Gastrointestinal Tuberculosis – Before initiating Olumiant evaluate and test perforations have been reported in Olumiant clinical studies, patients for latent or active infection and treat patients with although the role of JAK inhibition in these events is not known. latent TB with standard antimycobacterial therapy. Olumiant Use Olumiant with caution in patients who may be at increased should not be given to patients with active TB. Consider anti-TB risk for gastrointestinal perforation (e.g., patients with a history therapy prior to initiating Olumiant in patients with a history of of diverticulitis). Promptly evaluate patients who present with latent or active TB in whom an adequate course of treatment new onset abdominal symptoms for early identifi cation of cannot be confi rmed, and for patients with a negative test for gastrointestinal perforation. latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment. LABORATORY ABNORMALITIES: Viral Reactivation – Viral reactivation, including cases of Neutropenia – Olumiant treatment was associated with an herpes virus reactivation (e.g., herpes zoster), were reported increased incidence of neutropenia (absolute neutrophil count in clinical studies with Olumiant. If a patient develops herpes [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with VACCINATIONS: Avoid use of live vaccines with an ANC <1000 cells/mm3. Evaluate at baseline and Olumiant. Update immunizations in agreement with thereafter according to routine patient management. current immunization guidelines prior to initiating Lymphopenia – Absolute lymphocyte count (ALC) Olumiant therapy. 3 <500 cells/mm were reported in Olumiant clinical ADVERSE REACTIONS trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients Adverse reactions (≥1%) include: upper respiratory treated with Olumiant, but not placebo. Avoid tract infections (16.3%, 14.7%, 11.7%), nausea initiation or interrupt Olumiant treatment in patients (2.7%, 2.8%, 1.6%), herpes simplex (0.8%, 1.8%, with an ALC <500 cells/mm3. Evaluate at baseline and 0.7%), and herpes zoster (1.0%, 1.4%, 0.4%) thereafter according to routine patient management. for Olumiant 2 mg, baricitinib 4 mg, and placebo, respectively. Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid USE IN SPECIFIC POPULATIONS initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and PREGNANCY AND LACTATION: No information is thereafter according to routine patient management. available to support the use of Olumiant in pregnancy Liver Enzyme Elevations – Olumiant treatment was or lactation. Advise women not to breastfeed during associated with increased incidence of liver enzyme treatment with Olumiant. elevation compared to placebo. Increases to ≥5x and HEPATIC AND RENAL IMPAIRMENT: Olumiant is ≥10x upper limit of normal were observed for both not recommended in patients with severe hepatic ALT and AST in patients in Olumiant clinical trials. impairment or in patients with moderate or severe Evaluate at baseline and thereafter according to renal impairment. routine patient management. Promptly investigate the cause of liver enzyme elevation to identify Please see the following pages for Brief Summary potential cases of drug-induced liver injury. If of Prescribing Information, including Boxed increases in ALT or AST are observed and drug- Warning about Serious Infections, Malignancies, induced liver injury is suspected, interrupt Olumiant and Thrombosis. until this diagnosis is excluded. BA HCP ISI 01JUN2018 Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

References: 1. Olumiant [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018. 2. FDB MedKnowledge™, Analysource. Analysource.com. Updated 2018. Accessed September 1, 2018. 3. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374:1243-1252. 4. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. N Engl J Med. 2016;374(suppl):1-30. 5. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology. Preliminary deﬁ nition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-735. 6. Farheen K, Agarwal SK. Assessment of disease activity and treatment in rheumatoid arthritis. J Manag Care Pharm. 2011;17(9 suppl B):S09-S13. Olumiant® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates. PP-BA-US-0465 10/2018 ©Lilly USA, LLC 2018. All rights reserved. T:7”

OLUMIANT® (baricitinib) TABLETS BRIEF SUMMARY OF PRESCRIBING INFORMATION Monitor patients for the development of signs and symptoms of TB, including patients Consult the package insert for complete prescribing information. who tested negative for latent TB infection prior to initiating therapy. Viral Reactivation—Viral reactivation, including cases of herpes virus reactivation WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops SERIOUS INFECTIONS: herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Patients Patients treated with Olumiant are at risk for developing serious infections with evidence of active hepatitis B or C infection were excluded from clinical trials. Patients that may lead to hospitalization or death. Most patients who developed these who were positive for hepatitis C antibody but negative for hepatitis C virus RNA were infections were taking concomitant immunosuppressants such as methotrexate permitted to enroll. Patients with positive hepatitis B surface antibody and hepatitis B core or corticosteroids. antibody, without hepatitis B surface antigen, were permitted to enroll; such patients should If a serious infection develops, interrupt Olumiant until the infection is controlled. be monitored for expression of hepatitis B virus (HBV) DNA. Should HBV DNA be detected, Reported infections include: consult with a hepatologist. Perform screening for viral hepatitis in accordance with clinical • Active tuberculosis, which may present with pulmonary or extrapulmonary guidelines before starting therapy with Olumiant. disease. Patients should be tested for latent tuberculosis before initiating Malignancy and Lymphoproliferative Disorders—Consider the risks and benefits of Olumiant and during therapy. Treatment for latent infection should be Olumiant treatment prior to initiating therapy in patients with a known malignancy other considered prior to Olumiant use. than a successfully treated non-melanoma skin cancer (NMSC) or when considering • Invasive fungal infections, including candidiasis and pneumocystosis. Patients continuing Olumiant in patients who develop a malignancy. Malignancies were observed in with invasive fungal infections may present with disseminated, rather than clinical studies of Olumiant. localized, disease. Non-melanoma skin cancers—Non-melanoma skin cancers (NMSCs) have been reported in • Bacterial, viral, and other infections due to opportunistic pathogens. patients treated with Olumiant. Periodic skin examination is recommended for patients who The risks and benefits of treatment with Olumiant should be carefully considered are at increased risk for skin cancer. prior to initiating therapy in patients with chronic or recurrent infection. Thrombosis—Thrombosis, including deep venous thrombosis (DVT) and pulmonary Patients should be closely monitored for the development of signs and symptoms embolism (PE), has been observed at an increased incidence in patients treated with of infection during and after treatment with Olumiant including the possible Olumiant compared to placebo. In addition, arterial thrombosis events in the extremities development of tuberculosis in patients who tested negative for latent tuberculosis have been reported in clinical studies with Olumiant. Many of these adverse events were infection prior to initiating therapy. serious and some resulted in death. There was no clear relationship between platelet count MALIGNANCIES: elevations and thrombotic events. Olumiant should be used with caution in patients who Lymphoma and other malignancies have been observed in patients treated may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis with Olumiant. occur, patients should be evaluated promptly and treated appropriately. THROMBOSIS: Gastrointestinal Perforations—Events of gastrointestinal perforation have been Thrombosis, including deep venous thrombosis and pulmonary embolism, has been reported in clinical studies with Olumiant, although the role of JAK inhibition in these events observed at an increased incidence in patients treated with Olumiant compared is not known. to placebo. In addition, there were cases of arterial thrombosis. Many of these Olumiant should be used with caution in patients who may be at increased risk for adverse events were serious and some resulted in death. Patients with symptoms gastrointestinal perforation (e.g., patients with a history of diverticulitis). Patients presenting of thrombosis should be promptly evaluated. with new onset abdominal symptoms should be evaluated promptly for early identification of gastrointestinal perforation. INDICATIONS AND USAGE Laboratory Abnormalities Olumiant® (baricitinib) is indicated for the treatment of adult patients with moderately to Neutropenia—Treatment with Olumiant was associated with an increased incidence of severely active rheumatoid arthritis who have had an inadequate response to one or more neutropenia (absolute neutrophil count [ANC] less than 1000 cells/mm3) compared to placebo. tumor necrosis factor (TNF) antagonist therapies. Avoid initiation or interrupt Olumiant treatment in patients with an ANC less than 1000 cells/mm3. T:10” Limitation of use: Use of Olumiant in combination with other JAK inhibitors, biologic Evaluate at baseline and thereafter according to routine patient management. disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such Lymphopenia—Absolute lymphocyte count (ALC) less than 500 cells/mm3 were reported as azathioprine and cyclosporine is not recommended. in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. WARNINGS AND PRECAUTIONS Avoid initiation or interrupt Olumiant treatment in patients with an ALC Serious Infections—Serious and sometimes fatal infections due to bacterial, less than 500 cells/mm3. Evaluate at baseline and thereafter according to routine mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported patient management. in rheumatoid arthritis patients receiving Olumiant. The most common serious infections Anemia—Decreases in hemoglobin levels to less than 8 g/dL were reported in reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal hemoglobin less than 8 g/dL. Evaluate at baseline and thereafter according to routine candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, and cytomegalovirus, patient management. and BK virus were reported with Olumiant. Some patients have presented with disseminated Liver Enzyme Elevations—Treatment with Olumiant was associated with increased rather than local disease, and were often taking concomitant immunosuppressants such as incidence of liver enzyme elevation compared to placebo. Increases to greater than or equal methotrexate or corticosteroids. to 5x and greater than or equal to 10x upper limit of normal (ULN) were observed for both Avoid use of Olumiant in patients with an active, serious infection, including ALT and AST in patients in Olumiant clinical trials. localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant Evaluate at baseline and thereafter according to routine patient management. Prompt in patients: investigation of the cause of liver enzyme elevation is recommended to identify potential • with chronic or recurrent infection cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced • who have been exposed to tuberculosis liver injury is suspected, interrupt Olumiant until this diagnosis is excluded. • with a history of a serious or an opportunistic infection Lipid Elevations—Treatment with Olumiant was associated with increases in lipid • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high- • with underlying conditions that may predispose them to infection. density lipoprotein (HDL) cholesterol. Assessment of lipid parameters should be performed Closely monitor patients for the development of signs and symptoms of infection approximately 12 weeks following Olumiant initiation. during and after treatment with Olumiant. Interrupt Olumiant if a patient develops a Manage patients according to clinical guidelines for the management of hyperlipidemia. serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with Olumiant should undergo prompt and complete diagnostic Vaccinations—Avoid use of live vaccines with Olumiant. Update immunizations in testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy agreement with current immunization guidelines prior to initiating Olumiant therapy. should be initiated, the patient should be closely monitored, and Olumiant should be ADVERSE REACTIONS interrupted if the patient is not responding to therapy. Do not resume Olumiant until the Clinical Trials Experience—Because clinical studies are conducted under widely varying infection is controlled. conditions, adverse reaction rates observed in the clinical studies of a drug cannot be Tuberculosis—Evaluate and test patients for latent or active infection prior to administration directly compared to rates in the clinical studies of another drug and may not predict the of Olumiant. Patients with latent tuberculosis (TB) should be treated with standard rates observed in a broader patient population in clinical practice. antimycobacterial therapy before initiating Olumiant. The following data include six randomized, double-blind, placebo-controlled studies Olumiant should not be given to patients with active TB. Consider anti-TB therapy (three Phase 2, three Phase 3) and a long-term extension study. All patients had moderately prior to initiation of Olumiant in patients with a history of latent or active TB in whom an to severely active RA. Patients were randomized to placebo (1070 patients), Olumiant 2 mg adequate course of treatment cannot be confirmed, and for patients with a negative test (479 patients), or baricitinib 4 mg (997 patients). for latent TB but who have risk factors for TB infection. Consultation with a physician with Patients could be switched to baricitinib 4 mg from placebo or Olumiant 2 mg from as expertise in the treatment of TB is recommended to aid in the decision about whether early as Week 12 depending on the study design. All patients initially randomized to placebo initiating anti-TB therapy is appropriate for an individual patient. were switched to baricitinib 4 mg by Week 24.

OLUMIANT® (baricitinib) BA HCP BS 01JUN2018 OLUMIANT® (baricitinib) BA HCP BS 01JUN2018 T:7”

During the 16-week treatment period, adverse events leading to discontinuation methotrexate monotherapy, 1.9% and 1.3% of patients treated with baricitinib of treatment were reported by 35 patients (11.4 events per 100 patient-years) treated 4 mg monotherapy, and 4.7% and 1.9% of patients treated with baricitinib 4 mg with placebo, 17 patients (12.1 events per 100 patient-years) with Olumiant 2 mg, and plus methotrexate. 40 patients (13.4 events per 100 patient-years) treated with baricitinib 4 mg. Lipid Elevations—In controlled clinical trials, Olumiant treatment was associated with During 0 to 52 week exposure, adverse events leading to discontinuation of treatment dose-related increases in lipid parameters including total cholesterol, triglycerides, were reported by 31 patients (9.2 events per 100 patient-years) with Olumiant 2 mg, and LDL cholesterol, and HDL cholesterol. Elevations were observed at 12 weeks and remained 92 patients (10.2 events per 100 patient-years) treated with baricitinib 4 mg. stable thereafter. During the 12-week treatment period, changes in lipid parameters are Overall Infections—During the 16-week treatment period, infections were reported by summarized below: 253 patients (82.1 events per 100 patient-years) treated with placebo, 139 patients • Mean LDL cholesterol increased by 8 mg/dL in patients treated with Olumiant 2 mg and (99.1 events per 100 patient-years) treated with Olumiant 2 mg, and 298 patients by 14 mg/dL in patients treated with baricitinib 4 mg. (100.1 events per 100 patient-years) treated with baricitinib 4 mg. • Mean HDL cholesterol increased by 7 mg/dL in patients treated with Olumiant 2 mg and During 0 to 52 week exposure, infections were reported by 200 patients (59.6 events by 9 mg/dL in patients treated with baricitinib 4 mg. per 100 patients-years) treated with Olumiant 2 mg, and 500 patients (55.3 events per • The mean LDL/HDL ratio remained stable. 100 patient-years) treated with baricitinib 4 mg. • Mean triglycerides increased by 7 mg/dL in patients treated with Olumiant 2 mg and In the 0 to 52 week exposure population, the most commonly reported infections by 15 mg/dL in patients treated with baricitinib 4mg. with Olumiant were viral upper respiratory tract infection, upper respiratory tract infection, Creatine Phosphokinase (CPK)—Olumiant treatment was associated with increases in urinary tract infection, and bronchitis. CPK within one week of starting Olumiant and plateauing after 8 to 12 weeks. At 16 weeks, Serious Infections—During the 16-week treatment period, serious infections were reported the mean change in CPK for Olumiant 2 mg and baricitinib 4 mg was 37 IU/L and in 13 patients (4.2 events per 100 patient-years) treated with placebo, 5 patients (3.6 events 52 IU/L, respectively. per 100 patient-years) treated with Olumiant 2 mg, and 11 patients (3.7 events per Creatinine—In controlled clinical trials, dose-related increases in serum creatinine were 100 patient-years) treated with baricitinib 4 mg. observed with Olumiant treatment. At 52 weeks, the mean increase in serum creatinine was During 0 to 52 week exposure, serious infections were reported in 14 patients less than 0.1 mg/dL with baricitinib 4 mg. The clinical significance of the observed serum (4.2 events per 100 patient-years) treated with Olumiant 2 mg and 32 patients (3.5 events creatinine increases is unknown. per 100 patient-years) treated with baricitinib 4 mg. Other Adverse Reactions—Other adverse reactions are summarized in the following table. In the 0 to 52 week exposure population, the most commonly reported serious infections with Olumiant were pneumonia, herpes zoster, and urinary tract infection. Adverse Reactions occurring in greater than or equal to 1% of Olumiant 2 mg and baricitinib 4 mg Treated Patients in Placebo-Controlled Trials Tuberculosis—During the 16-week treatment period, no events of tuberculosis were reported. Weeks 0-16 During 0 to 52 week exposure, events of tuberculosis were reported in 0 patients treated Olumiant Baricitinib with Olumiant 2 mg and 1 patient (0.1 per 100 patient-years) treated with baricitinib 4 mg. Placebo 2 mg 4 mg Cases of disseminated tuberculosis were also reported. n=1070 n=479 n=997 Opportunistic Infections (excluding tuberculosis)—During the 16-week treatment period, Events (%) (%) (%) opportunistic infections were reported in 2 patients (0.6 per 100 patient-years) treated with a placebo, 0 patients treated with Olumiant 2 mg and 2 patients (0.7 per 100 patient-years) Upper respiratory tract infections 11.7 16.3 14.7 treated with baricitinib 4 mg. Nausea 1.6 2.7 2.8 During 0 to 52 week exposure, opportunistic infections were reported in 1 patient Herpes simplexb 0.7 0.8 1.8 (0.3 per 100 patient-years) treated with Olumiant 2 mg and 5 patients (0.6 per 100 patient- years) treated with baricitinib 4 mg. Herpes zoster 0.4 1.0 1.4 Malignancy—During the 16-week treatment period, malignancies excluding non-melanoma a Includes acute sinusitis, acute tonsillitis, chronic tonsillitis, epiglottitis, laryngitis, skin cancers (NMSC) were reported in 0 patients treated with placebo, 1 patient (0.7 per nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinobronchitis, 100 patient-years) treated with Olumiant 2 mg, and 1 patient (0.3 per 100 patient-years) sinusitis, tonsillitis, tracheitis, and upper respiratory tract infection. T:10” treated with baricitinib 4 mg. b Includes eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, During the 0 to 52 week treatment period, malignancies excluding NMSC were and oral herpes. reported in 2 patients (0.6 per 100 patient-years) treated with Olumiant 2 mg and 6 patients Additional adverse drug reactions occurring in fewer than 1% of patients: acne. (0.7 per 100 patient-years) treated with baricitinib 4 mg. Venous Thrombosis—During the 16-week treatment period, venous thromboses (deep DRUG INTERACTIONS vein thrombosis or pulmonary embolism) were reported in 0 patients treated with placebo, Strong OAT3 Inhibitors—Baricitinib exposure is increased when Olumiant is 0 patients treated with Olumiant 2 mg, and 5 patients (1.7 per 100 patient-years) treated co-administered with strong Organic Anion Transporter 3 (OAT3) inhibitors (such as with baricitinib 4 mg. probenecid). Olumiant is not recommended for use in patients taking strong OAT3 inhibitors, During the 0 to 52 week treatment period, venous thromboses were reported in such as probenecid. 2 patients (0.6 per 100 patient-years) treated with Olumiant 2 mg and 7 patients (0.8 per Other JAK Inhibitors or Biologic DMARDs—Olumiant has not been studied in combination 100 patient-years) treated with baricitinib 4 mg. with other JAK inhibitors or with biologic DMARDs. Arterial Thrombosis—During the 16-week treatment period, arterial thromboses were reported in 1 patient treated with placebo (0.3 per 100 patient-years), 2 patients (1.4 per USE IN SPECIFIC POPULATIONS 100 patient-years) treated with Olumiant 2 mg, and 2 patients (0.7 per 100 patient-years) Pregnancy treated with baricitinib 4 mg. Risk Summary—The limited human data on use of Olumiant in pregnant women are During the 0 to 52 week treatment period, arterial thromboses were reported in not sufficient to inform a drug-associated risk for major birth defects or miscarriage. In 3 patients (0.9 per 100 patient-years) treated with Olumiant 2 mg and 3 patients (0.3 per animal embryo-fetal development studies, oral baricitinib administration to pregnant rats 100 patient-years) treated with baricitinib 4 mg. and rabbits at exposures equal to and greater than approximately 20 and 84 times the Laboratory Abnormalities maximum recommended human dose (MRHD), respectively, resulted in reduced fetal body Neutropenia—During the 16-week treatment period, neutrophil counts below 1000 cells/mm3 weights, increased embryolethality (rabbits only), and dose-related increases in skeletal occurred in 0% of patients treated with placebo, 0.6% of patients treated with Olumiant 2 mg, malformations. No developmental toxicity was observed in pregnant rats and rabbits treated and 0.3% of patients treated with baricitinib 4 mg. There were no neutrophil counts below with oral baricitinib during organogenesis at approximately 5 and 13 times the exposure at 500 cells/mm3 observed in any treatment group. the MRHD, respectively. In a pre- and post-natal development study in pregnant female rats, Platelet Elevations—During the 16-week treatment period, increases in platelet counts oral baricitinib administration at exposures approximately 43 times the MRHD resulted in above 600,000 cells/mm3 occurred in 1.1% of patients treated with placebo, 1.1% of reduction in pup viability (increased incidence of stillborn pups and early neonatal deaths), patients treated with Olumiant 2 mg, and 2.0% of patients treated with baricitinib 4 mg. decreased fetal birth weight, reduced fetal body weight gain, decreased cytotoxic T cells on Mean platelet count increased by 3000 cells/mm3 at 16 weeks in patients treated with post-natal day (PND) 35 with evidence of recovery by PND 65, and developmental delays placebo, by 15,000 cells/mm3 at 16 weeks in patients treated with Olumiant 2 mg and by that might be attributable to decreased body weight gain. No developmental toxicity was 23,000 cells/mm3 in patients treated with baricitinib 4 mg. observed at an exposure approximately 9 times the exposure at the MRHD. Liver Enzyme Elevations—Events of increases in liver enzymes greater than or equal to The estimated background risk of major birth defects and miscarriage for the 3x ULN were observed in patients treated with Olumiant. indicated population(s) are unknown. All pregnancies have a background risk of birth defect, • During the 16-week treatment period, ALT elevations greater than or equal to 3x ULN loss, or other adverse outcomes. In the U.S. general population, the estimated background occurred in 1.0% of patients treated with placebo, 1.7% of patients treated with risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and Olumiant 2 mg, and 1.4% of patients treated with baricitinib 4 mg. 15-20%, respectively. • During the 16-week treatment period, AST elevations greater than or equal to 3x ULN Data occurred in 0.8% of patients treated with placebo, 1.3% of patients treated with Animal Data: In an embryofetal development study in pregnant rats, dosed orally during the Olumiant 2 mg, and 0.8% of patients treated with baricitinib 4 mg. period of organogenesis from gestation days 6 to 17, baricitinib was teratogenic (skeletal • In a phase 3 study of DMARD naive patients, during the 24-week treatment period, malformations that consisted of bent limb bones and rib anomalies) at exposures equal to or ALT and AST elevations ≥3x ULN occurred in 1.9% and 0% of patients treated with greater than approximately 20 times the MRHD (on an AUC basis at maternal oral doses of

OLUMIANT® (baricitinib) BA HCP BS 01JUN2018 OLUMIANT® (baricitinib) BA HCP BS 01JUN2018 T:7”

10 mg/kg/day and higher). No developmental toxicity was observed in rats at an exposure approximately 5 times the MRHD (on an AUC basis at a maternal oral dose of 2 mg/kg/day). In an embryofetal development study in pregnant rabbits, dosed orally during the period of organogenesis from gestation days 7 to 20, embryolethality, decreased fetal body weights, and skeletal malformations (rib anomalies) were observed in the presence of maternal toxicity at an exposure approximately 84 times the MRHD (on an AUC basis at a maternal oral dose of 30 mg/kg/day). Embryolethality consisted of increased post- implantation loss that was due to elevated incidences of both early and late resorptions. No developmental toxicity was observed in rabbits at an exposure approximately 12 times the MRHD (on an AUC basis at a maternal oral dose of 10 mg/kg/day). In a pre- and post-natal development study in pregnant female rats dosed orally from gestation day 6 through lactation day 20, adverse findings observed in pups included decreased survival from birth to post-natal day 4 (due to increased stillbirths and early neonatal deaths), decreased birth weight, decreased body weight gain during the pre-weaning phase, increased incidence of malrotated forelimbs during the pre-weaning phase, and decreased cytotoxic T cells on PND 35 with recovery by PND 65 at exposures approximately 43 times the MRHD (on an AUC basis at a maternal oral dose of 25 mg/kg/day). Developmental delays (that may be secondary to decreased body weight gain) were observed in males and females at exposures approximately 43 times the MRHD (on an AUC basis at a maternal oral dose of 25 mg/kg/day). These findings included decreased forelimb and hindlimb grip strengths, and delayed mean age of sexual maturity. No developmental toxicity was observed in rats at an exposure approximately 9 times the MRHD (on an AUC basis at a maternal oral dose of 5 mg/kg/day). Lactation Risk Summary—No information is available on the presence of Olumiant in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Baricitinib is present in the milk of lactating rats. Due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear. Because of the potential for serious adverse reactions in nursing infants, advise an Olumiant-treated woman not to breastfeed. Data—A single oral dose of 25 mg/kg radiolabeled baricitinib was administered to lactating female Sprague-Dawley rats on post-partum day 13. Drug exposure was approximately

45-fold greater in milk than in plasma based on AUC0-t values. Pediatric Use—The safety and effectiveness of Olumiant in pediatric patients have not been established. Geriatric Use—Of the 3100 patients treated in the four phase 3 studies, a total of 537 rheumatoid arthritis patients were 65 years of age and older, including 71 patients 75 years and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. T:10” Olumiant is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Hepatic Impairment—No dose adjustment is necessary in patients with mild or moderate hepatic impairment. The use of Olumiant has not been studied in patients with severe hepatic impairment and is therefore not recommended. Renal Impairment—Renal function was found to significantly affect baricitinib exposure. Olumiant is not recommended for use in patients with estimated GFR of less than 60 mL/min/1.73 m2. OVERDOSAGE Single doses up to 40 mg and multiple doses of up to 20 mg daily for 10 days have been administered in clinical trials without dose-limiting toxicity. Pharmacokinetic data of a single dose of 40 mg in healthy volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 24 hours. In case of an overdose, it is recommended that the patient should be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.

Additional information can be found at www.Olumiant.com

OLUMIANT® (baricitinib) BA HCP BS 01JUN2018 Vol. 28, No. 5 24 May 2019

Brilinta’s Low-Copay Gambit 18 e contract between UPMC Health Plan and AstraZeneca will help the brand-name antiplatelet drug compete against the generic versions of Plavix by lowering the copay to $10. By Ed Silverman

COVER STORY : WHAT ’S H IDDEN IN A MERICAN H EALTH C ARE Prices Are High, Confusing, and Opaque 24 30 A growing consensus demands that patients be given a clearer sense, in advance, of health care costs. But there are obstacles, and some people bene t from the current confusion. By Timothy Kelley

Insurers: Interoperability by 2020? No way! 30 CMS wants Medicare Advantage and quali ed health plans on the ACA exchanges to provide enrollees with immediate access to their health information starting in 2020. You can’t always get what you want. By Jan Greene

CAR-T’s Wobbly Wheels: High Price, Lack of Data 35 35 CAR-T therapy could be that proverbial game changer. But at about $1 million per treatment, the costs are astonomical. ere’s also a lack of long-term results. Still.... By Susan Ladika

Insurgent Care 38 For low-acuity conditions, urgent care centers are coming on strong as an alternative to hospital emergency departments. People like the convenience. But maybe they are too enticing? By Joseph Burns

DEPARTMENTS 38 Managing Editor’s Memo ...... 9 Viewpoints It’s better to light a candle. Tailoring Medicare for all ...... 44 By Deborah D. Gordon News & Commentary ...... 10 47 Digital Edition PBMs: Criticized but still needed ...... New guidelines for mammograms. By Dea Belazi www.managedcaremag.com/ digital Legislation & Regulation ...... 16 Web SNFs need real-time data ...... 49 www.managedcaremag.com Stark Law is due for an update. By Thomas Martin

COVER: GETTY IMAGES EDITORIAL ADVISORY BOARD

anaged Care publishes origi- MICHAEL T. HALPERN, MD, PhD BURTON I. ORLAND, BS, RPh nal papers and feature articles Associate Professor of Public Health President Mdealing with diverse elements of College of Public Health BioCare Consultants the health care system. Among these are University of Arizona Westport, Conn. impartial peer-reviewed research and Tucson, Ariz. STEVEN R. PESKIN, MD, MBA, FACP review articles examining clinical and JAN HIRSCH, PhD financial aspects of managed care. Associate Clinical Professor of Medicine Associate Professor of Clinical University of Medicine and ALAN G. ADLER, MD Pharmacy, Scaggs School of Pharmacy Dentistry of New Jersey– Health Care Consultant and Pharmaceutical Sciences Robert Wood Johnson Medical School Bryn Mawr, Pa. University of California–San Diego New Brunswick, N.J. San Diego, Calif. PARTHA S. ANBIL Principal GEORGE J. ISHAM, MD EMAD RIZK, MD The ConfluenceElite Group LLC Senior Adviser President & CEO West Chester, Pa. HealthPartners Cotiviti Atlanta, Ga. JAN BERGER, MD, MJ Minneapolis, Minn. President LUCY JOHNS, MPH JOHN ROGLIERI, MD, MBA Health Intelligence Partners Independent Consultant Medical Director Chicago, Ill. Health Care Planning and Policy New York Life Insurance Co. THOMAS BODENHEIMER, MD San Francisco, Calif. New York, N.Y. Family and Community Medicine ROBERT C. JOHNSON, MS University of California–San Francisco President, R.C. Johnson & Associates TIM SAWYERS, BPharm, MBA, PAHM San Francisco, Calif. Former President, American Pharmacy Consultant MedImpact Healthcare Systems PETER BOLAND, PhD Pharmaceutical Association Nashville, Tenn. President, Boland Healthcare Scottsdale, Ariz. Berkeley, Calif. THOMAS KAYE, RPh, MBA JAMES M. SCHIBANOFF, MD LARRY S. BORESS, MPA Pharmacy Consultant Editor-in-Chief, Milliman Care Guidelines President & CEO Louisville, Ky. Milliman USA Midwest Business Group on Health RANDALL KRAKAUER, MD, FACP, San Diego, Calif. Chicago, Ill. FACR STEPHEN W. SCHONDELMEYER, H. ERIC CANNON, PharmD Vice President, National Medical Director, PharmD, PhD Chief of Pharmacy Medical Strategy Professor & Director, PRIME Institute SelectHealth/Intermountain Healthcare Aetna University of Minnesota College Salt Lake City, Utah Princeton, N.J. of Pharmacy GEORGANNE CHAPIN, MPhil, JD PETER KONGSTVEDT, MD, FACP Minneapolis, Minn. President & CEO President Hudson Health Plan P.R. Kongstvedt Co. JAAN SIDOROV, MD, MHSA Tarrytown, N.Y. McLean, Va. Chief Medical Officer VIVIAN H. COATES, MBA THOMAS H. LEE, MD, SM medSolis Vice President Chief Medical Officer Frisco, Texas Information Services and Health Press Ganey Associates THOMAS D. SNOOK, FSA, MAAA Technology Assessment Wakefield, Mass. Principal & Consulting Actuary ECRI Institute ATEEV MEHROTRA, MD, MPH Milliman Inc. Plymouth Meeting, Pa. Associate Professor of Medicine and Phoenix, Ariz. HELEN DARLING Health Care Policy Strategic Adviser Department of Health Care Policy RICHARD G. STEFANACCI, DO, Former President and CEO Harvard Medical School MGH, MBA, AGSF, CMD National Business Group on Health Boston, Mass. Faculty, Thomas Jefferson Washington, D.C. University College of Population Health MICHAEL L. MILLENSON Chief Medical Officer, EVERSANA GARY SCOTT DAVIS, JD President Managed Markets Medical Director Partner, Health Law Department Health Quality Advisors LLC Population Health, AtlantiCare/Geisinger McDermott, Will & Emery LLP Highland Park, Ill. Miami, Fla. Philadelphia, Pa. THOMAS MORROW, MD D.S. (PETE) FULLERTON, PhD, RPh Chief Medical Officer F. RANDY VOGENBERG, PhD, RPh Strategic Pharmacy Innovations Next IT Principal Seattle, Wash. Spokane, Wash. Institute for Integrated Healthcare ARCHELLE GEORGIOU, MD SAM NUSSBAUM, MD Board Chair, Founder Executive Vice President Employer-Provider Georgiou Consulting and Chief Medical Officer Interface Council of HQF Minneapolis, Minn. Anthem Greenville, S.C. JEFF GOLDSMITH, PhD Indianapolis, Ind. JONATHAN P. WEINER, DrPH President, Health Futures Inc. MATT NYE, PharmD Professor and Director of the Charlottesville, Va. Vice President Center for Population Health ALICE G. GOSFIELD, Esq. Pharmacy Care Support Services Johns Hopkins University Principal, Gosfield & Associates Kaiser Permanente Bloomberg School of Public Health Philadelphia, Pa. Downey, Calif. Baltimore, Md.

8 MANAGED CARE / MAY 2019 MANAGING EDITOR’S MEMO

It’s Better To Light a Candle… By Frank Diamond

e focus this month on health care’s hidden costs … and also on Editor oncology. There’s a connection because there’s always something Peter Wehrwein new, and usually costly, in oncology. On April 4, the FDA said that [email protected] W Pfizer’s Ibrance (palbociclib) can be used to treat breast cancer in men. Each Managing Editor year in the United States, about 237,000 cases of breast cancer are diagnosed, Frank Diamond [email protected] of which 2,100 are in men. About 450 men die from it annually; the disease Senior Contributing Editors claims about 41,000 women each year. Michael D. Dalzell Breast cancer in men, like many niche diseases, shouldn’t be shortchanged Timothy Kelley in treatment just because it affects a relatively small population. In the best of Contributing Editors all worlds, that is. In the real world, it often comes down to dollars and cents Joseph Burns (Ibrance costs about $13,000 a month). However—and as our cover story on Jan Greene page 24 by Senior Contributing Editor Timothy Kelley shows—if, in this real Richard Mark Kirkner world, somebody knows what anything costs in health care, she or he’s not Thomas Reinke saying. Design Director Philip Denlinger Notice how much “real world” comes up. The Ibrance story springs from Designer the 21st Century Cures Act, which allows real-world evidence to be a factor in Kevin Riley drug approvals. Chris Boshoff, MD, who heads global product development for Pfizer, tips his hat to the act in saying that “the FDA has allowed us to take Divisional Principal a significant step forward in the use of real-world data to bring medicines to Sean P. Wagner, MPH patients who are most in need.” [email protected] Managed Care’s been on this, and back in May 2017 we noted that real- VP, Group Publisher world evidence faces real-world challenges: “The randomized clinical trial has Maureen Dwyer Liberti (267) 685-3603 been the gold standard in oncology research for decades and will remain so [email protected] for the foreseeable future.” Director of Production Well, the foreseeable future appears more seeable. When presented with Services real-world evidence about drugs for an underserved population, insurers will Dawn Flook have questions. (267) 685-3422 Like, for instance: “How much?” [email protected] Circulation Manager Jacquelyn Ott CONTACT E-MAIL ADDRESSES: (267) 685-3712 Editorial: [email protected] [email protected] Circulation: [email protected] Advertising: [email protected] Advertising Reprints: [email protected] Greg Pessagno (443) 512-8899 ext. 109 [email protected] Clinical judgment must guide each clinician in weighing the benefits of treatment against the risk of toxicity. Dosages, indications, and meth- ods of use for products referred to in this publication may reflect the professional literature or other clinical sources, or may reflect the clinical Amy Birnbach experience of the authors, and might not be the same as what is on the approved package insert. Please consult the complete prescribing (917) 837-4796 information for any products mentioned in this publication. MMMM Group LLC assumes no liability for the information published herein. [email protected] Managed Care (ISSN 1062-3388) is published monthly by MMMM Group LLC, an ICON Plc company, at 19 West College Avenue, Suite 100, Yardley, PA 19067. This is Volume 28, Issue 5. Send letters to the editor to Frank Diamond by email, [email protected], or by mail to Managed Care, 19 West College Avenue, Suite 100, Yardley, PA 19067. Managed Care is indexed in PubMed and in Scopus. The full contents of each issue are available free at Copyright 2019 by MMMM Group LLC. All rights reserved under the United States, International, and Pan-American copyright conventions. No www.ManagedCareMag.com. Major articles are part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, mechanical, photocopy- reviewed by appropriate members of the editorial ing, electronic, or otherwise, without the prior written permission of MMMM Group LLC. The copyright law of the United States governs the advisory board and/or other qualified experts. making of photocopies or other reproductions of copyrighted material. Opinions are those of the authors and not necessarily those of the institutions that employ the Subscriptions for individuals or institutions in the U.S.A. are $100 per year, $10 per single copy; elsewhere, $120 per year, $22 per single copy. authors, nor of the publisher, editor, or editorial Inquiries about paid subscriptions: Dawn Flook, telephone (267) 685-3422; email: [email protected]. anaged are advisory board of M C . Postmaster: Send address changes to Managed Care, P.O. Box 16658, North Hollywood, CA 91615-9967. Periodicals postage paid at North Hollywood, Calif., and at additional mailing offices.

MAY 2019 / MANAGED CARE 9 NEWS & COMMENTARY

Many Women Don’t Need Annual Mammograms; Screens Every Other Year Will Suffice

or women who are at average risk of breast cancer and who cians should offer screening for breast Fdon’t show symptoms, getting a mammogram every year after cancer with biennial mammography. Guidance Statement 3: In average- age 50 does not improve outcomes and might increase risks due risk women aged 75 years or older or to overdiagnosis, according to guide- in women with a life expectancy of lines by the American College of Phy- increase in the benefits….” 10 years or less, clinicians should dis- sicians. ACP researchers looked at breast continue screening for breast cancer. The guidelines, published in the cancer screening guidelines from Guidance Statement 4: In aver- April 9 issue of the Annals of Internal around the world published in Eng- age-risk women of all ages, clinicians Medicine, warn against screening too lish between Jan. 1, 2013 and Nov. 15, should not use clinical breast exami- early or too often. Mammograms may 2017. They also checked for updates nation to screen for breast cancer. catch small, slow-growing tumors that on cancer guideline websites on Dec. This far from settles the issue. As are not likely to become fatal. In addi- 10, 2018. Reuters reports, the American Cancer tion, such screening won’t help catch “The target audience is all clini- Society still says women, ages 45 to 54, advanced cancer cases any more than cians, and the target patient popu- should get mammograms every year. screening every other year would, ac- lation is all asymptomatic women At 55, women can choose between cording to the guidelines. with average risk for breast cancer,” yearly or biennial mammograms. The result can be unnecessary inva- the guidelines state. sive follow-up tests and treatments for Here are the updated guidelines; Insurer, AMA Put tumors that would never have become Guidance Statement 1: In average- threatening, let alone lethal. About 33 risk women aged 40 to 49 years, clini- New Spin on SDOH million mammograms are given in the cians should discuss whether to screen In what’s being hailed as the first orga- United States each year. for breast cancer with mammography nized effort to standardize how social Joann Elmore, MD, a professor at before age 50 years. Discussion should determinants of health data are col- the David Geffen School of Medicine include the potential benefits and lected, processed, and used for patient at the University of California–Los harms and a woman’s preferences. The care, nearly two dozen new ICD-10 Angeles, wrote an editorial accompa- potential harms outweigh the benefits codes related to SDOH have been cre- nying the guidelines. She told Reuters in most women aged 40 to 49 years. ated through a collaborative effort by that screening every year increases Guidance Statement 2: In average- UnitedHealthcare and the AMA. the harms “markedly, with less of an risk women aged 50 to 74 years, clini- The codes are designed to direct local and national social services to beneficiaries who could use some help when it comes to transportation, food, housing, and financial needs. They were created by combining traditional medical data with self-reported SDOH data, United and the AMA said in a joint statement. HealthLeaders points out that more states are directing Medicaid managed care plans to address SDOH. The quality of medical care and access to services explains only about 20% of a person’s health status, according to an oft-cited Robert Wood Johnson Foundation report. SDOH explains about half of the rest. Michael Cantor, MD, the CMO of CareCentrix, a consulting company

10 MANAGED CARE / MAY 2019 NEWS & COMMENTARY

date penalty was no longer in effect. 35% ($134.7 billion), and demand for The Trump administration is now uncompensated care would climb by agreeing with O’Connor. The ACA 82% ($50.2 billion). has survived several existential legal The institute also calculated the threats. The Trump administration is state-by-state effects of ACA repeal. hoping that Texas v. Azar finally wields States where the number of people the mortal blow. without insurance decreased the most If the law is repealed, the unin sured under the ACA would, not surpris- rate would increase by 65%, or 19.9 ingly, see the greater increase in their that helps providers and health plans million people, according to the number of uninsured. So, for example, better facilitate home care, told Man- Urban Institute’s estimates. Federal the number of uninsured would in- aged Care via email that the codes health care spending would drop by crease by 151% in Kentucky, compared would allow clinicians to document patients’ social barriers to care and refer them to community organiza- Third wave of opioid epidemic, tions that could meet those needs. featuring fentanyl, strikes U.S. “The codes will also indicate if patients are unable to pay for transpor- buse of prescription pain medications came first. But that could tation for medical appointments or A be an expensive habit and you usually need a physician to sign prescriptions as well as if they have off. So then came heroin, which could be bought cheaply from a inadequate social interaction or fears dealer. Now, it’s fentanyl, according to the latest CDC statistics. And about losing housing,” Cantor said. death rates from the drug have soared, with the number of deaths Medicare Advantage plans could increasing every quarter since the fourth quarter of 2013. use the codes to shift the site of care. Rates varied by region, with the highest number of deaths occurring “For example, if a dialysis patient is in New England. That region was followed by the Mid-Atlantic region being treated in a dialysis center three and Upper Midwest. On the other hand, death rates from fentanyl times a week, and the patient has the barely budged in the West, including Alaska and Hawaii. Kaiser Health code for transportation barriers, the News reports on the theories some experts hold. health plan care management team “One is that it’s easier to mix a few white fentanyl crystals into the could work with the patient’s clini- powdered form of heroin that is more common in Eastern states than cians to schedule dialysis treatments into the black-tar heroin that is sold more routinely in the West,” KHN in the home to improve outcomes and reports. “Another hypothesis holds that drug cartels used New England lower the cost of care,” Cantor said. as a test market for fentanyl because the region has a strong, long- standing market for opioids.” Possible Fallout If ACA Is Repealed Number of drug overdose deaths involving fentanyl There’s bad news and then worse news 6,000 for some states if the ACA is com- pletely eliminated, according to the Urban Institute. The institute updated 5,000 one of its studies on the heels of the

Trump administration’s decision to go 4,000 all out to kill the ACA. That study, first released last June, asks what would happen if the ACA were repealed. The 3,000

answer, in a nutshell: a lot of bad stuff. Number of deaths On March 25, the Department of 2,000 Justice filed a notice to the U.S. Court of Appeals for the Fifth Circuit arguing that the entire ACA should be 1,000 eliminated. In the case being appealed, Texas v. 0 Azar, Federal Judge Reed O’Connor Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2011 2012 2013 2014 2015 2016 of the Northern District of Texas had ruled that the ACA is unconstitutional Source: CDC, National Vital Statistics Report, March 21, 2019 because the individual insurance man-

MAY 2019 / MANAGED CARE 11 NEWS & COMMENTARY

with only a 12% increase in South states (Arizona, Delaware, Hawaii, stated in those states and the ACA Dakota, a state that has not expanded Massachusetts, New York, Vermont, is repealed, then the uninsured rate Medicaid and has had low enrollment and Wisconsin) that had expanded nationally would increase by 70%, or in the ACA marketplace. their Medicaid programs before pas- 21.2 million people. That’s the bad news. Now for the sage of the ACA using Section 1115 Federal health care spending would worse. waivers. drop by 36.2%, or $141.1 billion. Mean- The institute looked at the seven If the 1115 waiver is not rein- while, demand for uncompensated care

Centene, big in Medicaid managed care, wants to get even bigger lthough health insurer merg- that kind of scale is important,” Farha, were indicted and later Aers have been shot down Centene CEO Michael Neidorff convicted for concocting a $40 by regulators in recent years, told the Wall Street Journal. million Medicaid fraud scheme. Centene is hoping its proposed Centene became the country’s “That was a pretty rocky phase. acquisition of WellCare will be largest Medicaid managed care The reputation they have in at small enough to fly under the company two years ago. The ac- least some consumer circles is radar while helping to bolster its quisition of WellCare would give less than top notch,” says Hoad- lead in the Medicaid managed the company a total of 12 million ley. care market and shore up its posi- Medicaid members. Centene is In 2018, WellCare had about tion in the Medicare Advantage also the top insurer in the ACA 3% of the Medicare Advantage sector. exchange market, selling plans in market. That was far behind In late March, St. Louis-based 20 states. United Healthcare, which has Centene announced it was “It does suggest significant about a quarter of the MA mar- acquiring WellCare Health Plans, consolidation in the Medicaid ket, and Humana, which has a based in Tampa, in a deal valued market in particular,” and would 17% share. Centene currently has at $17.3 billion. The combined give states one less insurer to about 400,000 MA customers. companies would have about 22 contract with, says Jack Hoadley, In December, WellCare million members spread across an analyst with Georgetown Uni- purchased Aetna’s standalone all 50 states. versity’s Health Policy Institute. Medicare Part D plans as part of The move “gets your overhead WellCare might not bring the Aetna’s merger with CVS. down, so you can be more ef- best reputation to Centene. In With the merger, Centene is ficient. When you talk to govern- 2011, five of the company’s top taking on more members, which ment, the fact that you have executives, including CEO Todd will generate more premium dollars and spread the company’s Market footprint for Centene–WellCare combination risk, says Christopher J. Kutner, a partner in the law firm Rivkin Radler. Centene has acquired a number of companies in recent years, and with each acquisition they “acquire more data so they are better able to manage wellness and head off the high cost of medical care,” Kutner says. Whether federal antitrust regulators will approve the deal is a real question. They may require divestitures in certain states HI AK where Centene and WellCare’s business overlaps, such as Florida Health plan operations Medicaid and Medicare and Georgia. Medicaid or Medicare Medicaid / Medicare / Marketplace —Susan Ladika

Source: Centene

12 MANAGED CARE / MAY 2019 NEWS & COMMENTARY would climb by 87% ($53.3 billion). from the 2011–2015 National Hospital substance use disorder, psychosis, and In its conclusion, the institute takes Ambulatory Medical Care Survey, as other psychiatric reasons (personal- aim at the DOJ’s argument that with- well as a national survey of ED visits ity disorder or mental health proce- out the individual mandate penalty, across the United States. EDs are 24/7 dure). There were also classifications the rest of the ACA cannot be sus- operations, so it makes sense in a way for suicide attempt and intentional tained. that they’re where parents and guard- self-harm. The institute said its findings show ians take children under psychological “Because the ED is designed as an “that the private nongroup insurance duress. urgent medical facility, this setting markets continue to function effec- The ED visits were classified as be- often lacks the resources required to tively in the first year without the in- ing connected to mood (depression, identify and manage psychiatric popu- dividual mandate in place. Enrollment mania and/or hypomania, or anxiety), lations,” the study stated. “Discharge is down by approximately 3% in 2019, and this may translate into a notice- able increase in the number of people ONE YEAR LATER uninsured absent a mandate in some states; however, the decline appears to De Brantes’s current baby be modest, and some states are experi- he Value-Based Tools department in our May 2018 issue looked at encing enrollment increases.” Thow the medical episode of spending allowance (MESA) concept would turn the high-deductible health plan on its head. As Michael D. Dalzell, a senior contributing editor for Managed Care explained, instead of people paying for their care till their coverage kicks in, a MESA benefit design would provide first-dollar coverage but with a budgeted amount of coverage. The notion is that people—and insurers—would be motivated to shop around for the best MESA available. We caught up with François de Brantes, who Mental Health Sends was then with Altarum Institute, the not-for- More Youths to ED profit consultancy that was developing the MESA Emergency departments (EDs) saw a model. De Brantes is now at Remedy Partners 28% jump in the admittance of young François de Brantes and is still working on alternatives to high- people aged 6 to 24 for psychiatric deductible health care coverage. problems between 2011 and 2015, He is calling his current baby the Reference Price-based Benefits according to a study published in Plan (RPB, as de Brantes abbreviates it). So how would RPBs work dif- Pediatrics. ferently than MESAs? De Brantes explained it in an email. Just why that happened is difficult “MESA relies on underlying up/downside risk arrangements with to nail down, according to Luther Kalb providers to work because episode costs are capped for those provid- at Johns Hopkins and his colleagues. ers since they are liable for all costs above the negotiated price. “Ultimately, it is unclear if the “All costs not included in episodes—and that can vary between 30% findings represent a change in identification (by providers) or report- and 50% of total costs of care, depending on what you can contract ing (by patients or family members) in episodes—are then subject to normal underlying FFS prices. Those of mental health in the ED, a shift prices can easily be upward of 700% of Medicare for some facilities in in the epidemiology of psychiatric some markets unless you’re the dominant carrier. disorders in the United States, or “So,” continues deBrantes, “for a start-up plan trying to get a MESA fluctuations in referral patterns or design underway, you may be hard-pressed to demonstrate enough service-seeking behavior,” Kalb and aggregate savings to compete with the incumbents and doom the his colleagues stated. effort.” But something is going on and the De Brantes says his RBP plan solves this problem because costs findings garnered some headlines and above the MESA allowance would be capped by a percentage of clicks in March. Medicare fees (anywhere from 150% to 175%) that might be based on ED visits rose 54% for teens aged prevailing commercial insurance rates. 12–17. They rose 53% for all African- Interesting. Maybe we’ll check in again next year to see how it’s American youngsters, and 91% for all going. Latino youngsters. —Frank Diamond Kalb and colleagues looked at data

MAY 2019 / MANAGED CARE 13 NEWS & COMMENTARY

CMS needs to up its podcast game urnishing her image and flogging her message tal in shaping American health care, a quality CMS Bhave gotten Seema Verma into hot water lately. podcast would be welcome. That’s not what we have After a scathing Politico story, the HHS Office of In- got in “CMS Beyond the Policy,” which seems to be spector General is investigating CMS contracts with more about pushing Verma’s policies than getting three Republican media consultants (Pam beyond them. Stevens, Marcus Barlow, Nahigian Strate- As we went to press, only two episodes gies) that worked for Verma. had been produced and the first part of the As Politico and others have noted, CMS second one was Verma’s speech at the CMS already has a large, inhouse communica- Quality Conference, followed by interviews tions operation with a staff of about two with attendees discussing some of the dozen federal employees. Should taxpay- issues she raised. ers really be footing the bill (it’s in the There’s some value in finding out what millions of dollars) for additional enhance- CMS is putting out there. Maybe the pod- Seema Verma ment of Verma’s profile and message? casts will improve with time and experi- That context puts the CMS podcast, “CMS Beyond ence. But right now, they are, at the very least, a the Policy” in a different light. Everyone and their missed opportunity and another offkey example brother-in-law seems to have a podcast these days. of Verma tooting her own horn. Because CMS and its regulations are so instrumen- —Peter Wehrwein

Two studies of MA network size paint two very different pictures edicare beneficiaries are that over 80% of MA plans had primary care physicians, although Mflocking to Medicare Advan- broad networks and less than 2%, when the Kaiser researchers broke tage for many reasons, some of narrow ones. out the figures for primary care phy- which may have to do with the What accounts for the differ- sicians, their results were much the plans being overpaid. Regardless, ence? In a word, methodology. The same as those for all physicians. one of the presumed drawbacks of Kaiser researchers depended on Feyman was diplomatic when casting your Medicare lot with an provider directories and a data- we spoke with him: “I think our MA plan is that you will have fewer base of physicians to ascertain approach sheds light on narrow physicians to choose from (and network size. But provider direc- networks in a different way.” By therefore lack access to desirable tories are notoriously inaccurate, depending on provider directories, ones). A 2017 Kaiser Family Foun- so Feyman and his colleagues the Kaiser researchers were taking dation report confirmed that pre- ingeniously inferred plan networks an approach that is based on what sumption. The Kaiser researchers by looking at prescribing patterns. MA plan members experience found that roughly a third (35%) of If an MA plan member had gotten when they look for a physician, he Medicare beneficiaries were in MA at least one prescription from noted. His group’s approach may plans with narrow networks, which a physician, that physician was be useful for regulators and policy- for this and other studies is defined considered to be part of that plan’s makers because they can “get to as a plan that includes less than network. Their thinking was that what is actually under the hood.” 30% of the physicians in a county. plan members wouldn’t be getting Feyman also cautioned against A study published in the April prescriptions from out-of-network characterizing narrow networks as 2019 issue of Health Affairs painted doctors so a doctor having written a bad deal for MA members (“we a drastically different picture of a prescription for an MA plan can’t make normative statements”). MA plan networks—one that member is a reliable indicator for Some of his future research will upends the prevailing wisdom. being in a plan’s network. look at whether narrow networks Yevgeniy Feyman, a Boston Uni- Another big difference is that the are offset by, say, lower premiums versity School of Public Health PhD Kaiser study included all physicians and copays. student, and his colleagues found while Feyman et al. included just —Peter Wehrwein

14 MANAGED CARE / MAY 2019 NEWS & COMMENTARY planning is also a challenge because the wait for outpatient psychiatry is long and inpatient psychiatric beds are a dwindling resource.” Fifty-one percent of ED pediatric psychiatric visits lasted three hours or more. These are factors contributing to the long wait times for youngsters admit- ted with psychiatric problems. In an email exchange with Reuters, Kalb said that “using the ED as psychiatric crisis center needs to change. We need to find new ways to get to people in times of need where they are at, rather than rely on the ED.” The study pointed out that different approaches to psychiatric crisis intervention should be attempted, such as telemedicine, mobile crisis centers, and peer crisis services. Also, there should be centers with evening hours that focus on mental health problems. “I try to first do no harm, but there’s no money in it.” Briefly Noted Only in relatively rare circum- study at six anticoagulation clinics in a public health plan to be offered to stances should people on warfarin in Michigan…. No wonder hospi- individuals and small business health also be taking aspirin, but it happens, tals don’t like Medicare for all, even exchanges. Allowing consumers to partly because many people get into the milder version that would allow choose an existing private insurance the habit of taking aspirin as a pre- Americans to buy into the program. or a government-run Medicare-X ventive measure against heart attacks The Federation of American Hospitals Choice plan could result in more and stick with it after warfarin has and the American Hospital Associa- than 20 million people exiting com- been prescribed. Results reported in tion examines eight Congressional mercial plans. The exodus would cost JAMA Internal Medicine showed why proposals put forward in 2017 that hospitals over $800 billion over the the pairing should largely be avoided. would substantially broaden Medi- next decade because Medicare pays The study showed increased rates of care. Seven of them would have made hospitals about 11% below costs, ac- bleeding and emergency department Medicare available to many more cording to the analysis. and hospital admissions for bleed- people than are currently eligible, ing among those taking both drugs. what the analysis calls Medicare-X —Frank Diamond The study was based on data from Choice. Medicare-X Choice would a 6,359-person retrospective cohort use Medicare’s network of providers CORRECTION In the April 2019 issue, our article Managed Care contributor Lola Butcher about digital health products and finalist for NIHCM Foundation journalism award artificial intelligence (“Digitized Health Opens the RWE Floodgates; ola Butcher, a regular contributor to Managed Care, is a finalist for Can Artificial Intelligence Harness Lone of the most prestigious awards in health care journalism. the Power?” page 18) mischarac- Butcher’s cover story for our September 2018 issue, “Health Care tized the approval process for two Quality: Motherhood and Apple Pie Until You Start To Measure It,” is products, Reset-O and IDx-DR. in the running for the top prize in the trade publication division of They were approved under the the National Institute for Health Care Management’s print journalism FDA’s existing “de novo” pathway. awards. Other finalists include writers for Modern Healthcare, Nature, The Digital Health Precertification the Cancer Letter, MIT Technology Review, and the New England Journal (Pre-Cert) is a pilot program, and of Medicine. The winner will be announced at a dinner on May 13 in products have yet to be approved Washington, D.C. under the Pre-Cert program. Our apologies for the mistake.

MAY 2019 / MANAGED CARE 15 LEGISLATION & REGULATION

At 30, Stark Law Chugs Along But It’s Overdue for Repairs It is supposed to keep physicians from unduly profiting from referrals. But CMS Administrator Seema Verma and others see the Stark Law as an obstacle to ACOs and value-based care. By Richard Mark Kirkner, Contributing Editor

n 1989, when Congress passed the Ethics in statutes, so doctors can be found guilty of vio- Patient Referrals Act to prohibit health care lating the Stark law even if they don’t mean to. Iproviders from referring to facilities they had Violation of the antikickback statute requires a financial interest in, fee-for-service health was criminal intent. pretty much the only health care game in town. The ACA? Not even a glimmer in Congress’s eye. Why now? Today, with value-based payment models When CMS sought comments last year on gobbling up a greater share of the market, thanks proposed changes in payment rules, Stark was in part to the ACA, the law known as “Stark” is one of the top subjects that came up, Deputy Fair market still chugging along like a 30-year-old clunker, CMS Administrator Kimberly Brandt noted value is difficult according to advocates of coordinated care. at a Brookings panel in January 2019. “There to define, says CMS is now at work on revising Stark-related were a lot of people who felt that the amount of Kevin Mc regulations so providers don’t run afoul of Stark burden and the amount of uncertainty and lack Ananey, one when crafting shared-risk models. of clarity … with respect to the Stark Law, was a of the nation’s The Stark Law, named for former Rep. Fort- real impediment to them being able to provide leading authori ties on the Stark ney “Pete” Stark of California not Ned, is one value-based care or value in care, generally,” law. of two laws that prohibit health care providers Brandt told the Brookings audience. That’s why from referring patients to any entity—a hospital, last June, CMS put out a request for information surgery center, imaging center, laboratory, and (RFI) specific to Stark and received 375 com- so on—in which they have a “financial relation- ments totaling about 3,500 pages, Brandt said ship,” according to CMS; that is ownership, at the Brookings panel. investment, or compensation. Stark is a civil In a blog post last June, CMS Administrator statute that CMS regulates. The second law is Seema Verma wrote that the current physician an antikickback statute under the jurisdiction self-referral law “may prohibit some relation- of the Department of Justice and a criminal ships that are designed to enhance care coordin- law. Their common purpose is to eliminate the ation, improve quality, and reduce waste.” But temptation for physicians to profit from patient not everyone thinks that Stark and antikickback referrals. The antikickback statute falls under statutes should be brushed aside. In one of those Section 1320 of the U.S. Code and stipulates letters that were part of the voluminous response penalties for anyone who knowingly offers, pays, to CMS’s RFI, the American Hospital Associa- solicits, or receives anything of value for referrals tion, while urging greater flexibility in applying of patients within federal programs. Stark to ACOs, urged no changes in the law’s “Stark is actually more important because provisions prohibiting providers from having Stark is a strict liability statute,” says Kevin an ownership interest in entities they refer to. McAnaney, a New York City attorney who “That ban is a carefully developed policy that is specializes in health care regulation and who working as Congress intended,” the letter noted. participated in the second phase of Stark rule- Of course, preserving that prohibition gives making from 1997 to 2003 in the Office of In- hospital systems a leg up in competing against spector General at HHS. No proof of intent or physician-owned surgery centers and the like. negligence is necessary under strict liability McAnaney, considered one of the country’s

16 MANAGED CARE / MAY 2019 LEGISLATION & REGULATION leading authorities on Stark, has seen the perils terms have gotten skewed over the years in of Stark violations up close. He was consulted on court cases.” Many comments on Stark call for what’s considered a landmark case in the Stark getting back to the original statutory intent, he canon: the $72.4 million settlement Tuo mey says. “Let’s create a bright-line rule with regard Healthcare System of South Carolina reached to each three of these definitions. Everyone with the federal government in 2015 because wants to comply, but organizations spend so Tuomey’s part-time physician employment con- much money trying to figure this out from a tracts violated the law. McAnaney says that he compliance-cost standpoint, and the conse- “voiced great concerns” during talks between quences for not getting this right are enormous.” Tuomey and the doctors that the contracts Fair market value is one of those elements would violate Stark. However, Tuomey fol- that’s difficult to define, McAnaney says. “If I lowed the advice of its own lawyer and entered pay a doctor $1 for generating $4 in savings, Don’t be sur- into contracts with 19 specialists. Under those that’s a good deal, and that’s how the IRS views prised if CMS or contracts, Tuomey agreed to pay the physicians’ it. It’s just that in Stark world and in the kickback HHS proposes liability insurance premiums and employment world, they have very much of a regulatory gloss a rule this year taxes, and let physicians participate in the hospi- on what constitutes fair market value.” that attempts to update the Stark tal system’s health plan. In return, the physicians Possible fixes Law, says health had to send their outpatient surgery cases to care attorney the hospital or another Tuomey-owned facil- Going forward, McAnaney would like to see Troy Barsky. ity. One orthopedic surgeon, Michael Drake- CMS take a broad-based approach to easing self- ford, MD, refused to sign and filed a lawsuit referral strictures on value-based, coordinated- in 2005 under the whistleblower provision of care models beyond ACOs. “Rather than trying the Federal False Claims Act, which is the legal to make the regulation so prescriptive up front, mechanism for enforcing Stark. It’s difficult to they should make it broader up front and trust determine Drakeford’s share of the settlement, other laws they can use—the kickback statute, but the Constantine Cannon law firm says that for example,” he says. “But I think they should whistleblowers tend to get a 15% to 30% cut of err to make it broader at the beginning until any settlement. they see if there are problems.” Barsky says coming up with clearer defi- Stark navigation nitions of the three principles he previously ACOs rely on agreements between providers mentioned—fair market value, a metric for to share risk. To make that happen, the ACA evaluating referrals, and the meaning of “com- authorized CMS to create a mechanism that mercially reasonable”—are key elements of any grants Stark waivers to ACOs; they don’t have to fix. At the same time, CMS has to be mindful apply individually for the waivers. Troy Barsky, that most providers are also living in the fee- a health care attorney who oversaw Stark issues for-service world in which the Stark protections during the last four years of his 2002–2013 stint should apply. He calls it the “carrot-and-stick” in the HHS general counsel’s office, explains approach. “A reward or encouragement to move that transparency has been a key element of to value-based payment arrangements would be those waivers. ACOs have to publicize that they that Stark doesn’t apply anymore,” Barsky says. have a Stark waiver, a process for documenting Barsky notes that Congress has been look- their Stark-exempted transactions, and their ing at Stark for a few years. “I’m not sure if this boards have to articulate the ACO’s purpose would be the year, in light of the focus on drug (such as care coordination, improving care, pricing and the general political climate, that lowering costs). legislation would get through both houses of Barsky says navigating Stark and staying on Congress, but I still think it’s an issue that Con- the right side of the law depends on understand- gress is going to continue to evaluate,” he says. ing three key elements: The fair market value “I think it’s more likely there would be activity of collaborative care arrangements; not using from CMS and HHS in the form of a proposed volume or value of referrals between parties as rule this year.” a metric; and that the arrangements be “com- With 3,500 pages of comments to sift through, mercially reasonable.” Says Barsky: “Those three CMS has plenty of work to do.

MAY 2019 / MANAGED CARE 17 Lower Copays Sweeten Outcomes-based Deal for Brilinta The contract between UPMC Health Plan and AstraZeneca will help the brand-name antiplatelet drug compete against generic versions of Plavix by lowering the copay to $10.

generic drug and wring some extra revenue out of By Ed Silverman Brilinta before a key patent on the drug expires in 2024. UPMC officials say the lower copay was a secondary s the Trump administration attempts to lower issue for them—at least initially. drug prices for Americans, a health insurer “The motivation wasn’t actually the total cost of care, A and a drugmaker are making their own but improving cardiovascular outcomes,” says Bernie attempt to solve the problem by adjusting the dis- Good, MD, senior medical director for the Center for counts that a Medicare Part D plan will receive for Value-Based Pharmacy Initiatives, which is part of the a medication based on how patients respond. UPMC Center for High-Value Health Care. Outcomes-based deals are hardly new. But this one “However,” says Good, “the copay issue tends to for Brilinta (ticagrelor) has a unusual twist—patient be greatest in the Medicare population because they out-of-pocket costs automatically drop. don’t have access to drug coupons. And we heard Brilinta is an antiplatelet drug sold by AstraZeneca. from cardiologists that Medicare patients who they Other brand-name antiplatelet medications include thought would benefit from Brilinta got stuck on the Plavix (clopidogrel) and Effient (prasugrel), and aspirin copay issue. So that was the other thing we focused is the standby agent. Patients who have had a heart on.” Some recent research has cast some doubts about attack take antiplatelet drugs to reduce the chances the relationship of copays, adherence, and outcomes of a repeat occurrence, but adherence is a problem. (see “Modest, at Best: The Effect of Getting Rid of The outcomes-based contract for Brilinta is between Copays for Antiplatelet Drugs,” next page). UPMC Health Plan, the 3.5-million member health UPMC worked with its clinicians and academics insurance arm of the giant UPMC health care system to determine which outcomes to measure and what in Pittsburgh, and AstraZeneca. Under the contract, adjustments to the formulary should be made. The which was announced in January and went into effect health plan also surveyed patients to ensure that the a few weeks ago, UPMC gets a discount if a patient on agreement reflects their priorities. About 800 UPMC Brilinta has a heart attack or stroke during the first Health Plan members currently take Brilinta. year after starting the drug. The novel sweetener in But is this contract a good deal for Medicare? the deal is that UPMC will lower the monthly copay The program currently pays about $375 a month for for Brilinta from $45 to $10, which means the patient Brilinta and just $3 for generic Plavix, although prices cost for the brand-name drug will be about the same can vary depending upon health plan and pharmacy, as it is for generic Plavix. according to the Medicare Drug Finder. That is a This contract marks the first time that a health plan huge price difference, which translates into a much and a drugmaker have negotiated copays as part of higher cost for Medicare. The UPMC–AstraZeneca an outcomes-based contract. While this is just one contract might offset at least some of that higher contract that has yet to be duplicated, deals like this cost if Medicare were to get a share of the rebate that one hold promise for accomplishing a key Trump AstraZeneca pays UPMC. And if Brilinta does reduce administration goal—reducing what patients pay at the number of heart attacks, the program might realize the pharmacy counter. some savings from avoided hospitalizations and other AstraZeneca was quick to focus attention on the medical services. copay and shift the conversation away from list price— which is a contentious issue in the larger debate over A one-off deal? pricing—to demonstrate there are ways to lower the Say this contract works to the benefit of everyone cost to the overall health care system. “This is a novel involved—including the patients. There’s still some agreement,” crowed Rick Suarez, senior vice president question whether it can be replicated. of market access at AstraZeneca. The deal also gives As an integrated system that is both a payer and a AstraZeneca a chance to compete with a less-expensive provider, UPMC can create data systems and analytics

18 MANAGED CARE / MAY 2019 to track patients over time. UPMC also serves a distinct on Managed Care’s editorial advisory board. geographic area. “It’s a good idea, but I’m not sure it’s going to take UPMC’s Good says other drugmakers have yet to off,” he continued. “The goal is a good one, because contact him about contracts that would resemble the it aligns the interests of different stakeholders. What one that UPMC has with AstraZeneca. makes it difficult to replicate is you need all the pieces “You have to know everything about the patients— to align those interests properly. It may work in the all the primary medical data and clinical info—that Part D population, but in the commercial sector the you can use to make informed assessments about insurance rules are different when you talk about risk. getting a good outcome or not,” explains Randy So I see this as a research exercise.” Vogenberg, a principal at the Institute for Integrated Healthcare, a consulting and research firm that spe- Ed Silverman founded the Pharmalot blog and has cializes in health plan benefit designs. Vogenberg is covered the pharmaceutical industry for 20 years.

Modest, at best: The effect of getting rid of copays for antiplatelet drugs

study designed to test whether Brilinta (ticagrelor). The vouchers copays affect adherence. According A eliminating copays would covered the entire cost of the drugs to an editorial that accompanied the improve adherence to antiplatelet for people covered by Medicare or study, copays for clopidogrel range therapy showed that, yes, indeed, it Medicaid (because those programs from $47 to $203 per month; for does. don’t allow copay assistance) or Brilinta, they range from $53 to $387. But that takeaway came with a charged the copay to the study. At that level, you might expect the “so what” chaser. The study results Either way, for the patient, the elimination of copays to have more also showed no reduction in major voucher eliminated the copay and of an effect. The researchers noted cardiovascular events among those any out-of-pocket expense for the that some patients in the control who stuck with the medication. antiplatelet medication for a year. group might have taken advantage There are some plausible expla- Patients in the “usual care” group of voucher programs outside of the nations for the disconnect between didn’t get a voucher, so they paid study, thereby diluting the difference adherence and outcome. Still, the copays as usual. Doctors were free between the two groups. Another results sprinkle some fresh ques- to prescribe a third antiplatelet drug, wrinkle: A surprising proportion tion marks into the narrative that Effient (prasugrel), but the study (28%) of the people in the interven- getting rid of copays and improv- didn’t include vouchers for Effient. tion group didn’t use the vouchers. ing adherence will lead to better The researchers, led by Tracy Y. Reasons for not doing so included outcomes. Wang, MD, of Duke Clinical Research losing the physical voucher card and Results from the AstraZeneca- Institute, measured adherence in a the pharmacy not accepting the funded study were reported in the number of ways but the main one voucher. Jan. 1/8, 2019, edition of JAMA. Led was continued use (i.e., no gap of It is conjecture but there are ex- by researchers at Duke, ARTEMIS 30 days or longer) of antiplatelet planations for adherence not adding (Affordability and Real-World medication at 3, 6, 9, and 12 months. up to better outcomes. Antiplatelet Antiplatelet Treatment Effectiveness The results show that “medication drugs are just one of the drugs that After Myocardial Infarction Study) persistence”—as the researchers people take after a heart attack. was a massive undertaking that en- call it—for patients in the interven- Nudging adherence up a notch for rolled 11,000 heart attack patients at tion group was 87% vs. 83.8% in the one drug may not have much of an 301 American hospitals. The random- control group. That’s not a huge dif- effect. ization was done by hospital, rather ference, but it passed the muster of The editorial by Cynthia Jackson of than by patient, partly because the statistical significance. the Western University of the Health researchers figured that patient When researchers looked at Sciences in Pomona, Calif., and randomization would lead to high another primary endpoint, major Dennis Ko, MD, of the University of withdrawal rates. adverse cardiovascular events, they Toronto, says the voucher program Before they were discharged, found a difference (10.2% in the costs up to $1,600 per patient per patients at the 135 hospitals ran- intervention group vs. 10.6% in the year. It’s fair to ask whether that is domized to the intervention group usual care group), but it was deemed money well spent if outcomes didn’t were given vouchers for generic a tie once various statistical adjust- improve and adherence, by only a clopidogrel (Plavix) or Astra Zeneca’s ments were made. smidgen. brand-name antiplatelet drug, Other studies have shown that —Peter Wehrwein

MAY 2019 / MANAGED CARE 19 INDICATION Hypersensitivity Pneumonitis has been reported with ® the use of ARIKAYCE in the clinical trials. Hypersensitivity LIMITED POPULATION: ARIKAYCE is indicated in adults, who pneumonitis (reported as allergic alveolitis, pneumonitis, have limited or no alternative treatment options, for the interstitial lung disease, allergic reaction to ARIKAYCE) treatment of Mycobacterium avium complex (MAC) lung was reported at a higher frequency in patients treated disease as part of a combination antibacterial drug regimen with ARIKAYCE plus background regimen (3.1%) compared in patients who do not achieve negative sputum cultures to patients treated with a background regimen alone after a minimum of 6 consecutive months of a multidrug (0%). Most patients with hypersensitivity pneumonitis background regimen therapy. As only limited clinical safety discontinued treatment with ARIKAYCE and received and effectiveness data for ARIKAYCE are currently available, treatment with corticosteroids. If hypersensitivity reserve ARIKAYCE for use in adults who have limited or no pneumonitis occurs, discontinue ARIKAYCE and manage alternative treatment options. This drug is indicated for use patients as medically appropriate. in a limited and specific population of patients. Hemoptysis has been reported with the use of ARIKAYCE This indication is approved under accelerated approval in the clinical trials. Hemoptysis was reported at a based on achieving sputum culture conversion (defined higher frequency in patients treated with ARIKAYCE plus as 3 consecutive negative monthly sputum cultures) by background regimen (17.9%) compared to patients treated Month 6. Clinical benefit has not yet been established. with a background regimen alone (12.5%). If hemoptysis Continued approval for this indication may be contingent occurs, manage patients as medically appropriate. upon verification and description of clinical benefit in confirmatory trials. Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as Limitation of Use: ARIKAYCE has only been studied in asthma, bronchial hyperreactivity, bronchospasm, dyspnea, patients with refractory MAC lung disease defined as dyspnea exertional, prolonged expiration, throat tightness, patients who did not achieve negative sputum cultures wheezing) was reported at a higher frequency in patients after a minimum of 6 consecutive months of a multidrug treated with ARIKAYCE plus background regimen (28.7%) background regimen therapy. The use of ARIKAYCE is not compared to patients treated with a background regimen recommended for patients with non-refractory MAC alone (10.7%). If bronchospasm occurs during the use of lung disease. ARIKAYCE, treat patients as medically appropriate. IMPORTANT SAFETY INFORMATION Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical WARNING: RISK OF INCREASED RESPIRATORY trials. Exacerbations of underlying pulmonary disease ADVERSE REACTIONS (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of ARIKAYCE has been associated with an increased bronchiectasis) have been reported at a higher frequency risk of respiratory adverse reactions, including in patients treated with ARIKAYCE plus background regimen hypersensitivity pneumonitis, hemoptysis, (14.8%) compared to patients treated with background bronchospasm, and exacerbation of underlying regimen alone (9.8%). If exacerbations of underlying pulmonary disease that have led to hospitalizations pulmonary disease occur during the use of ARIKAYCE, treat in some cases. patients as medically appropriate.

Please see additional Important Safety Information and the Brief Summary on the following pages. Limited Population: the first and only FDA-approved treatment for refractory MAC lung disease in adults as part of a combination antibacterial drug regimen1

Ototoxicity has been reported with the use of ARIKAYCE in Contraindications: ARIKAYCE is contraindicated in patients the clinical trials. Ototoxicity (including deafness, dizziness, with known hypersensitivity to any aminoglycoside. presyncope, tinnitus, and vertigo) were reported with a Most Common Adverse Reactions: The most common higher frequency in patients treated with ARIKAYCE plus adverse reactions in Trial 1 at an incidence ≥5% for patients background regimen (17%) compared to patients treated using ARIKAYCE plus background regimen compared to with background regimen alone (9.8%). This was primarily patients treated with background regimen alone were driven by tinnitus (7.6% in ARIKAYCE plus background dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm regimen vs 0.9% in the background regimen alone arm) and (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), dizziness (6.3% in ARIKAYCE plus background regimen vs upper airway irritation (17% vs 2%), musculoskeletal pain (17% 2.7% in the background regimen alone arm). Closely monitor vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of patients with known or suspected auditory or vestibular underlying pulmonary disease (15% vs 10%), diarrhea (13% vs dysfunction during treatment with ARIKAYCE. If ototoxicity 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache occurs, manage patients as medically appropriate, (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% including potentially discontinuing ARIKAYCE. vs 2%), decreased weight (6% vs 1%), change in sputum (5% Nephrotoxicity was observed during the clinical trials vs 1%), and chest discomfort (5% vs 3%). of ARIKAYCE in patients with MAC lung disease but Drug Interactions: Avoid concomitant use of ARIKAYCE not at a higher frequency than background regimen with medications associated with neurotoxicity, alone. Nephrotoxicity has been associated with the nephrotoxicity, and ototoxicity. Some diuretics aminoglycosides. Close monitoring of patients with known can enhance aminoglycoside toxicity by altering or suspected renal dysfunction may be needed when aminoglycoside concentrations in serum and tissue. prescribing ARIKAYCE. Avoid concomitant use of ARIKAYCE with ethacrynic acid, Neuromuscular Blockade: Patients with neuromuscular furosemide, urea, or intravenous mannitol. disorders were not enrolled in ARIKAYCE clinical trials. Overdosage: Adverse reactions specifically associated Patients with known or suspected neuromuscular with overdose of ARIKAYCE have not been identified. disorders, such as myasthenia gravis, should be closely Acute toxicity should be treated with immediate monitored since aminoglycosides may aggravate withdrawal of ARIKAYCE, and baseline tests of renal muscle weakness by blocking the release of function should be undertaken. Hemodialysis may be acetylcholine at neuromuscular junctions. helpful in removing amikacin from the body. In all cases Embryo-Fetal Toxicity: Aminoglycosides can cause of suspected overdosage, physicians should contact the fetal harm when administered to a pregnant woman. Regional Poison Control Center for information about Aminoglycosides, including ARIKAYCE, may be associated effective treatment. with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use Please see the Brief Summary on the following pages. ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential Reference: 1. ARIKAYCE [package insert]. Bridgewater, NJ: Insmed hazard to the fetus. Incorporated; 2018.

Visit ARIKAYCEhcp.com © 2019 Insmed Incorporated. All Rights Reserved. Insmed and ARIKAYCE are trademarks of Insmed Incorporated. PP-ARIK-US-00399 ® higher frequency in patients treated with ARIKAYCE plus a background regimen (17%) compared to (amikacin liposome inhalation suspension) ARIKAYCE patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% BRIEF SUMMARY: For complete safety, please consult the full in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness Prescribing Information. (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm) [see Adverse Reactions (6.1)]. WARNING: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment ARIKAYCE has been associated with an increased risk of respiratory with ARIKAYCE. If ototoxicity occurs, manage the patient as medically appropriate, including potentially adverse reactions including, hypersensitivity pneumonitis, hemoptysis, discontinuing ARIKAYCE. bronchospasm, exacerbation of underlying pulmonary disease that have 5.6 Nephrotoxicity: Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients led to hospitalizations in some cases [see Warnings and Precautions with MAC lung disease but not at a higher frequency than the background regimen alone [see Adverse (5.1, 5.2, 5.3, 5.4)]. Reactions (6.1)]. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE. 1 INDICATIONS AND USAGE 5.7 Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a weakness by blocking the release of acetylcholine at neuromuscular junctions. minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical 5.8 Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral who have limited or no alternative treatment options. This drug is indicated for use in a limited and congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during specific population of patients. pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to This indication is approved under accelerated approval based on achieving sputum culture conversion the fetus [see Use in Specific Populations (8.1)]. (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon 6 ADVERSE REACTIONS verification and description of clinical benefit in confirmatory trials. The following clinically significant adverse reactions are described in greater detail in other sections of labeling: Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease • Hypersensitivity Pneumonitis [see Boxed Warning and Warnings and Precautions (5.1)] defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive • Hemoptysis [see Boxed Warning and Warnings and Precautions (5.2)] months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for • Bronchospasm [see Boxed Warning and Warnings and Precautions (5.3)] patients with non-refractory MAC lung disease. • Exacerbation of Underlying Pulmonary Disease [see Boxed Warning and Warnings and Precautions (5.4)] 2 DOSAGE AND ADMINISTRATION • Ototoxicity [see Warnings and Precautions (5.5)] 2.1 Important Administration Instructions: ARIKAYCE is for oral inhalation use only. Administer • Nephrotoxicity [see Warnings and Precautions (5.6)] by nebulization only with the LamiraTM Nebulizer System. Refer to the Instructions for Use for full • Neuromuscular Blockade [see Warnings and Precautions (5.7)] administration information on use of ARIKAYCE with the Lamira Nebulizer System. 6.1 Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, Instruct patients using a bronchodilator (‘reliever’) to first use the bronchodilator following the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the bronchodilator leaflet for use information before using ARIKAYCE. clinical trials of another drug and may not reflect the rates observed in practice. Pre-treatment with short-acting selective beta-2 agonists should be considered for patients with known Overview of Clinical Trials for Safety Evaluation hyperreactive airway disease, chronic obstructive pulmonary disease, asthma, or bronchospasm [see Within the refractory NTM clinical program, 388 patients that participated in three clinical trials were Warnings and Precautions (5.3)]. treated with ARIKAYCE at the dose of 590 mg/day (median duration of exposure to ARIKAYCE was 2.2 Recommended Dosage: The recommended dosage of ARIKAYCE in adults is once daily 169 days). inhalation of the contents of one 590 mg/8.4 mL ARIKAYCE vial (590 mg of amikacin) using the Lamira Trial 1 (NCT#02344004) was an open-label, randomized (2:1), multi-center Phase 3 trial in patients with Nebulizer System. refractory Mycobacterium avium complex (MAC) lung disease. Patients were randomized to either Administer ARIKAYCE with the Lamira Nebulizer System only. ARIKAYCE should be at room 8 months of ARIKAYCE plus a background regimen (n=223) or background regimen alone (n=112). temperature before use. Prior to opening, shake the ARIKAYCE vial well for at least 10 to 15 seconds Trial 2 (NCT#02628600) was a single-arm extension of Trial 1 for refractory MAC lung disease until the contents appear uniform and well mixed. The ARIKAYCE vial is opened by flipping up the patients that failed to achieve negative sputum cultures after 6 months of treatment or had a relapse plastic top of the vial then pulling downward to loosen the metal ring. The metal ring and the rubber or recurrence by Month 6 from either study arm of Trial 1. A total of 133 patients (n=74 from the prior stopper should be removed carefully. The contents of the ARIKAYCE vial can then be poured into the background regimen alone arm of Trial 1, and n=59 from the prior ARIKAYCE plus background regimen medication reservoir of the nebulizer handset. arm in Trial 1) participated in the trial. If a daily dose of ARIKAYCE is missed, administer the next dose the next day. Do NOT double the dose Trial 3 (NCT#01315236) was a double-blind, randomized, placebo-controlled Phase 2 study in patients to make up for the missed dose. with refractory nontuberculous mycobacterial (NTM) lung disease caused by MAC and Mycobacterium 4 CONTRAINDICATIONS abscessus. Patients were randomized to either ARIKAYCE plus background regimen or an inhaled diluted empty liposome placebo plus background regimen for 84 days. ARIKAYCE is contraindicated in patients with a known hypersensitivity to any aminoglycoside. Across all clinical trials of patients with and without refractory NTM lung infection, 802 patients were 5 WARNINGS AND PRECAUTIONS exposed to multiple doses of ARIKAYCE. 5.1 Hypersensitivity Pneumonitis: Hypersensitivity pneumonitis has been reported with the Adverse Reactions Leading to Treatment Discontinuation use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher In the three NTM studies, there was a higher incidence of premature discontinuation of ARIKAYCE. In frequency in patients treated with ARIKAYCE plus a background regimen (3.1%) compared to patients Trial 1, 33.5% discontinued ARIKAYCE prematurely; most were due to adverse reactions (17.4%) and treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis withdrawal by subject (9.4%). In the comparator arm 8% of subjects discontinued their background discontinued treatment with ARIKAYCE and received treatment with corticosteroids [see Adverse regimen, with 0.9% due to adverse reactions and 5.4% due to withdrawal by subject. In Trial 2 (the Reactions (6.1)]. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage the patient single-arm extension of Trial 1), 20.3% of patients starting on ARIKAYCE discontinued prematurely as medically appropriate. with 14.9% discontinuing due to adverse reactions. In Trial 3, all 9 (20.5%) premature discontinuations occurred in the ARIKAYCE plus background regimen-treated patients and there were no premature 5.2 Hemoptysis: Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. discontinuations in the placebo plus background regimen arm. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus a background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%) [see Adverse Serious Adverse Reactions in Trials 1 and 3 Reactions (6.1)]. If hemoptysis occurs, manage the patients as medically appropriate. In the two randomized trials (Trial 1 and Trial 3), there were more serious adverse reactions (SARs) 5.3 Bronchospasm: Bronchospasm has been reported with the use of ARIKAYCE in the clinical reported in the ARIKAYCE-treated arm as compared to the respective control arm. In Trial 1, 20.2% trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea of patients treated with ARIKAYCE plus background regimen reported SAR as compared to 16.1% of exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with background regimen alone. In addition, in Trial 1 [2 to 1 randomization, ARIKAYCE patients treated with ARIKAYCE plus a background regimen (28.7%) compared to patients treated with a plus background regimen versus background regimen alone], there were 82 hospitalizations in background regimen alone (10.7%) [see Adverse Reactions (6.1)]. If bronchospasm occurs during the 41 patients (18.4%) treated with ARIKAYCE plus background regimen compared to 23 hospitalizations use of ARIKAYCE treat the patients as medically appropriate. in 15 patients (13.4%) treated with background regimen alone. The most common SARs and reasons for hospitalization in the ARIKAYCE plus background regimen arm were related to exacerbation of 5.4 Exacerbation of Underlying Pulmonary Disease: Exacerbations of underlying pulmonary underlying pulmonary disease and lower respiratory tract infections, such as pneumonia. disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease, infective exacerbation of In Trial 3, 18.2% of patients treated with ARIKAYCE plus background regimen reported SARs compared chronic obstructive pulmonary disease, infective exacerbation of bronchiectasis) have been reported at to 8.9% of patients treated with background regimen plus inhaled placebo. a higher frequency in patients treated with ARIKAYCE plus a background regimen (14.8%) compared Common Adverse Reactions to patients treated with background regimen alone (9.8%) [see Adverse Reactions (6.1)]. If The incidence of adverse reactions in Trial 1 are displayed in Table 1. Only those adverse reactions with exacerbations of underlying pulmonary disease occurs during the use of ARIKAYCE, treat the patients a rate of at least 5% in the ARIKAYCE plus background regimen group and greater than the background as medically appropriate. regimen alone group, are shown. 5.5 Ototoxicity: Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a Table 1: Adverse Reactions in ≥5% of ARIKAYCE-treated MAC Patients and More Animal reproductive toxicology studies have not been conducted with inhaled amikacin. Subcutaneous Frequent than Background Regimen Alone in Trial 1 administration of amikacin to pregnant rats (up to 100 mg/kg/day) and mice (up to 400 mg/kg/day) ARIKAYCE plus Background during organogenesis was not associated with fetal malformations. Ototoxicity was not adequately evaluated in offspring in animal studies. Adverse Reaction Background Regimen Alone Regimen (n=223) (n=112) The estimated background risk of major birth defects and miscarriage for the indicated populations is n (%) n (%) unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In Dysphoniaa 105 (47) 1 (1) the U.S. general population, the estimated background risk of major birth defects and miscarriage in Coughb 87 (39) 19 (17) clinically recognized pregnancies is 2-4% and 15-20%, respectively. Bronchospasmc 64 (29) 12 (11) Data Hemoptysis 40 (18) 14 (13) Animal Data Ototoxicityd 38 (17) 11 (10) No animal reproductive toxicology studies have been conducted with ARIKAYCE or non-liposomal Upper airway irritatione 37 (17) 2 (2) amikacin administered by inhalation. Musculoskeletal painf 37 (17) 9 (8) Fatigue and asthenia 36 (16) 11 (10) Amikacin was subcutaneously administered to pregnant rats (Gestation Days 8-14) and mice (Gestation Exacerbation of underlying pulmonary diseaseg 33 (15) 11 (10) Days 7-13) at doses of 25, 100, or 400 mg/kg to assess developmental toxicity. These doses did not cause fetal visceral or skeletal malformations in mice. The high dose was excessively maternally toxic Diarrhea 28 (13) 5 (5) in rats (nephrotoxicity and mortality were observed), precluding the evaluation of offspring at this dose. Nausea 26 (12) 4 (4) Fetal malformations were not observed at the low or mid dose in rats. Postnatal development of the rats h Pneumonia 22 (10) 9 (8) and mice exposed to these doses of amikacin in utero did not differ significantly from control. Headache 22 (10) 5 (5) Ototoxicity was not adequately evaluated in offspring in animal developmental toxicology studies. Pyrexia 16 (7) 5 (5) Vomitingi 15 (7) 4 (4) 8.2 Lactation Rashj 14 (6) 2 (2) Risk Summary Weight decreased 14 (6) 1 (1) There is no information regarding the presence of ARIKAYCE in human milk, the effects on the breastfed Change in sputumk 12 (5) 1 (1) infant, or the effects on milk production after administration of ARIKAYCE by inhalation. Although Chest discomfort 12 (5) 3 (3) limited published data on other routes of administration of amikacin indicate that amikacin is present in aIncludes aphonia and dysphonia. human milk, systemic absorption of ARIKAYCE following inhaled administration is expected to be low bIncludes cough, productive cough, and upper airway cough syndrome. [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be c Includes asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat considered along with the mother’s clinical need for ARIKAYCE and any potential adverse effects on the tightness, wheezing. breastfed child from ARIKAYCE or from the underlying maternal condition. dIncludes deafness, deafness neurosensory, deafness unilateral, dizziness, hypoacusis, presyncope, tinnitus, vertigo. e Includes oropharyngeal pain, oropharyngeal discomfort, throat irritation, pharyngeal erythema, upper airway inflammation, 8.4 Pediatric Use: Safety and effectiveness of ARIKAYCE in pediatric patients below 18 years of age pharyngeal edema, vocal cord inflammation, laryngeal pain, laryngeal erythema, laryngitis. have not been established. f Includes back pain, arthralgia, myalgia, pain/body aches, muscle spasm, and musculoskeletal pain. gIncludes COPD, infective exacerbation of COPD, infective exacerbation of bronchiectasis. 8.5 Geriatric Use: In the NTM clinical trials, of the total number of patients receiving ARIKAYCE, h Includes atypical pneumonia, empyema, infection pleural effusion, lower respiratory tract infection, lung infection, lung 196 (50.5%) were ≥65 years and 55 (14.2%) were ≥75 years. No overall differences in safety and infection pseudomonas, pneumonia, pneumonia aspiration, pneumonia pseudomonas, pseudomonas infection, and effectiveness were observed between elderly subjects and younger subjects. Because elderly patients respiratory tract infection. are more likely to have decreased renal function, it may be useful to monitor renal function [see i Includes vomiting and post-tussive vomiting. Warnings and Precautions (5.6)]. jIncludes rash, rash maculo-papular, drug eruption, and urticaria. kIncludes increased sputum, sputum purulent, and sputum discolored. 8.6 Hepatic Impairment: ARIKAYCE has not been studied in patients with hepatic impairment. Selected adverse drug reactions that occurred in <5% of patients and at higher frequency in ARIKAYCE- No dose adjustments based on hepatic impairment are required since amikacin is not hepatically treated patients in Trial 1 are presented in Table 2. metabolized [see Clinical Pharmacology (12.3)]. 8.7 Renal Impairment: ARIKAYCE has not been studied in patients with renal impairment. Given the low Table 2: Selected Adverse Reactions in <5% of ARIKAYCE-treated MAC Patients and systemic exposure to amikacin following administration of ARIKAYCE, clinically relevant accumulation of More Frequent than Background Regimen Alone in Trial 1 amikacin is unlikely to occur in patients with renal impairment. However, renal function should be monitored ARIKAYCE plus Background Background Regimen in patients with known or suspected renal impairment, including elderly patients with potential age-related Regimen (n=223) Alone (n=112) decreases in renal function [see Warnings and Precautions (5.6), Use in Specific Populations (8.5)]. Anxiety 10 (4.5) 0 (0) Oral fungal infectiona 9 (4) 2 (1.8) 10 OVERDOSAGE Bronchitis 8 (3.6) 3 (2.7) Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute Hypersensitivity pneumonitisb 8 (3.6) 0 (0) toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Dysgeusia 7 (3.1) 0 (0) Respiratory failurec 6 (2.7) 1 (0.9) Hemodialysis may be helpful in removing amikacin from the body. Epistaxis 6 (2.7) 1 (0.9) In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for Neuromuscular disorderd 5 (2.2) 0 (0) information about effective treatment. In the case of any overdosage, the possibility of drug interactions Dry mouth 5 (2.2) 0 (0) with alterations in drug disposition should be considered. Pneumothoraxe 5 (2.2) 1 (0.9) 13 NONCLINICAL TOXICOLOGY Exercise tolerance decreased 3 (1.3) 0 (0) 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 2-year inhalation Balance disorder 3 (1.3) 0 (0) carcinogenicity study, rats were exposed to ARIKAYCE for 15-25, 50-70, or 155-170 minutes per day aIncludes oral candidiasis and oral fungal infection. for 96-104 weeks. These provided approximate inhaled doses of 5, 15, and 45 mg/kg/day. Squamous bIncludes allergic alveolitis, interstitial lung disease, and pneumonitis. cell carcinoma was observed in the lungs of 2 of 120 rats administered the highest dose tested. c Includes acute respiratory failure and respiratory failure. Maximum serum AUC levels of amikacin in the rats at steady state were approximately 1.3, 2.8, and dIncludes muscle weakness, neuropathy peripheral, and balance disorder. eIncludes pneumothorax, pneumothorax spontaneous, and pneumomediastinum. 7.6 mcg*hr/mL at the low, mid, and high doses, respectively, compared with 23.5 mcg*hr/mL (8.0 to 46.5 mcg*hr/mL) measured in humans. The squamous cell carcinomas may be the result of a high lung Refer to Table 1 and Table 2 for the incidence rate of hypersensitivity pneumonitis, bronchospasm, burden of particulates from ARIKAYCE in the rat lung. The relevance of the lung tumor findings with cough, dysphonia, exacerbation of underlying disease, hemoptysis, ototoxicity, upper airway irritation, regards to humans receiving ARIKAYCE is unknown. and neuromuscular disorders [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6)]. No evidence of mutagenicity or genotoxicity was observed in a battery of in vitro and in vivo 7 DRUG INTERACTIONS genotoxicity studies with a liposome-encapsulated amikacin formulation similar to ARIKAYCE (in vitro 7.1 Drugs with Neurotoxic, Nephrotoxic, or Ototoxic Potential: Avoid concomitant use of microbial mutagenesis test, in vitro mouse lymphoma mutation assay, in vitro chromosomal aberration ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. study, and an in vivo micronucleus study in rats). 7.2 Ethacrynic Acid, Furosemide, Urea, or Mannitol: Some diuretics can enhance No fertility studies were conducted with ARIKAYCE. Intraperitoneal administration of amikacin to male aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid and female rats at doses up to 200 mg/kg/day prior to mating through Day 7 of gestation were not concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol. associated with impairment of fertility or adverse effects on early embryonic development. 8 USE IN SPECIFIC POPULATIONS 13.2 Animal Toxicology and/or Pharmacology: To provide information about chronic dosing of 8.1 Pregnancy ARIKAYCE to another animal species, a 9-month inhalation toxicology study was conducted in dogs. Foamy alveolar macrophages associated with clearance of the inhaled product were present at dose- Risk Summary related incidence and severity, but they were not associated with inflammation, tissue hyperplasia, or the There are no data on ARIKAYCE use in pregnant women to evaluate for any drug-associated risk of presence of preneoplastic or neoplastic changes. Dogs were exposed to ARIKAYCE for up to 90 minutes major birth defects, miscarriage or adverse maternal or fetal outcomes. Although systemic absorption of per day, providing inhaled amikacin doses of approximately 5, 10, and 30 mg/kg/day. amikacin following oral inhalation is expected to be low [see Clinical Pharmacology (12.3)], systemic exposure to aminoglycoside antibacterial drugs, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness when administered to pregnant women [see Warnings and © 2018 Insmed Incorporated. All Rights Reserved. Insmed and ARIKAYCE Precautions (5.8)]. Advise pregnant women of the potential risk to a fetus. are trademarks of Insmed Incorporated. All other trademarks are property of their respective owner. PP-ARIK-US-00405 WHAT’S HIDDEN IN AMERICAN HEALTH CARE Prices: High, Confusing, and Opaque. Too often, the prices of health care services and drugs are cloaked in mystery. A growing consensus demands that patients be given a clearer sense, in advance, of what things will cost. But there are obstacles–and some people benefit from the present confusion.

By Timothy Kelley “That’d be $1,000,” an employee at my drugstore soon Senior Contributing Editor confirmed in person. Huh? “Your insurance doesn’t cover this medication, so we There is a lot of outrage about high prices in U.S. health applied a coupon,” said the matter-of-fact voice on the care today. But there is also concern—to some extent phone, that of an employee at a pharmacy 30 blocks separable—about why prices are often so hard to find out from my Manhattan home who declined to give his or understand. Many experts clamor for “transparency,” last name. I’d had a potentially precancerous half-inch and in the minds of many (particularly Republicans), if actinic keratosis growth removed from my right temple people only knew what they were going to have to pay, by a physician assistant at a dermatology clinic for my they’d make savvy choices, and those choices would exert standard office-visit copay of $40. (A lab-fee bill of $10 market pressure to keep prices in line. But in many situa- would come in the mail later). Now I sought the topical tions, health care pricing is the polar opposite—frustrat- ointment that clinician had recommended to heal the scar. ingly opaque, and full of mystery. I was told that at the distant pharmacy that medication Why, for instance, would a coupon reduce a price by would cost me $30. And if I chose to use my regular 97%—but only if I trek to a distant pharmacy I’ve never pharmacy instead? heard of? And where can I get such coupons for the other

24 MANAGED CARE / MAY 2019 Would Transparency Even Help?

things I buy in life? The temptation to irreverence is keen, ten private, and sometimes creating incentives that go as writer Kate Sidley proved when she spoofed itemized every which way—govern the relationships of employers hospital billing in a “Shouts & Murmurs” humor column with health insurers, insurers with enrollees, insurers in the March 4 New Yorker. She explained a charge of with hospitals, insurers with pharmacies, and hospi- “$900 for beeps” with the observation: “Boy, lots of things tals with doctors and other providers. The pricing that beep when you’re in the hospital. Each beep is 50 cents.” emerges from that labyrinth is so arcane, complex, and ill-explained that no one can be sure just what bills may Hard-to-learn prices be coming, when (it may be months after the service was Of course, when you’re sick or injured, it’s no joking delivered), and for how much. matter. “Don’t be afraid to push” to find out what a medi- Managed care has done little to fix the problem—and cal service you’re offered will actually cost, Elisabeth often exacerbates it. “There is no such thing as trans- Rosenthal, MD, counseled consumer readers in her 2017 parency in managed care pricing,” says Peter Boland, a book An American Sickness. But that push health care consultant in Berkeley, Calif., can be Sisyphean. Rosenthal told of a man and a member of Managed Care’s Edito- who had to struggle for a year and a half rial Advisory Board. “It is designed to be to find out from a dozen-plus Rhode Is- opaque because, at its root, is a contract- land labs what they charged for certain ing process that the public and individual basic blood tests. The fact that he was the consumers are cut out of.” He argues that state’s commissioner of health, in charge it’s in the financial interests of insurers of licensing the labs, didn’t seem to help. and hospitals to keep secret how prices (When at last revealed, the prices varied are arrived at, and that these prices often by a factor of 20.) “bear little resemblance to actual costs.” Until a couple of decades ago, doctors “Yes, prices are opaque, but Opaqueness is pervasive in health care, were known for their obliviousness to cost making them more transpar- and making things clearer may call for a information—even if patients asked them ent” doesn’t always mean vast rethinking of the industry—if Demo- about it, they were blissfully unaware. That affordability, Claire McAndrew crats, Republicans, and all the industry situation has improved but still has far to of Families USA says. sectors could ever agree on such an ambi- go. Rosenthal wrote of a mother who was tious undertaking. referred by her toddler’s pediatrician to a plastic surgeon Meanwhile, two areas in which consumers and oth- to close a cut on the child’s face by sewing three stitches. ers are flummoxed and sticker-shocked with particular Unfortunately, the pediatrician didn’t ask the plastic ferocity are prescription drug prices and “surprise” out- surgeon’s price, and neither did the mom—even though of-network bills. Each has lately inspired government she was a doctor herself and thus a presumably smart reform efforts. medical shopper. The three stitches turned out to cost $50,000. Rosenthal adds that the plastic surgeon’s office A surfeit of secrecy had “greased the wheels” for referrals by providing the The profusion of coupons and rebates by which pharma- pediatrician’s office occasionally with free sandwiches. ceutical manufacturers adjust their list prices when mak- Is a health care system critically influenced by sand- ing deals with insurers and PBMs has long made drug wiches and mysterious coupons—in effect, by secrets—any pricing a dark art. In recent years, some insurers and less ridiculous than one that features 50-cent beeps? PBMs have added to the confusion with a new “benefit” “The entire health care system is opaque, and some called a copay accumulator, which prevents costs paid via of that is just the nature of health care,” says Anthony E. a drugmaker’s coupon program from counting toward a Wright, executive director of Health Access, a California member’s deductible. That controversial new feature has health care advocacy organization. “You seek treatment increased the sniping among pharmaceutical manufactur- for one condition, then tests show you actually have three ers, PBMs, and insurers about who’s really to blame for other things. You go for a routine surgery, but complica- the sky-high and fast-rising prices consumers often pay. tions ensue.” In such situations, says Wright, costs to the Each industry sector “is very interested in making sure consumer may legitimately be unpredictable. the attention is elsewhere, and the reality is, that’s keep- But opaqueness goes way beyond that. Contracts—of- ing us from getting to the root of the problem,” AARP’s

MAY 2019 / MANAGED CARE 25 Leigh Purvis told Managed Care in 2018. Indeed, the lack of clarity in drug pricing has served How the money flowed in 2016 as a convenient smokescreen behind which cash regis- The biggest spender on prescription drugs was the ters keep clanging. Says Claire McAndrew, the director government (Medicare, Medicaid, Medicaid managed care, of campaigns and partnerships at Families USA: “We the VA, the Department of Defense), which accounted for 41% of the $341 billion spent on prescription drugs, have a very convoluted and complex system that a lot of or $139.8 billion. On the “money in” side of the ledger, entities make a lot of money off of.” The Pew Charitable manufacturers retained the biggest share, 60% of the $341 Trusts issued a report on retail pharmacy spending billion, or $204.6 billion. in March that, among a multitude of calculations, figured out how much of the drug dollar is retained Money Out by each link in the drug supply. Pew’s numbers show that drugmakers get the lion’s share ($204.6 billion of the $341 billion spent in 2016, which works out to 60%) followed by pharmacies ($79.6 billion, or 22.5%).

Removing perverse incentives Lawmakers are getting involved. In January, Demo- crats in the House and Republicans in the Senate both Patients: $103.8 bn (30%) held committee hearings on drug pricing. “There’s too much secrecy in this business,” Senate Finance Com- mittee Chair Sen. Chuck Grassley told reporters. The Employers: $97.5 bn (29%) Trump administration says it is taking several steps to lower drug prices and make them more discernible. In January 2019, it released a proposed rule aimed at eliminating rebates from pharma manufacturers Government: $139.8 bn (41%) to PBMs in Medicare Part D and Medicaid managed care organizations by replacing the HHS regulatory “safe harbor” to the antikickback statute with a much narrower one. The new rule’s intent was to replace rebates with “discounts provided to beneficiaries at the point of sale,” the administration said. If it becomes final, it could remove some of the perverse incentives in the Health plans: $19.6 bn (5.7%) system, such as drugmakers’ incentive to keep rais- ing list prices. See if you can follow the bouncing ball in this pas- PBMs: $22.4 bn (6.5%) sage of incisive analysis from a February 1 Health Affairs blog post by Rachel Sachs, a Washington Uni- versity associate law professor, on what’s screwy about Pharmacies: $76.9 bn (22.5%) the present rebate system: “It encourages pharmaceutical companies to continue increasing their list Wholesalers: $17.6 bn (5.2%) prices over time, if they can use an increasingly large rebate to negotiate a favorable formulary placement. PBMs, which are often paid at least in part based on the amount of discounts they are able to obtain for insurers, may profit directly from the list-to-net difference. The insurer may use its portion of the rebate to lower premiums across the board.” Manufacturers: $204.6 bn (60%) The administration admits it can’t predict just what industry responses its proposed regulatory change Money in might trigger. Its best guess? Beneficiaries’ out-of- pocket coinsurance obligations would go down, but Source: Pew Charitable Trusts, “The Prescription Drug Landscape, Explored,” premiums would rise. March 2019. Used with permission. Sachs noted that PBMs have been a target of the

26 MANAGED CARE / MAY 2019 administration’s rhetoric on drug pricing. The American argues. “So focusing on PBMs is not getting at the source Pharmacists Association called it a victory for transpar- of the problem.” ency last fall when the president signed bipartisan legislation banning the “gag clauses” by which PBM contracts The out-of-network ‘gotcha’ had prohibited pharmacists from telling consumers when On March 18, CBS This Morning reported the recent a drug’s cash price was actually lower than the applicable experience of Mississippi mom Michelle Mills, who took copay through their insurance. her young son to the local hospital emergency room But questions about PBMs didn’t end with that bill when he suffered a facial injury. (It turned out to be a signing. Says Edmund Haislmaier of the conservative broken nose.) Mills had the presence of mind to do what Heritage Foundation: “There are people who have clearly many mothers wouldn’t think to do before rushing out exploited opaqueness, and I think that’s part of what’s the door to take a child for emergency treatment. She going on now with the debate over the role of pharmacy called the hospital. benefit managers.” “Are y’all still in network with First Health?” she asked. Last fall, HHS proposed a new rule that would re- The answer was yes, so of course Mills concluded that quire drugmakers to include their list prices in direct-to- her challenge now was simply getting her son treated. consumer television ads; pharma lobbyists are fighting Surprise! The hospital was in network, but its emer- against it. Earlier, the Trump administration’s May 2018 gency room was not. Four months later, Mills received a “blueprint” proposal on drug prices complained that bill for an extra $1,800. She managed to get that whittled “lack of transparency in drug pricing benefits special down to $285, but she worried about others who might interests and prevents patients from being able to make accept such an invoice (officially illegal, according to a fully informed decisions about their care.” little-enforced state law) more credulously. The proposal sought to speed access to CBS reported that 65% of U.S. hospitals lower-cost drugs, curb gaming of the sys- use emergency rooms staffed by outside tem to “unfairly protect mono polies,” and companies—and that in a recent survey, make other changes. But Haislmaier says 57% of Americans said they had received what drew his attention in the proposal—a a surprise medical bill. “sleeper,” he calls it—was a line far down Surprise bills have become fertile ter- in the White House summary that called ritory for investigative journalists, and for “requiring pharmacy benefit manag- preventing them is a political no-brainer. ers to act in the best interests of patients.” (In a crowdsourcing project among the Haislmaier argues that PBMs are legally When a consumer has the time readers of Vox, writer Sarah Kliff collected fiduciaries of neither the supplier (drug he or she will shop for a better 1,182 ER bills and found that just the facil- companies) nor the customer (insurers), price for a procedure, argues ity fee—what one pays for walking into but instead are “exploiting opaqueness to Edmund Haislmaier of the con- the ER in the first place—varied from arbitrage in the middle.” In his view, that servative Heritage Foundation. $533 to “well over $3,000.”) Nine business contributes to both high prices and a lack and consumer organizations, including of transparency. America’s Health Insurance Plans, the health insurer’s Currently, PBMs depend on rebates for a large share trade group, issued a joint statement in December that of their revenues. Haislmaier suggests that they might endorsed banning surprise invoices for out-of-network better serve their customers by providing a fee-based providers. But the mechanics of how to do so have been service to insurers. (The PBMs’ trade association, the the subject of fierce debate. Pharmaceutical Care Management Association, stated in There are differences, too, over what level of govern- early March that “PBMs negotiate on behalf of consumers ment should address the problem. “There’s a tendency and work to keep a lid on overall costs for prescription to have a national fix when in fact that might not be ap- drugs with market-based tools that encourage competi- propriate,” says Haislmaier of the Heritage Foundation, tion among drug manufacturers and pharmacies, and arguing that because the states customarily regulate insur- incentivize consumers to take the most cost-effective ance and handle medical licensure, it should be their job. and clinically appropriate medication.”) McAndrew disagrees. While pointing out that bills McAndrew of Families USA agrees with Haislmaier passed in New York, California, and Florida offer good that nothing guarantees that the savings PBMs negoti- models, she favors a federal law for two reasons. First, ate will be passed down to insurers or consumers. “But state insurance regulators have limited authority over the entire reason we have a market where PBMs need to self-insured plans. Second, a state-by-state approach negotiate lower prices is because pharmaceutical manu- would inevitably lead to a situation in which some states facturers charge outrageous amounts for drugs,” she offer less protection than others.

MAY 2019 / MANAGED CARE 27 U.S. Senate bills introduced last session by New Hamp- one’s care, interviewing each about his or her network shire Democrat Maggie Hassan and Louisiana Republican status? And who would quiz the ambulance driver? In Bill Cassidy would have spared Americans the pain of 2014, says the Brookings–Schaeff er report, “more than surprise out-of-network billing—Cassidy’s by capping 50% of all ambulance cases involved an out-of-network charges at 125% of the median regional rate charged ambulance.” for the service, Hassan’s by prohibiting Th e surprise bills can be big ones. In bills at higher than the in-network rate what is perhaps not fully a coincidence, and mandating independent arbitration the specialties oft en involved in surprise between providers and insurers, with the out-of-network bills—anesthesiology, patient taken out of the middle. (And that emergency medicine, diagnostic radi- means not receiving the eye-popping bill ology, and pathology—are among the in the fi rst place.) So far, the Senate bills highest-charging specialties relative to have not been re-introduced in the cur- standard Medicare payments. Drawing rent session. on Medicare claims data, Loren Adler, According to a white paper on sur- the lead author of the white paper, and prise billing released in February by the his colleagues found that the top 25% of Brookings Institution and the Leonard Insurers need to maintain anesthesiology claims billed to Medicare D. Schaeff er Center for Health Policy and adequate networks that include patients had charges more than nine and specialists, says Vidor Friedman, Economics at the University of Southern a half times the Medicare rate. MD, of the American College California, a study of one large national of Emergency Physicians. Th e white paper adds that the mere insurer showed that out-of-network emer- ability to engage in out-of-network billing gency physicians’ charges averaged eight gives these docs leverage in negotiating times what Medicare pays for the same service. But pricey high in-network rates. Th e authors also observe in a out-of-network billing isn’t limited to the emergency footnote that even though “discordant network status department. between hospitals and hospitalists” is currently rare, Prudent consumers choose a primary care doctor who “recent private equity activity among hospitalist groups” is in their plan’s network, and if they’re able to plan their suggests that hospitalists may be gearing up for either visit to a hospital they make sure that facility is in network more out-of-network billing or more aggressive use of too. Th e trouble oft en comes with “ancillary” professionals such an option to win higher rates. Opaqueness may still they may encounter in the hospital, such as anesthesi- be a money-maker. ologists, diagnostic radiologists, and pathologists. Who Both Vidor Friedman, MD, president of the Ameri- would think to tick off this list of physicians involved in can College of Emergency Physicians, and Mary Dale Peterson, MD, president-elect of the American Society of Anesthesiologists, The prime surprise-bill suspects reject any notion that their specialties A high percentage of ambulance services and the emergency department are greedy outliers. Peterson says Medi- visits result in surprise out-of-network bills, according to recent studies. care payment for anesthesiology services 60% skews low, so that commercial rates for 51% 50% her specialty are a better index. Both doctors insist that it’s the health insurer’s 40% responsibility to maintain an adequate 30% network. At least occasionally, insurers 22% have knowingly shorted networks to 19% 20% stick patients with out-of-network bills, 9% they argue. Friedman and Peterson say 10% their groups support proposed legisla- 0% tion that would take patients “out of the Ambulance services Emergency Elective inpatient care Emergency middle” and make sure they no longer department department receive surprise out-of-network bills. For Garmon and Chartock, Cooper and Morton, New a properly functioning market-driven Health A airs, January 2017 England Journal of Medicine, health care system, says Peterson, “we Nov. 17, 2016 need more transparency—and also net- Source: USC–Brookings Schaeff er Initiative for Health Policy, “State Approaches To Mitigating Surprise Out-of-Network Billing,” February 2019 work adequacy.” Do health plans, then, deserve the

28 MANAGED CARE / MAY 2019 blame for surprise billing because of their too-narrow is, not given on an emergency basis or in the midst of networks? Adler and his Brookings–Schaeffer coauthors an admission. Not much shopping actually took place, say that in many cases insurers tell them they do try to they found; a physician’s referral, not the best price, was pressure hospitals to get their emergency department and the key determinant of where people got their MRIs. ancillary physicians to accept network payment rates, but lack the market clout to insist on it, especially if the hospital is No surprise about the high surprise billers one that is essential to have in their net- Anesthesiologists and other specialists are often the source of high out-of-network surprise bills. That makes sense because their average work. Add to that the fact that in some contracted payment rates, relative to Medicare rates, are among the communities the population of appro- highest. priate doctors is sparse; if an in-network doc is out sick or otherwise unavailable, 350% an out-of-network doc may have to be 300% called upon so that a procedure can be performed. 250% Transparency isn’t enough 344% 200% 306% On January 1, the administration started requiring that hospitals post their list 150% 204% prices online, but commentators quickly 128% questioned the helpfulness of the result- 100% ing information. A pair of Kaiser Health Anesthesiologists Emergency Radiologists All physicians physicians News writers called it “a dog’s breakfast of medical codes, abbreviations and dol- Source: USC–Brookings Schaeffer Initiative for Health Policy, “State Approaches To Mitigating Surprise Out-of-Network Billing,” February 2019 lar signs—in little discernible order.” In- deed, many experts say transparency by itself isn’t enough to usher in high-quality, cost-effective “Despite average out-of-pocket costs of $300 a scan and health care—and Wright, McA ndrew, and Haislmaier free access to a price transparency tool, less than 1% of are among them. individuals in our sample searched for the price of lower- “Yes, prices are opaque, but making limb MRI scans before accessing care,” them more transparent to consumers their report states. Patients on average doesn’t necessarily help consumers with traveled past six lower-priced providers affordability,” says McAndrew, “because on their way to the facility in which they information about prices can be hard to were scanned. The lack of reliable, intel- use, and there’s a question whether con- ligible information about prices, bad as it sumers who need health care really have is, would seem not to be the only barrier an opportunity to shop around when they to a cost-effective system. are sick and in urgent need of care.” McAndrew of Families USA evokes a “Seventy percent of hospital admis- picture of consumers who are pinching sions are through the emergency room,” their pennies more ardently—because Medicare payment skews low says Wright. “And there’s no comparison they must. “Transparency can be a good and commercial rates for her shopping on the gurney of an ambulance.” specialty are a better index, first step,” she says. “But most consumers Haislmaier concedes the point. “But says Mary Dale Peterson, MD, are seeking solutions that actually lower when you have to have some test or proce- of the American Society the price of health care so they aren’t left dure done and you have time in advance, of Anesthesiologists. to choose between their health and their there is shopping,” he says. He would em- financial well-being.” phasize giving consumers both the tools and the incen- Let’s give Kate Sidley the last word, even though her tives to shop for price where choice is possible. faux-itemized “invoice” in the New Yorker was the satiric Arguing against the realism of that hope, however, are equivalent of shooting fish in a barrel. She wrote: “Re- the results of a working paper from Yale’s Institution for member how at one point an anesthesiologist walked Social and Policy Studies by Harvard Medical School’s into your room and said, ‘Are you Mrs. Phillips?,’ and Michael Chernew and three coauthors. Studying data you said, ‘No,’ and she said, ‘Oh, OK, must be the wrong from a large national private insurer, they looked at lower- room,’ and left? The anesthesiologist was out of network. limb MRI scans that were “potentially shoppable”—that That’ll be $2,500.”

MAY 2019 / MANAGED CARE 29 Interopera-impossibility? New federal regulations are pushing for interoperability, but insurers say the 2020 deadlines are unrealistic. in February two federal agencies goosed the health By Jan Greene care industry with a pair of proposed regulations. The Contributing Editor regulations—one issued by CMS and the other by the Office of the National Coordinator for Health Informa- t’s been a decade since Congress pledged $35 tion Technology (ONC)—go after some of the main billion to drag America’s health care system into barriers to sharing information: conflicting technical a digital 21st century by paying for thousands of standards and the reluctance of some providers to hospital and physician practices to dump their share data because in health care, data is a treasured Iwalls of paper files and move the data into computers. asset, more often hoarded and hidden than shared. A big chunk of that federal cash went to states to set The new rules would require health plans working up information exchanges to share patient data less with federal programs to move ahead right away with clunkily. And yet, the fax machine, that relic from allowing their databases to connect with consumer- the 1980s, still clutters the counters of most medical facing apps. practices. Patients continue to struggle to get paper They would also put some teeth into rules against copies of their medical records, much less being able “information blocking”—providers hanging on to to pull them all together in one place online—an patient information for their own financial gain. They unmet promise getting dusty with age. could light a fire under hospitals, medical practices, Recognizing both technical and business barriers to and health plans by requiring them to make it easy for the speedy exchange of patient medical information, patients to get their own data electronically. continued on page 33

30 MANAGED CARE / MAY 2019 CMS APPROVES REIMBURSEMENT FOR EXPAREL IN THE ASC

Effective January 1, 2019 C9290

Under the new rules, the Healthcare Common Procedure Coding System (HCPCS) code C9290 that is assigned to EXPAREL was designated a payment status of “allowed” when used in a surgical procedure on Medicare patients in Medicare-certified ambulatory surgery centers (ASCs). • The “allowed” payment status enables EXPAREL to be reimbursed separately by Medicare and, potentially, commercial payors

For reimbursement questions, please call 1-855-RX-EXPAREL (1-855-793-9727), email [email protected], or visit www.EXPAREL.com/reimbursement.

CMS, Centers for Medicare & Medicaid Services.

Indication EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation. If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine. EXPAREL is not recommended to be used in the following patient population: patients <18 years old and/or pregnant patients. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use. The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials. Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression. Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability which may lead to dysrhythmias, sometimes leading to death. Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients. Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use. Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use. Please refer to Brief Summary of full Prescribing Information on the following page. For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727).

©2018 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-4400 12/18 Other than bupivacaine as noted above, EXPAREL should not be admixed with circulatory depression may require administration of intravenous fluids and, other drugs prior to administration. when appropriate, a vasopressor dictated by the clinical situation (such as Water and Hypotonic Agents ephedrine to enhance myocardial contractile force). Do not dilute EXPAREL with water or other hypotonic agents, as it will result in If not treated immediately, both convulsions and cardiovascular depression Brief Summary disruption of the liposomal particles can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If (For full prescribing information refer to package insert) USE IN SPECIFIC POPULATIONS cardiac arrest should occur, standard cardiopulmonary resuscitative measures INDICATIONS AND USAGE should be instituted. Pregnancy EXPAREL is indicated for single-dose infiltration in adults to produce postsurgical Endotracheal intubation, employing drugs and techniques familiar to the local analgesia and as an interscalene brachial plexus nerve block to produce Risk Summary clinician, maybe indicated, after initial administration of oxygen by mask, if postsurgical regional analgesia. There are no studies conducted with EXPAREL in pregnant women. In animal difficulty is encountered in the maintenance of a patent airway or if prolonged Limitation of Use: Safety and efficacy has not been established in other nerve blocks. reproduction studies, embryo-fetal deaths were observed with subcutaneous ventilatory support (assisted or controlled) is indicated. administration of bupivacaine to rabbits during organogenesis at a dose CONTRAINDICATIONS equivalent to 1.6 times the maximum recommended human dose (MRHD) DOSAGE AND ADMINISTRATION EXPAREL is contraindicated in obstetrical paracervical block anesthesia. While of 266 mg. Subcutaneous administration of bupivacaine to rats from implanta- Important Dosage and Administration Information EXPAREL has not been tested with this technique, the use of bupivacaine HCl tion through weaning produced decreased pup survival at a dose equivalent to • EXPAREL is intended for single-dose administration only. with this technique has resulted in fetal bradycardia and death. 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women • Different formulations of bupivacaine are not bioequivalent even if the WARNINGS AND PRECAUTIONS of the potential risks to a fetus. milligram strength is the same. Therefore, it is not possible to convert Warnings and Precautions Specific for EXPAREL The background risk of major birth defects and miscarriage for the indicated dosing from any other formulations of bupivacaine to EXPAREL. As there is a potential risk of severe life-threatening adverse effects population is unknown. However, the background risk in the U.S. general • DO NOT dilute EXPAREL with water for injection or other hypotonic associated with the administration of bupivacaine, EXPAREL should be population of major birth defects is 2-4% and of miscarriage is 15-20% of agents, as it will result in disruption of the liposomal particles. administered in a setting where trained personnel and equipment are available clinically recognized pregnancies. • Use suspensions of EXPAREL diluted with preservative-free normal to promptly treat patients who show evidence of neurological or cardiac toxicity. Clinical Considerations (0.9%) saline for injection or lactated Ringer’s solution within 4 hours Caution should be taken to avoid accidental intravascular injection of EXPAREL. Labor or Delivery of preparation in a syringe. Convulsions and cardiac arrest have occurred following accidental intravascular Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. • Do not administer EXPAREL if it is suspected that the vial has been injection of bupivacaine and other amide-containing products. While EXPAREL has not been studied with this technique, the use of bupivacaine frozen or exposed to high temperature (greater than 40°C or 104°F) for Avoid additional use of local anesthetics within 96 hours following administration for obstetrical paracervical block anesthesia has resulted in fetal bradycardia an extended period. of EXPAREL. and death. • Inspect EXPAREL visually for particulate matter and discoloration prior Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, to administration, whenever solution and container permit. Do not EXPAREL has not been evaluated for the following uses and, therefore, is not administer EXPAREL if the product is discolored. recommended for these types of analgesia or routes of administration. or pudendal block anesthesia, can cause varying degrees of maternal, fetal, • epidural and neonatal toxicity. The incidence and degree of toxicity depend upon the Recommended Dosing in Adults procedure performed, the type, and amount of drug used, and the technique Local Analgesia via Infiltration • intrathecal of drug administration. Adverse reactions in the parturient, fetus, and neonate • regional nerve blocks other than interscalene brachial plexus nerve block involve alterations of the central nervous system, peripheral vascular tone, and The recommended dose of EXPAREL for local infiltration in adults is up to a • intravascular or intra-articular use cardiac function. maximum dose of 266mg (20 mL), and is based on the following factors: EXPAREL has not been evaluated for use in the following patient population and, Data • Size of the surgical site • Volume required to cover the area therefore, it is not recommended for administration to these groups. Animal Data • patients younger than 18 years old Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits • Individual patient factors that may impact the safety of an amide local • pregnant patients during the period of organogenesis (implantation to closure of the hard plate). anesthetic The potential sensory and/or motor loss with EXPAREL is temporary and Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times As general guidance in selecting the proper dosing, two examples of infiltration varies in degree and duration depending on the site of injection and dosage the MRHD, respectively, based on the BSA comparisons and a 60 kg human dosing are provided: administered and may last for up to 5 days as seen in clinical trials. weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/kg/day (equivalent to 0.1, • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL ADVERSE REACTIONS 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and was administered with 7 mL infiltrated into the tissues surrounding the a 60 kg human weight). No embryo-fetal effects were observed in rats at the osteotomy, and 1 mL infiltrated into the subcutaneous tissue. Clinical Trial Experience doses tested with the high dose causing increased maternal lethality. An increase • In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL) of Adverse Reactions Reported in Local Infiltration Clinical Studies in embryo-fetal deaths was observed in rabbits at the high dose in the absence EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided The safety of EXPAREL was evaluated in 10 randomized, double-blind, local of maternal toxicity. into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock administration into the surgical site clinical studies involving 823 patients Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and face and slowly infiltrating one aliquot to each of the even numbers to undergoing various surgical procedures. Patients were administered a dose post-natal development study when pregnant animals were administered produce a field block. ranging from 66 to 532 mg of EXPAREL. In these studies, the most common subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride Regional Analgesia via Interscalene Brachial Plexus Nerve Block adverse reactions (incidence greater than or equal to 10%) following EXPAREL (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA administration were nausea, constipation, and vomiting. The common adverse The recommended dose of EXPAREL for interscalene brachial plexus comparisons and a 60 kg human weight) from implantation through weaning nerve block in adults is 133 mg (10 mL), and is based upon one study of patients reactions (incidence greater than or equal to 2% to less than 10%) following (during pregnancy and lactation). EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, undergoing either total shoulder arthroplasty or rotator cuff repair. hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, Lactation Compatibility Considerations muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain. Risk Summary Admixing EXPAREL with drugs other than bupivacaine HCl prior to administra- Adverse Reactions Reported in Nerve Block Clinical Studies Limited published literature reports that bupivacaine and its metabolite, tion is not recommended. The safety of EXPAREL was evaluated in four randomized, double-blind, placebo- pipecoloxylidide, are present in human milk at low levels. There is no available • Non-bupivacaine based local anesthetics, including lidocaine, may cause controlled nerve block clinical studies involving 469 patients undergoing various information on effects of the drug in the breastfed infant or effects of the drug an immediate release of bupivacaine from EXPAREL if administered surgical procedures. Patients were administered a dose of either 133 or 266 mg on milk production. The developmental and health benefits of breastfeeding together locally. The administration of EXPAREL may follow the of EXPAREL. In these studies, the most common adverse reactions (incidence should be considered along with the mother’s clinical need for EXPAREL and administration of lidocaine after a delay of 20 minutes or more. greater than or equal to 10%) following EXPAREL administration were nausea, any potential adverse effects on the breastfed infant from EXPAREL or from the • Bupivacaine HCl administered together with EXPAREL may impact the pyrexia, and constipation. underlying maternal condition. pharmacokinetic and/or physicochemical properties of EXPAREL, and The common adverse reactions (incidence greater than or equal to 2% to less Pediatric Use this effect is concentration dependent. Therefore, bupivacaine HCl and than 10%) following EXPAREL administration as a nerve block were muscle Safety and effectiveness in pediatric patients have not been established. EXPAREL may be administered simultaneously in the same syringe, and twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, Geriatric Use bupivacaine HCl may be injected immediately before EXPAREL as long as hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhid- Of the total number of patients in the EXPAREL local infiltration clinical studies the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL rosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, (N=823), 171 patients were greater than or equal to 65 years of age and does not exceed 1:2. edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, 47 patients were greater than or equal to 75 years of age. Of the total number The toxic effects of these drugs are additive and their administration post-procedural hematoma. of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients should be used with caution including monitoring for neurologic and Postmarketing Experience were greater than or equal to 65 years of age and 60 patients were greater than cardiovascular effects related to local anesthetic systemic toxicity. These adverse reactions are consistent with those observed in clinical studies or equal to 75 years of age. No overall differences in safety or effectiveness • When a topical antiseptic such as povidone iodine (e.g., Betadine®) and most commonly involve the following system organ classes (SOCs): Injury, were observed between these patients and younger patients. Clinical experience is applied, the site should be allowed to dry before EXPAREL is Poisoning, and Procedural Complications (e.g., drug-drug interaction, with EXPAREL has not identified differences in efficacy or safety between elderly administered into the surgical site. EXPAREL should not be allowed to procedural pain), Nervous System Disorders (e.g., palsy, seizure), General and younger patients, but greater sensitivity of some older individuals cannot come into contact with antiseptics such as povidone iodine in solution. Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), be ruled out. Studies conducted with EXPAREL demonstrated that the most common Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Hepatic Impairment implantable materials (polypropylene, PTFE, silicone, stainless steel, and Disorders (e.g., bradycardia, cardiac arrest). Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. titanium) are not affected by the presence of EXPAREL any more than they are DRUG INTERACTIONS Patients with severe hepatic disease, because of their inability to metabolize by saline. None of the materials studied had an adverse effect on EXPAREL. The toxic effects of local anesthetics are additive and their co-administration local anesthetics normally, are at a greater risk of developing toxic plasma Non-Interchangeability with Other Formulations of Bupivacaine should be used with caution including monitoring for neurologic and cardio- concentrations, and potentially local anesthetic systemic toxicity. Therefore, Different formulations of bupivacaine are not bioequivalent even if the vascular effects related to local anesthetic systemic toxicity. Avoid additional consider increased monitoring for local anesthetic systemic toxicity in subjects milligram dosage is the same. Therefore, it is not possible to convert dosing from use of local anesthetics within 96 hours following administration of EXPAREL. with moderate to severe hepatic disease. any other formulations of bupivacaine to EXPAREL and vice versa. Renal Impairment Patients who are administered local anesthetics may be at increased risk of Liposomal encapsulation or incorporation in a lipid complex can substantially developing methemoglobinemia when concurrently exposed to the following Bupivacaine is known to be substantially excreted by the kidney, and the risk affect a drug’s functional properties relative to those of the unencapsulated or drugs, which could include other local anesthetics: of toxic reactions to this drug may be greater in patients with impaired renal nonlipid-associated drug. In addition, different liposomal or lipid-complexed function. This should be considered when performing dose selection of EXPAREL. products with a common active ingredient may vary from one another in the Examples of Drugs Associated with Methemoglobinemia: OVERDOSAGE chemical composition and physical form of the lipid component. Such differences Class Examples Clinical Presentation may affect functional properties of these drug products. Do not substitute. Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Acute emergencies from local anesthetics are generally related to high plasma CLINICAL PHARMACOLOGY concentrations encountered during therapeutic use of local anesthetics or to Pharmacokinetics Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, unintended intravascular injection of local anesthetic solution. mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Administration of EXPAREL results in significant systemic plasma levels of Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, bupivacaine which can persist for 96 hours after local infiltration and 120 hours Antineoplastic cyclophosphamide, flutamide, hydroxyurea, ifosfamide, dizziness, dysarthria, confusion, mental obtundation, sensory and visual after interscalene brachial plexus nerve block. In general, peripheral nerve blocks agents rasburicase disturbances and eventually convulsions) and cardiovascular effects (that range have shown systemic plasma levels of bupivacaine for extended duration when Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, from hypertension and tachycardia to myocardial depression, hypotension, compared to local infiltration. Systemic plasma levels of bupivacaine following sulfonamides bradycardia and asystole). administration of EXPAREL are not correlated with local efficacy. Antimalarials chloroquine, primaquine Plasma levels of bupivacaine associated with toxicity can vary. Although PATIENT COUNSELING concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early Inform patients that use of local anesthetics may cause methemoglobinemia, a Anticonvulsants Phenobarbital, phenytoin, sodium valproate subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have serious condition that must be treated promptly. Advise patients or caregivers Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine been reported at levels as low as 800 ng/mL. to seek immediate medical attention if they or someone in their care experience Management of Local Anesthetic Overdose the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); Bupivacaine headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue. Bupivacaine HCl administered together with EXPAREL may impact the phar- At the first sign of change, oxygen should be administered. macokinetic and/or physicochemical properties of EXPAREL, and this effect The first step in the management of convulsions, as well as underventilation or is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be apnea, consists of immediate attention to the maintenance of a patent airway administered simultaneously in the same syringe, and bupivacaine HCl may be and assisted or controlled ventilation with oxygen and a delivery system injected immediately before EXPAREL as long as the ratio of the milligram dose capable of permitting immediate positive airway pressure by mask. Immediately of bupivacaine HCl solution to EXPAREL does not exceed 1:2. after the institution of these ventilatory measures, the adequacy of the circula- Pacira Pharmaceuticals, Inc. Non-bupivacaine Local Anesthetics tion should be evaluated, keeping in mind that drugs used to treat convulsions San Diego, CA 92121 USA sometimes depress the circulation when administered intravenously. Should Patent Numbers: EXPAREL should not be admixed with local anesthetics other than bupivacaine. convulsions persist despite adequate respiratory support, and if the status of Nonbupivacaine based local anesthetics, including lidocaine, may cause an the circulation permits, small increments of an ultra-short acting barbiturate 6,132,766 5,891,467 5,766,627 8,182,835 immediate release of bupivacaine from EXPAREL if administered together (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may Trademark of Pacira Pharmaceuticals, Inc. locally. The administration of EXPAREL may follow the administration of be administered intravenously. The clinician should be familiar, prior to the For additional information call 1-855-RX-EXPAREL (1-855-793-9727) lidocaine after a delay of 20 minutes or more. There are no data to support use of anesthetics, with these anticonvulsant drugs. Supportive treatment of administration of other local anesthetics prior to administration of EXPAREL. Rx only November 2018 continued from page 30 The rules are lengthy and complex, going on for technology and ensure that third parties will be able hundreds of pages, but nothing in them is a big sur- to connect. All of that takes time. prise. They carry out what Congress mandated in 2016 The rules get into the nitty gritty of making in- in its 21st Century Cures Act, a catch-all bill that also formation systems talk with each other and making included language to further “interoperability.” health care organizations adopt business policies to Advocates of interoperability (which is pretty much share patient information. The documents mention everybody but a few naysayers with privacy concerns) insurers only a few times in passing, but health plans say they welcome the CMS and ONC proposals. “I would definitely be affected by their approval, particu- view these rules as pretty groundbreaking,” says Anne larly in making their data accessible via APIs within Phelps, U.S. policy and regulatory leader at Deloitte a year or two. consulting. “They contain very laudable goals. The Other sections of the rules: idea is that patients will have more ... access to all the information about them, whether that’s claims infor- • Define what kind of patient information must mation or medical records, so as they move around be made available the health care system they are able to share that with • Prohibit information blocking (with seven spe- every touch point.” cific but limited exceptions, such as preventing Ben Moscovitch, who directs the Pew Charitable harm and protecting privacy) Trusts’ health information technology initiative, calls • Encourage sharing of data through “trusted” the ONC proposal “a key turning point.” exchanges Mike Funk, Humana vice president in the office • Require payers to provide additional resources of the chief medical officer, says the proposed rules on privacy and security will help ease the way for value-based care and the • Suggest how APIs and apps could be used to multiple sources of patient information that need to extract and transport data for whole patient be collected and shared. “You have hospital claims, populations, not just individuals clinical information, labs, data from personal devices, • Address how providers and plans can charge all collected in the EMR,” Funk says. “Along with the reasonable fees for packaging and sending data social determinants of health, that provides a longi- to other organizations. tudinal view of the patient’s health. That’s the great potential we see.” ONC also recognizes another sticky problem holding up exchange of information—the ability to Unrealistic deadline know for sure two different records with It’s not all sunshine and light. Insur- the same name belong to the same indi- ers are worried about meeting the 2020 vidual. The agency is asking for advice deadline for application programming on how to proceed to improve patient interface (API) software that will allow matching. their data bases to share information In a separate but related request for with third parties, such as mobile apps. information, CMS asked plans and provid- The CMS rule requires Medicaid, CHIP, ers to offer ideas about how to share their Medicare Advantage plans, and qualified negotiated rates and costs with the public. health plans on the exchanges to provide Phelps sees that price-transparency rule enrollees with immediate electronic access ONC’s attempt to remove some as something of a sleeper issue that will to medical claims and other information, of the barriers to sharing infor- dovetail with the data-sharing rules. starting in 2020. mation is “a key turning point,” Another open question is how patient America’s Health Insurance Plans says Ben Moscovitch, of the data will be protected as it gets passed from (AHIP), the health insurer trade organi- Pew Charitable Trusts. place to place. Particularly concerning is zation, issued a cautious statement that the fact that HIPAA privacy protections insurers strongly support providing patients with apply only to health care organizations, including meaningful access to their health information as long providers and payers. They don’t apply to third parties as it remains secure and private. But AHIP added that that develop digital apps such as Apple, for instance, the proposed deadlines are not feasible and would pose and are not considered part of the health care system. significant compliance burdens on health insurers. A Senate panel’s March 26 hearing on inter- Standards for the technical part of sharing are still operability ended up focusing largely on this dis- being developed, AHIP said, and once they’re done, connect, with senators and experts alike noting the insurers will have to build and test new standardized need to fix the gap.

MAY 2019 / MANAGED CARE 33 Pow-FHIR-ful tool that a 30-day medication reconciliation was done for On the optimistic side, the CMS rule also recognizes a particular patient on a specific date, and coverage strides being made by cooperative private sector initia- discovery, which allows care providers to request and tives such as the Da Vinci Project, which has providers, receive information on health plan coverage require- payers, and heath IT vendors working together to ments at the point of service. promote specific “use cases” of information sharing to Jocelyn Keegan, the project’s program manager, solve stubborn technology problems using a technical describes FHIR as “a really powerful tool” that allows standard known as FHIR (also strongly endorsed by developers to create “really great recipes” from a well- ONC). While Da Vinci has been around less than a stocked larder. “You bring in the smartest people year, it has already made progress on two use cases: a and build the best recipe you can to make pasta,” she simple workflow that care providers can use to show explains. “You could also take that base recipe and then make tortellini or ravioli. And you can make sure you get exactly the same pasta as someone else Leonardo’s list who is making it across the country.” 37 organizations are participating in the Da Vinci Da Vinci has several more use cases in development Project, an effort to iron out hard-to-solve health and wants to move fast to get them going, Keegan says. IT problems. Insurers are motivated to make these data-sharing • Allscripts technologies work because without them, value-based • Anthem payment models will stall. “We have competitors • ATI Physical Therapy sitting side-by-side on calls trying to solve these table • Blue Cross Blue Shield Association stakes kind of issues so the market can compete on • Blue Cross Blue Shield of Alabama differentiating factors, not just how to make data flow • Blue Cross Blue Shield of Michigan from point A to point B,” she says. • Blue Cross Blue Shield of Tennessee Phelps at Deloitte encourages both payers and • Blue Cross of Idaho providers not to look at interoperability as just an IT • Cambia Health Solutions department problem or a compliance issue. “Look at • Casenet it from a strategic point of view as well,” she urges. • Cerner While insurers will first be reading the final rule— • Cigna potentially out this summer—with an eye to how to • CMS avoid running afoul of federal bureaucrats, they will • Cognosante also be thinking about how to make it work for them, • Edifecs Phelps says. • Epic Phelps urges her clients to look at the big picture • Guidewell of where federal health care agencies are pushing the • Health Care Service Corp. industry, with interoperability and with MACRA’s • HealthLx alternative payment mechanisms carrot-ing and stick- • HIMSS ing providers into measurably efficient care. • HL7 “We’ve been talking about these issues for a long • Humana • Independence Blue Cross time—value-based care, improving quality, giving • InterSystems patients more information,” she says. “This is all a road • Juxly map of how they want us to do it, where the future • MultiCare Connected Care of health care is. I’m not saying it’s easy, it’s going to • NCQA be bumpy and the timelines are short, but these are • Oregon Health & Science University the goals.” • Optum • Rush Medical TELL US ABOUT WHAT’S NEW • Surescripts • Sutter Health Managed Care is seeking ideas and opinions for • Texas Health Resources our July–August Innovations issue. What is your • UnitedHealthcare company or group doing that is new—and dazzling? • Virence Maybe you have added a novel twist to an existing • Weill Cornell Medicine program? Or ventured into entirely uncharted terri- • ZeOmega tory. Any early results? Write to our managing editor, Frank Diamond, at [email protected].

34 MANAGED CARE / MAY 2019 Beware of the CAR-T Hitches CAR-T treatments are all the rage and showing some remarkable results. But the high price, along with the lack of long-term results, quiets the optimism. Perhaps it will. CMS, for example, is taking steps By Susan Ladika to set a national policy for coverage, although it has strings attached that some doctors and hospitals find avneet Majhail, MD, seldom sees medical objectionable. Among those strings are a requirement developments as game changing. After all, to monitor patients for two years after treatment with Nmedical progress tends to be a game of inching an eye toward assessing which types of patients would forward, not rewriting the rules. benefit most from CAR-T. But the director of the Cleveland Clinic’s blood and Meanwhile, clinical trials are underway to deter- marrow transplant program is making an exception mine if CAR-T could prove effective for other cancers, for CAR-T. Majhail’s caution and aversion to rah-rah including some of the most common ones, such as is on display when he describes CAR-T rather dryly as breast cancer. Million-dollar price tags have lost their “a unique, highly innovative therapy that reprograms the body’s immune system.” By doing so, he says, it provides “an option for treatment for patients who would not have meaningful therapies.” But the enthusiasm comes through when he talks about one of his patients, a woman in her 30s with non-Hodgkin’s lymphoma. Conventional chemotherapy and a stem cell transplant had failed to reduce a mass in her abdomen. CAR-T treatment was a different story. Six weeks later, the mass had vanished. That’s the buzz. The buzzkill is the price, as well as the lack of long-term results. The two CAR-T therapies approved for certain blood cancers have price tags of $475,000 and $373,000—and those prices don’t include other costs for In CAR-T therapy, a patient’s T cells are harvested and modified so they express a services that are integral to the treat- chimeric antigen receptor that recognizes and binds to antigens on the cancer cells ments, such as harvesting a patient’s T (pictured in green). cells. Moreover, patients typically have a lengthy hospital stay after treatment. Serious side shock value, partly because what actually gets paid can effects can land patients treated with CAR-T therapies be far less. But it’s hard to imagine even the spendthrift in the ICU for days. American health care system being able to afford When you add it all up, a CAR-T treatment costs, on CAR-T at its current price levels if it becomes a routine average, about $1 million, says Mara Bloom, executive treatment for common types of cancer. director of Massachusetts General Hospital’s Cancer Technologies like CAR-T drop in price as they Center. Hospitals are providing CAR-T because “this become more widespread, say optimists. CAR-T is the right thing to do by the patient,” she says. (Favor- technology could mean a day of reckoning for heed- able publicity and staying ahead in the medical arms less American health care expenditure, counter the race may also be factors.) Currently, the costs often pessimists. outpace insurer payments, so CAR-T treatment can leave hospitals hundreds of thousands of dollars in the Some firsts red. But, as with other innovative treatments, hospitals There’s no denying the amazing ingenuity of CAR-T. A are hoping “reimbursement will catch up,” notes Bloom. dose is produced by harvesting a patient’s T cells and

MAY 2019 / MANAGED CARE 35 then sending them to a manufacturing center where But the collective payer brow is furrowed. “These they are genetically engineered to include a gene that therapies, while innovative, do not have the long-term targets and kills the specific cancer cells. The relative evidence to confirm they are a lifetime cure,” said handful of genetically modified T cells is multiplied Kristine Grow, a senior communications official for many times over so millions are shipped back to the America’s Health Insurance Plans (AHIP), the health hospital, where they are infused back into the patient insurers’ trade group, in an email. “Many of these to home in on cancer cells and kill them off. gene therapies have not yet effectively demonstrated “We’re entering a new frontier in medical innovation long-term safety or duration of effect.” Insurers are with the ability to reprogram a patient’s own cells to reviewing CAR-T therapies on a case-by-case basis, attack a deadly cancer,” former FDA Commissioner wrote Grow, and keeping an eye on FDA safety notices Scott Gottlieb gushed in a press release in August 2017, and new clinical findings. when the agency approved the first CAR-T agent, Bloom at Mass General says that private insurers Novartis’s Kymriah (tisagenlecleucel). Kymriah was ap- were receptive after the FDA approved Kymriah and proved as a treatment for refractory or relapsed B-cell Yescarta: “There was an understanding that this was precursor acute lymphoblastic leukemia something of high value to patients.” in patients younger than 25. At Mass General, coverage of CAR-T has been approved on a case-by-case basis, Still ascendant with only a few denials, she says. As the Some consider Kymriah the first FDA- hospital has treated more patients, the approved manifestation of precision medi- approval process has become more stream- cine. “This truly is personalized medi- lined. In the 2018 fiscal year, which ran cine,” says Bloom. The FDA also anointed from October 2017 to October 2018, the Kymriah the first gene therapy, although hospital performed CAR-T “standard of there’s some disagreement about what care” treatments for 21 patients, (along should be considered gene therapy. Even “We’re still learning why with 50 patients who were treated in clini- by today’s standards, the $475,000 price tag it works and why not,” says cal trials). Bloom says Mass General offi- was staggering. Two months after giving Navneet Majhail, MD, of cials expect to treat about 40 patients with Kymriah the go ahead, the FDA approved the Cleveland Clinic, about CAR-T each year, in addition to patients a second CAR-T therapy, Yescarta (axi- CAR-T therapy. in clinical trials. As Mass Gen negotiates cabtagene ciloleucel) as a treatment for new contracts with private insurers, Bloom relapsed or refractory large B-cell lymphoma in adults. hopes to move to bundled arrangements for CAR-T The $373,000 price tag was a bit less than Kymriah’s and other standardized agreements. but in the same league. Anyone who has witnessed the advent of a new or Long hospital stays are common semi-new cancer treatment is familiar with the flight As is so often the case with new treatments and tech- of hope and hype, followed by the fall back down to nology, the future of CAR-T—at least during the next earth. By and large, CAR-T is still on the ascendant few years—will be shaped to a large extent by Medi- side of the narrative. For example, in a presentation at care coverage. “Even though it’s gotten significantly the American Society of Hematology’s annual meeting better, it’s still terrible,” says Gary Goldstein, business in December 2018, physicians from the Children’s manager of the blood and marrow transplant program Hospital of Philadelphia reported an 82% remission at Stanford Health Care, part of Stanford University. rate within three months of an infusion with Kymriah A CMS decision that took effect in October puts in children and young adults being treated for acute inpatient reimbursement for the CAR-T product at lymphoblastic leukemia. “To see this 82% remission a maximum of $186,500, according to Goldstein. rate in our patients is beyond what I ever imagined That doesn’t include hospitalization and other costs. when we treated our first patient in 2012,” Stephan However, for outpatient care, CMS said last spring it Grupp, MD, director of the cancer immunotherapy at would reimburse hospitals about $400,000 for Yescarta, the children’s hospital, said in a press release issued by and about $500,000 for Kymriah treatments. the hospital. The Philadelphia physicians also reported Goldstein says CMS has never explained the dif- a 62% relapse-free survival rate at 24 months. ference in reimbursement levels for inpatient and At the same conference, Gilead announced that outpatient CAR-T therapy: “It’s especially troubling almost 40% of lymphoma patients treated with its because most CAR-T treatments take place in the CAR-T therapy, Yescarta, were responding at least inpatient setting.” Because of CAR-T’s toxicity, it’s two years after treatment. sometimes not safe or practical to deliver the therapy

36 MANAGED CARE / MAY 2019 on an outpatient basis, Goldstein says. December 2017 and December 2018, two did not A review of costs by Vizient, the health care consult- survive 30 days after the infusion, while four didn’t ing company, found that adult patients who receive survive one year. Of the other five, the company only CAR-T have a median hospital stay of 15 days, at a had claims data on one patient, who was still alive median cost of more than $85,000. For patients under after more than six months. the age of 25, the median hospital stay is 19 days, with If CAR-T was administered sooner after diagnosis, a median total cost of more than $242,000. patients might not be as ill and it could save money In February 2019, CMS proposed a nationwide in terms of patients not having to go through other policy for Medicare coverage for CAR-T, rather than treatments that ultimately fail, such as chemotherapy leaving it up to the decision of local Medicare admin- or stem cell transplants. “That could greatly offset istrative contractors. Under the proposed policy, for its costs and ultimately be a cost savings to society,” patients to be covered they would have to be enrolled in Goldstein says. a CMS-approved registry or clinical study, with patients CAR-T proponents welcome the CMS coverage, of monitored for at least two years following treatment. course, but the interplay between coverage and medical CMS argues that the registry and trials would give CMS advances can be awkward. Goldstein is concerned the data it needs to determine which patients benefit that CMS will approve CAR-T reimbursement for from CAR-T and would influence future coverage particular types of cancers, but then researchers will decisions. A final decision on nationwide coverage is discover that it works for other types of cancers that expected this month. UnitedHealthcare had requested aren’t covered by CMS. the national coverage decision. The American Society for Blood and Marrow Off the shelf would be cheaper Transplantation has some qualms about the cover- One possible scenario is that the price of CAR-T will age decision. Majhail, at the Cleveland Clinic and fall so the coverage issues become less problematic. the society’s president, says the proposed require- Maria Whitman, managing principal with the pharma- ment that patients be part of a registry or a clinical ceutical consultancy ZS Associates, says savings could trial, with no funding provided to help cover the come from more standardized manufacturing pro- costs that would be incurred, would be “onerous” cesses. Currently it takes between one and four weeks and duplicative. He says hospitals already provide from the time T cells are collected until the genetically detailed information to the Center for International engineered versions are infused back into the patient. Blood and Marrow Transplant Research (CIBMTR). Vulnerable patients have to get through that period The center is a research collaboration between the while the tailor-made therapy gets made. Whitman National Marrow Donor Program/Be the Match and says researchers are looking at whether CAR-T may the Medical College of Wisconsin. The center works to become an off-the-shelf product, manufactured from improve the treatment, survival, and quality of life for the stem cells of healthy donors, so patients could be transplant patients. An international network of trans- treated much more quickly. plant centers submit patient data, and CIBMTR has More manufacturers are looking to enter the CAR-T been collecting data on the outcomes of hematopoietic market. “I think when we see more competition in the cell (stem cell) transplantation for more than 45 years. marketplace, [price] will go down,” says Goldstein. Last year, CIBMTR reached agreements with both Entering the market might become even more ap- CAR-T makers to collect long-term safety and efficacy pealing if it is used to treat a wider range of cancers. data from patients. Experts say CAR-T may next be approved by the FDA for treatment of multiple myeloma. Clinical Humana’s experience trials are underway to gauge its effectiveness fight- Despite all the promise of CAR-T, there’s still much ing solid tumors, such as breast cancer and prostate to be done to determine its success as a long-term cancer. It is already showing promise as a treatment treatment, as well as to determine if it can become for glioblastoma. financially viable. Experts hope research will identify On the other hand, success fighting these other types the patients who will benefit the most—and also find of cancers could push up demand. The skyhigh prices ways to reduce complications, Majhail says. “We’re might even go higher. “From a society perspective we still learning why it works and why not.” don’t condone the high cost,” says Majhail. “This is Humana’s letter to CMS outlining its clients’ ex- just not sustainable.” periences with CAR-T shows that the learning curve remains steep. Of the 11 Humana Medicare benefi- Susan Ladika is an independent journalist in Tampa, ciaries who had received CAR-T treatment between who covers health care and other issues.

MAY 2019 / MANAGED CARE 37 OUR YEARLONG LOOK: EMERGENCY CARE EXAMINED

THE URGENT CARE SURGE They are touted as an alternative to emergency departments. Private companies are seeing an opportunity. But are urgent care centers meeting a demand or creating one?

By Joseph Burns system with a middle-ground price point: below what Contributing Editor hospitals charge patients for an ED visit but perhaps just a bit higher than what a physician might charge loor-to-ceiling windows line three sides of the for last-minute walk-in care. glass and steel front of one of the newest urgent Max Puyanic, CEO of ConvenientMD, says the Fcare centers in Massachusetts. In the resort town average charge in its 15 facilities in New England is of Falmouth (winter population of 30,000 but almost $150. Most patients are insured and hand over a copay three times as many in the summer), ConvenientMD and a fee for ancillary services. On average, insured opened the latest of its 15 urgent care centers in New patients have out-of-pocket costs of $60 or less and England. rarely pay more than $250 for a visit, he says. On one of Falmouth’s busiest streets, ConvenientMD built this two-story structure last year, replacing a 8 to 8 former BP filling station. One day in late February, Since 2013, the privately held company has opened the waiting room was empty except for three long nine such centers in New Hampshire and three each couches and dozens of black fabric and steel-legged in Maine and Massachusetts. In the coming months, chairs against the windows. Inside is a suite of 15 it plans to open 11 more. Each is open from 8 a.m. rooms, two each for triage and procedures, eight for to 8 p.m. every day of the year except Thanksgiving exams, and one for patients requiring IVs. It also has and Christmas. an X-ray room and an area to run routine clinical Puyanic views the Falmouth facility as a calculated laboratory tests. risk. It’s located less than a mile from two other urgent A far cry from a crowded hospital emergency de- care centers and less than a mile and a half from partment, it’s a spotless and shiny example of urgent Falmouth Hospital. “We chose Falmouth because care, a growing presence in the American health care it has very high ED utilization per capita,” he says.

38 MANAGED CARE / MAY 2019 “It also has a low number of PCPs per capita, which The UC, ED lines crossed contributes to high ED volume.” Urgent care visits for low-acuity conditions overtook ConvenientMD is among a growing number of ED visits for those conditions in 2012. urgent care centers in the country owned by private companies. According to an annual report from the Urgent Care Association (UCA), private companies 200 now own 39% of the urgent care centers in the country. 180 160 The next large group are joint ventures with a hospital Total 140 (16%), followed by hospital-owned centers (15%), and 120 those owned by physician groups (14%). 100 Emergency department 80 What’s driving the numbers 60

The appetite for convenience and health insurers’ need Visits per 1000 Members 40 Urgent care Retail clinic 20 to provide members with access to primary care and, Telemedicine of course, the drive for cost control, are among the 0 factors driving up the number of urgent care centers. 2008 2009 2010 2011 2012 2013 2014 2015 Year As of November 2018, there were 8,774 such centers in the United States, up 8% from 8,125 in 2017, ac- Source: Poon SJ et al., JAMA Internal Medicine, October 2018 cording to the UCA report. Although they are not exclusively for people with insurance, just under half fostering such growth given that UCA traces the birth (47%) of the patients seen in urgent care centers are of urgent care to PCPs themselves. “Urgent care centers covered by commercial insurance, according to the emerged largely as a physician or physician-group UCA survey, and a quarter (27%) are covered by either strategy,” UCA says in its 2018 industry report. In Medicare or Medicaid. 2008, physicians owned 54.1% of urgent care centers About a third of the patients visiting urgent care and hospitals had 24.8% of the total. Six years later, the centers have no primary care physicians, says UCA two owned about an equal share of the market when CEO Laurel Stoimenoff. “For that reason, urgent care physicians had 40% and hospitals 37%, according really is a great connector because the number one to those who responded to a UCA member survey. referral we make is to primary care or into a medical home.” Hospitals fear loss of revenue It’s ironic that a lack of access to primary care is Hospitals have scrambled to get into urgent care centers to prevent their insured patients from leaking away Vocabulary lesson

The Urgent Care Association defines urgent centers as facilities that offer a range of care for immediate but nonemergency or non–life-threatening conditions. At these centers, providers will treat patients who have the flu, broken bones, or asthma or who need concussion screening. They will provide X-rays, intravenous fluids, and routine lab tests onsite. Most insurers provide coverage for urgent care services, according to the association. Retail or walk-in clinics are in supermarkets or pharmacies. They offer services for conditions less serious than those handled at urgent care centers or EDs, such as uncomplicated minor illnesses and preventive care such as vaccinations. Onsite clinics that some employers offer to workers and their family members are similar to retail clinics in that they provide wellness and Urgent care ”really is a great connector because the num- preventive services that vary by location, accord- ber one referral that we make is to primary care or into a ing to the association. medical home,” says Laurel Stoimenoff, CEO of the Urgent Care Association.

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hile ConvenientMD is aggressively pursuing Ocean off the Southeast corner of Massachusetts is just Wmarket share in New England, so too is Cape Cod one example of how urgent care is growing nation- Healthcare (CCHC) in the 13 towns that make up its Cape wide. In Saint Augustine, Fla., urgent care operators Cod home. In 2017, CCHC opened an urgent care facility have opened four such centers since 2010 to compete on Teaticket Highway in Falmouth, just steps away from against family medicine physician Scott Michaels, MD, the Falmouth Walk-In Medical Center & Urgent Care, who operates an urgent care center in addition to his which Paul C. Lee, MD, has operated for more than 35 family practice, and Island Doctors, which opened years, and just over a mile from the Falmouth Hospital three urgent care centers. emergency department. As CCHC seeks to meet those needs, its four urgent CCHC has also opened three other urgent care centers care centers are not licensed under the same regula- on Cape Cod, one in 2016 and two others in 2017. tion as CCHC’s two hospitals, says CEO Mike Lauf. “That’s In 2012, CareWell Urgent Care entered the market, why we’ve been able to reduce the cost so much so that opening a facility in the town of Dennis, about 45 min- health insurers have been very good to work with in this utes from Falmouth. That’s six urgent care centers all area,” he adds. opened in seven years, not including an untold number Health insurers in Massachusetts have responded of physician-owned walk-in clinics such as the one that favorably, says Lauf. One of those insurers is Blue Cross Lee operates. Blue Shield of Massachusetts, which has more than 110 This narrow spit of land jutting into the Atlantic urgent care centers in network. to alternative sites of care, comments Ateev Mehrotra, it defined as urgent care, dental centers, and physical MD, an associate professor of health care policy and therapy outlets. medicine at Harvard Medical School. “Why should hospitals let their patients go elsewhere for care?” Insurers are definitely interested he asks. Fearing the loss of revenue is an important Insurers, of course, have a dog in this fight—they don’t factor, but also hospitals want to keep these patients want to pour money into ED costs—and some are so they can retain patients’ electronic health record helping members consider options to the expensive data. If patients get care elsewhere, those records emergency department care. Katherine Dallow, the could be lost. “That’s really a quality concern, but it’s vice president of clinical programs and strategy for an important one,” he says. Blue Cross Blue Shield of Massachusetts, notes that both the BCBSMA website and smartphone app list Potentially lucrative emergency department alternatives, including urgent Owning urgent care centers helps hospitals and health systems such as Dignity Health, HCA, Aurora Health, Surging ahead and Intermountain Health attract patients they might Urgent Care Association surveys show a 44% growth in otherwise lose, notes Mehrotra, who is also a member the number of urgent care centers since 2013. of Managed Care’s Editorial Advisory Board. In 8,774 recent years, hospitals have spent freely to acquire 8,125 physician practices. Now, by opening urgent care 7,271 centers, hospitals and health systems can steer patients 6,946 6,400 who lack primary care physicians to those recently 6,100 acquired practices, Mehrotra explains. Health insurers also are getting into urgent care. One reason UnitedHealth Group’s Optum division acquired DaVita Medical Group two years ago was to gain access to its 35 urgent care centers. In 2015, Optum purchased MedExpress Urgent Care, which runs 250 centers in 20 states. According to UCA, private-equity investors are getting involved, an indication that urgent care is a potentially lucrative business. In an article last year in Forbes, Bain & Company reported that private equity 2013 2014 2015 2016 2017 2018 was making its way into retail health centers, which Source: Urgent Care Association, 2018 survey responses, March 2019

MAY 2019 / MANAGED CARE 41 care centers. BCBSMA tells members they should go to the nearest ER if their condition is life-threatening. “However, for other situations, including urgent care, you have options that can save you time and money,” the website says. Among five listed options, the first is to call the toll-free nurse hotline. The price category of the next four is indicated with dollar signs in the same way that restaurant guides show how expensive a restaurant is. The BCBSMA website also instructs members about the types of medical problems each service can deal with. Video visits (aka telehealth), which have a two dollar sign ranking ($$), are for back pain, cough, diarrhea, or respiratory and sinus infections, among other ailments. BCBSMA says “limited-service clinics” (aka retail clinics), which also get a $$ cost ranking, are for those who have a cold or flu, bronchitis, sore throat, gout, or strep throat. Urgent care is categorized at a $$$ price and is for members who have broken Are urgent care centers meeting a demand or creating a new one? It’s debatable, says Sabrina Poon, MD, an emergency medicine physician who cowrote a study detailing Anthem reportedly trends in the industry for JAMA Internal Medicine. backs away from bones (presumably minor fractures), minor burns, and controversial ED policy other minor injuries or who need X-rays or lab tests. Last and the most expensive is the ED ($$$$$$). The ver the past two years, Anthem has taken Oheat from the American College of Emer- BCBSMA website says the ED should be reserved for gency Physicians, the American Heart Associa- those needing “full hospital service for severe symp- tion, and groups such as AARP when it denied toms that could seriously jeopardize your health or claims for ED visits that it deemed avoidable. the health of another (including an unborn child).” The federal Emergency Medical Treatment and Urgent care is coming on strong as patients and Labor Act (EMTALA) of 1986 requires hospitals to payers struggle with the escalating cost of emergency stabilize and treat anyone who shows up at an department care. According to the Health Care Cost ED regardless of their insurance status. Under the Institute (HCCI), from 2012 to 2016, the cost of an law, health insurers cannot deny coverage for an outpatient ER visit rose 31% to $1,917. During the ED visit that a “prudent layperson” would deem same period, ER use increased by 2%, or about four reasonable. visits per 1,000 insured individuals. “The price in- “However, insurers have utilized that am- biguous standard to deny claims for emergency crease, in combination with the slight increase in use, room care retroactively, arguing that a visit was drove 40% of the increase in total outpatient spending ‘avoidable’ based on the final diagnosis, not between 2012 and 2016,” said an HCCI report issued the symptoms that prompted the emergency in January 2018. department treatment,” according to the Doctor- A different study painted a different (and bright- Patient Rights Project, a not-for-profit coalition er) picture for insurers worried about ED costs. In of doctors, caregivers, and patients that gets October, Mehrotra and other researchers reported funding from pharmaceutical companies and results in JAMA Internal Medicine showing that ED patients’ groups. visits for low-acuity conditions (such as bronchitis, According to news reports, Anthem has since urinary tract infection, rash, and muscle strains) de- backed off on that policy, but no one at the creased by 36% from 2008 through 2015. Over those company would answer questions for this article. Instead, a company representative provided a same eight years, visits to non-ED sites (urgent care, statement saying that its goal is to ensure access retail clinics, and telemedicine) increased by 140%. to high quality, affordable health care by encour- The use of urgent care rose by only 119% while the aging members to seek care in the most appro- use of retail clinics rose by 214%, the researchers priate setting. reported. However, a closer look shows that in absolute numbers many more patient visits occurred

42 MANAGED CARE / MAY 2019 The UC patient payer mix $1,637 per visit in 2015, Mehrotra and his colleagues Almost half of the patients seen in urgent care centers found. The increase in price per ER visit came in part in 2017 were covered by commercial insurance. as a result of treating patients with more complex needs. “Visits for the same complexity became more costly and more visits were coded as more complex,” Mehrotra says. “Whether they were truly more complex or the physicians got better at coding them as Medicare or more complex is less clear.” Medicaid 27% There’s also the larger question whether urgent care Commercial centers are meeting an existing demand or creating a 47% new one, says Sabrina Poon, MD, the first author of Other the JAMA Internal Medicine study and an emergency 4% medicine physician and instructor at Vanderbilt Uni- Fully cash pay versity School of Medicine. 7% “What some people might say about that is the demand is there among patients,” she says. “Therefore, there is a health need for urgent care, and it’s providing Occupational health or workers’ comp 15% an important service. On the other hand, the convenience of urgent care may be inducing unnecessary Source: Urgent Care Association, 2018 survey responses, March 2019 demand among those who may not have sought care otherwise. So, is this kind of service wasteful?” she in urgent care settings than in retail clinics in 2008, asks. “What is the need and are we fulfilling that need and that difference continued through 2015. responsibly?” Visits to ED and urgent care centers are both go- To answer this question, Lindsay Allen and co- ing up, in part because patients often struggle to get authors published a National Bureau of Economic timely appointments even if they a have a PCP, notes Research study titled, “Urgent Care Centers and the Mehrotra. No one wants to go to the emergency de- Demand for Non-Emergent Emergency Department partment if the trip can be avoided, he says, because of Visits.” the cost—the ED is a major source of out-of-network An assistant professor of health economics and surprise billing—and the waits. The alternatives to the policy at West Virginia University, Allen says the re- ED satisfy a widely held preference. search shows that urgent care has cut demand for ED In addition to lower cost and more convenience, visits. To analyze the use of urgent care centers versus other factors are fostering the growth of urgent care. the demand for nonemergent ED visits nationwide, “I don’t think there’s a single driving factor,” Mehrotra she and her colleagues looked at ED demand after 8 says. Instead, there are more urgent care centers be- p.m., when most urgent care centers close. cause private companies have emerged to fill the need “After UCCs close each day, local nonemergent left by PCPs who have no open appointments for days ED visits increase by 1.43% in areas with multiple or weeks, he says. UCCs,” they wrote. This effect occurs, however, only “When we talk to patients they say the number among the privately insured population, which has one, number two and number three reasons are con- been the target group of UCCs. If the reduction seen venience,” says Mehrotra. “That implies that the exist- in the NBER study were applied to all ED care, there ing care options are a royal pain.” Almost all (94%) would be 2.4 million fewer ED visits and $1 billion patients see a provider in less than 30 minutes, says in savings annually, Allen says. the Urgent Care Association, and more than 70% of While their study focused on the insured popula- patients wait less than 20 minutes. For most patients tion, in part because urgent care centers were founded (85%), the total visit time is less than 60 minutes. initially to treat these members, the number of visits While visits to urgent care centers are rising, costs to urgent care centers among Medicaid and uninsured were steady in such centers over the eight years stud- patients is also rising, she adds. ied. Using inflation-adjusted prices, Mehrotra and “There used to be a very small percentage of urgent colleagues showed that for low-acuity conditions, care centers that accepted Medicaid and very few un- the price of a visit to an urgent care center declined insured patients would visit them,” Allen says. Today, slightly from $165 in 2008 to $162 in 2015. Medicaid programs also want to take advantage of But over the eight years in the study, charges for the lower costs relative to hospital emergency rooms, ED care rose by 79% from $914 per visit in 2008 to she says.

MAY 2019 / MANAGED CARE 43 VIEWPOINT Medicare for All Should Not Be One Size Fits All

By Deborah D. Gordon lives. To protect their privacy, their names have been changed. ith Medicare for all emerging as a defin- ing issue in the 2020 election, single payer The cost of hope Whealth care seems more plausible than ever. On Easter Sunday in 2015, Leah, a married, 43-year- But for Medicare for all to truly work for all Ameri- old mother of a young boy, headed to the emer- cans it must do more than provide uniform, basic gency room with excruciating abdominal pain. She insurance. It must also create room for consumer- questioned whether she should bother, but a family driven choice. member insisted she go. After a battery of tests, Leah In more than 60 consumer interviews for my received a shocking diagnosis: stage 3 ovarian cancer. Harvard Kennedy School research on health care She started on a treatment plan and set off to fight an purchasing, I repeatedly heard anger and frustration often-lethal cancer. from consumers who felt the available options just Leah can’t quite explain her treatment’s costs. “It’s did not work for them. While some consumers felt so awful to look at hospital bills, even though most helpless and resigned to a poorly functioning health of it is covered.” She imagines the drug keeping her system, others expended great personal energy to alive, Lynparza (olaparib), is extremely expensive. extract the value they wanted. “I don’t even want to know what this medication is In some cases, navigating the system was more than costing my insurance.” She speculates it is “thousands a hassle; it was a matter of life and death. and thousands of dollars.” The stories of two consumers—Leah and Andrea— Her husband had gotten a job two months prior at illustrate how consumer-driven health care can save a regional bank with generous family health benefits.

44 MANAGED CARE / MAY 2019 Nonetheless, Leah accumulated a balance bill that Like shopkeepers with set inventories, Andrea’s hovers constantly around $1,000. She pays it down doctors offered what they had, but no more. “I’m $65.54 a month. my own advocate. My husband’s my advocate. We A few states away, Andrea knows exactly what are the quarterbacks, we’re in charge of the process.” Lynparza costs. A young mother, she first went to She learned to play this role when it became clear no the emergency room in 2017 with jaundice and se- one else would. “I’ve always trusted my doctors and vere itching. Her diagnosis was similarly devastating: did what they said. This was my first experience with pancreatic cancer. Facing a 9% five-year survival rate, health care where I realized it’s not up to them, it’s up Andrea felt overwhelmed by bleak odds. Her cancer to me, and I need to figure things out for myself as to didn’t respond to the first-line chemotherapy, and how I want to be treated, where I want to be treated, tumors spread to her liver. She and her family feared and when.” the worst. Andrea’s efforts paid off. The drug is holding her Andrea traveled to get several medical opinions. Ex- cancer markers in the normal range. “For me it was pert advice led her to genetic testing and to Lynparza, a life-and-death situation. We wanted to do anything approved for breast and ovarian cancer but still experi- that we could to keep me healthy and alive.” mental as a pancreatic cancer treatment. “I had the option of going into a [clinical] trial,” she explained. The benefits of breaking the mold “But the trial has people on a placebo. At 37 years old, Would Medicare for all afford Andrea this choice? with three young children, I wasn’t willing to take the Today, we have potential cures for the worst cancers. risk that the cancer could metastasize more.” Instead, If you have one of those, you may be able to trust she decided to pay for the drug out of pocket. The the standard of care, accepted as such because best- monthly bill? $14,700. Andrea and her husband, a available evidence suggests it holds the most promise real estate executive, use savings for the most people. In this camp, Leah leans heavily to pay for it. on her doctors’ guidance. “I feel these are the best doctors, probably in the Forging a unique path world for what I have.” She rarely questions them. “I Leah and Andrea are like two let the doctors worry about that. I just feel like it’s different shoppers preparing for their job, they get paid the big bucks to think about a formal gala. Leah walked into this stuff, and then I just do what they tell me.” With a high-end designer store and insurance, their recommended treatment is likely to found a dress on the rack; the be covered. Deborah D. Gordon standard size fit with no altera- If you don’t fit the mold, you still might be able to tions. Maybe she even found it get the best care, but only if you’re willing and able on sale, putting the still-pricey dress within reach. to find it for yourself. You may also have to foot the Andrea chose to commission a custom gown to get whole bill, which is impossible for many people. one that fit her well, at great expense. They both look Perhaps a reluctantly empowered health care con- fabulous but arrived at the same outcome through sumer, Andrea benefited from free-market forces very different means. not always at work in American health care. She first Leah benefits from an effective treatment that has rebalanced the classic information asymmetry between been studied, approved, and is now the standard of patients and doctors—in which patients must rely on care for her cancer. She credits a maintenance dose doctors for answers—and found a nonstandard path of Lynparza with keeping her in remission. Under to life-saving treatment. Her economic circumstances Medicare for all, more people like Leah would likely gave her options that others don’t have; her drug costs have access to the same life-saving treatment, made many times most people’s rent or mortgage. “I can’t affordable through broader insurance coverage. imagine if I didn’t have the money to pay for it,” she Andrea, on the other hand, had to forge her own says. “Knowing it’s out there and you can’t access it path, an option she may not have in a single-payer unless you have the money to pay for it, it’s just a system. Her initial treatment was based on protocol, terrible feeling.” not her specific situation. That protocol didn’t work, so she sought a personalized solution. “If you have Little flexibility caregivers and you, yourself, are feeling well enough Today, only the very wealthy and extremely resourceful to do research to find out about all these trials, I think get early access to the most promising treatments until the information is out there, but it requires a lot of they become the standard. Single-payer schemes don’t time and effort.” typically offer flexibility to deviate from that standard,

MAY 2019 / MANAGED CARE 45 but Medicare for all proposals should strive to distribute such access more equitably. Join Formkit.com These proposals should also provide consumer sup- and get formulary data port. When the stakes are life or death, not all consumers can act as their own health care advocates, nor should when you need it! they have to. Andrea was able to self-advocate thanks to a mix of privilege—financial means, a supportive family and strong Current kits community, and a lifetime of elite education—and tenac- Thanks for reading, and happy new ity born of hardship. When she was a teenager, her father INGREZZA™ year to you and all the kids, big and small, left while her mother was hospitalized. The traumatic (valbenazine) tabletsin your world. n separation left her largely on her own to parent herself. This personal history equipped her with the resiliency to navigate a terrifying diagnosis without institutional KEDRAB™ support. (Rabies Immune Globulin [Human])

‘People don’t know what they’re not asking’ Even before Andrea’s financial resources came into play, LOKELMA™ hard-won transparency allowed her to advocate for a (sodium zirconium cyclosilicate) 10 g for oral treatment about which she otherwise would not have suspension known. “I think it’s very difficult to be a health care consumer right now,” Andrea observed. “People don’t know what questions they’re not asking. So it’s not like you can NEW: PERSERIS™ figure out what you’re doing wrong. A lot of people don’t (risperidone) for extended-release injectable even know that they’re doing anything wrong. They’re suspension just kind of going through the process. They don’t know that there are other options out there. And I don’t think that the options are always provided to them.” Formkit.com provides around-the-clock free ac- In the health care market, information may be as cess to specific formulary kit information for the valuable as effective treatment; without information (in key decision makers at hospitals, managed care combination with the tenacity to uncover it), consumers organizations, and federal facilities. may never find options that work best for them. To help other consumers achieve Andrea’s level of The site includes: empowerment, not only do treatments need to be more • Product overviews affordable and accessible, but information about op- • Disease overviews tions must also be more accessible—and their financial • Dosing information implications more clear. Support through a new system • Product fact sheets of health care advocates should also be available to help • Product monographs consumers who lack capacity to find and process infor- • Clinical summaries mation on their own. • Slide decks For any given condition, there will be people like Leah • Full prescribing information for whom the standard approach works. But there will • Important safety information also be Andreas, consumers who need a tailored approach and who, today, must aggressively engage to find solutions Formkit.com is part of PTCommunity.com and is the system does not readily offer. available only to verified P&T committee members. In health care, as in fashion, consumers need different options. To truly reform health care, solutions must allow customization and consumer choice.

Deborah D. Gordon (@gordondeb) is a senior fellow at the Harvard Kennedy School’s Mossavar–Rahmani Center for Business and Government. She formerly served as chief marketing officer for Network Health, a Massachusetts managed Medicaid plan.

46 MANAGED CARE / MAY 2019 VIEWPOINT PBMs: Criticized But Still Needed

gaining momentum, partly as the result of a growing By Dea Belazi understanding of the genetics of health and disease. AscellaHealth Personalized medicine parses diseases into smaller and smaller subgroups to the point where treat- he PBM industry stands at the intersection ments will be truly individualized, and yet there is of two recent blockbuster announcements. no model—public or private—in our current third- TMergers, acquisitions, and other activities party payment system to handle “one-off” custom have resulted in a growing number of health plans drug solutions. owning a PBM capability similar to Anthem’s inhouse PBM IngenioRx. And the Acute diseases are now chronic conditions Trump administration proposed Finally, these broader trends all reflect a growing a rule to eliminate rebates from reliance on pharmaceuticals as the way to treat dis- pharmaceutical companies to ease—and turn acute diseases into chronic conditions PBMs. While every stakeholder that people live with for decades. Many cancers, heart in the health care system braces disease, and HIV/AIDS have followed this path. One for the impact of these and other byproduct of this turn toward pharmaceuticals is the potential changes, PBMs will cer- need for greater clinical coordination between phar- Dea Belazi tainly be most affected and are macists and the rest of the health care system. More- likely to experience pronounced over, millions of Americans have multiple diseases, aftershocks that should elicit innovative responses. leading to polypharmacy with patients taking many PBMs used to be familiar only to insiders. Now prescriptions. A pharmacist can help quarterback they are, uncomfortably, in the glare of an often un- polypharmacy to steer patients away from dangerous flattering spotlight. In April, for example, five PBM interactions. executives were called to testify before the Senate PBMs have been criticized as middlemen. But Finance Committee. Anthem’s decision to make an early exit from its re- Many in the industry regard this environment as lationship with Express Scripts while maintaining a “open season” that will shake up old arrangements and temporary PBM relationship with CVS Health and ways of doing business in the complex, often secretive building up IngenioRx demonstrates an important drug supply chain. Anthem CEO Gail Boudreaux point. It shows that for all the criticism aimed at PBMs, has, for example, promised that IngenioRx will be they provide a necessary function. the opposite of the caricature of PBMs: transparent, That a large insurer would integrate a PBM inter- user friendly, and not driven by rebates. nally is not new. For example, UnitedHealth Group These changes in the PBM industry are not happen- owns OptumRx. This has happened before and will ing in a vacuum. Many factors are coming together to likely happen again as the market adjusts itself to the drive attention to the increasing share of the health acquisition of the three largest players. care dollar that is spent on drugs: The emergence of new PBMs, whether inside or outside an insurer, should drive new solutions and Two developments the development of new models. While it may take First, climbing market share of specialty drugs. Spe- Anthem some time to grow its capabilities, certainly cialty drugs are far more expensive than other drugs it hopes to improve the quality of service and the cost and target complicated, potentially life-threatening to their members. conditions such as cancer, hepatitis, nervous sys- Diversity works, and the PBM space could use tem or blood disorders, rheumatoid arthritis, and more of it. The bottom line is that PBMs can play an autoimmune conditions. Specialty drugs represent important role in the pharmaceutical supply chain and approximately 45% of the overall pharmaceutical are positioned to protect consumers and save them market spend in U.S. hospitals, and health systems out-of-pocket costs. saw approximately 16% growth in the specialty drug market in 2018. Dea Belazi is president and CEO of AscellaHealth, a Second, the trend toward personalized medicine is PBM in Berwyn, Pa.

MAY 2019 / MANAGED CARE 47 Government Health Care Congress July 16-17, 2019 | WASHINGTON, D.C. Medicare | Medicaid Business of Government Health Care

Growth. Value. Quality of Care. Engage with thought leaders from health plans, government agencies, states, providers, and community organizations to explore operational strategies and the future landscape of policy in government-sponsored health care.

2019 Key Themes: · Population Health · Provider Collaboration · Complex Care Needs · LTSS · Partnerships · Duals · Interoperability · VA Health Choices · Value-Based Design · Post-Acute Care · Benefit Flexibility · Technology

Reserve your seat today! Use promo code MMC19 to receive $150 off of this experience. Visit www.worldcongress.com/GHCC for details. VIEWPOINT SNFs Need Real-Time Data To Succeed

to a claims-based readmission measure. The skilled By Thomas Martin nursing facility readmission measure (SNFRM) has a CarePort Health measurement window that extends beyond a patient’s SNF stay. Based on the most recently reported per- MS has been pushing acute providers to connect formance data, 75% of SNFs took a pay cut. In fact, the continuum for several years. Now that from 2015 to 2017, the industry performed worse on Cmultiple CMS programs include claims-based this measure. measures that track patients outside of skilled nursing To improve on the SNFRM and similar measures, facilities—the Value-Based Purchasing, SNF QRP SNFs need a consistent view into patient activity post- (Quality Reporting Program), and discharge—as events are unfolding. With real-time Five-Star programs—it’s clear that alerts, if SNFs see a pattern of patients being readmit- post-acute providers are expected ted to the hospital shortly after their stays, for example, to start monitoring patients across they can seek out the root cause of the issue with that care settings as well. Because this is care transition and address it. Perhaps patients are a new concept for most SNFs, it’s being discharged too early or perhaps their discharge no surprise that performance on plans are inadequate. Either way, the first step toward claims-based measures is mark- resolving the issue and avoiding future penalties is to Thomas Martin edly worse than on traditional become aware of it. minimum data set (MDS)-based measures. The inherent lag time in the calculation of Showcasing value claims-based measures only compounds the problem. Post-acute care accounts for 10% of all Medicare How can a SNF provider proactively respond to a spending, so acute providers participating in bundled patient event if they’re not even aware it happened payment programs, ACOs, and other value-based until months later? Much like the acute industry, the arrangements are now building preferred post-acute SNF industry is now recognizing that real-time patient provider networks to manage this end of the con- data is a critical ingredient for success in today’s CMS tinuum. To gain access to these networks, SNFs need programs. With real-time data, SNFs can manage their to be able to share a comprehensive quality story. patients and resources more effectively, improve care Being limited to the quality measures that are transitions while reducing hospital readmissions, and available in the public domain can put SNFs at a showcase their value to referral partners. disadvantage. Measures that are reported on a smaller Many SNFs operate on thin margins and have finite lag time because they are calculated from the MDS resources, so it is imperative that their staffs have fail to capture important outcomes outside of the a way to flag high-risk patients who require more SNF setting. On the other hand, measures that are complex care (e.g., patients with a lack of mobility, based on claims data are too old to represent a facil- who take certain medications, or who require special ity’s quality with accuracy. When it comes to joining treatments) as soon as they enter the building. One a network, what’s truly valuable is the ability to drill way to get this real-time information is through ADT down and calculate quality measures by condition (admissions, discharge, and transfer) feeds. At Care- (e.g., by COPD, congestive heart failure, or joint Port, we’ve developed an ADT model that stratifies replacement) or even specifically for patients from patients by risk using ICD-10 diagnosis codes that a certain referral partner. are included in these data feeds. The need for real-time data in health care is uni- versal, but it is particularly pressing for post-acute Improving care transitions providers, who are now joining their hospital and Because they are reliant on outdated claims data, post- health system peers in being held responsible for acute providers are struggling with CMS programs patient outcomes. that hold them responsible for patients after they are discharged. A prime example is the SNF Value- Thomas Martin is the director of post-acute data Based Purchasing Program, which ties up to 2% of a analytics at CarePort Health, a care coordinaton soft- provider’s Medicare fee-for-service reimbursement ware company in Boston.

MAY 2019 / MANAGED CARE 49 A Missed Opportunity to Recognize Narcolepsy Symptoms Can Have a Signiﬁ cant Impact on Pediatric Patients

$ Personality and Behavior Academic Economic Anxiety, depression, introversion, About 3.5 times higher likelihood 5 times higher medical feelings of inferiority, and of repeating a grade vs pediatric costs vs pediatric patients sorrowfulness1-3 patients without narcolepsy4* without narcolepsy5†

Visit NarcolepsyLink.com/Pediatric to learn more about pediatric narcolepsy.

* Based on a health-related quality of life (HRQL) study assessed through a questionnaire completed by children and adolescents with narcolepsy (N=117) and control subjects (N=69). Academic performance was evaluated in the study.4 † Based on a retrospective, cross-sectional, case-control, claims-based analysis of health care utilization and costs, that included narcolepsy patients ≤18 years of age (N=1427) and control subjects (N=4281).5

References: 1. Nevsimalova S. Narcolepsy in childhood. Sleep Med Rev. 2009;13(2):169-180. 2. Marcus C. Daytime sleepiness in children: when a quiet child is not necessarily a good thing. Paediatr Respir Rev. 2018;25:1-2. 3. Blackwell JE, Alammar HA, Weighall AR, Kellar I, Nash HM. A systematic review of cognitive function and psychosocial well-being in school-age children with narcolepsy. Sleep Med Rev. 2017;34:82-93. 4. Inocente CO, Gustin M-P, Lavault S, et al. Quality of life in children with narcolepsy. CNS Neurosci Ther. 2014;20(8):763-771. 5. Reiss Reddy S, Broder MS, Tieu R, et al. Disease burden in pediatric narcolepsy: a claims-based analysis of health care utilization and costs and medical comorbidity. Poster presented at: SLEEP 2018, the 32nd Annual Meeting of the APSS; June 2-6, 2018; Baltimore, MD.