Reps. Peter Welch (D-Vt.), Buddy Carter (R-Ga.), Vicente NCPA IN Gonzalez (D-Texas) and Morgan Griffith (R-Va.), circu- ACTION lated a sign on letter among their colleagues addressed to President Trump expressing disappointment that the administration failed to act on pharmacy DIR fees.

What have we done for you lately? Here's the lowdown on NCPA PRESIDENT HEADS TO THE HILL NCPA's recent advocacy activity — and why it matters. What happened: NCPA President Bill Osborn and Federal and State Government Affairs VP Anne Cassity met with several community pharmacy champions on Capitol Hill. New York report slams The visits: Osborn and Cassity met with Sens. Shelley PBM practices Moore Capito (R-W.Va.), Jim Inhofe (R-Okla.), James Lankford (R-Okla.), and Jon Tester (D-Mont.), and Reps. Peter Welch (D-Vt.) and Morgan Griffith (R-Va.). These The New York Senate Committee on Investigations and members of the Senate and House are among those leg- Government Operations recently completed an inves- islators who consistently support measures to address tigation into PBM practices and their impact on rising the issues facing community pharmacy. drug prices and declining patient access. The committee found that "the consolidation and vertical integration of PBMs has contributed to skyrocketing list prices and declining patient access" and "PBMs often employ con- troversial utilization and management tools to generate revenue for themselves in a way that is detrimental to health plan sponsors, patients, and pharmacies."

The committee concluded that a lack of transparency, oversight, and accountability enables PBMs "to engage in anticompetitive practices at the detriment of con- sumers and pharmacists across New York State," and recommended action for the legislature to take.

To better understand how PBMs affect independent and community pharmacies, the committee made multiple site visits to pharmacies and relied on input from the Pharmacists Society of the State of New York.

CMS FINAL DRUG PRICING RULE FAILS TO ADDRESS DIR REFORM In mid-May, CMS announced its final rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. Most notably, CMS declined to take the opportunity to reform pharmacy DIR. In a joint statement, NCPA and the National Asso- ciation of Chain Drug Stores vowed to continue to fight for pharmacy DIR reform. “Pharmacies are in a tenuous situation, and our organizations are exploring all options to accomplish desperately needed reforms to pharmacy DIR. It is necessary for community pharmacies and for Clockwise from top, NCPA President Bill Osborn and NCPA the benefit of seniors that this reform take effect as soon Federal and State Government Affairs VP Anne Cassity (far as possible,” the statement said. left), with Sen. Shelley Moore Capito (R-W.Va.).; Osborn with Sen. Jim Inhofe (R-Okla.); Osborn and Cassity with Sen. Jon Senate pharmacy champions Sens. Shelley Moore Capito Tester (D-Mont.); and Osborn with Sen. James Lankford (R-W.Va.) and Jon Tester (D-Mont.) and House champions (R-Okla.).

10 America’s PHARMACIST | July 2019 Patient copay collection and documentation is a MUST Pharmacies may claim that pa- tients are indigent and unable to Copayments are used by insur- year that ties to a specific prescrip- pay, and in the case of Medicaid, ers to sensitize patients to the tion? Banks are required to keep this is an acceptable practice. cost of their medications and copies of canceled checks for seven However, for other insurers, give patients financial incen- years, but it can be an arduous you must have a formal, written tives to reject medications that task. Patients paying with cash also policy to address a potential are not medically necessary or create record-keeping headaches. hardship waiver. This includes add limited-to-no value to their Being able to show the copay re- an application for waiver com- treatments. ceivables for a given period and the pleted by the patient, tax return corresponding bank deposits can be documentation collected by the Third-party contracts obligate challenging. How often do you make pharmacy to show proof of need, pharmacies to collect patient deposits? Do you ever pull money and a host of other requirements. copayments in full. However, out of the till to pay vendors where merely collecting copayments amounts wouldn’t reconcile? As a reminder, manufacturer upon dispensing is not nearly copay discount cards cannot be enough. You must also be able House charge accounts add another used with Medicare, Medicaid, to show proof of copay col- layer of complexity for pharmacies. and Tricare patients. Many PBMs lection. The Pharmacy Audit Developing a robust policy and have additional restrictions on Assistance Service continues procedure on billing, collection, what manufacturer copay cards to see pharmacies struggle with record keeping, and management of they will allow pharmacies to use. copay collection documentation accounts is an absolute necessity to due to inferior point-of-sale sys- prevent issues. When payments are Financial recoupment on claims tems, poor record keeping, and received, are you using a tick-and- for which you cannot show proof banking relationships. tie accounting practice, or are you of copay collection should be the applying payments to the oldest least of your worries. Network To show proof of copay collec- outstanding balance? How do you termination could ensue. The tion, pharmacy benefit managers handle payments that only cover a pharmacy risks fraud, waste, and may ask for front and back copies partial copay? abuse investigation, and charges of canceled checks, bank depos- stemming from the False Claims its, and even credit card mer- Be wary of copay collection schemes Act. Copay collection are not chant account reporting, includ- and artifices. Some pharmacies worth putting your license and ing evidence of settlement and have tried to “bury” the copay in the your pharmacy at risk! payment through bank records. reimbursement for compounded prescriptions (including pain and By Jason Crawford, RPh, PAAS Stop and think for a moment scar creams). They create house National®, the Pharmacy Audit about how you would prove charge accounts with no intent to Assistance Service. For more copay collection. Can you find a collect outstanding balances, thereby information, call 888-870-7227 toll- payment transaction from last waiving the copay. free or visit www.paasnational.com.

BIPARTISAN SENATE LEGISLATION released a discussion draft of legislation to reduce health TAKES AIM AT PBMS care costs, of which NCPA submitted comments to the What happened: Sen. Lamar Alexander committee. The Lower Health Care Costs Act of 2019 (R-Tenn.), chairman of the Senate Health, includes more than 30 provisions addressing surprise Education, Labor and Pensions Committee, medical billing, prescription drug costs, transparency, and Ranking Member Patty Murray (D-Wash.) health information technology, and public health priorities. www.ncpanet.org/ap 11 NCPA IN ACTION

MEET YOUR Champion: David Burke, RPh

Spotlighting a pharmacist/elected official who is a champion for community pharmacy and the patients you serve.

David Burke is passionate about pharmacy. You can hear it in his voice. It first hit him as a youngster growing up in Marion, Ohio, when his family took him to the local independent pharmacy to get some medication.

“The pharmacist knew everyone who came into the store,” Burke says. “He seemed very positive and happy about what he was doing, and that just always stuck with me.”

Burke graduated from Ohio Northern University College of Pharmacy in 1990, and in 1997 he and wife Donna (also a pharmacist) opened Name: David Burke, RPh Dave’s Pharmacy in Marysville, Ohio. A decade later, he was launching a state-level political career, first in the Ohio House of Representatives, Elected Office: Serving second and now in his second term in the Ohio Senate, serving District 26. term in Ohio Senate, District 26

Burke says he sees plenty of similarities between being a pharmacist Profession: Owner, Dave’s and a legislator. It’s about providing service. “It’s no different than what Pharmacy, Marysville, Ohio I do at the drugstore,” he says. “I don’t think pharmacists should be hesitant to run for office. I think politics is a natural way for pharmacists Legislative Committees: Chair, to deliver care. You are just doing it in a different type of setting.” Health, Human Services, and Medicaid Committee; Vice-chair, The Ohio General Assembly is comprised of 33 senate districts, Finance Committee; Energy and Burke is part of the 24-9 Republican majority. (The House of and Public Utilities Committee; Representatives has 99 members, with three per district.) The General Insurance and Financial Assembly operates in two-year cycles; the 133rd session started in Institutions Committee; Rules January. Burke serves in several leadership roles, notably as Health, and Reference Committee; Human Services, and Medicaid Committee chairman. Finance — Health and Medicaid Subcommittee Burke’s pharmacy is about 30 minutes northwest of the capital, Columbus. He works at the pharmacy on Mondays and Fridays, about 13 Education: Ohio Northern hours each day, and a few hours on Sundays to catch up on paperwork. University College of Pharmacy, The 3,000-square-foot pharmacy does standard retail and non-sterile 1990; Capital University (MBA), 1994 compounding and dispenses about 2,000 prescriptions weekly.

“It's a solid business,” Burke says.

Burke says what he is doing is the essence of democracy, as a citizen legislator.

“It’s awesome to me that you can still have a business and a life, and still help people at the state level through participating in the political process,” he says. “I am honored to do what I do.”

12 America’s PHARMACIST | July 2019 About PBMs: PBMs are addressed in the draft, with term care pharmacists can aid in enhancing these services. language that would prohibit PBMs from using spread NCPA’s view: NCPA pointed to improved patient out- pricing. The draft would also require that PBMs pass on comes and cost savings as just a few of the benefits of 100 percent of any rebates or discounts they negotiate medical-at-home services. Specifically, we urged CMS with drug companies to insurers. to recognize, reimburse, and promote medical-at-home Looking ahead: The bill may be considered by the full pharmacy services at the same level as pharmacy Senate in July. services that are provided to skilled nursing patients.

NCPA SUBMITS COMMENTS ON COMMUNITY PHARMACY FINDS A SEAT AT SBA OVERTIME REGULATIONS ROUNDTABLE What happened: NCPA submitted comments to the What happened: NCPA officer and pharmacy owner Department of Labor on proposed overtime regulations. Justin Wilson, PharmD, testified at a Small Business Comments: The DOL changes to the salary-level test Administration’s Office of Advocacy Regulatory Reform under the Obama administration required overtime pay Roundtable in Oklahoma City. requirements for personnel compensated less than What he said: Wilson’s testimony focused on the nega- $47,476 per year. This doubling of the salary-level test tive aspects of pharmacy DIR fees on his small business meant more pharmacy personnel met the test, diverting community pharmacy. Wilson also addressed concerns money away from small business community pharma- about the proposal to change the rebate safe harbor cies to grow their businesses and create more jobs. to assess all manufacturer rebates at the point of sale Thus, NCPA supports this Proposed Rule to the extent through a series of chargebacks to the pharmacy. this proposal ensures that the Obama administration’s changes should never go into effect. NCPA WEIGHS IN ON TRACK-AND-TRACE AT FDA What happened: NCPA staff, along with NCPA board FDA CLARIFIES 503A BULKS member Michael Kim, represented community pharma- LIST FINAL RULE cy’s interests at an FDA session on upcoming require- What happened: The FDA issued a guidance ments under the Drug Supply Chain Security Act. to answer questions on the final rule that Details: Kim discussed the challenges community establishes the agency’s criteria for evaluating bulk drug pharmacies may face with the upcoming (Nov. 27, substances that may be used to compound drugs under 2019) saleable return verification requirement and gave section 503A of the Federal Food, Drug, and Cosmetic Act. specific examples of how the requirement might affect The rule places six substances on the 503A bulks list and community pharmacies’ inventory management and went into effect on March 21, 2019. financial viability.

CMS ADDRESSES PBM SPREAD PRICING NCPA STATE PRIORITY ISSUES: IN MEDICAID AND CHIP 36 BILLS AND COUNTING What happened: CMS issued guidance, effectively elim- So far in the 2019 legislative session, 36 bills in 20 states inating “spread pricing” in Medicaid and CHIP managed have been signed into law that relate to NCPA’s top three care plans. state priorities – Medicaid managed care reform, PBM Details: The guidance clarifies that the amount retained regulation and reform, and scope of practice/compensa- from a PBM under “spread pricing” must be excluded tion for services. See your daily qAM for ongoing state from the amount of actual claims used in calculating Med- news. Here are a few state updates: icaid and CHIP managed care plans’ medical loss ratio. • Oklahoma signs PBM law NCPA’s view: CEO Douglas Hoey said the guidance What happened: Gov. Kevin Stitt (R) signed HB 2632, shows that CMS and the Trump administration recognize which is similar to a bill he had vetoed previously. that PBM practices have led to increased costs for states What the bill does: Protects patient access to phar- and taxpayers. NCPA had several meetings with CMS on macy services by establishing network adequacy the issue and had encouraged the agency to eliminate and “any willing pharmacy” requirements, minimiz- spread pricing. es PBM conflicts of interest by prohibiting higher reimbursement rates for PBM-owned pharmacies, NCPA ASKS CMS TO RECOGNIZE and limits PBM abuses by prohibiting retroactive MEDICAL-AT-HOME SERVICES claim adjustments and denials. What happened: NCPA submitted a letter to CMS outlining • Minnesota governor signs PBM licensure bill the benefits of medical-at-home services and how long- What happened: Gov. Tim Walz (D) signed SF 278, www.ncpanet.org/ap 13 the Minnesota Pharmacy Benefit Manager Licen- What happened: (D) sure and Regulation Act. announced that his office plans to audit the PBMs What the bill does: Requires licensure of PBMs in that serve Iowa's Medicaid managed care program. Minnesota. Joining the club: Iowa joins Pennsylvania, Ohio, Bipartisan: The bill passed unanimously in the Sen- Kentucky, and other states that have investigated ate and with only two dissenting votes in the House. the practices of PBMs operating in their Medicaid • Tennessee passes comprehensive PBM reform bill programs. What happened: Tennessee Gov. Bill Lee (R) signed Kudos: Iowa State Rep. John Forbes (D), who is also HB 786 into law. a pharmacist, has been instrumental in bringing About the bill: The bill strengthens fair pharmacy attention to the state Medicaid program. audit laws, prohibits claims adjudication fees unless reported on the remittance advice, and provides Information is current as of June 7, 2019. additional patient and pharmacy protections. • Louisiana legislature passes PBM reform legislation What happened: Louisiana SB 41, a PBM reform bill that requires PBM licensure, strengthens and expands current MAC laws, and prohibits spread pricing by PBMs without prior notice to the insurer, passed the legislature and was signed by Gov. John Bel Edwards (D). • S.C. governor signs PBM regulation bill What happened: Gov. Henry McMaster (R) signed ADVOCACY ON THE ROAD S. 359, which requires PBM licensure, increases • Federal and State Government Affairs VP Anne reimbursement transparency, and controls anti- Cassity presented at the Mississippi Independent competitive PBM practices. Pharmacies Association annual meeting on NCPA • Georgia enacts anti-steering bills state and federal legislative priorities and discussed What happened: Gov. Brian Kemp (R) signed two NCPA’s efforts to address pharmacy DIR fees and PBM anti-steering bills into law. reform the pharmacy payment model in Medicaid. About the bills: HB 233 prohibits pharmacies from • Director of Policy and Regulatory Affairs Kala profiting off of prescriptions “steered” from their Shankle attended the Pharmaceutical Distribution PBM and insurance affiliates, and HB 323 restricts Security Alliance’s public workshop to discuss the PBM and insurer patient “steering,” strengthens potential for an independent governance body to anti-mandatory mail order, adds additional audit pro- oversee the final implementation requirements tections, prohibits PBMs from knowingly misleading under the Drug Supply Chain Security Act (DSCSA). patients, and restricts mining of patient data. In early June, Shankle also presented at the Integra Kudos: The Georgia Pharmacy Association and User Conference on supply chain issues concerning many Georgia pharmacists worked hard to get these LTC pharmacies, including upcoming requirements bills over the finish line. under the DSCSA. • Illinois passes PBM registration bill • Advocacy Center Director Karry La Violette, and What happened: The Illinois General Assembly Pharmacy Policy VP Ronna Hauser, PharmD, spoke passed HB 465. At press time it was awaiting the about LTC pharmacy advocacy issues at the governor’s signature. GeriMed 2019 Conference. About the bill: Illinois HB 465 is a PBM reform bill • NCPA staff attended the 2019 National Association that requires PBM registration with the Department of of Boards of Pharmacy annual meeting in Minne- Insurance, MAC transparency, and fair audits reporting apolis. NCPA hosted a breakfast at the meeting to and transparency requirements in Medicaid managed discuss issues such as compounding, electronic care. Additionally, it prohibits gag clauses in contracts. prescriptions, PBM reform, and scope of practice. • Alabama passes PBM reform bill • L a Violette presented at the Northeast Pharmacy What happened: Alabama SB 73 is a PBM reform Services Corporation 2019 EXPO in Springfield, bill that requires PBM licensure and prohibits gag Mass. She provided an advocacy update on NCPA clauses in contracts. At press time it was awaiting federal and state advocacy priorities highlighting the governor’s signature. NCPA’s efforts to address pharmacy DIR fees and • Iowa auditor says state will audit PBMs Medicaid managed care pharmacy payment reforms.

14 America’s PHARMACIST | July 2019