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ACCC 2020 OPPS-PFS Proposed Rule Briefing[1]

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ACCC 2020 OPPS-PFS Proposed Rule Briefing[1] Medicare Hospital Outpatient Prospective Payment System (OPPS) & Physician Fee Schedule (PFS) Proposed Rules for 2020: What You Need to Know September 3, 2019 Beth Roberts, Partner [email protected] (202) 637-8626 Beth Halpern, Partner [email protected] (202) 637-8609 OPPS Proposed Rule for CY 2020 QUICK FACTS WHO? WHAT? Centers for Medicare & Medicaid Hospital Outpatient Prospective (CMS) Payment System (OPPS), Ambulatory Surgical Center (ASC) Payment System, and Quality Reporting Programs Proposed Rule for calendar year (CY) 2020 CMS-1717-P 84 Fed. Reg. 39,398 (August 9, 2019) WHERE? WHEN? • Nationwide • Released on July 29, 2019 • Published in Federal Register on August 9, 2019 • Comments due September 27, 2019 Hogan Lovells 2 OPPS Proposed Rule for CY 2020 Highlights • 2.7% projected update for 2020 ➢ market basket increase of 3.2% ➢ minus 0.5% productivity adjustment 2% payment reduction for hospitals that fail to report quality data • Total Medicare payments to OPPS providers will increase by approximately $6 billion to approximately $79 billion • Total Medicare payments to ASCs would increase by approximately $200 million to approximately $4.89 billion • Addenda available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices- Items/CMS-1717-P.html. Hogan Lovells 3 OPPS Proposed Rule for CY 2020 What is proposed to stay the same. Policies Proposed to Remain the Same What is proposed to stay the same. • Payment at Average Sales Price (ASP)+6% for drugs, biologicals, and radiopharmaceuticals with pass-through status • Payment at ASP+6% for separately payable drugs, biologicals, and therapeutic radiopharmaceuticals without pass-through status if not purchased under the 340B Drug Discount Program • Payment for non-pass through drugs acquired under the 340B Program at ASP-22.5% • Payment for blood and blood products using the blood-specific cost-to-charge ratio (CCR) methodology • Estimation of outlier payments to be 1% of aggregate total OPPS payments Hogan Lovells 5 Payment for Drugs, Biologicals, and Radiopharmaceuticals What is proposed to stay the same. • Drugs with pass-through status paid at ASP+6%, as required by statute – Pass-through status would continue for 61 drugs – Pass-through status would be extended for 4 drugs per by section 1301(a)(1)(C) of the Consolidated Appropriations Act of 2018. – Pass-through status would expire for 6 drugs • Separately payable drugs, biologicals, therapeutic radiopharmaceuticals, and clotting factors not purchased under the 340B drug discount program also paid at ASP+6% – CMS would to continue to pay the “statutory default” amount as drug acquisition cost data are not available – Statutory default sets reimbursement at rate for drugs administered in the physician office setting • CMS would continue to pay for biosimilar biological products based on the payment allowance of the product as determined under Social Security Act § 1847A – (100% of the biosimilar’s ASP) + (6% of the reference product’s ASP) when the product has pass- through status • Blood clotting factors would continue to be paid at ASP+6% plus an updated furnishing fee Hogan Lovells 6 Payment for Drugs, Biologicals, and Radiopharmaceuticals 65 drugs with continuing pass-through status PASS- PASS- PASS- PASS-THROUGH CY 2020 PROPOSED CY THROUGH THROUGH CY 2020 PROPOSED CY THROUGH PROPOSED CY PROPOSED CY PAYMENT HCPCS CY 2020 LONG DESCRIPTOR 2020 STATUS HCPCS CY 2020 LONG DESCRIPTOR 2020 STATUS PAYMENT PAYMENT PAYMENT 2020 APC EXPIRATION 2020 APC CODE INDICATOR EFFECTIVE CODE INDICATOR EFFECTIVE EXPIRATION DATE DATE DATE DATE Lutetium lu 177, dotatate, A9513 G 9067 07/01/2018 6/30/2021 Injection, factor viii, (antihemophilic therapeutic, 1 millicurie C9141 factor, recombinant), pegylated-aucl G 9299 04/01/2019 3/31/2022 Florbetapir f18, diagnostic, per (jivi) 1 i.u. A9586* G 9084 10/01/2018 9/30/2020 study dose, up to 10 millicuries Iodine i-131 iobenguane, diagnostic, 1 C9407 G 9184 01/01/2019 12/31/2021 millicurie Injection, aripiprazole lauroxil C9035 G 9179 01/01/2019 12/31/2021 Iodine i-131 iobenguane, therapeutic, 1 (aristada initio), 1 mg C9408 G 9185 01/01/2019 12/31/2021 millicure C9036 Injection, patisiran, 0.1 mg G 9180 01/01/0219 12/31/2021 Injection, phenylephrine and ketorolac, C9447* G 9083 10/01/2018 9/30/2020 Injection, risperidone (perseris), 4 ml vial C9037 G 9181 01/01/2019 12/31/2021 0.5 mg C9462 Injection, delafloxacin, 1 mg G 9462 04/01/2018 3/31/2021 Injection, mogamulizumab-kpkc, 1 Injection, conivaptan hydrochloride, 1 C9038 G 9182 01/01/2019 12/31/2021 C9488 G 9488 04/01/2017 3/31/2020 mg mg C9039 Injection, plazomicin, 5 mg G 9183 01/01/2019 12/31/2021 J0185 Injection, aprepitant, 1 mg G 9463 04/01/2018 3/31/2021 Injection, fremanezumab-vfrm, 1 C9040 G 9197 04/01/2019 3/31/2022 mg J0517 Injection, benralizumab, 1 mg G 9466 04/01/2018 3/31/2021 Injection, coagulation factor J0565 Injection, bezlotoxumab, 10 mg G 9490 07/01/2017 6/30/2020 C9041 Xa(recombinant), inactivated G 9198 04/01/2019 3/31/2022 (andexxa), 10mg J0567 Injection, cerliponase alfa, 1 mg G 9014 01/01/2018 12/31/2021 C9043 Injection, levoleucovorin G 9303 04/01/2019 3/31/2022 Injection, c-1 esterase inhibitor C9044 Injection, cemiplimab-rwlc, 1 mg G 9304 04/01/2019 3/31/2022 J0599 G 9015 01/01/2018 12/31/2021 (human), (haegarda), 10 units Injection, moxetumomab C9045 G 9305 04/01/2019 3/31/2022 pasudotox-tdfk, 0.01 mg Injection, dexamethasone 9%, J1095 G 9172 10/01/2018 9/30/2021 Cocaine hydrochloride nasal intraocular, 1 microgram C9046 solution for topical administration, G 9307 04/01/2019 3/31/2022 1 mg J1301 Injection, edaravone, 1 mg G 9493 10/01/2017 9/30/2020 HoganHogan Lovells Lovells 7 * Pass-through status extended through September 30, 2020 due to the Consolidated Appropriations Act of 2018 Payment for Drugs, Biologicals, and Radiopharmaceuticals 65 drugs with continuing pass-through status PASS- PASS- PASS- PASS-THROUGH CY 2020 PROPOSED CY THROUGH THROUGH CY 2020 PROPOSED CY THROUGH PROPOSED CY PROPOSED CY PAYMENT HCPCS CY 2020 LONG DESCRIPTOR 2020 STATUS HCPCS CY 2020 LONG DESCRIPTOR 2020 STATUS PAYMENT PAYMENT PAYMENT 2020 APC EXPIRATION 2020 APC CODE INDICATOR EFFECTIVE CODE INDICATOR EFFECTIVE EXPIRATION DATE DATE DATE DATE J1428 Injection, eteplirsen, 10 mg G 9484 04/01/2017 3/31/2020 Injection factor ix, (antihemophilic J7203 factor, recombinant), glycopegylated, G 9468 04/01/2018 3/31/2021 Injection, fosnetupitant 235 mg (rebinyn), 1 iu J1454 G 9099 10/01/2018 9/30/20201 and palonosetron 0.25 mg Hyaluronan or derivative, durolane, for J7318 G 9174 04/01/2018 3/31/2021 intra-articular injection, 1 mg Injection, granisetron extended J1627 G 9486 04/01/2017 3/31/2020 Hylauronan or derivative, gelsyn-3, for release, 0.1 mg J7328 G 1862 04/01/2017 3/31/2020 intra-articular injection, 0.1 mg J1628 Injection, guselkumab, 1 mg G 9029 01/01/2018 12/31/2020 Aminolevulinic acid hcl for topical J7345 G 9301 01/01/2018 12/31/2020 administration, 10% gel, 10 mg J2326 Injection, nusinersen, 0.1 mg G 9489 07/01/2017 6/30/2020 J9023 Injection, avelumab, 10 mg G 9491 10/01/2017 9/30/2020 J2350 Injection, ocrelizumab, 1 mg G 9494 10/01/2017 9/30/2020 J9057 Injection, copanlisib, 1 mg G 9030 07/01/2018 6/30/2121 J2797 Injection, rolapitant, 0.5 mg G 9464 04/01/2018 3/31/2021 Injection, liposomal, 1 mg J9153 G 9302 01/01/2018 12/31/2020 J3245 Injection, tildrakizumab, 1 mg G 9306 04/01/2019 3/31/2022 daunorubicin and 2.27 mg cytarabine J9173 Injection, durvalumab, 10 mg G 9492 10/01/2017 9/30/2020 Injection, triamcinolone acetonide, Injection, gemtuzumab ozogamicin, 0.1 J3304 preservative-free, extended-release, G 9469 04/01/2018 3/31/2021 J9203 G 9495 01/01/2018 12/31/2020 microsphere formulation, 1 mg mg Injection, inotuzumab ozogamicin, 0.1 Injection, triptorelin, extended- J9229 G 9028 01/01/2018 12/31/2020 J3316 G 9016 01/01/2018 12/31/2020 mg release, 3.75 mg Ustekinumab, for intravenous J3358 G 9487 04/01/2017 3/31/2020 J9285 Injection, olaratumab, 10 mg G 9485 04/01/2017 3/31/2020 injection, 1 mg Injection, voretigene neparvovec- J3398 G 9070 07/01/2018 6/30/2021 rzyl, 1 billion vector genomes Injection, rituximab 10 mg and J9311 G 9467 04/01/2018 3/31/2021 hyaluronidase Injection, emicizumab-kxwh, 0.5 J7170 G 9257 07/01/2018 6/30/2021 mg HoganHogan Lovells Lovells 8 Payment for Drugs, Biologicals, and Radiopharmaceuticals 65 drugs with continuing pass-through status PASS-THROUGH CY 2020 HCPCS PROPOSED CY 2020 PASS-THROUGH PAYMENT CY 2020 LONG DESCRIPTOR PROPOSED CY 2020 APC PAYMENT EFFECTIVE CODE STATUS INDICATOR EXPIRATION DATE DATE Axicabtagene ciloleucel, up to 200 million autologous anti-cd19 car Q2041 positive viable t cells, including leukapheresis and dose G 9035 04/01/2018 3/31/2021 preparation procedures, per therapeutic dose Tisagenlecleucel, up to 600 million car-positive viable t cells, Q2042 including leukapheresis and dose preparation procedures, per G 9194 04/01/2018 3/31/2021 therapeutic dose Q4195* Puraply, per square centimeter G 9175 10/01/2018 9/30/2020 Q4196* Puraply am, per square centimeter G 9176 10/01/2018 9/30/2020 Q5103 Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg G 1847 04/01/2017 3/31/2020 Q5104 Injection, infliximab-abda, biosimilar, (renflexis), 10 mg G 9036 04/01/2018 3/31/2021 Injection, epoetin alfa, biosimilar, (retacrit) (for esrd on dialysis), Q5105 G 9096 10/01/2018 9/30/2021 100 units Injection, epoetin alfa, biosimilar, (retacrit) (for non-esrd use), Q5106
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