Medicare Prescription Drug Fraud Prevention Act of 2019

S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2087: "The STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs. S.2199: The Insulin Price Reduction Act, require private health insurance plans and Medicare Part D plans to eliminate rebates for insulin and limit out of pocket costs ($250 for individuals, and $500 for families) if manufacturers reduce insulin list prices to prices during plan year 2006 and do not raise insulin prices above inflation. S.2543: The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, -Legislation to amend Medicare and Medicaid to lower prescription drug prices and strengthen safeguards related to prescription drugs. Provisions related to inflation protection provisions and PBM transparency. S.2247: Phair Relief Act, Provisions related to pharmacy DIR. H.R. 3: Lower Drug Costs Now Act of 2019, Provisions to establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollment. CMS Proposed rule: "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses," (CMS-4180-P)-provisions related to pharmacy Direct and Indirect Negotiation.

Client expense: $80,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.771/H.R.1776: Improving Access to Affordable Prescription Drugs Act, issues related to ensuring a competitive marketplace for prescription drugs. H.R.1316: The Prescription Drug Price Transparency Act, issues related to ensuring the continuity of MAC pricing. Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program Proposed Rule & Request for Information--Provisions on Part D. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain. CMS Proposed and Final Policy Changes and Updates for Medicare Advantage and the Prescription Drug Benefit Program for Contract Year 2019 (CMS-4182-P as in proposed and final version CMS-4182-F, particularly issues related to pharmacy DIR and implementation of a real-time-benefit tool); provisions in a Request for Information related to rebates at the point-of-sale and pharmacist direct and indirect renumeration. Proposed HHS-OIG rule currently under OMB review entitled, Removal of Safe Harbor Protections for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection, RIN-936-AAO8. (See https://www.reginfo.gov/public/do/eoReviewSearch for questions). Outreach and education on pharmacy Direction and Indirection Remuneration in Medicare. Provisions related to opening the Medicare doughnut hole in P.L. 115-123. HR 803: Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, pharmacy payments & adjustments in Part D/ DIR. HR 789: To amend title XVIII of the Social Security Act to prohibit prescription drug plan sponsors and MA-PD organizations under the Medicare program from retroactively reducing payment on clean claims submitted by pharmacies." HR 1035: The Prescription Drug Price Transparency Act, requires greater transparency and accountability from PBMs. HR 1034/S 640: The Phair Pricing Act, lowers the cost of prescription medication for patients in the Medicare Part D program. HR 965/S 340: "The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act." S 476: The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act. S 657: Drug Price Transparency Act, eliminates rebates in ERISA plans. Proposed Rule: Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, HHSIG-2019-0001-0001. Proposals to address pay-for-delay, orphan drug abuse and patent evergreening. Implementation of the e-prescribing provisions of controlled substances provisions of the SUPPORT Act, (P.L. 115-271). The Payment Commission Data Act, H.R. 1264, H.R. 1781 and S. 801: provisions allowing MACPAC and MedPAC access to certain drug price concession and rebate information. S. 1497: Health Care Price Check Act of 2019, requires Medicare and insurance companies to make available an online tool and a toll-free # for beneficiaries to inquire about the cost, for that specific consumer, of any services, procedure or product including prescription drugs. S. 64: Preserve Access to Affordable Generics and Biosimilars Act, bars pay-for-delay for generics and biosimilars. S. 1416: The Affordable Prescriptions for Patients Act of 2019, address product hopping and patent thickets by giving the FTC greater powers to investigate and bring legal actions. S. 1384: The Prescription Drug Rebate Reform Act, would require all patients coinsurance obligations be set as a percentage of net price, rather than list price, before or after a deductible is met. S. 1505: a bill to require prescription drug plans and MA-PD plans to report potential fraud, waste, and abuse to the Secretary of Health and Human Services under Medicare part D, and for other purposes. S. 1532: The Pharmacy Benefit Manager Accountability Study Act of 2019, (Provisions requiring GAO to submit a report on PBMs). Modernization and cost-sharing of the Part D drug benefit. H.R. 2115: the "Public Disclosure of Drug Discounts Act, requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive. H.R. 2087: "The STAR (Sunshine, Transparency, Accountability and Reporting) Act," provisions related to disclosure of PBM-pharmaceutical company negotiated rebates. H.R. 2376/S. 1227: Prescription Pricing for the People Act of 2019, FTC study of PBMs.

Client expense: $83,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE