PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION for PHARMACEUTICAL CARE MANAGEMENT ASSOCIATION

Health Issues HCR

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.

Contacted: Office of Management & Budget (OMB); Food & Drug Administration (FDA); SENATE; Health & Human Services, Dept of (HHS); Federal Trade Commission (FTC); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Medicare Payment Advisory Commission (MedPAC)

Bills named: S. 297 (115th), S. 413 (115th), H.R. 2051 (115th), H.R. 2077 (115th), H.R. 1939 (115th), S. 974 (115th), H.R. 749 (115th), S. 637 (115th), H.R. 1038 (115th), H.R. 6143 (115th), H.R. 3528 (115th), H.R. 2026 (115th), S. 2554 (115th), S. 771 (115th), H.R. 1316 (115th), S. 2553 (115th), H.R. 5343 (115th), H.R. 4841 (115th), S. 2460 (115th), S. 1044 (115th), H.R. 6144 (115th), H.R. 2212 (115th)

Medicare/Medicaid MMM

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits. Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

Contacted: Medicare Payment Advisory Commission (MedPAC); SENATE; Food & Drug Administration (FDA); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); Federal Trade Commission (FTC); Health & Human Services, Dept of (HHS)

Bills named: H.R. 5343 (115th), H.R. 4841 (115th), H.R. 6143 (115th), H.R. 1038 (115th), S. 1044 (115th), S. 771 (115th), H.R. 5958 (115th), S. 2553 (115th), S. 413 (115th), S. 637 (115th), S. 2554 (115th), S. 2460 (115th), H.R. 1316 (115th), H.R. 6144 (115th)

Pharmacy PHA

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks. Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, Direct and Indirect Remuneration (DIR), pharmacy networks, and mail-service pharmacy. Issues included in the Part D Rule and accompanying RFI. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Issues related to pharmacy gag clauses. HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R.3528, The Every Prescription Carried Safely Act S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018

Contacted: Federal Trade Commission (FTC); Food & Drug Administration (FDA); Centers For Medicare and Medicaid Services (CMS); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Medicare Payment Advisory Commission (MedPAC); Office of Management & Budget (OMB); SENATE; Executive Office of the President (EOP)

Bills named: S. 1044 (115th), S. 771 (115th), H.R. 3528 (115th), H.R. 1316 (115th), H.R. 5343 (115th), S. 2553 (115th), S. 413 (115th), H.R. 1038 (115th), S. 637 (115th), H.R. 6143 (115th), H.R. 6144 (115th), H.R. 4841 (115th), H.R. 1939 (115th), S. 2554 (115th)