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 related to prescription drug abuse. 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. 1703, Medical Product Communications 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 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.

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

Bills named: H.R. 1038 (115th), H.R. 1316 (115th), H.R. 749 (115th), H.R. 2051 (115th), S. 637 (115th), S. 413 (115th), H.R. 2026 (115th), S. 1044 (115th), S. 771 (115th), S. 974 (115th), H.R. 1703 (115th), H.R. 2212 (115th), S. 297 (115th), H.R. 1939 (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 related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. 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

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

Bills named: H.R. 1316 (115th), S. 637 (115th), H.R. 1038 (115th), S. 413 (115th), H.R. 1939 (115th), S. 771 (115th), S. 1044 (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, and mail-service pharmacy. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare. 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 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). 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

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

Bills named: H.R. 1939 (115th), S. 771 (115th), H.R. 1316 (115th), S. 1044 (115th), H.R. 1038 (115th), S. 413 (115th), S. 637 (115th)