Trump Administration budget proposal to address prescription drug prices: In advance of the Feb. 12 release of the President’s FY 2019 budget proposal, aides previewed a range of proposals intended to address prescription drug prices. The White House Council of Economic Advisers released a 30-page report which calls out high concentration in the PBM market and perverse incentives for PBMs in Medicare Part D. It recommends efforts to discourage “plan formulary design that speeds patients to the catastrophic coverage phase of benefit and increases overall spending.” It also recommended lowering co-pays for generic drugs in Part D; shifting Medicare Part B drug coverage to Part D; and tightening eligibility requirements in the 340b drug discount program. Next week HHS Secretary Alex Azar is scheduled to testify before congressional hearings examining the budget proposal.
Budget agreement enacted, including health care provisions: President Trump signed into law a sweeping budget measure enacted by Congress to fund the government through March 23 and increase budgetary caps through fiscal year 2019. The measure directed $6 billion to address the opioid epidemic and included a range of health care provisions. Of note to pharmacy, the law requires a GAO study of the prevalence and effectiveness of medication synchronization programs in Medicare Part D. The move comes in response to recommendations NCPA previously provided Senators working to improve care for patients with chronic conditions. Additional provisions include closing the Part D coverage gap (or “doughnut hole”) in 2019, one year earlier than scheduled; extension of the Children’s Health Insurance Program for four more years; a two-year extension of the Medicare Independence at Home demonstration project supported by long-term care providers; giving Part D plans greater access to Medicare Part A and B data; repealing the controversial Independent Payment Advisory Board; and requiring CMS to more rigorously enforce the requirement that durable medical equipment suppliers in the competition bidding program offer at least 50 percent of the diabetes test strip brands used by beneficiaries.
House subcommittee to review concentration of health care industry: The House Energy & Commerce Subcommittee on Oversight & Investigations will hold a hearing Feb. 14 to examine consolidation trends in the health care sector. The panel will hear from three academics. In announcing the hearing, subcommittee Chairman Gregg Harper (R-Miss.) called consolidation “an important piece of the puzzle as we explore broader issues like the drug supply chain and the cost of medications.”
PCMA comments on proposed Part D rule made public: NCPA has been tracking the proposed regulation and noticed publication of PCMA’s official, 183-page comments which, as expected, argue against several NCPA-supported provisions. These include CMS’ proposed clarification of “any willing pharmacy”; approaches to specialty pharmacy access and defining mail order pharmacy; availability to pharmacies of Part D plan sponsor/PBM contract terms and conditions; and the concept of applying retroactive pharmacy DIR fees to the point-of-sale instead. Often PCMA cites the “non-interference” clause, the endangerment of preferred pharmacy arrangements and quality-incentives for pharmacies to question CMS’ proposals. NCPA’s official comments to CMS pre-emptively addressed many of these arguments.
Reps. Roskam, Johnson lead letter to CMS against Part D proposed rule: The lawmakers urged the agency to consider alternatives to accounting for a percentage of manufacturer rebates and all pharmacy DIR fees at point-of-sale. The letter (attached) was signed by Reps. Peter Roskam (R-Ill.), Bill Johnson (R-Ohio); Sam Johnson (R-Texas); Erik Paulsen (R-Minn.); Jim Renacci (R-Ohio) and Tim Walberg (R-Mich.). It comes following an NCPA-supported, bipartisan letter to CMS backing the pharmacy DIR fee proposal, signed by 80 lawmakers, and a similar letter from 21 Senators.
NCPA submitted comments to the FDA regarding their “Review of Existing Center for Drug Evaluation and Research Regulatory and Information Collection Requirements”: Specifically, NCPA commented Feb. 5 on the FDA’s draft Memorandum of Understanding (“MOU”) on the relationship between state and federal laws on compounding pharmacies. NCPA highlighted concerns with FDA’s interchangeable and inconsistent use/definition of “dispensed” and “distribution” and the elimination of all non-sterile office-using compounding and the severe limitations on access to sterile office-using compounding in the MOU. NCPA also commented on FDA’s guidance regarding 503A pharmacies, specifically noting that using such guidance as a basis for enforcement actions against state-licensed pharmacies operating in compliance with state pharmacy laws and regulations circumvents Congressional intent of the DQSA.
Webinar Feb. 14: What’s in Store for Community Pharmacy in 2018: Learn how NCPA is crafting a strategy to forward members’ advocacy priorities and provide business solutions for you during an NCPA Innovation Center webinar Feb. 14. NCPA CEO Doug Hoey will share the legislative and regulatory actions NCPA is taking to protect the interests of community pharmacists and the patients they serve. The webinar is FREE and open to all pharmacists and technicians. (CE credit available only to those participating in the entire live webinar.)
Senators pledge committee action on opioid legislation: In conjunction with the panel’s fourth hearing on the subject, Senate HELP Committee Chairman Lamar Alexander (R-Tenn.) announced plans to hold a markup for committee approval of new legislation to address the epidemic. Sen. Alexander suggested it would give NIH more flexibility to administer research funding and complement parallel efforts of the Senate Finance Committee. NCPA and other pharmacy organizations worked together on a statement for the hearing’s record in support of easier access to, and greater pharmacist involvement in, medication-assisted treatment.
Recent Successes in State Legislatures:
- South Dakota SB 141, which prohibits PBMs from restricting pharmacists from providing information to patients on medication costs, passed the South Dakota Senate.
- Virginia HB 1177, which prohibits PBMs from restricting pharmacists from providing information to patients on medication costs, charging patients a copay higher than the cash price for the drug, restricting pharmacies from providing ancillary delivery services, and charging adjudication fees, passed the Virginia House of Representatives.
- The Kentucky legislature approved regulation 201 KAR 2:380 that allows the Kentucky Board of Pharmacy to approve protocols for 13 authorized conditions that allow pharmacists to initiate the dispensing of non-controlled or over-the-counter medications and related professional services.
- Florida HB 351 and SB 1494, both of which would require PBMs to register with the Office of Insurance Regulation, provide for generic drug pricing transparency, and prohibit PBMs from restricting pharmacists from providing information to patients on medication costs or charging patients a copay higher than the reimbursement received by the pharmacy, passed the House Appropriations Committee and Senate Health Policy Committee, respectively.
- Alaska HB 240, which contains provisions on PBM registration, generic drug pricing transparency, and fair pharmacy audit practices, passed the House Labor and Commerce Committee.
- Hawaii SB 3104, which would place PBMs under the purview of the Department of Commerce and Consumer Affairs and provide for generic drug pricing transparency, passed the Senate Commerce, Consumer Protection, and Health Committee.
Other State News
Hearing in Kentucky Probes PBM Issues in the State: A hearing was held in the Kentucky Senate Health & Welfare Committee recently where excellent testimony (attached) was given on SB 5 and the PBM issues in Kentucky. NCPA commends the Kentucky Pharmacists Association and the Kentucky Independent Pharmacist Alliance for their continued advocacy work on behalf of community pharmacists.
Arkansas Attorney General looking into low PBM reimbursement: AG Leslie Rutledge announced the effort Feb. 8.
NCPA joins PSSNY, others to oppose NY surcharge on opioids: The organizations argued against a 2 cent per morphine milligram equivalent surcharge on nearly all opioids sold in New York “due to how it would be applied and its unintended consequences.”