NCPA Urges Ban on Spread Pricing and
End to DIR Fees in Budget Reconciliation
This week, NCPA sent a letter to Senate Majority Leader Charles Schumer (D-N.Y.), House Speaker Nancy Pelosi (D-Calif.), Senate Finance Committee Chairman Ron Wyden (D-Ore.), and House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) strongly supporting the inclusion of language to reform pharmacy direct and indirect remuneration fees and eliminate spread pricing in Medicaid managed care within the budget reconciliation package being developed by policymakers. Democrats have set a deadline of September 15 for committees to complete their work on compiling the legislation. If you are represented by a democrat in the House and/or Senate, click here to send them an email encouraging them to support inclusion of these provisions in the final bill.
Delaware State Auditor Urges Congress to
End Abusive Spread Pricing and DIRs
Kathleen McGuiness, Delaware State Auditor and pharmacist, urged both President Biden and Congress to include in the current budget reconciliation package, a ban on Medicaid spread pricing and a Medicare Part D DIR fix. In her letter, she cited two reports (which can be viewed here and here) released by her office that have “garnered national attention and helped shine a light on how PBMs have gouged millions of dollars out of Delaware taxpayers and are strangling independent pharmacies’ ability to stay open and serve as the first line of defense for their customers who are hurt or sick." We appreciate Auditor McGuiness’ hard work to shine a light on opaque PBM practices. A copy of her letter to the Administration and Congress can be found here.
Oral Arguments Heard in PCMA v. Wehbi
On September 1, 2021, a three-judge panel of the 8th Circuit heard oral arguments from lawyers representing the North Dakota Attorney General and PCMA in the case of PCMA v. Wehbi. The panel of judges is the same panel that heard this matter previously and were engaged in the lawyer’s presentations. What stood out in the arguments was the fact that PCMA had to concede that a number of ERISA challenges in its initial argument (e.g., provisions related to claw backs) had to be withdrawn because PCMA had no answers to North Dakota’s position following the unanimous decision in Rutledge. We anticipate the panel will render a decision sometime near the end of the year. A recording of the oral arguments can be found here.
U.S. Chamber of Commerce Drops Lawsuit on
Transparency Rule After HHS Delays Enforcement
On August 20, 2021, HHS published a guidance document which contains an explanation of the delay of Transparency in Coverage rule pending additional rulemaking. HHS is delaying enforcement from January 1, 2022 to July 1, 2022 of a requirement for prescription drug information to be reported by issuers and plans to the government. Following the publication of the guidance, the Chamber dropped its lawsuit filed earlier this month and the local Tyler, Texas Chamber affiliate requested it be dropped as a plaintiff based on local business feedback in support of transparency in drug pricing. At this time, PCMA is continuing to move forward with its lawsuit over the requirement of historical net prices be publicly disclosed.
Medicare Trustees Release 2021 Report on Program
On August 31, 2021, CMS posted the 2021 Annual Report by the Boards of Trustees of the Federal Hospital Insurance and Federal Supplementary Medicare Insurance Trust Funds. The Hospital Insurance (HI) trust fund assists in paying for Medicare Part A benefits, while SMI covers Part B and Part D services and prescription drugs. The Trustees found the HI program would remain solvent until 2026 – same as the previous year and the SMI program would be adequately funded for the next 10 years. The Trustees did not find that the COVID-19 pandemic had a significant impact – as increased expenditures in testing and other related services were offset by reduced elective procedures. Part D spending decreased due to increased DIR – which the trustees define as “drug manufacturer rebates and pharmacy rebates that Part D plans negotiate” and a shift of patients towards Medicare Advantage plans. The Trustees expect DIR to increase from 28.3% to 33.5% (expressed as a percentage of total drug costs) over the 2020-2030 window. The Trustees believe this, along with higher rebates, will continue to keep premium increases down but did not account for new specialty drugs on the market which might impact expenditures.
NCPA Comments on DSCSA Draft Guidance
NCPA submitted comments to FDA in response to their Draft Guidance for Industry: Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA). The draft guidance, which can be found here, presents—for the first time—FDA’s views of what constitutes “enhanced drug distribution and security at the package level,” which will go into effect in 2023. NCPA’s comments highlight concerns with the draft guidance, including the need for dispenser flexibility when dealing with clerical errors, lack of clarity regarding the appropriate use of inference, and the infeasibility of a “system” where FDA and other government officials would be able to access, electronically and automatically, the confidential transaction data for all DSCSA-covered product purchases and sales held by supply chain partners.
USP Releases Revisions to Chapters <795> and <797>; Opens Public Comment Period
On September 1, 2021, USP published proposed revisions to chapters <795> and <797>, including changes to the Beyond Use Date (BUD) rubric. USP believes these revisions reflect the input of stakeholder engagement – including previous opportunities for NCPA members to provide feedback directly to the organization - and public health considerations. USP is now soliciting feedback from the public on the proposed revisions until January 31, 2022. NCPA will work with its Compounding Committee to review the proposals and respond to ensure the chapters adequately account for the needs of compounding pharmacies. Additionally, USP will be hosting open forums to review the revisions during the new year. Further information on those dates and registration can be found here.
Join Us in Charlotte, N.C. for the NCPA 2021 Annual Convention
If you have not yet done so, register for the in-person NCPA 2021 Annual Convention in Charlotte, N.C. from Oct. 9-12. Don’t miss the chance to reconnect with your colleagues for four days of best-in-class business education, networking opportunities, and a little fun in Charlotte. We look forward to seeing you there.
Anti-steering Bill Passes California Assembly
SB 524 passed the California Assembly. The bill would protect patient access to community pharmacy services by prohibiting insurers and PBMs from steering patients to insurer/PBM-owned pharmacies. The bill is now awaiting concurrence by the Senate. NCPA has urged California lawmakers to support the bill.
NCPA State Legislative Activity Update
NCPA tracks state legislation related to our top three state priorities: Medicaid reform, scope of practice and compensation for services, and PBM reform and regulation. Click each issue for a report of bills that have been introduced so far this session specifically dealing with these three issue areas. You can access the individual bill language and basic information on the bill by clicking on the bill numbers in the attached report. Bills that have moved this week are listed at the top in the “Recently Updated” section.
NCPA’s Advocacy Center Update provides a weekly detailed summary of recent and breaking legislative, regulatory, and state developments impacting independent community pharmacy and NCPA’s efforts to affect policies benefitting its membership and the industry. The weekly update is distributed to NCPA leadership, steering committees, allied organizations/stakeholders and major contributors to the NCPA LDF and PAC. The weekly update is intended exclusively for the recipient and is not for external distribution.