Notes from Joe
by Joe Pugliese
It has been a very active first half of the year in our space and the broader debate over health care policy in Washington. Certainly, the biggest news has been the distribution of COVID vaccines that have allowed many of us to return to a more normal life. Of course, the delta variant and the other variants to follow remain a cause for concern, especially since efforts to vaccinate have slowed noticeably and cases have been rising. If you or a loved one hasn’t gotten vaccinated yet, please do! It’s clear the best thing you can do to protect yourself and everyone else. In terms of policy, there has been a flurry of court cases, requests for information (RFIs) and executive orders.
On the regulatory front, I’m pleased to share that the final rule implementing the Hemophilia SNF Access Act was just released last night. CMS has listened to the comments that the Alliance submitted with NHF and HFA and is adding a few new J Codes to the list of drugs that SNFs will be able to bill separately. We know that everyone is excited for our patients to have better access to SNFs starting in October. Stay tuned for more information about how the law will be implemented and how your HTC can work with SNFs near you to serve your patients.
In last month’s Newsletter, we shared information about the California v. Texas lawsuit about the Affordable Care Act (ACA) and recent litigation related to manufacturers declining to provide 340B drugs if dispensed by contract pharmacies. Despite all of this litigation, I remain very positive about the unwavering support we enjoy form our manufacturing partners and confident that our ability to use contract pharmacies will remain unimpeded.
President Biden has also not been shy about issuing executive orders (EOs), with 52 to date. As a few points of comparison, President Trump averaged 55 per year, FDR is the clear winner with 3,721 EOs, and Presidents Adams, Madison and Monroe are tied for last with just one each. The most recent Biden EO that’s relevant to us is expansive, impacting a dozen federal agencies and many policies and programs with the goal of increasing competition. The EO comments on high prices for prescription drugs and consolidation within the health care industry that increases costs and asks for his agencies to give him policies to lower drug costs and increase competition in the health care space. We’ll provide updates as any of these policies is released.
On the regulatory front, the Alliance recently joined with NHF and HFA to submit comments on an RFI regarding Reporting on Pharmacy Benefits and Prescription Drug Costs, about implementation of a new law enacted last year that will require public reporting from insurers and PBMs about drug prices and financial relationships between them. Our comments focused on copays accumulators and the new and pernicious alternate funding model, and encourage HHS to look at the impact of manufacturer rebates paid to PBMs and health plan on drug costs. We are now reviewing the impact of the 2022 Hospital Outpatient Prospective Payment System (HOPPS) proposed rule, in which CMS proposes to continue the 30% cut to 340B hospitals’ reimbursements. In past years, we have determined that no HTCs have been affected by this reduction and are confirming that will remain true. This policy is also the subject of litigation, which will go before the US Supreme Court next year.
As if that weren’t enough, there’s also been activity in Congress. The PROTECT 340B Act (HR 4390) was recently introduced. It is remarkable in several respects. First, it is bipartisan and second it is trying to address what has been terms “pickpocketing,” where commercial interests want to take some or all of the 340B discount from covered entities. We are encouraged by the proposed legislation put forth by Reps. McKinley and Spanberger and are reviewing and giving input on specific language. Finally, we’re keeping our eyes out for what relevant health policies might be included in the BIF, the Bipartisan Infrastructure Framework and its sibling reconciliation bill. Rumors are that there may be some drug pricing provisions included to help pay for the other elements, and we’re advocating to make sure that there aren’t any harmful provisions for HTCs.
Suffice it to say, the Alliance leadership and Washington Team are hoping for but not really anticipating a quieter half of 2021. We will continue to update you about everything happening in Washington and hope that you will contact us with any questions.