The dictionary says a “watershed moment” is a crucial dividing point, line or factor – a turning point – where everything changes and is never the same. Have we arrived at such a critical juncture in late March? Possibly, but many questions remain.
Will the $1.9 trillion American Rescue Plan deliver the stimulus that helps us recover from the economic and health effects of the COVID-19 pandemic and ongoing recession? Will the narrowly won confirmation of Xavier Becerra fuel the panacea of priorities he pledged during his confirmation hearings – and will 340B remain a top priority of his? Can a federal judge’s preliminary injunction stop HHS from implementing or enforcing the 340B drug pricing program’s new administrative dispute resolution or does HHS still have an ace up its sleeve? And will CMS nearly doubling the COVID-19 vaccine administration rate for Medicare beneficiaries fuel an exponential rise in vaccinations nationwide?
A lot has transpired in just the last few weeks, but we’re here to dig into it. Don’t blink – you might miss something.
President Joe Biden signed the American Rescue Plan Act of 2021
On March 11, 2021, the first anniversary of COVID-19 being declared a global pandemic by the World Health Organization, President Joe Biden signed the American Rescue Act. The final amended bill was passed by the House on March 10 by a vote of 220–211, with one Democrat voting against it with all Republicans.
While much of the attention on the most recent COVID relief has been on stimulus payments, the bill includes language that could impact 340B. Beginning in 2024, ceiling prices on some branded drugs could be set at lower than one penny and outpatient drugs used for COVID-19 prevention/treatment can now be covered by Medicaid.
Additional aspects of the bill include an $8.5 billion reimbursement package for rural health care providers and a $7.6 billion initiative to help community health centers get vaccines to patients while implementing transmission tracing.
The U.S. Senate confirmed Xavier Becerra as Secretary of Health and Human Services
Fifty-seven days after his nomination, Xavier Becerra became the 25th Secretary of the Department of Health and Human Services, promising that confronting the coronavirus pandemic would be his first priority. During his nomination hearings, Becerra pledged to expand health insurance, rein in prescription drug costs and reduce racial and ethnic disparities in medical care.
Seen as a strong supporter of the 340B program and 340B covered entities, Becerra is the antithesis of his predecessor Alex Azar, who made 340B reform a priority in the previous administration. In his confirmation hearing, Becerra said, “340B has become an indispensable program for some of these providers who are really helping some of our neediest populations.” Becerra is widely seen as being a vigorous proponent for healthcare coverage and equity and is a champion for patients, the underserved and healthcare safety net programs.
A federal judge granted Eli Lilly’s motion to halt the 340B Dispute Resolution System
A ruling by a U.S. District Judge in Indiana granted a motion by Eli Lilly, who sought to block the Administrative Dispute Resolution (ADR) by claiming the rule should not have been put into place without an additional comment period before its release. The judge ultimately blocked the Biden administration from implementing the ADR, noting that the rule was finalized at the end of 2020 without offering an opportunity for comments after the rule had been paused in 2017.
Attorneys who represent the Ryan White Clinics for 340B Access in its suit to force HHS to take action against Lilly and other manufacturers denying 340B pricing on their products, said the injunction was based on a procedural formality, and the court did not hold that the ADR rule was substantively defective. Should it choose, they said, HHS could decide to reissue the rule with the procedural defects cured. HHS has issued no statement as of this writing.
CMS to create a standard rate for each COVID-19 vaccine administration for Medicare beneficiaries
Effective March 15, CMS announced it would significantly increase Medicare reimbursements rates for the administration of new COVID-19 vaccines in an effort to accelerate rollout. As a result of the announcement, the national average payment rate will rise from approximately $28 to $40 for the administration of single-dose vaccines and from approximately $45 to $80 for the administration of COVID-19 vaccines requiring two doses.
CMS said in an email to journalists that “This new and higher payment rate will support important actions taken by providers that are designed to increase the number of vaccines they can furnish each day, including establishing new or growing existing vaccination sites, conducting patient outreach and education, and hiring additional staff.”
- On March 19, HHS announced it would delay a Trump administration rule that would require health centers to provide insulin and injectable epinephrine to low-income patients at the price the centers pay for those drugs under the 340B program.
- States stand up against PBMs – Multiple states have introduced bills blocking PBMs from discriminating against covered entities. The bills vary in depth, with some simply noting that PBMs cannot discriminate against 340B covered entities, while others aim to prevent additional fees/chargebacks, below-average payments or penalties on pharmacies for sharing pricing information.
Is this a watershed moment? Only time will tell.
Will the American Rescue Plan create some form of national normalcy, absent some of the precautions we’ve all grown accustomed to? How about a reinvigorated economic revival, jobs, restored lives, growth and, most importantly, hope?
Will Xavier Becerra and his team defeat CODID-19 and accomplish his aggressive objectives to the benefit of…everyone? We hope so. But in the meantime, the safety net still needs mending – and the people in it, healing, and you and the 340B program, sustenance. If not a Watershed Moment, maybe this is a nurturing ground spring of hope and love – for all of us.
Thank you for all you do every day to support the safety net we continue to provide to sustain the health and the dignity of the people in our communities. It is much appreciated.