The focal point of recent news has understandably been focused on the Russia-Ukraine war, which was addressed by President Biden in the opening of his first State of the Union Address. Healthcare and prescription drug costs, however, still had a presence in the president’s address. President Biden indicated that he wants to cap the cost of insulin to $35 per month to increase access to more patients, mentioning that although insulin costs approximately $10 per vial for drug manufacturers to produce, the cost to patients is up to 30 times this amount. He subsequently proposed that Medicare be allowed to negotiate drug pricing, similar to how the Department of Veterans Affairs (VA) currently negotiates pricing.1,2
The Build Back Better Act (BBBA) bill has essentially stalled in the Senate after passage by the House. Abridged versions of the proposed legislation have been discussed with few details shared, but in early March, Senator Joe Manchin, who was primarily responsible for halting the BBBA’s progress, shared a much narrower version of the act. Tax reform and drug pricing reform are key elements, suggesting that a program to address the high cost of pharmaceuticals specifically for Medicaid and Medicare should be modeled on the current methods of the VA, as similarly mentioned by President Biden in his address.3
Another piece of pricing reform legislation was proposed on February 9 by Senators Bernie Sanders and Amy Klobuchar. The Cutting Medicare Prescription Drug Prices in Half Act would limit the reimbursement of Medicare Parts B and D drugs at either the lower costs or the acquisition costs paid by the VA or the acquisition costs through the Federal Supply Schedule of the General Services Administration.4
In early January, the Centers for Medicare and Medicaid (CMS) issued the CY 2023 Medicare Advantage (MA) and Part D Proposed Rule, which aims to lower out-of-pocket costs for Medicare Part D drugs and improve health equity in both MA and Part D. The proposed rule also suggests other revisions, such as updating marketing and communications regulations, new or expanded MA and Part D plan criteria, quality ratings, and pharmacy price concessions.5
Pharmacy Benefit Managers (PBMs), key market access stakeholders, have long been under scrutiny for their reported role in escalating drug pricing. The Federal Trade Commission (FTC) was recently urged by independent pharmacists to investigate PBM practices that impact drug pricing and pharmacies. After a vote was held on February 17, however, the study was not approved. Just 1 week later, the FTC released a request for public comments on how large, vertically integrated PBMs are affecting drug affordability and access. It will be interesting to see if this will lead to future investigation of PBMs by the FTC and how such investigations might potentially influence drug pricing reform.6,7
One of the known positive outcomes of COVID has been the expansion of telehealth in response to the public health emergency. Initially, many providers were scrambling to invest in and implement systems and capabilities to accommodate this need, but the measure is still considered to be a temporary allowance. Many experts have predicted that this could be one of the measures that becomes permanent in the near future. Bipartisan legislation, known as the Telehealth Extension and Evaluation Act, was recently introduced by Senators Catherine Cortez-Masto and Todd Young to extend the current telehealth prescribing waivers through 2024. Cortez-Masto also previously introduced additional legislation to permanently expand telehealth access to Americans with high-deductible health plans.8,9
Healthcare and drug policy often have direct and indirect impacts to market access stakeholders. Key takeaways from these recent potential drug policy disruptors include:
- While drug policy and related legislation impacting market access may take a temporary backseat due to the current global climate, payers and manufacturers will need to continue monitoring these potential market disruptors.
- Drug pricing reform, whether part of the BBBA or others, will likely continue to be at the forefront of most pharmaceutical-related legislation, and impacted stakeholders will need to pivot accordingly based on which provisions ultimately move forward. Refer to our January 2022 edition of All Access for more information.
- Telehealth may have a permanent home in US healthcare; therefore, payers and manufacturers should continue to account for this expanded point of patient care access in strategic decision-making and leverage this allowance to improve upon patient access to care and drug therapies.
- The White House. Remarks of President Joe Biden – State of the Union Address as prepared for delivery. March 1, 2022. https://www.whitehouse.gov/briefing-room/speeches-remarks/2022/03/01/remarks-of-president-joe-biden-state-of-the-union-address-as-delivered/
- Brennan Z. Biden continues his pledge for Medicare drug price negotiations in State of the Union speech. Endpoints News. Published March 2, 2022. https://endpts.com/biden-continues-his-pledge-for-medicare-drug-price-negotiations-in-state-of-the-union-speech/
- Bolton A. Manchin proposes dramatically scaled down version of Build Back Better. The Hill. Published March 2, 2022. https://thehill.com/homenews/senate/596580-manchin-proposes-dramatically-scaled-down-version-of-build-back-better
- JD Supra. Health & Life Sciences: Drug Pricing Digest-February 2022. Published February 15, 2022. https://www.jdsupra.com/legalnews/healthcare-life-sciences-drug-pricing-8438147/
- Federal Register. Medicare program; contract year 2023 policy and technical changes to Medicare Advantage and Medicare prescription drug benefit programs. Published January 12, 2022. https://www.federalregister.gov/documents/2022/01/12/2022-00117/medicare-program-contract-year-2023-policy-and-technical-changes-to-the-medicare-advantage-and
- Federal Trade Commission. Open commission meeting transcript. February 17, 2022. https://www.ftc.gov/system/files/documents/public_events/1600809/ftc_transcript_february_17_2022_open_commission_meeting.pdf
- FTC requests public comment on the impact of pharmacy benefit managers’ practices. Federal Trade Commission. February 24, 2022. https://www.ftc.gov/news-events/press-releases/2022/02/ftc-requests-public-comments-impact-pharmacy-benefit-managers
- Landi H. Senators introduce bipartisan bill to extend patient access to telehealth through 2024. Fierce Healthcare. Published February 8, 2022. https://www.fiercehealthcare.com/health-tech/senators-introduce-bipartisan-bill-extend-patient-access-telehealth-through-2024
- Cortez-Mastro, Daines introduce bipartisan bill to make pandemic-driven expanded telehealth access permanent. Senator Catherine Cortez-Mastro. May 19, 2021. https://www.cortezmasto.senate.gov/news/press-releases/cortez-masto-daines-introduce-bipartisan-bill-to-make-pandemic-driven-expanded-telehealth-access-permanent