Washington Wire: August 2022

On August 16, 2022, President Biden signed into law the Inflation Reduction Act (IRA). The massive bill took a long and torturous path through Congress before finally passing on a party-line vote. It includes significant health care provisions, along with climate, energy, and tax initiatives.

One part of the IRA, in particular, answers a key policy "ask" of HFA and many other patient groups: extending extra financial assistance for those who buy their own health insurance. Last year, as part of its response to the COVID-19 pandemic, Congress temporarily increased the availability and generosity of premium subsidies for people who enroll in insurance through the Affordable Care Act Marketplaces. Thanks to the 2021 law, insurance became much more affordable for millions of Americans. But the enhanced subsidies, absent further Congressional action, were set to expire at the end of 2022 – meaning that insurance premiums would spike for those purchasing ACA insurance for 2023. The IRA extends the enhanced premium subsidies for three years, avoiding the rate shock that would otherwise have caused an affordability crisis for many.

A separate, highly publicized set of health reforms contained in the IRA pertain to drug pricing. These provisions, among other things:

• Subject a defined number of brand name drugs to Medicare drug price negotiation, beginning in 2026 with Part D drugs (a category that excludes injectable and infusible bleeding disorders products);
• Subject a smaller number of Medicare Part B drugs to drug price negotiation in 2028 (while bleeding disorders products fall into this category, they are unlikely to be targeted for negotiation due to their comparatively small share of the Medicare market basket);
• Require drug manufacturers to pay rebates to Medicare if their drug prices increase faster than inflation;
• Phase in limits on seniors' annual out-of-pocket spending on Part D drugs; and
• Cap seniors' out-of-pocket costs for insulin at $35/month.

HFA and its coalition partners released a statement applauding the IRA's extension of the enhanced ACA premium subsidies – and urging Congress to take up the unfinished work of closing the Medicaid coverage gap, another key ACA-related priority.

Quick Hits

• In the wake of the Supreme Court's decision in Dobbs v. Jackson Women's Health Organization, HFA has heard from community members who are concerned about their continued access to the hormonal therapies that they use to control or mitigate menstrual bleeding. HFA has posted a policy priorities document reiterating our steadfast support for access to these and all other therapies and services needed by people with bleeding disorders – and providing FAQs and resources for people who rely on hormone therapies for control of bleeding.
• The U.S. Food and Drug Administration, the American Red Cross, and the Plasma Protein Therapeutics Association all issued statements addressing blood and plasma safety in the context of the current spread of the monkeypox virus (MPXV). PPTA concludes, based on donor screening, plus virus inactivation and removal steps used in plasma processing, that "the current MPXV outbreak is not a concern for the safety margins of plasma protein therapies manufactured by PPTA member companies." FDA advises blood centers that there have been "no reports of transmission of monkeypox virus through blood transfusion and the risk of transfusion-transmission remains theoretical;" as a result, FDA is not recommending adding any donor questions or lab tests at this time. The Red Cross notes that it already screens donors' arm skin for lesions and, beginning in October, will require people who have been diagnosed with or exposed to MPXV to wait 21 days before giving blood.
• In July 2022, NHF filed a Citizen Petition with the FDA, asking the agency to require certain safeguards (a "Risk Evaluation and Mitigation Strategy," or REMS), if FDA approves either of two investigational gene therapies for hemophilia that are currently under regulatory review. On August 29^th, HFA submitted a comment letter supporting the petition. HFA's comments stress that the requested REMS will support patients' ability to make informed decisions about the treatment options that best serve their individual goals.
• Federal regulators released a final rule laying out the process for resolving surprise billing disputes between providers and insurers. (Recall that, as of January 1, 2022, the federal No Surprises Act protects patients against surprise medical bills for emergency services at out-of-network hospitals, and for non-emergency services delivered by out-of-network providers at an in-network hospital).
• On August 5^th, the U.S. Department of Health and Human Services and Centers for Medicare & Medicaid Services marked the 25^th anniversary of the Children's Health Insurance Program (CHIP). CHIP (which goes by different names in some states) provides health coverage for uninsured children in families who earn too much to qualify for Medicaid, but too little for private insurance. A joint federal-state program, CHIP covers over 9 million children across the country, including many in the bleeding disorders community.
• Since the start of the COVID public health emergency (PHE), the federal government has provided extra funding to help states cover their increased Medicaid responsibilities. In exchange for this enhanced funding, states have been required to keep existing Medicaid beneficiaries continuously enrolled for the duration of the PHE. When the PHE ends, eligibility redeterminations and disenrollments will resume. It now appears that the PHE will continue at least through the end of 2022, since HHS did not give its promised 60-day notice to state Medicaid programs ahead of the current October 13 expiration date. But planning for the PHE unwinding moves forward, nonetheless, in the hope of avoiding massive coverage losses. In August, CMS awarded $99M to ACA navigators in states that use the federal Marketplace (healthcare.gov); $12.5M of that sum is earmarked to help navigators transition newly-ineligible Medicaid enrollees into ACA Marketplace coverage.