Congress Passes the Inflation Reduction Act

Congress ended a busy work period after passing the Inflation Reduction Act (IRA) over the weekend. Congress has now adjourned for August recess. The Senate returns on September 6, and the House returns on September  13.

Of note for UMDF members, the Act includes prescription drug pricing reform, caps out-of-pocket drug costs for Medicare beneficiaries, and extends the American Rescue Plan’s (ARP’s) increased Affordable Care Act advanced premium tax credit (APTC) subsidies for three years.

The additional APTC subsidies enacted in the ARP have led to significant increases in coverage, and the extension of these subsidies is important, given that millions of people will become ineligible for Medicaid once the COVID-19 public health emergency ends.  These subsidies work on a sliding scale.  Under the original law, people whose incomes are at or just above the federal poverty level (FPL) received the most generous subsidies, and no subsidies were provided for those above 400% of poverty.   However, the American Rescue Plan Act (ARPA) expanded the premium tax credits for a two-year period, making them more generous for lower-income beneficiaries and also extending them beyond the 400% FPL cut-off by capping beneficiary premiums at no more than 8.5% of an individual’s income for a silver plan.  The ARPA tax credits were originally set to expire on January 1, 2023.  However, as mentioned above,  these credits will now be extended for another three years.

The lRA also allows the Medicare program to set the price of certain high-expenditure prescription drugs. Drugs subject to the new negotiated price requirement will be initially selected in 2023, and the prices set will be applied beginning in 2026.  Drugs must be selected by the Centers for Medicare and Medicaid Services (CMS), and an agreement reached with the manufacturer two years before the new price will apply.  The IRA also includes enforcement provisions. Manufacturers will be subject to significant civil monetary penalties (CMPs) and can be assessed an escalating excise tax beginning at 65 percent of the drug’s prior year’s total sales, increasing to 95 percent once the manufacturer is out of compliance for more than 270 days. Alternatively, the manufacturer may withdraw its products from Medicare instead of engaging in negotiations.

Among other notable changes, the IRA restructures the Medicare Part D benefit to provide financial protections for beneficiaries. Currently, there is no out-of-pocket cap for Medicare beneficiaries in Part D; once patients reach the “catastrophic phase” of the benefit, they can be asked to pay 5 percent of the cost of their drugs, without limit, which can total thousands of dollars per year. For the first time, the IRA eliminates this 5 percent cost-sharing in the catastrophic phase (taking effect in 2024) and caps patients’ out-of-pocket costs in Part D at $2,000 (taking effect in 2025).

The IRA also requires coverage of certain adult vaccinations under Medicaid, eliminates some cost-sharing, and requires coverage of approved, recommended adult vaccines and their administration under the Children’s Health Insurance Program (CHIP) for individuals age 19 and older and eliminates cost sharing.

The House of Representatives Passes an Extension of Telehealth Waivers

Thanks to the advocacy efforts of UMDF members, on  July 27, 2022, the House passed the Advancing Telehealth Beyond COVID-19 Act of 2021 (H.R. 4040), led by Reps. Liz Cheney (R-WY) and Debbie Dingell (D-MI). The bill extends several COVID-19-related telehealth flexibilities through the end of 2024, including geographic and originating site flexibilities, meaning patients can continue to receive care via telehealth in their homes, which is critical to mitochondria patients.

The bill also increases the types of providers eligible to provide telehealth, waives in-person requirements for behavioral health services, allows coverage of audio-only telehealth, and lets telehealth satisfy face-to-face requirements for hospice care. At this juncture, it is unclear if the Senate will take this up during the remaining legislative days in 2022 or possibly pass a different telehealth extension bill with similar characteristics to the House bill.  Under current law, equivalent telehealth authorities have been provided for up to five months following the end of the COVID-19 public health emergency (PHE) declaration. As of this writing, it is unclear when the Administration might lift that declaration.

Mitochondrial Disease Priorities Included in the FY 2023 Appropriations Bill

UMDF has long advocated with help from the Congressional Mitochondrial Disease Caucus (co-chaired by Reps. McGovern (D-MA) and Fitzpatrick (R-PA) for the inclusion of mitochondrial disease as an area of medical research eligible for the Department of Defense (DoD) Peer-Reviewed Medical Research Program.  We are pleased to report that mitochondrial disease is included in the FY 2023 appropriations bill.  To date, due to this inclusion, there has been millions in funding for mitochondrial disease through DOD’s Peer-Reviewed Medical Research Program. 

CMS Unveils Guidance on a Medicaid Health Home Benefit for Children with Medically Complex Conditions

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), recently rolled out guidance on a Medicaid health home benefit that is newly available for children with complex medical conditions.  The new optional benefit helps state Medicaid programs connect Medicaid-eligible children with complex medical conditions with person-centered care management, care coordination, and patient and family support. The benefit provides a variety of services, including access to a full range of pediatric specialty and subspecialty medical services, including services from out-of-state providers. For more information on CMS’ latest guidance, you can refer to the state Medicaid director letter found here. 

HHS to Create an Office of Long COVID Research and Practice

The Department of HHS is creating a new long COVID office as part of a White House plan to better understand why some patients continue to face symptoms long after they’ve shed the infection. The new Office of Long COVID Research and Practice will fall under the Health and Human Services assistant secretary for health, according to the White House’s National Research Action Plan on Long COVID released last week.  Notably, the mitochondria are impaired in some individuals that contract Long COVID, resulting in extreme fatigue and neurological problems. This has continued the need to highlight the lack of therapeutic interventions to address mitochondrial disease/dysfunction. As Congress puts significant resources into Long Covid, UMDF will work with Congress and the Administration to continue to push for the need for better mitochondrial therapeutics for those plagued with Long COVID and the many others with impaired mitochondria functionality resulting from primary or secondary disease.