July 18, 2022 This Week in Health Policy for July 18 This week (July 18 - July 22) The House Energy and Commerce Oversight and Investigations Subcommittee holds a hearing on "Roe Reversal: The Impacts of Taking Away the Constitutional Right to an Abortion."
The Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee holds a hearing on food safety and the Food and Drug Administration.
Last week (July 11-15) Health Care Highlights Reconciliation discussions. Congressional Democrats started a three-week sprint to pass a budget reconciliation bill by the August recess this week, amid a flurry of speculation about what is in and what is out of the scaled-back package. One of the most likely items to be included is a Senate drug pricing plan, which would allow Medicare to negotiate prescription drug prices, among other items, projected to save about $288 billion over 10 years. Lawmakers are still negotiating other tax, health and climate measures primed for potential inclusion. Senator Joe Manchin (D-WV) has made clear he is wary of adding provisions that would contribute to inflation, however recent reports suggest he may be open to a two-year extension of the enhanced Affordable Care Act (ACA) tax credits set to expire in December despite previously rejecting temporary policies. Other news this week suggested he would not support a package with new climate spending or tax increases, a marked shift after weeks of negotiation, however Manchin has since disputed those claims. Manchin said today on a West Virginia radio program he told Schumer that "the one thing you know you can get done [in July] … is letting Medicare negotiate [drug prices]." He said he also told Schumer that "it's not prudent to do the other [provisions] right now" but added that "as far as I'm concerned, I want climate, I want energy policy." Meanwhile, the Senate parliamentarian is reviewing Democrats' latest drug pricing plan, which the Senate Finance committee unveiled last week. The plan would allow Medicare to negotiate prescription drug prices beginning in 2023 — with prices taking effect in 2026, and includes other provisions to impose inflationary rebates, redesign Medicare Part D and encourage biosimilar competition. The revised version does not include monthly insulin copay caps that were in previous iterations and also drops provisions aimed at increasing transparency and oversight of pharmacy benefits managers. User fee agreements flounder. This week, bicameral negotiations to reauthorize the Food and Drug Administration (FDA) user fee agreements seemed to flounder, as Senate HELP Committee ranking member Richard Burr (R-NC) introduced a bill this week that simply reauthorizes the underlying user fee agreements for five years and strips out major riders and amendments. Senate HELP Committee Chair Patty Murray (D-WA), however, said she still wants to move forward with the broader bill that has already advanced out of committee, saying "It makes absolutely no sense to back out of bipartisan negotiations now … I urge Senator Burr to return to the table and finish what he started." The bipartisan leaders of the House Energy and Commerce Committee also issued a joint statement urging the Senate to bring their bipartisan package to the floor for a vote before August, signaling that the holdup is coming from the Senate. If Congress does not reach a deal soon, the FDA may have to send out furlough notices at the start of August to thousands of employees, however the agency likely has enough carryover funding to stall immediate layoffs. House Republicans issue one pager on health care affordability. The House Republican Healthy Future Task Force Affordability Subcommittee released a one pager recommending policies to "improve health care choices for workers and small business owners, promote innovation and transparency, and lower costs and increase options through competition." An accompanying press release and op-ed are available. House Republicans issue one pager on health care affordability. The House Republican Healthy Future Task Force Affordability Subcommittee released a one pager recommending policies to "improve health care choices for workers and small business owners, promote innovation and transparency, and lower costs and increase options through competition." An accompanying press release and op-ed are available. HHS renews public health emergency (PHE). On Friday (July 16), the Department of Health and Human Services (HHS) renewed the COVID-19 PHE declaration for another 90 days, as expected. The latest renewal comes as the contagious Omicron offshoot BA.5 has led to a spike in case rates, hospitalizations and deaths. The PHE will now expire in mid-October, barring additional action, with a promise in place from HHS Secretary Xavier Becerra to warn states 60 days in advance of the end to the PHE given the many flexibilities tied to the declaration. Biden administration issues guidance on abortion access. On Monday (July 11), HHS published guidance restating its view that the Emergency Medical Treatment and Labor Act (EMTALA) preempts state abortion bans when the procedure is needed for emergency care to save the life of the patient, and it warned that hospitals and doctors not heeding the law could be kicked out of Medicare. The guidance was quickly followed by a lawsuit from the state of Texas. HHS also issued guidance on Wednesday (July 13) to retail pharmacies, clarifying their responsibility to provide patients with the medication they were legally prescribed even if it could be used in an abortion. The guidance builds on the goals the department included in HHS' recent reproductive health care access agenda and follows President Biden's July 8 executive order directing HHS to expand access to abortion and reproductive health care. The Department of Justice also announced this week the creation of a Reproductive Rights Task Force, to "identify ways to protect access to reproductive health care." House lawmakers today also passed two bill todays that would codify the right to an abortion — the Women's Health Protection Act, and reaffirm the right for someone seeking an abortion to travel freely across state lines — the Ensuring Women's Right to Reproductive Freedom Act. The largely symbolic votes comes as Democrats move to signal their continued commitment to abortion rights following the Supreme Court ruling. FDA authorized Novavax's COVID-19 vaccine. On Wednesday (July 13), the FDA authorized Novavax's COVID-19 shot for emergency use for adults ages 18 and older, adding a fourth vaccine to the U.S. arsenal. Novavax's vaccine could appeal to people who have been reluctant to receive one of the mRNA vaccines, as the shot was manufactured using a different process. Once the Centers for Disease Control and Prevention (CDC) signs off, vaccination can begin. The agency's Advisory Committee on Immunization Practices is scheduled to meet on July 19. 988 mental health emergency hotline launches this weekend. Starting this weekend, Americans experiencing a crisis can dial 988 to reach a hotline for mental health emergencies. The hotline builds on the current National Suicide Prevention Lifeline, which Americans can call, text or online chat call centers and receive counseling. According to HHS, the ultimate goal is to be able to dispatch mobile crisis teams immediately to those in need, however HHS officials stressed this week that there is a long way to go before every America can expect immediate crisis care. The launch is expected to vary widely from state to state; HHS has held calls with states' mental health and substance abuse commissioners in recent weeks to discuss 988 implementation. ICYMI over recess:
Reports, Studies, and Journals HCCI: Average Payments for Childbirth Among the Commercially Insured and Fee-for-Service Medicaid. Data show that the average ESI payment for childbirth was greater than the average FFS Medicaid payment for childbirth in all 38 states, with an average difference of $8,732 for all deliveries, $11,084 for c-section deliveries, and $7,461 for vaginal births. The Commonwealth Fund: When Medicaid's COVID-19 Pandemic Continuous Enrollment Guarantee Unwinds, Safety-Net Providers Will Play a Critical Role. Ending continuous enrollment will result in an estimated 13 million to 16 million people losing coverage. This figure could be far higher, given the potential disruption caused by redetermining eligibility for more than 80 million people in a compressed time period, even as new applications flow in. Urban Institute: Women's Coverage Losses in 2023 If the American Rescue Plan Act's Premium Tax Credits Expire. About 850,000 additional adult women of reproductive age (19 to 44) will be uninsured in 2023 if the enhanced premium tax credits (PTCs) passed under the American Rescue Plan Act (ARPA) are allowed to expire at the end of 2022 as they are slated to under current law. USC-Brookings Schaeffer Initiative for Health Policy: Profits, medical loss ratios, and the ownership structure of Medicare Advantage plans. In this paper, authors examine sources of earnings and profits by MA plans and focus on potential sources of profits, the measurement challenges in tracking profitability, and the role that MLR regulations have in constraining the potential for overpayments. ———————————————
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