Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Build Back Better Pared Down to Drug Pricing, ACA Subsidies

After more than a year of negotiations, Sen. Joe Manchin (D-W.Va.) announced that he will only support provisions to lower the cost of prescription drugs and extend enhanced Affordable Care Act subsidies in the latest iteration of the President’s Build Back Better economic agenda. Democrats need the support of their entire caucus to pass the package via the budget reconciliation process. Manchin had previously raised concerns about the Democratic proposal to expand some taxes on businesses to extend the solvency of the Medicare program. He had stated that the language should be further scrutinized to ensure that it would not contribute to inflation or negatively impact taxpayers, but then pivoted to outright opposition to all tax increases in the package later in the week. The West Virginia Democrat also stated that he would not support new spending on climate measures or tax increases in the reconciliation bill. President Joe Biden has endorsed Democrats moving ahead on the drug pricing and ACA provisions, vowing to take executive action on the issue of climate change. Schumer has said he wants to pass the reconciliation bill by early August. Democrats are currently working with the Senate Parliamentarian to ensure the drug pricing measure complies with the rules of budget reconciliation. September 30 is the hard deadline for Democrats to use the fast-track budget process via the current resolution.

Burr Exits UFA Negotiations and Introduces Clean Bill

Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Richard Burr (R-N.C.) has pulled out of negotiations on the reauthorization of the Food and Drug Administration’s medical product user fees. Burr introduced a clean version of the reauthorization legislation last week. The Food and Drug Administration Simple Reauthorization Act (S. 4535) does not include provisions to overhaul the accelerated approval pathway or regulation of cosmetics, dietary supplements, and laboratory-developed tests – measures that are a part of the version of the bill (S. 4348) advanced by the Senate HELP Committee in June. He stated that his legislation “preserves the user fee agreements as they’ve already been negotiated—without harmful additions.” House Energy and Commerce Committee leadership Frank Pallone (D-N.J.) and Cathy McMorris Rodgers (R-Wash.) issued a statement urging the Senate to quickly take up the House-passed proposal (H.R. 7667). Congress must reauthorize the user fee programs for the next five fiscal years before the current agreements expire on September 30. Industry-paid user fees comprise a large part of the FDA’s budget. Therefore, if the timeline for passage slips, the FDA may need to send out pink slips notifying employees of impending furloughs or layoffs to comply with Federal employee union contracts requiring 60 days’ notice.

House Passes Veteran Burn Pit Legislation

The House of Representatives passed the Sergeant First Class Heath Robinson Honoring Our Promise to Address Comprehensive Toxics (PACT) Act (S.3373) last week by a 342-88 vote. The legislation would support veterans who have been exposed to toxic substances during military deployments. The bill would increase access to medical care and disability benefits for veterans by establishing presumptions of service connection related to toxic exposure, and by adding 23 burn pit and toxic exposure-related conditions to the VA’s list of service presumptions. It would also mandate more federal research on toxic burn pits. The Senate must clear the legislation before it is sent to President Joe Biden for his signature.

Appropriations Update

Senate Appropriations subcommittee chairs are working to draft their fiscal year (FY) 2023 spending bills for release at the end of this month, according to a panel spokesman. On the other side of the Capitol, House Democratic leadership is aiming to pass nine of the 12 annual appropriations bills by the August recess, with Defense, Homeland Security, and Legislative Branch being held back. A continuing resolution (CR) will likely be necessary to keep the government funded beyond the end of the fiscal year on September 30.

Focus Remains on Abortion, Reproductive Health

Abortion remains a focus of lawmakers on Capitol Hill following the recent Supreme Court decision to overturn Roe v. Wade. The House of Representatives passed two bills last week aimed at protecting access to abortion. The Women’s Health Protection Act (H.R. 8296) would codify the right to an abortion. The Ensuring Access to Abortion Act (H.R. 8297) is focused on interstate abortion services and would protect individuals and abortion providers from prosecution. The votes were largely along party lines. The House plans to vote this week on legislation to create a statutory right to contraception (H.R. 8373). Sen. Catherine Cortez Masto (D-Nev.) attempted to pass legislation (S.4504) similar to H.R. 8297 last week, but Sen. James Lankford (R-Okla.) blocked the bill. Sen. Tim Kaine (D-Va.) stated that he is working with Sen. Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska) on legislation to codify “a minimum federal guarantee of reproductive freedom” that would reflect the status quo prior to the Supreme Court ruling.

A group of more than 80 House Democrats sent a letter to the White House urging the Biden administration to issue a national emergency and public health emergency declaration on abortion access and to invoke the Public Readiness and Emergency Preparedness Act. “A public health emergency declaration can provide significant new authority and flexibility for a federal emergency response. Relevant activities may include but are not limited to Public Health Services Corps team deployments, Medicaid State Plan Amendment flexibilities to support safe-haven states, and the ability to accelerate access to new medications authorized for abortion,” the letter states.

The Biden administration released updated guidance last week to assure health care providers that they are protected by the Emergency Medical Treatment and Active Labor Act (EMTALA) if they terminate a pregnancy as a part of treatment in emergency circumstances. Since the Supreme Court overturned Roe v. Wade last month, there has been confusion around when providers can perform abortions without risking prosecution in states that have enacted bans on the procedure. “Today, in no uncertain terms, we are reinforcing that we expect providers to continue offering these services, and that federal law preempts state abortion bans when needed for emergency care,” said Health and Human Services Secretary Xavier Becerra. “Under the law, no matter where you live, women have the right to emergency care — including abortion care.” HHS issued the rule saying that EMTALA requires that physicians’ judgment prevail to protect the health of women in labor and with conditions such as ectopic pregnancies or dangerously high blood pressure. To ensure hospitals and physicians comply, HHS said it will fine them and block payments from Medicare and Medicaid for non-compliance. Those in violation face fines ranging from about $60,000 to $120,000. In response, Texas has sued to block the new Biden administration rule.

The Federal Trade Commission (FTC) has committed to enforcing improper and illegal consumer location and health data privacy practices. Many lawmakers have raised concerns about the selling of location data by data brokers following the Supreme Court’s overturning of Roe v. Wade. “We will vigorously enforce the law if we uncover illegal conduct that exploits Americans’ location, health, or other sensitive data,” Acting Associate Director of the FTC’s Division of Privacy and Identity Protection Kristen Cohen wrote in a blog post last week. “The FTC’s past enforcement actions provide a roadmap for firms seeking to comply with the law.”

Marijuana Decriminalization Bill Coming This Week

According to recent reports, Senate Democrats plan to introduce legislation to decriminalize marijuana this week. The package has been negotiated by Majority Leader Chuck Schumer (D-N.Y.), Cory Booker (D-N.J.), and Ron Wyden (D-Ore.). The Cannabis Administration and Opportunity Act would remove marijuana from the list of drugs covered by the Controlled Substances Act, create grant programs to aid communities and individuals most impacted by drug offenses, and establish funding programs to provide loans to small cannabis businesses owned by disadvantaged individuals. It also requires that federal non-violent cannabis-related convictions and arrests be expunged within one year of enactment. The House of Representatives passed similar legislation earlier this year, but the bill faces long odds in the Senate, where most Republicans and some Democrats have expressed opposition to the proposal.

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