HEALTH CARE BRIEFING: Gun Bill Seen as Avenue for Opioid Action

Congress in the next two weeks is slated to make major investments in expanding mental health services for the poorest Americans and make key policy changes aimed at reducing drug overdoses.

The Senate’s gun violence prevention package—which congressional leaders hope to pass before the July 4 recess—includes up to $8 billion to take the Certified Community Behavioral Health Clinics model nationwide, from 10 states currently, and to bolster access to other behavioral health and suicide prevention programs, according to Sen. Debbie Stabenow (D-Mich.), a key negotiator of the legislation.

Senate Democrats say they’ve been opposed to tying mental health issues to gun violence in the past, but won’t pass up the opportunity to make some progress on both issues. “We always risk creating the impression that people with mental illness are prone to violence, when the opposite is true,” Sen. Chris Murphy (D-Conn.) told reporters on Tuesday. “But we shouldn’t forsake the opportunity to put billions of dollars into new mental health services.”

Certified Community Behavioral Health Clinics began in eight states in 2016 to allow states to experiment with new models of care, focused on 24-hour crisis interventions that have led to major reductions in hospitalizations, according to a Government Accountability Office report from 2021. The model has spread to dozens of states. The gun violence measure would allow any state to apply to be a part of the health clinics program and open up planning grants for states to prepare to adopt the model.

The House will vote on a package (H.R. 7666) that includes the termination of a special waiver that doctors need to prescribe substance use disorder treatment medications, according to advocates who support the measure. The legislation would also increase funds and services for mental health and people suffering from drug addiction.

Lawmakers have been trying to find ways to deal with what many call a mental health crisis plaguing the nation. The Centers for Disease Control and Prevention reported this month that over 107,000 people died of drug overdoses in 2021, an all-time high, Alex Ruoff reports.

Also on Lawmakers’ Radars

Thursday’s Hearings:

• The Senate Health, Education, Labor and Pensions Committee holds a Thursday hearing on the federal response to and current status of Covid-19. Top public health officials including Centers for Disease Control and Prevention Director Rochelle Walensky, FDA Commissioner Robert Califf, and HHS Assistant Secretary for Preparedness Dawn O’Connell are scheduled to attend. National Institute of Allergy and Infectious Diseases Director Anthony Fauci, who tested positive for Covid-19 on Wednesday, asked to participate remotely, according to a Democratic aide familiar with the situation, Madison Muller reports.
• BGOV Calendar: See the full week of events.

Warren Seeks Ban on Brokers Selling Health Data: Senate Democrats, including Sen. Elizabeth Warren (D-Mass.), on Wednesday introduced a bill to ban data brokers from selling or transferring sensitive health and location data in an industry worth billions of dollars, pointing to the Supreme Court’s expected reversal of Roe v. Wade. Read more from Maria Curi.

Labor’s Health Standard on Track, Walsh Says: The Labor Department is on track to finalize a permanent Covid-19 safety standard for the health-care industry, according to Secretary Marty Walsh. Walsh is aiming for the health-care industry standard to be completed in the next three to six months, according to his remarks to a Senate Appropriations subcommittee on Wednesday. Read more from Paige Smith.

AHA Warns of Medicare Sequester Cuts to Hospitals: The American Hospital Association called on congressional leaders to prevent additional Medicare sequester cuts to hospitals, which are set to go into effect on July 1. Hospitals and health systems “need financial relief from this pending cut in order to maintain access to care for the patients and communities they serve,” it said in a letter, citing additional workforce pressures due to the pandemic. Read the letter here.

The Coronavirus Pandemic

FDA Advisers Back Moderna, Pfizer Shots for Youngest: Covid vaccines for infants and toddlers from Moderna and Pfizer won support from a panel of US regulatory advisers, putting parents one step closer to being able to protect their youngest against Covid-19 for the first time. The 21-member FDA advisory panel unanimously backed Pfizer’s vaccine for children six months through 4 years, and gave the same solid endorsement for Moderna’s shot for children six months through 5 years. The FDA and the Centers for Disease Control and Prevention still need to give the green light. Read more from Fiona Rutherford.

Covid Response to Spur Swifter FDA Guidance for Drugmakers: Drugmakers can expect the FDA to release guidance more efficiently with fewer documents languishing in draft form, said Peter Stein, director of the Office of New Drugs. Covid propelled the FDA to release guidance in record time, often in weeks rather than years. Jeannie Baumann has more.

More Headlines:

• OSHA Panel Suggests Against Construction-Specific Covid Rule
• Hospital Beds in US With Covid-Infected Patients Rise to 30,264
• 4E’s Plan for Toxic Hand Sanitizer Draws Skepticism from Trustee

Industry and Regulation

Woodcock Admits ‘Miscalculation’ in OxyContin Decision: A top FDA official who oversaw the approval of Purdue Pharma‘s OxyContin said the agency failed to adequately predict the harms associated with the drug that’s fallen into the center of the US opioid epidemic. Janet Woodcock, now the FDA’s principal deputy commissioner, said that there was a “miscalculation about projected harms” of the opioid. Celine Castronuovo has more.

Billions in Medicare Savings Envisioned With Aligned Payments: Medicare would have spent $6.6 billion less in 2019, and beneficiaries would have saved $1.7 billion in out-of-pocket expenses if payment rates for care provided at hospital outpatient agencies, ambulatory surgical centers, and doctor’s offices were priced the same, according to a Medicare Payment Advisory Commission in its annual June 2022 report to Congress. Read more from Tony Pugh.

Biden to Order Crackdown on ‘Conversion Therapy’: Biden will direct HHS to create guidance blocking federal funding for organizations that subject LGBTQ youth to harmful and discredited practices known as conversion therapy. In an effort to counter a series of state-level anti-LGBTQ legislation and policies, Biden on Wednesday was set to sign an executive order as a show of support for LGBTQ people, senior White House officials said. Read more from Ella Ceron.

More Headlines:

• FDA: Mead Johnson Formula Powder to Begin Shipping in June
• EPA Says Safe Exposure Is Nearly Zero for Two PFAS Chemicals
• HHS Civil Rights Office Settles Title IX Bias Complaint With USC
• WHO to Hold Emergency Meeting on Monkeypox Amid Spread

From the Courts

Ending Roe Risks Big Economic Hit, Biden Aide Says: Ending the constitutional right to an abortion may hurt women’s labor force participation and other economic gains achieved since the landmark 1973 Roe v. Wade decision, Cecilia Rouse, the chair of the Council of Economic Advisers said. Michael Sasso has more.

Red States Can’t Join Public Charge Rule’s Defense: Arizona and other GOP-led states can’t defend a Trump-era immigration “public charge” rule after the US Supreme Court threw out the states’ appeal despite hearing oral argument. Read more from Kimberly Strawbridge Robinson.

Court Sides With Hospitals on Medicare Reimbursement: The Supreme Court said the federal government improperly cut over $1 billion a year in Medicare reimbursements to hospitals in a ruling that limits regulators’ power to control what the program pays for some drugs. The justices Wednesday sided unanimously with the American Hospital Association. Read more from Greg Stohr.

More Headlines:

• Nursing Homes Face DOJ False Claims Suit Over Standards of Care
• Reynolds Owes Philip Morris $11 Million in E-Vapor Patent Trial
• California Justices Will Consider Medical Device Warning Case
• Abbott’s Similac Formulas Face Patent Suit Over Key Ingredient
• Neuriva $8 Million Deal Wrongly Approved, Appeals Court Told

To contact the reporters on this story: Brandon Lee in Washington at blee@bgov.com; Alex Ruoff in Washington at aruoff@bgov.com

To contact the editors responsible for this story: Giuseppe Macri at gmacri@bgov.com; Michaela Ross at mross@bgov.com