HEALTH CARE BRIEFING: Biden Ends Rule Banning Abortion Referrals

Federally funded doctors will be able to refer pregnant people to facilities that provide abortions under a final rule released by the Biden administration yesterday.

The measure, a reversal of a Trump-era final rule (RIN 0937–ZA00) banning such referrals, will take effect 30 days after publication in the Federal Register. The Biden rule was first proposed April 14. Opponents of the Trump-era rule had described it as “domestic gag rule” because it nixed a requirement that providers offer pregnant people the chance to receive unbiased counseling on their options, including termination.

Providers may offer their patients the opportunity for “nondirective options counseling” on prenatal care and delivery, infant care, foster care, adoption, and abortion once the rule takes affect.

The final rule is another example of the tension between the president’s agenda, the Supreme Court, and Congress when it comes to abortion. With a right-leaning Supreme Court, the Biden administration is using other avenues to uphold abortion rights.

Under the Trump administration’s order, providers were prohibited from using Title X funding to “perform, promote, or support abortion as a method of family planning.” Title X of the Public Health Services Act is a federal grant program for family planning, which finances community clinics and other facilities to provide these services. The program supports “millions of low-income or uninsured individuals,” according to the Department of Health & Human Services.

Providers receiving Title X funds are still barred from “directly promoting or performing abortion” due to statutory requirements. President Joe Biden’s ordinance tosses a requirement that clinics that receive federal funds maintain a “strict physical and financial separation” from facilities that provide abortions. Read more from Allie Reed.

Guam Telehealth Abortion Fight on Hold: Meanwhile in Guam, officials trying to enforce an in-person abortion counseling rule must wait until after the Supreme Court decides a case testing a Mississippi law barring abortions after 15 weeks of gestation, the Ninth Circuit ruled. Guam’s federal trial court blocked the requirement that women receive counseling in person from a qualified individual at least 24 hours prior to the procedure, which the officials in Guam appealed. Read more from Mary Anne Pazanowski.

On Lawmakers’ Radars

Biden Tells Progressives He’s Open to Means-Testing Programs: Biden told a group of progressives and members of the House leadership yesterday that he is open to setting income limits for some of the programs in his social-spending bill, to lower the price tag, according to a person familiar with the discussion.

During the virtual meeting, Biden also reiterated that he expects the legislation—which could beef-up spending on health care, climate initiatives and increase taxes on the wealthy and corporations —would eventual fall in the range of $1.9 trillion to $2.2 trillion—down from the $3.5 trillion originally proposed, the person, who asked for anonymity to discuss the private talks, said. Washington Representative Pramila Jayapal (D), head of the Congressional Progressive Caucus, said in a statement that the discussion with Biden was “productive and necessary,” but gave no details. Read more from Emily Wilkins.

• Today Biden is scheduled to speak virtually with House Democratic lawmakers to negotiate the bipartisan infrastructure bill and larger tax and spending package, according to a White House schedule.

Nominations: The nomination of Susan Harthill to be a member of the Occupational Safety and Health Review Commission was sent to the Senate, according to a White House press release yesterday.

Tribal Bills: The House Natural Resources Indigenous Peoples of the United States Subcommittee scheduled a hearing to discuss legislation related to tribal health and lands.

FCC Commissioner to Testify in Senate Telehealth Hearing: Brendan Carr, the head Republican on the Federal Communications Commission, will appear before a Senate panel on broadband for telehealth services. The Commerce, Science, and Transportation Committee’s panel on communications will hold a hearing on Thursday “to examine the state of telehealth, focusing on removing barriers to access and improving patient outcomes,” the committee announced. Read more from Maria Curi.

Senators Push Domestic Medical Supply Production: A bipartisan Senate duo introduced a bill ordering the Health and Human Services “to maintain a voluntary list of domestic manufacturers to produce medical supplies during severe shortages, and create a streamlined process for U.S. manufacturers” to work with HHS to determine production capacity and technical assistance needs, a statement from Sens. Jacky Rosen (D-Nev.) and Bill Cassidy (R-La.) says, citing Covid-19 as a test of readiness.

The Coronavirus Pandemic

Biden Vaccine Order Reaches Deep Into Contractor Realm: New Covid-19 vaccination mandates for federal contractors have tentacles long enough that they will cover even employees who aren’t directly involved in work with the government and those working from home. The White House ordered federal contractors to be fully vaccinated by Dec. 8. Lawyers say their contractor clients want to know just how far the mandate extends down through their workforces. Read more from Bruce Rolfsen.

China PCR Purchases Increased Before First Known Cases: The Chinese province that was the initial epicenter of the Covid-19 outbreak made considerable purchases of equipment to test for infectious diseases months before Beijing notified international authorities of the emergence of a new coronavirus, an Australian-U.S. cybersecurity firm found. Hubei’s purchase of PCR testing equipment surged in 2019, with most of the spike coming in the second half of the year, it found. Read more from Jamie Tarabay.

U.S. Has Half-Million Excess Deaths in 2020: Racial and ethnic minorities accounted for a disproportionate number of the half million excess deaths last year, according to a new U.S. study that examines mortality both directly and indirectly related to Covid-19. Researchers compared the number of people who died from March to December 2020 with the number of deaths that had been projected to occur before the pandemic. They found 477,200 excess deaths, with more than twice as many occurring among Blacks, Latinos, American Indians and Alaskan Natives compared with Whites and Asians of similar age. About 74% of the excess deaths were attributed to Covid-19. Read more from Anushree Dave.

More Headlines:

• AstraZeneca Seeks U.S. Emergency Approval for Covid Antibody
• Long-Covid Symptoms May Be Caused by Micro Clots: Scientists
• NYC Says 95% of School Staff Is Vaccinated Following Mandate
• Colorado Steps Up Pressure on Unvaccinated State Employees
• Construction Groups Sue Over Denver’s Covid-19 Vaccine Rule
• Palantir Wins NIH Virus Data Collection Pact Worth Up to $60M
• Top DeSantis Donor Wishes Governor Would Avoid Mask Wars
• EU Approves Pfizer-BioNTech, Moderna Boosters for High-Risk
• U.S. Presses Singapore to Let American Travelers Enter Freely

What Else to Know Today

NIH Director Francis Collins Nears Retirement Announcement: Francis Collins, the doctor and geneticist who has led the U.S. National Institutes of Health through three presidential administrations, is expected to soon announce plans to retire, people familiar with the matter said.

The move would leave a key position to fill in the government’s pandemic response team. An announcement is expected as soon as today, said two of the people, who asked not to be identified discussing private information. Collins and the White House didn’t respond to a request for comment, and NIH had no immediate response. Read more from Riley Griffin, Josh Wingrove, and Jeannie Baumann.

SCOTUS Returns With Skeletal Audience: The Supreme Court heard arguments in person for the first time in over 18 months yesterday, kicking off a new term as never before, in a quarter-filled courtroom with piped-in questions from one justice in self-isolation after a Covid-19 diagnosis, Greg Stohr reports. Justices opted not to take up a handful of health-care cases, including ones touching on Medicaid payments and opioids:

• Court Rejects Doctors’ Plea to Review Health Fraud Convictions
• High Court Won’t Hear Ohio Bid to Recoup Medicaid Payments
• Supreme Court Tosses Payout Row Over Alleged Vaccine Death
• New York Opioid Tax Lawsuit Won’t Get Supreme Court Review
• Justices Skip Adventist Doctor’s Bid to Alter Suit Post-Judgment

Also on the High Court’s Radar:

• J&J Talc Verdict May Upend FDA Process, Ex-Head Tells SCOTUS
• Whistleblowers Ask High Court to Revive Hospice Kickback Suit
• Bayer Should Get High Court Review on Roundup, Groups Say

FDA Rule Eases Path for Low-Risk Medical Devices: Device makers will have a more efficient pathway for getting new, low-risk equipment on the market under a final rule released yesterday. The rule from the Food and Drug Administration lays out criteria and procedures for manufacturers to request a de novo review, which allows devices without a previously approved comparative, to be designated as a lower-risk class device and get a quicker path to approval. Alexis Kramer and Jeannie Baumann have more.

More States to Use Own ACA Enrollment Platform: Kentucky, Maine, and New Mexico will transition to their own state-based health insurance marketplaces when the 2022 Affordable Care Act open enrollment period begins in November. The three states were among six that were considered to have state-based marketplaces in 2021 but used the federal HealthCare.gov website to determine eligibility and enroll people in individual coverage, according to the Kaiser Family Foundation. Read more from Tony Pugh.

Also From the Courts & Industry:

• OSHA Seeks to Revive Obama-Era Injury, Illness Reporting Rule
• HHS Says Boehringer Ingelheim Is on Hook for Drug Discounts
• Eli Lilly Recalls Diabetes Drug From Plant Cited by FDA: Reuters
• Tata America Loses Protest of NIH’s $50 Billion IT Procurement
• Long-Term Care Providers’ Medicaid Lawsuit Revived in Illinois
• Omeros Value Loses $400 Million as FDA Reviews Narsoplimab
• Tax Court Allows Alimony Deduction for Health Insurance Premiums

To contact the reporter on this story: Brandon Lee in Washington at blee@bgov.com

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