October 9, 2023
This Week in Health Policy for October 9
This Week (October 9 - 13)
Congress is in recess this week, though McHenry as Speaker pro tempore, can call House members back to vote on the Speakership.
Last Week (October 2 - 6)
Health Care Highlights
Congress averts Oct. 1 government shutdown and McCarthy is ousted as Speaker. Late Saturday (September 30), Congress passed a continuing resolution (CR) to prevent a government shutdown and fund the government at the FY2023 level through November 17 along with several health programs, while also extending the Federal Aviation Administration reauthorization/taxes through the end of the year. The health programs extended through November 17 include community health centers, National Health Service Corps, Teaching Health Center GME, and the Special Diabetes Programs, as well as the Medicaid Disproportionate Share Hospital (DSH) cut delays. However, several other programs did expire on Oct. 1, including the SUPPORT Act, the U.S. President's Emergency Plan for AIDS Relief known as PEPFAR, the Pandemic and All-Hazards Preparedness Act, maternal and infant health research program funding, Children's Hospital GME funding, and more. While the government can move money around to keep many of those programs funded, they each require reauthorization to continue. Lawmakers could try to reauthorize the programs in a future CR or spending deal ahead of the next November 17 deadline shutdown deadline, but current progress on such a deal is unclear.
Following the CR passage, the House, led by a small group of conservatives who were joined by Democrats, on Tuesday (October 3) voted 216-210 to remove Rep. Kevin McCarthy (R-CA) as Speaker. Rep. Patrick McHenry (R-NC), who is the Financial Services Committee Chairman, was named as acting speaker, and Rep. McCarthy has said he will not try to regain the gavel. Currently, Reps. Steve Scalise (R-LA) and Jim Jordan (R-OH) are the two official candidates for the leadership role. However, the House, which is in recess until Tuesday (October 10) is essentially in a holding pattern until a new Speaker is elected. McHenry, as Speaker pro tempore, does not have the full authorities of the Speaker; he will be able to oversee the votes for a New Speaker, but he must be in the chair for all proceedings and cannot designate someone to fill that role. McHenry can recess the House after each Speaker vote if no one has secured a majority of the votes (currently 217 votes) to be Speaker, but when they come back from adjournment they must again vote on the Speaker. This process, which currently is expected to begin Wednesday (October 11), will continue until a new Speaker is elected. In the current House, a Speaker can lose four Republicans and still win the vote with no support from Democrats.
Depending on the length of the process, delays in House proceedings could have implications for the November 17 government funding deadline. The next Speaker will have to contend with the regular order appropriations process and reconciling differences with the Senate — or shepherd another funding patch through Congress to avoid a government shutdown after the just-around-the-corner November 17 deadline — plus the border and Ukraine issues that fell by the wayside in last week's action to avoid a government shutdown.
DEA extends controlled medicine telehealth prescribing flexibilities. On Friday (October 6), the Department of Health and Human Services (HHS) and the Drug Enforcement Administration published a temporary rule, further extending the COVID-19 public health emergency flexibilities that enable providers to prescribe controlled substances without an in-person visit. HHS and DEA said that the extension, which now expires December 31, 2024, will provide more time for the agencies to review feedback as they consider revisions to proposed rules issued in March.
HHS reopens Surprise Billing IDR portal with new guidance on QPAs. On Friday (October 6), HHS reopened the No Surprises Act's independent dispute resolution (IDR) portal, allowing parties to submit new disputes dating back to August 3, 2023. HHS had temporarily suspended the portal as it worked to align guidance and operations with court rulings. The Departments of Labor, Health, and Treasury (the Departments) also issued an FAQ related to the court rulings, including changes to the methodology for calculating the qualifying payment amount. The Departments said they would exercise enforcement discretion for insurers who are relying on QPAs calculated in accordance with the July 2021 interim final rules methodology for patient cost sharing, providing required disclosures with an initial payment or notice of denial of payments, and providing required disclosures and submissions under the IDR process. HHS said it similarly will exercise enforcement discretion for providers, facilities, or air ambulance service providers who bill or hold liable patients for a cost-sharing among based on the previous QPA calculations. A fact sheet on the reopening is available here. The FAQ is available here.
HHS seeks comment on research misconduct policies. On Friday (October 6), HHS published a notice of proposed rulemaking seeking comments on ways to update its 2005 policies on public health service research misconduct, including clarifying and updating certain terms to better identify research misconduct, streamlining the appeals process for disputes, and clarifying the roles of HHS, the Office of Research Integrity, and institutions funded by the Public Health Service Act in addressing, reporting, documenting, and investigating allegations of research misconduct. HHS is accepting public comments through December 5.
CBO calls for new research into anti-obesity medications. On Thursday (October 5), the Congressional Budget Office (CBO) published a blog post in which it said it is looking for new research that examines how anti-obesity medications will save the health care system money to consider as it scores legislative proposals on Medicare coverage for those treatments.
Drug companies enter negotiation. On Tuesday (October 3), the White House said all 10 drug companies whose products were selected for the Medicare Drug Price Negotiation Program have agreed to participate in the negotiation process. Companies that do not comply with the negotiation process can face an excise tax of at least 185% of the drug's sale price per day. The announcement came after a district judge in Ohio denied the U.S. Chamber of Commerce's request for a preliminary injunction to halt Medicare's drug price negotiation program while lawsuits challenging its constitutionality proceed. As a result, the program is progressing as scheduled while the legal challenges continue through the courts.
Court strikes down Trump-era rule. On Monday (October 2), a federal district court judge struck down a Trump administration rule that enabled insurers to not count the value of copay assistance offered by drug companies toward a patient's out-of-pocket drug costs, which are applied to their deductible and out-of-pocket maximums.
Supreme Court health care cases to watch this session. On Monday (October 2), the Supreme Court kicked off a new term with several cases on the docket that directly and indirectly impact health care. The health care cases before the Court this session includes those focused on access to Mifepristone, a drug used in medication abortions, and state restrictions on gender-affirming care. Other cases before the Court that could indirectly affect health care by restricting federal agencies' power, include a challenge to commercial fishing regulations, which will put the Chevron precedent back before the Court.
FDA issues rule on LDT oversight. On Friday (September 29), the Food and Drug Administration (FDA) published a proposed rule that would regulate most laboratory-developed tests (LDTs) as medical devices. The rule proposes ending the current enforcement discretion for LDTs over a four-year period to give labs time to come into compliance with medical device regulations and includes no grandfathering provisions for existing tests, including those performed at academic medical centers. FDA is accepting public comments on the rules through December 4.
Cigna reaches settlements in MA fraud cases. On Friday (September 29), HHS' Office of Inspector General (OIG) and Cigna reached a $172 million settlement in two cases over claims the insurer submitted false or inflated diagnosis codes for Medicare Advantage (MA) patients to make them appear sicker, resulting in overpayments. As part of the settlement Cigna also will enter into a corporate integrity agreement with OIG. Cigna also reached a $37 million settlement in a related case brought by a whistleblower. On Monday (October 2), OIG also published compliance audit findings and recommendations for Aetna, Inc.'s MA business.
Reports, Studies, and Journals
Reagan-Udall Foundation: Strategies for Improving Public Understanding of FDA-Regulated Products. The report, which was requested by FDA Commissioner Robert Califf, offers strategies FDA could adopt to combat misinformation and improve public understanding of the FDA and the products it regulates.
HHS Office of Inspector General: Biosimilars Have Lowered Costs for Medicare Part B and Enrollees, but Opportunities for Substantial Spending Reductions Still Exist. The report, which examined the prices and costs related to biosimilars in Medicare Part B, found Part B spending could have declined by 4% in 2021 if biosimilars had been used more often than their associated biologics.
Health Affairs: How Hospitals Are Addressing The Effects Of Racism: A Mixed-Methods Study Of Hospital Equity Officers. The study, which examines hospital equity officers' ability to address the factors that contribute to health care disparities, including structural racism, found about 50% of survey respondents reported obstacles to achieving their health equity objectives.