The 118th Congress and the Biden administration were hard at work in the last quarter to push their health technology policy priorities forward before their terms come to an end this December.
Since April, Congress has tackled a two-year Medicare telehealth policy extension, comprehensive health data privacy legislation, cybersecurity controls and a road map for healthcare AI. Congress has not passed any major health technology legislation yet in 2024, which leaves health program extenders to be hammered out after the August recess—or, more likely, during the lame duck session post-election.
The executive agencies have pushed out a trove of proposed and final regulations in the last four months. The Department of Health and Human Services (HHS) finalized changes to the Health Insurance Portability and Accountability Act's Health Breach Notification Rule, the Affordable Care Act's Section 1557 nondiscrimination rule and the Office of the National Coordinator for Health IT's (ONC's) information blocking rule. HHS also overhauled its technology office and opened a short hiring window for a chief technology officer, a chief data officer and a chief AI officer to head up initiatives in the department.
The Supreme Court ended its 2024 term with decisions that majorly impact healthcare. Namely, it overturned the Chevron doctrine, allowed emergency abortions to continue in Idaho and kept abortion medication mifepristone on the market.
What to read:
CONGRESS
- In May, Senate Majority Leader Chuck Schumer, D-New York, released the Senate’s artificial intelligence framework, which spanned sectors. The main takeaways for healthcare were for Congress to appropriate funds for AI and for congressional healthcare committees to consider AI policy frameworks.
- Competing telehealth bills emerged from two House healthcare committees. Both pieces of legislation would extend Medicare telehealth flexibilities for two years, through December 2026. The House Ways and Means Committee has forwarded its bill, while the House Energy and Commerce Committee canceled a full committee vote on the bill minutes before the markup began in late June.
- The E&C innovation subcommittee successfully passed Chairwoman Cathy McMorris-Rodgers’ American Privacy Rights Act. The health data privacy legislation was supposed to be marked up with the telehealth extension bill, but the markup was canceled.
- The Senate passed the fiscal year 2025 Labor/HHS appropriations bill. The House failed to vote on the legislation before it took its recess in early August.
- W&M passed its bill that would allow for Medicare coverage of FDA-designated breakthrough devices. The bill passed E&C last year. The Centers for Medicare & Medicaid Services (CMS) also released the final version of the Transitional Coverage for Emerging Technologies (TCET) rule, which addresses the same issue but to some does not go far enough to pay for medical devices. Medical device manufacturing advocates pressed Congress to move forward with the bill.
- The Healthcare Cybersecurity Act was introduced by Sens. Jacky Rosen, D-Nevada, Todd Young, R-Indiana, and Angus King, I-Maine. It was referred to the Committee on Homeland Security and Governmental Affairs.
AGENCIES
- CMS released the FY2025 Physician Fee Schedule, which contained a new proposed billing framework for digital therapeutics and permanent audio-only telehealth coverage.
- ONC is now called the Office of the Assistant Secretary for Technology Policy (ASTP). The office announced its reorganization, and additional leading tech policy roles, in late July.
- ONC finalized its information blocking rule.
- ASTP/ONC released the proposed HTI-2 rule.
- FDA announced the first sitting members of its Digital Health Advisory Committee.
- Micky Tripathi, Ph.D., (ONC) and Troy Tazbaz (FDA) resigned from the board of health AI trade group, the Coalition for Health AI.
- The Office of Management and Budget released its biannual schedule of regulatory actions. The schedule noted that the highly anticipated Drug Enforcement Administration rule on telehealth prescribing of controlled substances will come out in September.
- HHS’ Office for Civil Rights (OCR) finalized the Section 1557 nondiscrimination rule which had implications for telehealth and AI. OCR also finalized updates to HIPAA's privacy protections for reproductive health information.
- A federal judge in Texas vacated HHS policy against hospital web trackers.
- The Federal Trade Commission finalized changes to the Health Breach Notification Rule.
Special edition: SCOTUS
The Supreme Court made major decisions this summer that impact healthcare.
- SCOTUS overruled a 1984 case that established what has been known as the Chevron doctrine in Loper Bright Enterprises v. Raimondo. The decision will scale back how much leeway healthcare agencies have to interpret laws passed by Congress.
- The Supreme Court allowed for emergency abortions to continue in Idaho when it dismissed the cases Moyle v. United States and Idaho v. United States. Idaho’s abortion ban continues to be blocked because it conflicts with the Emergency Medical Treatment and Labor Act (EMTALA) of 1986.
- It also threw out the case Food and Drug Administration v. Alliance for Hippocratic Medicine which challenged the approval of mifepristone, a drug used for medication abortion, keeping the drug on the market for now.