This Week in Washington: House Speaker and Senate Majority Leader reach topline appropriations deal; OCR releases final rule on conscience rights; Senate HELP Committee Democrats launch investigation into cost of asthma inhalers; State of the Union scheduled for March 7.
Congress
House
Senate
Administration
- HHS Launches Medicaid/CHIP Renewal Resource Hub
- HHS Secretary Appoints Chief Competition Officer
- ARPA-H Launches HEROES Program
- CMS Approves New York Section 1115 Demonstration Amendment
- FDA Releases Draft Guidance Regarding ANDA Reconsideration Requests
- FDA Encourages Use of Vaporized Hydrogen Peroxide for Device Sterilization
- FTC Prohibits Data Broker from Sharing and Selling Sensitive Location Data
Proposed Rules
- DOJ Civil Rights Division Proposes Rule Regarding Medical Diagnostic Equipment Access for the Disabled
- FDA Proposes Rule Regarding Classification of Wound Dressings and Washes
- IHS Proposed Rule Removes Outdated Regulations
Final Rules
- OCR Final Rule Strengthens Conscience Protections
- CMS Final Rule Updates CLIA Fees and Clarifies Fee Regulations
- ONC Final Rule Establishes Transparency Requirements for Artificial Intelligence and Predictive Algorithms
- FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards
- FDA Issues Final Rule Regarding Mammography Quality Standards
Courts
Reports
- GAO Releases Report Regarding Prenatal Supplement Product Labels
- GAO Releases Report Regarding VHA Office of Rural Health Improvements
House
House Speaker and Senate Majority Leader Reach Topline Appropriations Deal
On Jan. 7, House of Representatives Speaker Mike Johnson (R-LA) and Senate Majority Leader Chuck Schumer (D-NY) reached an agreement on topline appropriations levels for fiscal year 2024. The Speaker and Senate Majority Leader agreed to a topline amount of $1.59 trillion, of which $886 billion would go to defense and $704 billion would go to non-defense discretionary spending.
Due to the tight turnaround before the approaching Jan. 19 funding deadline, the Senate Majority Leader has already taken the first procedural step on creating a short-term continuing resolution (CR) to allow for more time to work on the specifics of the agreement and avoid a partial government shutdown. However, it remains unclear whether the House would pass a CR.
Senate
Senate HELP Committee Democrats Launch Investigation into Cost of Asthma Inhalers
On Jan. 8, Senate Health, Education, Labor and Pensions Committee Chairman Bernie Sanders (I-VT) and Sens. Baldwin (D-WI), Luján (D-NM) and Markey (D-MA) sent letters to the chief executive officers of AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline and Teva, concerning the prices they charge for asthma inhalers.
The chairman and senators are concerned over the tactics used on inhaler product patents and are seeking information on the costs involved in inhaler manufacturing and asthma and chronic obstructive pulmonary disease research and development. This investigation piggybacks on the Federal Trade Commission’s work on improperly listed patents in the Food and Drug Administration’s Orange Book.
For more information, click here.
Administration
HHS Launches Medicaid/CHIP Renewal Resource Hub
On Jan. 11, the Department of Health and Human Services announced the launch of a new Medicaid and Children’s Health Insurance Program online resource hub. The hub is intended to inform individuals of their states’ renewal process and provide them resources needed to renew their coverage.
For more information, click here.
HHS Secretary Appoints Chief Competition Officer
On Jan. 8, Department of Health and Human Services Secretary Xavier Becerra appointed Stacy Sanders to the role of Chief Competition Officer. Sanders will be responsible for coordinating and identifying opportunities to promote competition in healthcare markets and will work alongside the Federal Trade Commission and Department of Justice to identify healthcare market concentration.
For more information, click here.
ARPA-H Launches HEROES Program
On Jan. 9, the Advanced Research Projects Agency for Health announced the launch of the Health Care Rewards to Achieve Improved Outcomes (HEROES) Program. The program aims to lower the rate of preventable deaths by increasing investments into community-level preventative care resources, particularly among underserved communities.
For more information, click here.
CMS Approves New York Section 1115 Demonstration Amendment
On Jan. 9, the Centers for Medicare and Medicaid Services approved an amendment to New York’s Medicaid Section 1115 Demonstration, which seeks to strengthen integration between primary care providers, community-based organizations and behavioral health specialists. The amendment will allow New York to establish base rates for safety net hospitals serving underserved communities and will increase investments in the state’s healthcare workforce.
For more information, click here.
FDA Releases Draft Guidance Regarding ANDA Reconsideration Requests
On Jan. 11, the Food and Drug Administration released draft guidance concerning consideration requests for abbreviated new drug applications (ANDAs). The draft guidance provides recommendations on the procedures that applicants should follow if they wish to request an ANDA reconsideration. It also reflects the most recent reauthorization of the Generic Drug User Fee Amendments.
For more information, click here.
FDA Encourages Use of Vaporized Hydrogen Peroxide for Device Sterilization
On Jan. 8, the Food and Drug Administration (FDA) revised final guidance concerning devices labeled as sterile and listed vaporized hydrogen peroxide (VHP) as an Established Category A method of sterilization. The FDA is encouraging stakeholders to use VHP and other ethylene oxide sterilization alternatives to sterilize medical devices.
For more information, click here.
FTC Prohibits Data Broker from Sharing and Selling Sensitive Location Data
On Jan. 9, the Federal Trade Commission (FTC) announced that it would prohibit data broker X-Mode Social Inc./Outlogic from sharing or selling sensitive location data, after the FTC determined that it failed to implement reasonable and appropriate safeguards on the use of consumer sensitive location data by third parties.
The FTC alleges that the company sold precise location data that could be used to track an individual’s visits to locations including medical and reproductive health clinics, places of worship and domestic abuse shelters.
For more information, click here.
Proposed Rules
DOJ Civil Rights Division Proposes Rule Regarding Medical Diagnostic Equipment Access for the Disabled
On Jan. 9, the Department of Justice Civil Rights Division released a proposed rule that seeks to improve access to medical diagnostic equipment (MDE) for people with disabilities. The proposed rule would update regulations under Title II of the Americans with Disabilities Act (ADA) and would implement new technical standards that state and local governments would have to adhere to, to meet obligations under Title II of the ADA.
The proposed rule would:
- Adopt the U.S. Access Board’s MDE standards as the technical standards for accessible MDE;
- Require state and local government entities to ensure that programs, services and activities using MDE are accessible to individuals with disabilities;
- Require entities to address access barriers resulting from a lack of existing accessible MDE;
- Implement new requirements for newly acquired MDE; and
- Ensure that staff are able to successfully operate accessible MDE and assist with transfers and positioning of individuals with disabilities.
Public comments will be accepted until Feb. 12, 2024. For more information, click here.
FDA Proposes Rule Regarding Classification of Wound Dressings and Washes
On Nov. 30, the Food and Drug Administration (FDA) released a proposed rule that would classify certain types of wound dressings and liquid wound washes containing antimicrobials and other chemicals, as solid wound dressings. The FDA currently regulates gel, cream, ointment and liquid wound dressings and washes as unclassified devices requiring premarket notification.
Under the proposed rule, the FDA would classify wound dressings and liquid wound washes with a high level of antimicrobial resistance concern as Class III medical devices. In addition, wound dressings and washes with a medium or low level of antimicrobial resistance would be classified as Class II medical devices.
Public comments will be accepted until Feb. 28, 2024. For more information, click here.
IHS Proposed Rule Removes Outdated Regulations
On Jan. 8, the Indian Health Service (IHS) released a proposed rule that aims to remove outdated regulations in the Code of Federal Regulations that do not align with current statutory text of the Hyde Amendment. The proposed rule intends to eliminate confusion regarding the legal effect of outdated regulations and seeks to align IHS guidelines with congressional guidelines governing the Department of Health and Human Services.
Public comments will be accepted until March 8, 2024. For more information, click here.
Final Rules
OCR Final Rule Strengthens Conscience Protections
On Jan. 9, the Department of Health and Human Services Office for Civil Rights (OCR) released a final rule that seeks to strengthen the process for enforcing federal conscience laws and provide new protections against conscience and religious discrimination. The final rule will:
- Partially rescind a May 2019 conscience final rule that was deemed unlawful by three federal district courts. The rule strengthened the rights of healthcare workers to refuse to provide services such as abortions and gender-affirming care based on moral and religious beliefs;
- Restore OCR’s role in overseeing the enforcement process for federal healthcare conscience protection statutes;
- Strengthen protections against discrimination on the basis of conscience;
- Encourage entities to post a notice of rights to inform providers and patients of their rights under federal healthcare conscience protection statutes; and
- Implement a severability provision to preserve portions of the rule if part of the rule is deemed unlawful.
In addition, the final rule states that OCR investigations will be prompt and clarifies that certain conscience statutes apply to more than just providers.
The final rule will go into effect on March 11, 2024. For more information, click here.
CMS Final Rule Updates CLIA Fees and Clarifies Fee Regulations
On Dec. 28, the Centers for Medicare and Medicaid Services (CMS) released a final rule that updates Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies CLIA fee regulations. The final rule will:
- Implement a sustainable funding process for the CLIA program through a biennial two-part increase of CLIA fees;
- Finalize the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated compliant surveys and revised certificates;
- Finalize the distribution of administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees;
- Clarify the methodology used to calculate program compliance fees;
- Amend histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes; and
- Amend provisions governing alternative sanctions, including civil money penalties, a directed plan of correction, a direct portion of a plan of correction and on-site state monitoring, to allow for their imposition on CoW laboratories.
In addition to CMS, the Centers for Disease Control and Prevention is also proposing the rule.
The rule will go into effect on Jan. 27, 2024. However, some sections will go into effect on Dec. 28, 2024.
For more information, click here.
ONC Final Rule Establishes Transparency Requirements for Artificial Intelligence and Predictive Algorithms
On Dec. 13, the Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) released a final rule that updates the ONC Health IT Certification Program and establishes new standards, implementation specifications and certification criteria. The final rule will:
- Establish transparency requirements for artificial intelligence and other predictive algorithms that are part of certified health IT;
- Adopt the United States Core Data for Interoperability Version 3 as the new baseline standards within the ONC Health IT Certification Program as of Jan. 1, 2026;
- Revise certain information-blocking definitions and exceptions to support information sharing; and
- Require developers of certified health IT to report certain metrics as part of their participation in the Certification Program, to better understand how certified health IT is used to support care delivery.
The final rule will go into effect on Feb. 8, 2024. For more information, click here.
FDA Final Rule Implements Direct-To-Consumer Prescription Drug Ad Standards
On Nov. 21, the Food and Drug Administration (FDA) released a final rule that implements new standards for direct-to-consumer (DTC) television and radio prescription drug advertisements. The final rule will require advertisers to:
- Present information using language that is clear and readily understandable by consumers;
- Place textual information against a contrasting background for a sufficient duration, using a font style and size that is easily legible;
- Announce prescription drug information in the same volume, articulation and pacing used in the rest of the ad;
- Certify that no distracting representations including statements, text, images or sounds are used during the ad’s major statement; and
- Simultaneously present visual and audible information for ads in television format.
The final rule complements a final guidance the FDA issued in June that outlined how advertisers should present quantitative efficacy and risk information in DTC promotional labeling and ads.
The final rule will go into effect on May 20, 2024. The compliance date of the rule is Nov. 20, 2024.
For more information, click here.
FDA Issues Final Rule Regarding Mammography Quality Standards
On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:
- Improve the delivery of mammography services;
- Strengthen communication of healthcare information;
- Require mammography facilities to provide patients with additional health information;
- Ensure the availability of qualified mammography personnel;
- Bolster medical outcome audits;
- Modernize technological aspects of mammography services; and
- Implement enforcement tools to deal with noncompliant facilities.
The rule will go into effect on Sept. 10, 2024. For more information, click here.
Courts
U.S. Supreme Court to Hear Cases That Could Overturn the Chevron Doctrine
On Jan. 17, the U.S. Supreme Court will hear two cases that could overturn the landmark Chevrondoctrine. In addition, the court will hear arguments in April for a case that examines whether Idaho’s strict abortion ban is overridden by the federal EMTALA law requirement that emergency room doctors perform the procedure in certain circumstances.
Last year, the Supreme Court agreed to hear two cases, Loper Bright v. Raimondo and Relentless, Inc. v. Dept. of Commerce, that could take away HHS’s and other federal agencies’ discretion to reasonably interpret ambiguous statutory language. Sixteen public health and consumer advocacy groups filed an amicus brief that said a decision to overturn the longstanding Chevron doctrine could pose a “significant threat to the country’s health care system” by undermining CMS’s decision-making.
Supreme Court Justice Elena Kagan in an unrelated case last year raised concerns about the future of Medicare after the Supreme Court moved the goalposts for triggering the major-questions doctrine in the case Biden v. Nebraska. The major-questions doctrine is a legal precedent that Congress maintains decisions of political or economic importance rather than delegate them to the executive branch’s agencies.
Reports
GAO Releases Report Regarding Prenatal Supplement Product Labels
On Jan. 11, the Government Accountability Office (GAO) released a report that examines whether prenatal supplement labels accurately reflect the amount of vitamins and minerals in them. After contracting with an accredited laboratory for testing, the GAO found that 11 out of 12 prenatal supplements had at least one tested nutrient that contained an amount outside of the acceptable deviations from the amount printed on the label.
In addition, the GAO discovered that there are many challenges surrounding the oversight of dietary supplements and is recommending that Congress grant the Food and Drug Administration additional authority to oversee dietary supplements. The GAO conducted this study because it was asked to assess the accuracy of over-the-counter prenatal supplement labels.
For more information, click here.
GAO Releases Report Regarding VHA Office of Rural Health Improvements
On Jan. 9, the Government Accountability Office (GAO) released a report that examines the progress the Veterans Health Administration (VHA) Office of Rural Health has made toward implementing improvement recommendations issued by the GAO in May 2023. The GAO had recommended that the Office communicate research funding opportunities across the Department of Veterans Affairs and develop performance goals.
As of Oct. 2023, the GAO found that the VHA Office of Rural Health has begun taking steps toward developing performance goals and has started developing standard operating procedures for communicating research funding opportunities.
For more information, click here.
