On December 17, 2024, the House Task Force on Artificial Intelligence (Task Force) released a highly-anticipated report titled, “Bipartisan House Task Force Report on Artificial Intelligence,” (the Report) which establishes guiding principles and issues recommendations to guide U.S. innovation in artificial intelligence (AI), including in the healthcare sector. The Report is intended to serve as a blueprint for Members of Congress as they conduct oversight and introduce legislation to address advances in AI technologies, including the regulation of health-specific AI applications.

Continue Reading House Task Force on AI Issues Report and Proposes Healthcare Recommendations

On November 21st, the Food and Drug Administration (FDA) released final guidance for the 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review processes, which clarifies how the FDA will use third party review organizations (ROs) to review 510(k) submissions and EUA requests during a public health emergency. The guidance provides guidance on the FDA’s conduct of both the 510(k) Third Party Review Program and EUA third party review, including guidance on device eligibility and procedures for 510(k) Third Party Review Organizations, and expectations for Third Party review to ensure quality, consistency, and conflict prevention.

Continue Reading FDA releases final guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

FDA approved drugs and medical devices are often studied further by sponsors and other firms to generate additional scientific information around other potential benefits and uses of those products.  Providing the results of this additional scientific activity to health care providers (“HCPs”) has led to enforcement from the U.S. Food and Drug Administration (“FDA), as those additional uses and benefits have not been evaluated by the FDA. If a firm communicates information about unapproved uses of an approved product, it could lead to a determination by FDA that the firm is promoting an unapproved intended use, which could lead to enforcement action for distributing a misbranded or adulterated product.  In an effort to provide recommendations on how to avoid FDA enforcement activity when providing the results of this additional scientific activity, FDA recently issued final guidance on how to communicate scientific information on unapproved uses (“SIUU”) of approved or cleared medical products to HCPs while avoiding FDA enforcement action.

Continue Reading FDA Clarifies Enforcement Policy Around Communications of Scientific Information on Unapproved Uses of Drugs and Medical Devices

On October 18, 2024, the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT) Editorial Panel released a Summary of Panel Actions from its September 2024 Panel Meeting, which includes six new remote physiologic monitoring (RPM) and remote therapeutic monitoring (RTM) codes in addition to revisions to the existing codes. Effective January 2026, these changes include removing the current requirement for healthcare providers to receive 16 days’ worth of data to bill RPM codes. The AMA CPT Editorial Panel likely made these updates in response to stakeholder feedback that the 16-day billing threshold was not necessary in certain clinical use cases. Additionally, two new codes will reimburse providers for 10-19 minutes of managing RPM or RTM data in a month.  

Continue Reading AMA’s CPT Editorial Panel Approves New Codes Covering Remote Patient Monitoring Services

Federal policy efforts to advance health data exchange and interoperability are continuing to change rapidly. The latest changes are the publication of two final rules by the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) finalizing parts of the Health Data, Technology, and Interoperability (HTI-2) Proposed Rule. These rules adopt requirements regarding the Trusted Exchange Framework and Common Agreement (TEFCA) (HTI-2 Final Rule), and create a new Information Blocking exception under Protecting Care Access (HTI-3 Final Rule), published on December 16th and 17th, respectively.

Continue Reading End of Year Regulations on Interoperability

Federal policy efforts to advance health data exchange and interoperability through the Trusted Exchange Framework and Common Agreement (TEFCA) have advanced rapidly in the past several months. Since TEFCA became operational in December 2023, the seven designated Qualified Health Information Networks (QHINs) have been facilitating data exchange under the TEFCA framework. The Sequoia Project, Inc., the TEFCA Recognized Coordinating Entity (RCE) or the organization responsible for providing oversight and the governing approach for QHINs, released over the past several months (on July 1, August 6, and November 13, 2024) its latest batch of Standard Operating Procedures (SOPs), which are written procedures or other provisions that are adopted pursuant to the Common Agreement. In the below summary, we outline a number of TEFCA-related policy developments and highlight considerations from the SOPs that are important to health information networks (HINs)/health information exchanges (HIEs) and other entities keeping apprised of interoperability policy developments.

Continue Reading RCE Issues Technical Guidance Governing TEFCA Exchange

On October 2, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS) released final guidance outlining the process for the second cycle of negotiations through the Medicare Drug Price Negotiation Program. This guidance provides additional information for manufacturer effectuation of negotiated prices for drugs, which the statute refers to as Maximum Fair Prices (MFPs). Within this guidance, CMS intends to ensure that individuals with Medicare can access drugs at negotiated prices from both cycles in 2026 and 2027.

Continue Reading HHS Releases Final Guidance for the Second Cycle of the Medicare Drug Price Negotiation Program

On October 9, the Centers for Medicare & Medicaid Services (CMS) Innovation Center, issued a Request for Information (RFI) about the Innovation Center’s proposed Medicare $2 Drug List Model (the M2DL Model), which aims to test whether offering low-cost, clinically important generic drugs can improve medication adherence, lead to better health outcomes, and improve satisfaction with the Medicare Part D prescription drug benefit. The RFI includes a sample list of prescription drugs that it intends to include and seeks input from healthcare stakeholders on the sample list of drugs and other features (i.e., outreach efforts and maximizing stakeholder participation) of the model. Comments in response to the RFI may be submitted through the Innovation Center’s online survey portal by December 9, 2024.

Continue Reading CMS Innovation Center Seeks Feedback on Medicare $2 Drug List Model

The FDA recently provided its opinion on a pharmaceutical television ad that should help other pharmaceutical companies in their own advertisements.  The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) informed pharmaceutical company AbbVie that their television ad for migraine medication, Ubrelvy, featuring Serena Williams “…makes false or misleading representations and suggestions about the efficacy of Ubrelvy.” The letter focused on efficacy claims made in the advertisement.  The 30-second ad shows Serena Williams experiencing symptoms of a migraine while getting ready to go on stage. The ad then goes on to show how one dose of Ubrelvy helped Serena feel better, and she is later shown smiling and laughing as she walks onto a talk show stage. The FDA’s letter explains that in the original storyboard for the ad, Serena experiences migraine pain in the afternoon and feels better before her talk show appearance in the evening. The FDA contends that the televised ad does not accurately portray the time lapse that was in the storyboard version. The FDA stated that, “This compelling before-and-after presentation in conjunction with claims such as, “One dose works fast to eliminate migraine pain” and “UBRELVY QUICKLY ELIMINATES MIGRAINE PAIN” (emphasis added) misleadingly suggests that Ubrelvy eliminates migraine pain and symptoms more quickly than was demonstrated in the clinical trials.” The letter also claims that the ad “…misleadingly suggests that Ubrelvy will provide a greater treatment benefit to patients suffering from migraine headache than has been demonstrated.” 

Continue Reading FDA Calls Out a Migraine TV Ad for Misleading Viewers

On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule (2025 PFS Proposed Rule), which contains proposals to update PFS payment rates, improve payment for and access to behavioral health services, extended telehealth flexibilities, establish ways to enhance access to primary care services, and strengthen the Medicare Shared Savings Program (MSSP).

Key Takeaways

  • The CY 2025 PFS Proposed Rule continues efforts by the Biden-Harris Administration to strengthen access to primary and behavioral health care by establishing new codes and payments and adding services to help beneficiaries and practitioners to safely administer and receive care in their own home.
  • CMS put out several press releases and fact sheets to inform the public on these changes. The complete proposed rule can be found in the Federal Register here.

The CY 2025 PFS Proposed Rule includes the following proposals:

  • Updates to the PFS payment rates: CMS is proposing to lower PFS payment rates by 2.93% in 2025 compared to payment rates in 2024. In dollars, this change amounts to a conversion factor of $32.36 which is a decrease of $0.93 from the CY 2024 conversion factor of $33.29.
  • New codes for Caregiver Training Services (CTS): CMS would like to establish new coding and payment for caregiver training for direct care services and for caregiver behavior management and medication training. Topics of training can include techniques to prevent decubitus ulcer formation, wound dressing changes, infection control, special diet preparation, and medication administration. CMS is also proposing to allow the training services to be provided to caregivers via telehealth.
  • Services addressing Health-Related Social Needs (HRSNs): CMS is issuing a broad Request for Information (RFI) on the Community Health Integration (CHI) services, Principal Illness Navigation (PIN) services, and Social Determinants of Health (SDOH) Risk Assessment to engage the public on how the agency can refine the program for future rulemaking. CMS is specifically requesting comments on other types of auxiliary personnel (including clinical social workers); other certification/training requirements that are not captured in current coding and payment for these services; how codes are furnished in conjunction with community-based organizations; and how to improve utilization in rural areas.
  • Updates to Telehealth Services:  Starting in January 1, 2025, CMS is proposing a telecommunications system that can include two-way, real-time audio-only communication technology for any telehealth service provided to a beneficiary in their home if the beneficiary is incapable of or does not consent to using video. In addition, this proposed rule will continue to allow distant site practitioners to use their currently enrolled practice location instead of their home address when they provide telehealth services from their home. CMS is also proposing to permanently adopt a definition of “direct supervision” that allows physicians or supervising practitioners to provide said supervision through-real time audio and visual interactive telecommunications. Lastly, for billing purposes, CMS is proposing to continue their current policy that allows for teaching physicians to administer care virtually when residents are involved in all teaching settings. For example, a three-way telehealth visit with the patient, resident, and teaching physician all in separate locations.
  • New codes for Advanced Primary Care Management Services (APCM): The 2025 PFS Proposed Rule establishes three new HCPCS G-codes and payments for a new set of APCM services. These new services incorporate elements of existing care management and communication technology-based services into a bundle of services including Principal Care Management, Transitional Care Management, and Chronic Care Management. Beginning January 1, 2025, CMS is proposing that physicians and non-physician practitioners (NPPs) who use an advanced model of care delivery can bill for APCM services as long as they are responsible for their patient’s primary care needs. CMS is proposing a performance measurement requirement as a condition of payment for APCM services called the Value in Primary Care MIPS Value Pathway (MVP) which was developed to include clinical quality measures that are foundational to primary care.
  • Updates to Behavioral Health Services: CMS is proposing several updates for behavioral health services. To increase access to psychotherapy, the agency is proposing to use Medicare payment for digital mental health treatment devices used in both professional behavioral health services and ongoing behavioral health care treatment within a behavioral health treatment plan of care. CMS is also proposing to establish separate coding and payment for safety planning interventions for patients in crisis including those with suicidal ideation or at risk of suicide or overdose. More specifically, CMS will create an add-on G code that would be billed with an E/M visit or psychotherapy service when practitioners personally provide safety planning interventions. Additionally, CMS will create codes for the following services:
    • Three new HCPCS codes to monitor how digital mental health treatment devices are used as a part of overall behavioral health care;
    • Six G codes to mirror current interprofessional consultation CPT codes for practitioners in specialties whose covered services are limited by statute to services for the diagnosis and treatment of mental illness (including Clinical Psychologists, Clinical Social Workers, Marriage and Family Therapists, and Mental Health Counselors);
    • A monthly billing code that requires specific protocols in furnishing post-discharge follow-up contacts that are performed in conjunction with a discharge from the emergency department for a crisis encounter, as a bundled service describing four calls in a month.
  • Changes in coverage for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs): CMS is proposing to make a significant change for RHCs and FQHCs for primary care services. CMS will require that RHCs and FQHCs to explicitly provide primary care services instead of being “primarily engaged” in providing these services as indicated in sub-regulatory guidance. This new rule will not stop RHCs or FQHCs from continuing to provide specialty care, but it will encourage RHCs and FQHCs especially in rural areas to provide primary care services in those communities.
  • Changes to the Medicare Shared Savings Program (MSSP): CMS proposes establishing a new “prepaid shared savings” option which will help ACOs that have a history of earning shared savings an advance of savings which they use to make investments that would aid beneficiaries such as investments in direct beneficiary service, staffing, and investments to improve care coordination. CMS is also proposing a new quality measure set called the Alternative Payment Model (APM) Performance Pathway (APP) Plus Quality Measure Set to move towards the Universal Foundation of quality measures and to better align with the quality measures reported by Shared Savings Program ACOs with the Medicaid Core Sets, the Marketplace Quality Rating System, and Medicare Advantage and Part D Star Ratings. In the PFS proposed rule, CMS also proposes to further incentivize ACOs that serve members in rural and underserved communities by adopting a health equity benchmark adjustment similar to the one in the ACO REACH Model, which has been associated with increased safety net provider participation. Lastly to improve financial calculations within the program, CMS is proposing a calculation methodology to address the impact of improper payments in recalculating expenditures and payment amounts used in Shared Savings Program financial calculations upon reopening a payment determination.

Conclusion

Public comments on the Medicare PFS Proposed Rule closes on September 9, 2024 and is expected to be finalized by November 1, 2024. If finalized, these rules will take effect on January 1, 2025. To learn more about recent federal proposed rules such as the CY 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) proposed rule (CY 2025 OPPS/ASC Proposed Rule), visit our blog or contact the professionals listed below.