The following is the latest health policy news from the federal government for April 26 – May 2.  Some of the language used below is taken directly from government documents.

No Surprises Act – Independent Dispute Resolution Process

CMS has announced a new process for resubmitting Independent Dispute Resolution (IDR) disputes that were originally improperly batched or bundled.This new resubmission process is automated in the federal IDR portal and seeks to streamline federal IDR operations.  For further information about this new process and an implementation timetable, see this CMS announcement.  CMS also has posted a user guide for the IDR resubmission process; find that guide here.

Department of Health and Human Services
  • HHS’s Office for Civil Rights and CMS have issued a final rule under Section 1557 of the Affordable Care Act advancing protections against discrimination in health care based on race, color, national origin, sex, age, and disability and reducing language access barriers, expanding physical and digital accessibility, address bias in health technology, and more.  Among other things, the rule:
    • Holds HHS’s health programs and activities to the same non-discrimination standards as recipients of federal financial assistance.
    • Considers Medicare Part B payments as a form of federal financial assistance for purposes of triggering civil rights laws enforced by the department, ensuring that providers and suppliers receiving Part B funds are prohibited from discriminating on the basis of race, color, national origin, age, sex, and disability.
    • Requires covered health care providers, insurers, grantees, and others to inform people that language assistance services are available at no cost to patients.
    • Requires covered health care providers, insurers, grantees, and others to let people know that accessibility services are available to patients at no cost.
    • Clarifies that covered health programs and activities offered via telehealth must also be accessible to individuals with limited English proficiency and individuals with disabilities.
    • Protects against discrimination by codifying that Section 1557’s prohibition against discrimination based on sex includes LGTBQI+ patients.
    • Respects federal protections for religious freedom and conscience and makes clear that recipients may simply rely on those protections or seek assurance of them from HHS.
    • Respects the clinical judgment of health care providers.
    • Protects patients from discriminatory health insurance benefit designs made by insurers.
    • Clarifies the application of Section 1557 non-discrimination requirements to health insurance plans.

Learn more about the rule from this HHS news release; this fact sheet; this HHS FAQ; and this pre-publication version of the rule itself.  The rule takes effect 60 days after its official publication, which is currently scheduled for May 6.

  • HHS has issued a final rule that prohibits discrimination on the basis of disability.  This rule seeks to advance equity and bolster protections for people with disabilities under Section 504 of the Rehabilitation Act.  It strengthens civil rights protections for people with disabilities, addresses discrimination in medical treatment, adds enforceable standards for accessible medical diagnostic equipment, and ensures accessible web content and mobile apps.  The rule seeks to protect people with disabilities from experiencing discrimination in any program or activity receiving funding from HHS because of their disability.  Learn more about the rule and the specific changes it requires and the protections it affords from this HHS news release; this fact sheet; and this pre-publication version of the final rule.  The rule takes effect 60 days after its official publication, which is currently scheduled for May 9.
  • HHS has issued a final rule to affirm non-discrimination in HHS-funded grant programs and services.  The rule protects LGBTQI+ people by clarifying and reaffirming the prohibition on discrimination on the basis of sex – including sexual orientation and gender identity – in specific health and human services programs.  The final rule confirms these protections in specific HHS programs, including services and grants that provide aid to refugees, early childhood education services, assistance to people experiencing homelessness, substance use disorder treatment and prevention, community mental health services, maternal and child health services, and community services.  Learn more from this HHS news release and this pre-publication version of the final rule.  The rule will take effect 30 days after its official publication, which is currently scheduled for May 3.
  • HHS has published its plan for promoting the responsible use of artificial intelligence in automated and algorithmic systems by state, local, tribal, and territorial governments in the administration of public benefits.  Learn more from this HHS news release, which includes a link to the plan.
  • HHS and its Health Resources and Services Administration (HRSA) have awarded $105 million in funding to support more than 100 community-based organizations working to improve maternal and infant health.  The money will be spent to support the agency’s Healthy Start program.  Learn more from this HHS news release, which includes a link to a list of the grant recipients.
  • HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) has published a report on the current state of available patient navigation programs in the Medicare program as reported in current health care literature.  Go here for an introduction to the report and links to the entire report and additional resources.
Centers for Medicare & Medicaid Services
  • CMS has published a bulletin updating its “stay of enrollment” policy.  Stay of enrollment is a term used for providers whose continued participation or enrollment as a Medicare provider is under review.  Find the bulletin here.  The revised policy takes effect on May 30.
  • CMS has announced that the Medicare Promoting Interoperability Program 2023 hardship exception application period opened on May 1.  The deadline for submitting a hardship exception application for the calendar year 2023 reporting period is August 31 for eligible hospitals and November 30 for critical access hospitals.  Learn more about the process of seeking a hardship exception and the circumstances that qualify for such an exception from this CMS notice.
  • CMS has updated three resources that address skilled nursing facility billing issues:
HHS Newsletters
  • CMS – MLN Connects – May 2
  • AHRQ News Now – April 30
  • HRSA eNews – April 19 (includes funding opportunities)
  • HRSA Office for the Advancement of Telehealth Announcements – April 30
  • CMMI Evaluation Digest – April
Food and Drug Administration
  • The FDA has published a final rule amending its regulations to make explicit that it will phase out, over the course of four years, its general enforcement discretion approach for laboratory-developed tests, or LDTs.  LDTs are in vitro diagnostic products, or IVDs, that are intended for clinical use and designed, manufactured, and used within a single clinical laboratory that meets certain regulatory requirements.  Historically the FDA has exercised enforcement discretion for most LDTs, meaning that the agency generally has not enforced applicable requirements for them.  Now, the FDA has concluded that the risks associated with most modern LDTs are much greater than the risks associated with LDTs at the time it adopted its enforcement discretion approach decades ago, so the agency intends to increase its enforcement of its standards for these tests and regulate them as medical devices.  Learn more from this FDA news release, which includes links to guidance documents, information about LDTs, an FAQ about LDTs, and the final rule itself.
  • The FDA has launched a new initiative, Home as a Health Care Hub, to help reimagine the home environment as an integral part of the health care system with the goal of advancing health equity.  The focus of this endeavor will be medical devices used in the home.  Learn more from this FDA news release.
Centers for Disease Control and Prevention
  • Effective May 1, hospitals are no longer required to report COVID-19 hospital admissions, hospital capacity, or hospital occupancy data to HHS through the CDC’s National Healthcare Safety Network (NHSN) but the CDC encourages continuing, voluntary reporting of hospitalization data.  Learn more from this CDC notice.
  • The CDC has recommended that all people ages 65 and older receive an additional dose of any updated COVID-19 vaccine.  Learn more from this CDC report.
Congressional Budget Office
  • The director of the CBO recently delivered a presentation on the federal budget and health care policy at a conference organized by the Economic Policy Innovation Center and the Paragon Health Institute.  The presentation outlines how the federal government spends money on health care, how it expects that spending to change in the future, factors that affect that spending, and how that spending might be reduced.  Find the presentation here.
Stakeholder Events

CMS – Ambulance Open Door Forum – May 9

CMS will hold an open-door forum for ambulance organizations on Thursday, May 9 at 2:00 (eastern).  Go here to register to participate.

CMS – Home Health, Hospice, and DME Open Door Forum – May 22

CMS will hold an open-door forum for home health, hospice, and durable medical equipment providers on Wednesday, May 22   at 2:00 (eastern).  Go here to register to participate.

CMS – Physicians, Nurses, and Allied Health Professionals Open Door Forum – May 23

CMS will hold an open-door forum for physicians, nurses, and allied health professionals on Thursday, May 23 at 2:00 (eastern).  Go here to register to participate.

CMS – Hospital Open Door Forum – May 28

CMS will hold an open-door forum for hospitals on Tuesday, May 28 25 at 2:00 (eastern).  Go here to register to participate.

CMS – Healthcare Common Procedure Coding System Public Meeting – May 28-30

CMS will hold virtual Healthcare Common Procedure Coding System (HCPCS) public meetings on Tuesday, May 28 through Thursday, May 30 to discuss its preliminary coding, Medicare benefit category, and payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non-biological items and services.  Learn more about the meetings, including how to participate, from this CMS notice.

CMS – Health Equity Conference – May 29-30

CMS will hold its second annual CMS Health Equity Conference on Wednesday, May 29 and Thursday, May 30.  The free, hybrid conference will be held in person in Bethesda, Maryland and available online for virtual participation and involve health equity leaders from federal and local agencies, health provider organizations, academia, community-based organizations, and others. Conference participants will hear from CMS leadership on recent developments and updates to CMS programs; explore the latest health equity research; discuss promising practices and creative solutions; and collaborate on community engagement strategies.  Go here for information about how to register to participate and here to find the conference agenda.

CMS – Rural Health Open Door Forum – May 30

CMS will hold an open-door forum for rural hospitals on Thursday, May 30 at 2:00 (eastern).  Go here to register to participate.

CMS – Annual Public Meeting About New and Reconsidered Clinical Diagnostic Laboratory Test Codes for 2025 – June 25

CMS will hold a public meeting on Tuesday, June 25 at 9:00 (eastern) to receive comments and recommendations on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule for calendar year 2025.  This meeting also will provide a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.  Go here to learn more about the meeting, including how to submit information and questions and register to participate.

CMS – Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests – July 25-26

CMS’s Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests will hold public meetings on Thursday, July 25 and Friday, July 26.  The panel advises the Secretary of the Department of Health and Human Services and the CMS Administrator on issues involving clinical diagnostic laboratory tests.  Learn more about the meetings and how to participate from this CMS notice.