The following is the latest health policy news from the federal government for April 12-18.  Some of the language used below is taken directly from government documents.

The White House

The administration has launched a new global health security strategy that seeks to drive action across federal departments and agencies and rally support from other countries, the private sector, and civil society to better prevent, detect, respond to, and recover from infectious disease threats.  The strategy seeks to build on the lessons learned from the response to the COVID-19 pandemic.  Learn more from this White House statement; the administration’s strategy document; and this White House fact sheet.

House Energy and Commerce Committee

This week the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations held a public hearing it called “Examining How Improper Payments Cost Taxpayers Billions and Weaken Medicare and Medicaid.”  Among the testimony was submissions by:

Updated 340B Arbitration Process

HHS’s Health Resources and Services Administration (HRSA) has updated its 340B administrative dispute resolution (ADR) process, which by law is required to resolve claims by covered entities that they have been overcharged for covered outpatient drugs by manufacturers and claims by manufacturers that a covered entity has violated the prohibition on diversion or duplicate discounts.  The final rule establishes new requirements and procedures to make the ADR process more accessible and efficient.  Learn more about the regulation from this Federal Register notice.  The regulation takes effect on June 18.  HRSA expects to provide additional information about filing claims, including a webinar, in the coming weeks.

No Surprises Act Implementation

Along with the departments of Labor and Treasury, HHS has announced a new process it will introduce through which the federal Independent Dispute Resolution (IDR) portal will send disputing parties a unique web form to resubmit disputes they had previous submitted improperly – a change from the current process in which disputing parties receive a request from their certified IDR entity.  Learn more from this announcement, which includes a link for seeking additional information.

Centers for Medicare & Medicaid Services
  • CMS has updated payment rules for patients enrolled in Medicare Advantage organizations.  Learn about differences in services and billing between traditional Medicare and Medicare Advantage from this CMS fact sheet.
  • CMS has published the April quarterly update of its 2024 durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule.  Find it here.  Some of the changes took effect on January 1 and others took effect on April 1.
  • CMS has delayed implementation of new options for health policy researchers to gain access to Research Identifiable File data.  In response to an increase in data breaches, in March the agency issued a request for information presenting two options for gaining access to those files and solicited stakeholder feedback on those options.  While CMS intended to implement its new approach in August, it has decided to delay implementation until at least 2025 while it continues to evaluate that feedback.  Learn more about this issue, the proposed changes, and the delay in implementation from CMS’s “Important Research Data Request & Access Policy Changes” web page.
Department of Health and Human Services
  • HHS’s Office of the Inspector General (OIG) has issued a favorable opinion about patient assistance funds operated by a non-profit, tax-exempt charitable organization.  Find that opinion here.
  • HHS’s OIG has added new audits to its April workplan.  Find the updated plan here.
  • HHS’s Health Sector Cybersecurity Coordination Center and its Office of Information Security has issued a health sector alert about a vulnerability in Palo Alto Networks firewalls.  Learn more about the vulnerability and how to respond to it from this health care sector alert.
HHS Newsletters
Centers for Disease Control and Prevention (CDC)
  • The CDC has updated its strategy for improving the data, technology, policy, and administrative challenges associated with improving data exchange between health care organizations and public health authorities and between state, tribal, local, territorial, and federal public health authorities as a means of rapidly detecting and responding to new public health threats.  Learn more from this CDC news release, which includes a link to the updated strategy.
  • The CDC is seeking nominations for membership on its Healthcare Infection Control Practices Advisory Committee, which consists of 14 experts in fields including but not limited to infectious diseases, infection prevention, health care epidemiology, nursing, clinical and environmental microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related fields.  Learn more about the committee, its work, and the requirements for submitting nominations from this Federal Register announcement.  The deadline for submitting applications is September 30.
Government Accountability Office (GAO)
  • At the request of members of Congress, the GAO has reviewed states’ regulation of pharmacy benefit managers – PBMs – that serve private health plans.  Among other things, its report describes actions selected states have taken to regulate PBMs and lessons learned that state regulators identified for PBM regulation.  Go here for an overview of the GAO report “Prescription Drugs:  Selected States’ Regulation of Pharmacy Benefit Managers” and links to a summary of the report and the complete report itself.
  • A new GAO study looks at how several state Medicaid programs worked to fulfill their responsibility to ensure that program participants received COVID-19 vaccinations during the pandemic and the challenges, including access to data, that affected their efforts.  Learn more from the GAO report “Medicaid:  COVID-19 Vaccination Data Access and Strategies Used to Improve Immunization Rates.”
  • A new GAO study describes the federal response to the mpox outbreak; assesses the extent to which the federal mpox response presented challenges similar to those experienced in past public health emergencies; and assesses federal efforts to address recurring public health emergency challenges.  Learn more from “Public Health Preparedness:  Mpox Response Highlights Need for HHS to Address Recurring Challenges.”
Stakeholder Events

CMS – Long-Term Care Support and Services Open Door Forum – April 23

CMS will hold an open-door forum for long-term-care support and services providers on Tuesday, April 23 at 2:00 (eastern).  Go here to register to participate.

CMS – Rural Hospitals Open Door Forum – April 25

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

CMS – Skilled Nursing Facilities/Long-Term Care Open Door Forum – May 2

CMS will hold an open-door forum for skilled nursing facilities and long-term care facilities on Thursday, May 2 at 2:00 (eastern).  Go here to register to participate.

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 – 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.

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 Regarding 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.