The following is the latest health policy news from the federal government for April 9-25.  Some of the language used below is taken directly from government documents.

Updated 340B Arbitration Process

Last week HHS’s Health Resources and Services Administration (HRSA) published a regulation modifying the administrative dispute resolution (ADR) process it uses to adjudicate payment disputes between 340B-eligible providers and pharmaceutical companies.  The major changes in the ADR process include the use of HRSA experts to serve on ADR panels; elimination of the $25,000 damage threshold for filing a claim; 340B-eligible providers may now challenge manufacturers that seek to prevent or limit their ability to pursue drug discounts through contract pharmacies; decisions on disputes within one year; an appeal process; the ability to address Medicaid duplicate discount disputes tied both to Medicaid managed care and Medicaid fee-for-service programs; and more.  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.

New CMS Medicaid Managed Care, Access, and Finance Regulations

  • CMS has issued a final rule imposing new Medicaid and CHIP managed care access, finance, and quality requirements.  The rule seeks to strengthen standards for timely access to care and states’ monitoring and enforcement efforts by establishing wait times to schedule appointments for certain services and using secret shoppers to measure whether they are being met; to revise quality and fiscal and program integrity standards for state directed payments; to specify the scope of “in lieu of” services and settings to better address health-related social needs; to further specify medical loss ratio requirements; and to establish a quality rating system for Medicaid and CHIP managed care plans.  Learn more about this final rule from this CMS news release; a CMS fact sheet; and a pre-publication version of the final rule, which is scheduled for official publication on May 10 and takes effect on July 9.  See also this chart, which includes implementation deadlines that differ from the July 9 general implementation date, and this informational bulletin CMS issued to state Medicaid programs about the exercise of enforcement discretion until 2028 for existing health care-related tax programs with hold-harmless arrangements involving the redistribution of Medicaid payments.
  • CMS has issued a final rule governing access to Medicaid and CHIP services that creates national standards that will seek to give people enrolled in Medicaid and CHIP better access to care and strengthen home- and community-based services (HCBS).  This final rule sets minimum threshold standards for payments to the direct care workforce, pursues greater engagement with Medicaid consumers, and seeks to advance provider rate transparency.  Learn more about the Medicaid and CHIP access rule from this CMS news release; this fact sheet; and this pre-publication version of the final rule, which is scheduled for final publication on May 10 and will take effect 60 days after publication.  See also this chart, which includes implementation date requirements for certain aspects of the final rule.

New CMS Skilled Nursing Facility Staffing Regulation

  • Another new CMS final rule establishes minimum staffing standards for nursing homes.  The rule also requires states to collect and report on the percentage of Medicaid payments spent on compensation for direct care workers and support staff delivering care in nursing facilities and intermediate-care facilities for individuals with intellectual disabilities.  To increase transparency and accountability, CMS will publicly report the data reported by states while the states themselves also will be required to report this data for each facility on a state-operated website.     Learn more about the nursing home staffing standards final rule from this CMS news release; this CMS fact sheet; and this pre-publication version of the final rule, official publication of which is scheduled for May 10.  Except for specifically identified requirements, this regulation takes effect on June 21.

Federal Trade Commission (FTC)

  • The FTC has issued a final rule banning the use of non-compete contracts as a means for companies to limit the ability of their employees to change jobs.  Under the new rule, existing non-compete contracts for the vast majority of workers will no longer be enforceable after the rule takes effect.  Existing non-compete contracts for senior executives, who represent less than 0.75 percent of workers, can remain in force but employers are banned from entering into or attempting to enforce any new such contracts even if they involve senior executives.  Employers will be required to provide notice to workers other than senior executives who are bound by an existing non-compete contract that they will not be enforcing those contracts against them.  While the FTC does not have authority over non-profit organizations, it has warned that some organizations that currently claim non-profit status most likely are subject to the new rule, such as when they have for-profit entities operating under their non-profit umbrella.  Learn more from this FTC news release; this FTC overview of the rule, with links to other resources; this FTC fact sheet; and the final rule itself.
  • The FTC, the Justice Department, and HHS have launched an online portal for the public to report health care practices that may harm competition.  Complaints will undergo preliminary review by staff at the FTC and Justice Department.  If a complaint raises sufficient concern under antitrust laws or is related to HHS authorities it will be selected for further investigation by the appropriate agency.  This action may lead to the opening of a formal investigation.  The general categories the FTC offers of different types of anti-competitive activities for which it invites inquiries are consolidation, joint ventures, and “roll-ups” of health care providers or companies; limiting choice and fair wages for health care employees; collusion or price fixing among competitors; preventing transparency; health care contract language and other practices that restrict competition; anti-competitive uses of health care data; and unnecessary provider recertification or accreditation requirements.  Learn more from this FTC news release and find the new portal here.

Centers for Medicare & Medicaid Services

  • CMS has published a bulletin describing updates in its Medicare claims processing manual for inpatient rehabilitation facilities.  Find that bulletin here.  The changes it describes take effect on July 12.
  • CMS has issued a statement about a proposed local coverage determination from Medicare Administrative Contractors (MACs) for skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers.  Learn more from this CMS news release.

Department of Health and Human Services

  • HHS’s Office for Civil Rights has issued a final rule that seeks to strengthen the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule by prohibiting the disclosure of protected health information related to lawful reproductive health care in certain circumstances.  Among other things, this rule prohibits the use or disclosure of protected health information when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such care is provided or to identify persons involved in such activities.  Learn more about the rule from this HHS news release; this HHS fact sheet; and this pre-publication version of the final rule.  The rule takes effect 60 days after official publication – currently scheduled for April 26 – and the deadline for compliance with its requirements is 240 days after official publication.
  • HHS has selected 20 states to participate in two separate technical assistance programs that together will help participating states better recruit, train, and retain direct care workers who provide home- and community-based services (HCBS) for older adults and people with disabilities.  Each state will receive up to 250 hours of individualized technical assistance, have a coach, and have access to subject matter experts to support them in addressing their state’s unique direct care worker challenges.  Each team includes representatives from the state’s Medicaid, aging, disability, and workforce development agencies in addition to other stakeholders.  Learn more from this HHS news release.
  • HHS and the Department of Labor have released key recommendations for building data infrastructure to support the development of policies and initiatives to strengthen the HCBS direct care workforce.  Learn more from this HHS news release and this HHS/Department of Labor issue brief.
  • HHS’s Office of the National Coordinator for Health Information Technology (ONC) and its Recognized Coordinating Entity, The Sequoia Project, Inc., have released the Common Agreement Version 2.0 (CA v2.0).  The Common Agreement establishes the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other under commonly accepted guidelines.  The seven designated Qualified Health Information Networks under the Trusted Exchange Framework and Common Agreement (TEFCA) can now adopt and begin implementing the new version.  Learn more about the updated Common Agreement and its implications for introducing a nationwide data-sharing network for patient health data from this ONC news release.
  • HHS’s Office of Civil Rights has posted an FAQ about the Change Healthcare cyberattack.  Many of the questions address HIPAA-related issues.  Find the FAQ here.
  • HHS’s Office of Information Security and the Cybersecurity and Infrastructure Security Agency have issued a health sector alert encouraging organizations that use Palo Alto network firewalls to review the agencies’ updated security advisory and apply any mitigations to prevent serious damage.  Learn more about the problem and actions that can be taken to address them and find links to additional resources from this health sector alert.
  • HHS’s Office of Information Security and the Cybersecurity and Infrastructure Security Agency have posted a presentation on social engineering attacks targeting the health care sector.  Parts of the presentation are intended for a general audience and parts are for a technical audience.  Find the presentation here.
  • HHS’s Assistant Secretary for Planning and Evaluation (ASPE) has published a report about how administrative data on demographic characteristics is used to assess service equity in HHS-funded programs.  Go here for an overview of the report and a link to the complete document.

HHS Newsletters

Centers for Disease Control and Prevention (CDC)

The CDC has issued a health alert informing clinicians about the risks of counterfeit or mishandled botulinum toxin (botox) injections.  The CDC, the FDA, and state and local agencies are investigating clusters of 22 people in 11 states reporting adverse effects after receiving injections with counterfeit botulinum toxin or injections administered by unlicensed or untrained individuals or in non-health care settings.  Find the health alert here.

Congressional Budget Office (CBO)

The CBO has published the results of its assessment of Medicare accountable care organizations (ACOs) and the factors that have contributed to or limited their ability to achieve net budgetary savings for the Medicare program.  Learn about what the CBO found in its report “Medicare Accountable Care Organizations:  Past Performance and Future Directions.”

Stakeholder Events

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 – 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.