The following is the latest health policy news from the federal government for February 6-16. Some of the language used below is taken directly from government documents.
No Surprises Act
- A federal judge in Texas has vacated parts of a regulation governing the arbitration process that is a major aspect of implementation of the No Surprises Act. In his ruling, the judge found that the arbitration process unfairly favored payers over providers, most notably by placing undue emphasis on the qualified payment amount (QPA) that is a major part of the arbitration process. The decision explains that “The Court first held that the interim rule improperly ‘places its thumb on the scale for the QPA, requiring arbitrators to presume the correctness of the QPA and then imposing a heightened burden on the remaining statutory factors to overcome the presumption.’” It adds that “The interim rule, moreover, characterized the non-QPA factors as ‘permissible additional factors’ that an arbitrator may consider only ‘when appropriate’ and concludes that “The interim rule thus conflicted with the Act, which unambiguously requires arbitrators to consider ‘all the specified information in determining which offer to select’ and nowhere instructs them ‘to weigh any one factor or circumstance more heavily than the others.’” See the court’s decision here.
- This decision means HHS now must work to revise the regulation – a need CMS acknowledged on its “Payment disputes between providers and health plans” web page, writing that
…the Departments are in the process of evaluating and updating Federal IDR process guidance, systems, and related documents to make them consistent with the TMA II decision. Effective immediately, certified IDR entities should not issue new payment determinations until receiving further guidance from the Departments. Certified IDR entities also should recall any payment determinations issued after February 6, 2023 [emphasis in original]. Certified IDR entities should continue working through other parts of the IDR process as they wait for additional direction from the Departments.
Centers for Medicare & Medicaid Services
- CMS has published what it calls a “COVID-19 Public Health Emergency Transition Roadmap” that outlines which aspects of the federal response to COVID-19 will continue when the public health emergency ends after May 11 and which aspects will end. Among the subjects the roadmap addresses are Medicare and Medicaid flexibilities and waivers, access to and payment for COVID-19 vaccines and tests, the continuation of FDA emergency use authorizations for various drugs, Medicaid flexibilities and waivers, access to drugs for treating opioid disorders, and more. Learn more from CMS’s roadmap fact sheet.
- CMS and HHS have chosen three new models for testing by the CMS Innovation Center (CMMI) to help lower the high cost of drugs, promote access to drug therapies, and improve quality of care. The models are:
- The Medicare $2 Drug List: For chronic conditions like high blood pressure and high cholesterol, Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that participate in the model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.
- The Cell and Gene Therapy Access Model: Cell and gene therapies are an emerging area of new drug development, but these therapies can cost upwards of $1 million. Under this model, state Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies.
- The Accelerating Clinical Evidence Model: Some drugs are approved before they have established evidence of improvement in a clinical endpoint. CMS would develop payment methods for drugs approved under such accelerated approval, encourage timely drug trial completion, and improve access to post-market safety and efficacy data. This would reduce Medicare spending on drugs that have no confirmed clinical benefit.
- CMS and HHS have published initial guidance for their Medicare Part B and Part D Prescription Drug Inflation Rebate Program under which drug companies will pay rebates to Medicare when their prescription drug prices increase faster than the rate of inflation for certain drugs dispensed to people insured by Medicare. Learn more about the program and its objectives and the issues on which CMS seeks comments from this CMS news release; a fact sheet on this guidance; the Medicare Part B Prescription Drug Inflation Rebate guidance; and the Medicare Part D Prescription Drug Inflation Rebate guidance to pharmaceutical companies. The deadline for submitting comments is March 11. See this Federal Register notice for information about submitting comments.
- CMS has sent a brief memo to state Medicaid and CHIP programs to remind them of two upcoming requirements: they must report certain data about their value-based purchasing arrangements under a CMS-authorized supplemental rebate agreement and certify their state drug utilization data. See the CMS memo here.
- In an effort to increase the transparency of nursing home ownership and management, HHS has issued a proposed rule to require nursing homes to disclose to CMS and states additional ownership and management information. The rule also includes private equity and real estate investment trust definitions, setting the stage for the disclosure of whether nursing home owners are private equity investors or real estate investment trusts. The proposed rule would implement a portion of the Affordable Care Act by requiring nursing homes enrolled in Medicare or Medicaid – the majority of nursing homes – to disclose additional information regarding owners, operators, and management; for example, nursing homes would be required to disclose individuals or entities that provide administrative services or clinical consulting services to the nursing homes. Learn more about what HHS has proposed, and its underlying rationale, from this news release; a CMS fact sheet; and this announcement, which includes a link to a Federal Register notice. The deadline for submitting comments is April 14.
- CMS has published a bulletin about updated HCPCS codes for skilled nursing facility consolidated billing.
- CMS has posted information about tools and best practices for the home- and community-based services (HCBS) direct service workforce. For further information about these resources, including training programs and background papers, go here.
- The CMS has posted a new blog entry on addressing rural health inequities in Medicare.
- CMS has published new editions of MLN Connects, its online newsletter with information about Medicare reimbursement issues. The February 9 edition includes coding recommendations for drugs and biologicals, a message about resubmitting previously returned home health telehealth claims, a quarterly update of the list of laboratory services subject to reasonable charge payments, and more while the February 16 edition includes new instructions for billing Medicare Part B for insulin, ICD-10 and other coding additions, and more.
- CMS has released a proposed National Coverage Determination decision that would expand coverage for power seat elevation equipment on certain power wheelchairs to Medicare beneficiaries. If finalized, power seat elevation equipment would be covered by Medicare for individuals with a Group 3 power wheelchair, which is designed to help improve the ability of those with severe disabilities to transfer from a wheelchair to other surfaces. Learn more from this CMS news release and the proposed National Coverage Determination decision memorandum. The deadline for submitting comments is March 17.
- CMS is creating a technical expert panel to advise a vendor with which it has contracted to work on the continued implementation of exchange health plan quality initiatives by providing input on topics such as public engagement efforts, guidance materials, data analysis and methodology, and measure set refinements. Learn more about the project, the role of the technical expert panel, the backgrounds sought among panel participants, and the time commitment involved from this CMS notice. The deadline for submitting nominations is March 1.
Department of Health and Human Services
- HHS Secretary Xavier Becerra has written to governors explaining that his latest renewal of the COVID-19 public health emergency will be the last and will expire on May 11. See his letter here.
- HHS’s Office of the National Coordinator for Health Information Technology (ONC) has chosen the first set of networks to be approved to implement the Trusted Exchange Framework and Common Agreement, or TEFCA, as Qualified Health Information Networks (QHINs). The six networks are CommonWell Health Alliance, eHealth Exchange, Epic TEFCA Interoperability Services, Health Gorilla, Kno2, and KONZA. Learn more about the role these networks are expected to play in advancing interoperability at scale for patients, health care providers, hospitals, public health agencies, health insurers, and other authorized health care stakeholders from this ONC announcement.
- HHS has issued a supplemental notice of proposed rulemaking to solicit public comment on its proposal to remove provisions authorized under the Controlled Substances Act (CSA), as amended by the Drug Addiction Treatment Act of 2000 (DATA-2000), to eliminate the requirement that practitioners obtain a waiver to prescribe certain schedule III-V medications for the treatment of opioid use disorder. HHS also seeks public comment on any benefits or drawbacks of the proposed amendments set forth in the proposed rule and on any issues raised by the proposed changes consistent with the law, including any potential unintended adverse consequences and benefits to people with opioid use disorders. Learn more from this announcement about the proposed rulemaking, which includes a link to a Federal Register notice. The deadline for submitting comments is March 14.
- The deadline for providers that believe their Provider Relief Fund Phase 4 or American Rescue Plan Rural payment was not calculated correctly to submit a request for recalculation of that payment is February 21. Go here to learn more about the limits of a reconsideration request and how to apply for it.
- HHS’s Health Sector Cybersecurity Coordination Center (HC3) has published a bulletin about Distributed Denial of Service (DDoS) attacks that have the potential to deny health care organizations and providers access to vital resources and have a detrimental effect on their ability to provide care. Such disruptions due to a cyber-attack may interrupt business continuity by keeping patients or health care personnel from gaining access to critical health care assets such as electronic health records, software-based medical equipment, and websites to coordinate critical tasks. Find the bulletin here.
- HHS’s Agency for Healthcare Research and Quality (AHRQ) is seeking comment on a draft report it has posted examining evidence on whether and how health care algorithms, including algorithm-informed decision tools, exacerbate, perpetuate, or reduce racial and ethnic disparities in access to health care, quality of care, and health outcomes. Find information about the draft report and a link to the report here. The deadline for submitting comments is March 9.
- AHRQ has announced that it intends to publish a request for applications to expand access to comprehensive, coordinated, and person-centered care for people with Long COVID, especially underserved, rural, vulnerable, or minority populations that are disproportionately affected by Long COVID. Through this funding, AHRQ intends to support existing multidisciplinary Long COVID clinics to develop and implement new or improved care delivery models, provide services to more people with Long COVID, expand services offered, strengthen care coordination, implement and share best practices for Long COVID management, support the primary care community with Long COVID education and management, evaluate project success, and disseminate findings. AHRQ anticipates publishing the request for applications in April or May and making up to $9 million in awards by September 30. AHRQ’s purpose in publishing this notice is to encourage organizations with existing Long COVID clinics and investigators with appropriate expertise and capabilities to begin to consider applying for this funding. Applications are not being requested at this time. Learn more from this AHRQ notice.
- HHS has issued a request for information seeking feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal HHS stakeholders, and other interested constituents on the development of a report on promising practices for advancing health equity for intersex individuals. The purpose of the report on promising practices for advancing health equity for intersex individuals is to ensure access to high-quality care for intersex people. Learn more about the request for information and the kind of information HHS seeks from this HHS notice, which includes a link to a Federal Register announcement. The deadline for submitting comments is March 13.
- HHS’s Office of the Inspector General has updated its work plan of reviews and audits for the month of February. Find the additions to the agency’s February work plan here.
- HHS has updated its Pediatric Surge Resources web page.
FEMA has announced that the incident period for all COVID-19 major disaster declarations and the nationwide emergency declaration will close effective May 11. Eligibility of work and costs reimbursable through public assistance funding will end at that time. For further information, see this FEMA notice, which includes a link to a Federal Register announcement, and this FEMA news release.
Centers for Disease Control and Prevention
The CDC’s Advisory Committee on Immunization Practices has added COVID-19 vaccines to its Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger.
Food and Drug Administration
The FDA has issued emergency use authorization for the first point-of-care mpox test. Emergency use of this test is limited to authorized laboratories. Learn more from this FDA letter granting the emergency use authorization.
National Institutes of Health
- Black and Hispanic Americans appear to experience more symptoms and health problems related to Long COVID than white people but are not as likely to be diagnosed with the condition, according to new research funded by the NIH. Learn more from this NIH news release.
- The NIH has initiated a multi-site clinical trial evaluating an investigational antiviral for the treatment of COVID-19. The therapeutic, known as S-217622 or ensitrelvir fumaric acid, has received emergency approval for use in Japan. Learn more from this NIH news release.
Medicare Payment Advisory Commission (MedPAC)
MedPAC has submitted formal comments to CMS in response to a regulation CMS has proposed for contract year 2024 policy and technical changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and other aspects of Medicare. MedPAC’s letter responds to CMS proposals addressing applying Dual Eligible Special Needs Plan (D-SNP) look-alike requirements to plan benefit package segments; the process for plans changing their formularies; amending the definition of severe or disabling chronic conditions; defining Chronic Condition Special Needs Plans (C-SNP) and plan types; and coding chronic conditions. Learn more from MedPAC’s letter to CMS.
Medicaid and CHIP Payment and Access Commission (MACPAC)
MACPAC has submitted formal comments to CMS in response to proposed rule changes for the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and other programs. In its letter, MACPAC expressed support for CMS’s move to close loopholes for Dual Eligible Special Needs Plan (D-SNP) look-alike plans but expressed concern that such plans may still persist and therefore suggested that CMS continue to monitor the situation to prevent growth in D-SNP look-alike plans. MACPAC also expressed support for proposed changes in language access and marketing practices and for expansion of the Low-Income Subsidy program’s eligibility from 135 percent of the federal poverty level to 150 percent. MACPAC also conveyed its support for proposed changes that would establish the Limited Income Newly Eligible Transition program as a permanent program. See MACPAC’s letter here.
HRSA – Data Bank Administrator Training Webinar – February 22
HHS’s Health Resources and Services Administration and the National Practitioner Data Bank will hold a webinar on Wednesday, February 22 at 2:00 (eastern) to explain the roles and responsibilities of data bank administrators and National Practitioner Data Bank account management. The webinar will include a Q&A session with National Practitioner Data Bank staff members. Participants are eligible for continuing education credits. Go here for further information and to register to participate.
CDC – Evaluating and Supporting Children and Adolescents Presenting with Post-COVID Conditions – February 23
The CDC will hold a virtual event to discuss evaluating and supporting post-COVID conditions in children and adolescents and the recommended clinical approach to identifying and managing post-COVID conditions in children and adolescents on Thursday, May 23 at 2:00 (eastern). Learn more about the event and how to participate from this CDC notice. Participants are eligible for continuing education credits.
CDC – Epidemiology, Testing, and Management of Extensively Drug-Resistant Shigellosis Webinar – February 28
The CDC will hold a webinar on the epidemiology, testing, and management of extensively drug-resistant shigellosis on Tuesday, February 28 at 2:00 (eastern). This strain of shigellosis is resistant to all generally recommended antibiotics in the U.S., making it difficult to treat, and it is easily transmissible and can spread antimicrobial-resistant genes to other enteric bacteria. The webinar will address how to diagnose and treat this problem. For further information about the webinar and how to participate, see this CDC notice. Continuing education credits are offered for participation.
MedPAC – Commissioners’ Meeting – March 2-3
MedPAC’s commissioners will hold their next public meeting on Thursday, March 2 and Friday, March 3. An agenda for the meeting and information about participation are not yet posted, but when they are they will be here.
MACPAC – Commissioners’ Meeting – March 2-3
MACPAC’s commissioners will hold their next public meeting on Thursday, March 2 and Friday, March 3. An agenda for the meeting and information about participation are not yet posted, but when they are they will be here.
CDC – ICD-10 Coordination and Maintenance Committee – March 7-8
The CDC’s ICD-10 Coordination and Maintenance Committee will meet virtually on Tuesday, March 7 and Wednesday, March 8 at 9:00 (eastern) on both days. The tentative agenda includes discussions about a variety of ICD-10-CM and ICD-10-PCS topics. For further information about the specific topics currently on the agenda and how to participate in the meeting, see this agency notice.
FDA – Workshop on Fatal Overdoses, Product Development, and Public Health Interventions – March 8-9
The FDA, in partnership with the Reagan-Udall Foundation for the FDA, will hold a two-day virtual public meeting entitled “Understanding Fatal Overdoses to Inform Product Development and Public Health Interventions to Manage Overdose.” The event, to be held on Wednesday, March 8 and Thursday, March 9 at 1:00 (eastern) both days, is for stakeholders, including people who use drugs, their families, harm reduction programs, clinicians, academic researchers, and federal partners. Go here to learn more about the event and how to register to participate.
CMS – Medicare Home Health Prospective Payment System CY 2023 Webinar – March 29
CMS will hold a webinar on Medicare’s calendar year 2023 home health prospective payment system on Wednesday, March 29 at 1:30 (eastern). During this webinar CMS will provide an overview of several provisions from the CY 2023 home health prospective payment system final rule related to behavior changes, the construction of 60-day episodes, and payment rate development. Learn more about the webinar here and go here to register to participate.