Other Regulatory News
Centers for Medicare and Medicaid Services (CMS)
CMS Interoperability and Patient Access Final Rule
The Centers for Medicare and Medicaid Services (CMS) has issued the final rule on interoperability and patient access, aimed at improving the sharing of health information among providers and patients. This rule seeks to enhance patient access to their health data and facilitate better care coordination. The rule emphasizes the importance of data sharing in healthcare and outlines requirements for healthcare providers and payers to improve interoperability. The rule is a response to the growing need for accessible health information in the context of patient-centered care.
#Patient, #Provider
CMS shift sparks hope for high-needs ACO REACH extension
Accountable care organizations participating in ACO REACH are optimistic about its future under the new CMS agenda. The shift in CMS priorities could lead to extended support and funding for high-needs populations.
#Payer
CMS revises ACO REACH benchmark, risk policies
The Centers for Medicare and Medicaid Services (CMS) has not confirmed whether the ACO REACH program will continue past next year. The uncertainty surrounding the program’s future raises concerns among stakeholders about ongoing reforms in accountable care organizations.
#PROVIDER
CMS solicits public feedback to help Medicare beneficiaries
The Centers for Medicare and Medicaid Services is seeking public input to enhance the services provided to Medicare beneficiaries, aiming to improve patient access and care quality.
#PATIENT
#ALL
CMS Administrator Outlines His Vision for CMS at NFP Healthcare Investors Conference
The CMS Administrator shared insights on the future direction of the Centers for Medicare and Medicaid Services during a healthcare investors conference. The Administrator’s vision focuses on improving healthcare delivery and efficiency through innovation and technology. Specific initiatives or strategies were not detailed in the summary provided, but the emphasis on innovation suggests a proactive approach to healthcare management
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Medicare Advantage News
Trump’s DOJ Accuses Medicare Advantage Insurers of Paying ‘Kickbacks’ for Primo Customers
The Trump administration’s Department of Justice has accused Medicare Advantage insurers of engaging in kickback schemes to attract high-value customers, termed “Primo Customers.” These allegations highlight concerns regarding the integrity of Medicare Advantage programs and the potential for unethical financial practices within the industry. Accusations suggest that these kickbacks undermine the Medicare program’s fairness and efficacy, potentially leading to higher costs for taxpayers and patients.
#Patient, #Payer
Trump, building on Biden policy, to speed up audits of Medicare Advantage insurers
President Trump’s administration plans to expedite audits of Medicare Advantage insurers, potentially recovering $500 million annually for taxpayers. The Centers for Medicare and Medicaid Services (CMS) intends to hire 2,000 additional coders and utilize advanced technology to ensure that diagnoses submitted by insurers are supported by medical records. However, the implementation is complicated by a lawsuit from Humana. The audits are part of an effort to reduce improper spending in Medicare Advantage programs, which has been a longstanding issue. Previous federal estimates indicate significant potential savings from these audits, but the lawsuit could hinder progress.
#Payer
CMS to crack down on Medicare Advantage overpayment
CMS will conduct annual audits of every Medicare Advantage plan to identify and eliminate improper payments. This initiative aims to ensure fiscal responsibility and accountability within the Medicare Advantage program. The move is part of a broader effort to combat wasteful spending within the Medicare system.
https://www.modernhealthcare.com/policy/medicare-advantage-audits-cms
#Payer
CMS deploying more coders, ‘advanced systems’ to audit all Medicare Advantage contracts
CMS is enhancing its auditing capabilities by deploying additional coders and advanced systems to review Medicare Advantage contracts. The goal is to improve the accuracy and efficiency of audits, ensuring that claims are legitimate and supported by adequate documentation. The initiative aligns with ongoing efforts to curb fraud and ensure proper spending in Medicare programs.
#Payer
Food and Drug Administration (FDA)
Opinion: The end to animal testing marks the beginning of better biomedicine
The FDA’s decision to phase out animal testing in favor of advanced human-relevant methods is seen as a transformative shift in drug development. This move aims to enhance the relevance of preclinical testing and improve therapeutic outcomes for patients.
#All
FDA Regulations on Single-Use Medical Devices Reprocessing Market By 2031
FDA is expected to implement new regulations regarding the reprocessing of single-use medical devices by 2031, aiming to enhance safety and efficacy in medical practices.
#Device
Medtronic Gains a Key Approval for Evolut TAVR Valves
Medtronic’s Evolut TAVR valves have received approval, expanding patient access to redo TAVR procedures. This approval signifies advancements in cardiac care technologies, enhancing treatment options for patients with heart valve diseases.
#Device, #Patient, #Provider
Covid Vaccines
New FDA framework on Covid vaccines leaves pediatricians confused and concerned
The FDA has announced a new framework for Covid-19 vaccine approvals that requires new clinical trial data for vaccines administered to healthy individuals under 65, including children. This has raised concerns among pediatricians regarding the implications for vaccine access for younger populations. The FDA’s decision reflects a shift in policy towards requiring more substantial evidence before approving vaccines for younger demographics. The commentary in the New England Journal of Medicine and subsequent discussions highlight the need for clarity in vaccine recommendations for children.
Opinion: The FDA is circumventing key roles and procedures for licensure and use of Covid vaccines
F.D.A. Poised to Restrict Access to Covid Vaccines
Five burning questions on the FDA’s new Covid-19 vaccine framework
Making sense of the FDA’s new Covid vaccines framework, and how we know mRNA shots are safe
Opinion: I’m a Republican former congressman and doctor. The new HHS placebo-controlled trial mandate is dangerous – Larry Bucshon
#Drug, #Patient
Health and Human Services (HHS)
Departments of Labor, Health and Human Services, Treasury Announce Move to Strengthen Healthcare Price Transparency
The departments of Labor, Health and Human Services, and the Treasury took action to advance President Trump’s directive to ensure Americans have clear, accurate, and actionable information about healthcare prices. The departments jointly issued a Request for Information (RFI) seeking public input on how to improve prescription drug price transparency. The agencies also released updated guidance for health plans and issuers that sets a clear applicability date for publishing an enhanced technical format for disclosures. These improvements are designed to eliminate meaningless or duplicative data and make cost information easier for consumers to understand and use. Separately, CMS released new guidance, available on the Hospital Price Transparency resources website, to strengthen the Hospital Price Transparency requirements, requiring hospitals to post the actual prices of items and services, not estimates. CMS also issued its own RFI to gather public feedback on how to boost hospital compliance and enforcement and ensure data shared is accurate and complete.
- https://www.dol.gov/sites/dolgov/files/ebsa/laws-and-regulations/laws/affordable-care-act/for-employers-and-advisers/rfi-regarding-prescription-drug-machine-readable-file-requirement-in-the-transparency-in-coverage-final-rule.pdf
- https://www.dol.gov/agencies/ebsa/about-ebsa/our-activities/resource-center/faqs/aca-part-70
- https://www.cms.gov/priorities/key-initiatives/hospital-price-transparency/resources
- https://www.cms.gov/priorities/key-initiatives/hospital-price-transparency/accuracy-and-completeness-rfi
Takeaways From the White House’s ‘Make America Healthy Again’ Report
The MAHA report identifies childhood chronic disease as a significant health crisis, attributing it to factors such as ultra-processed foods, environmental chemicals, sedentary lifestyles, and over-medicalization., reflecting the views of Health Secretary Robert F. Kennedy Jr. Notable omissions in the report raise questions about the comprehensiveness of its recommendations. The report characterizes the current generation of children as the “sickest” in American history and calls for a reevaluation of health policies affecting children. Cited statistics from the CDC and discussions regarding the impact of various lifestyle and environmental factors on children’s health. Source article.
#ALL
Saving Pediatric Cancer Drugs from the ‘Valley of Death’
Despite advancements in pediatric cancer research, many therapies fail to reach children due to funding gaps and regulatory hurdles, referred to as the “valley of death.” The article advocates for a new Pediatric Advanced Medicines Biotech model to help bridge this gap and facilitate the commercialization of pediatric therapies. Dr. Catherine Bollard emphasizes the need for hospital support and innovative funding strategies to advance pediatric drug development.
#Drug, #Patient
R.F.K. Jr. Has Unlikely Allies in His Drive to Limit Atrazine
Health Secretary Robert F. Kennedy Jr. is gaining support from an unexpected coalition for his initiative to impose restrictions on atrazine, a pesticide linked to health issues. This push reflects a growing concern about environmental health impacts. The coalition’s formation highlights the intersection of public health and environmental policy.
#All
RFK Jr. Meets with Health Tech Startups, Most Backed by Andreessen Horowitz
HHS Secretary Robert F. Kennedy Jr. met with health tech leaders, mostly funded by a prominent venture capital firm, to discuss innovations in health technology. The meeting underscores the administration’s focus on preventative care and the integration of technology in health services. The article notes the backing of the startups by Andreessen Horowitz, highlighting a trend in health tech investments.
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HHS agencies move to expand patient access, push forward on interoperability
HHS agencies are advancing efforts to improve patient access to healthcare and enhance interoperability among health information systems. These initiatives aim to streamline patient care and ensure that health data is readily available across different healthcare settings.
#All
What the 340B ruling means for drug rebate models
A federal district court ruled in favor of the Health Resources and Services Administration, affirming its authority over the 340B Drug Pricing Program. This ruling raises questions about the future administration of the program and the legitimacy of rebate-based pricing models proposed by pharmaceutical companies.
#Drug, #Hospital
How a Trump plan risks politicizing NIH research
A Trump administration proposal to replace career scientists with political appointees could undermine the objectivity of NIH research and impact scientific integrity. Historical context and expert opinions highlight the potential risks associated with politicizing science funding.
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Hill Happenings
Trump’s ‘Big Beautiful Bill’
House Passes Budget Bill, with Huge Medicaid Cuts and Potential Medicare Fallout
The House has passed a budget bill that includes significant cuts to Medicaid, raising concerns about the implications for Medicare. Critics note the potential fallout from these cuts, emphasizing the risks to healthcare access for vulnerable populations.
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GOP budget bill would slash Medicare funding by $490B: CBO
GOP works through unresolved issues on Medicaid work requirements
GOP Senators promise changes to Medicaid-cutting tax bill
Senate Dems Urge HHS to Undo Rule Barring Some Public Comments
Senate Democrats are calling on the HHS to reverse a rule that eliminates public comment periods for certain proposed regulations, emphasizing the need for transparency in the regulatory process.
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Legislative watchdog rebuffs DOGE efforts to install on-site team
The Government Accountability Office (GAO) rejected attempts by the Department of Government Efficiency (DOGE) to assign staffers to its agency, emphasizing its independence as a legislative branch entity. This incident highlights ongoing tensions between DOGE and congressional oversight agencies.
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Blunt Rochester presses RFK Jr. on CDC acting director
Senator Lisa Blunt Rochester has demanded clarification from Health Secretary Robert F. Kennedy Jr. regarding the status of the CDC’s acting director, questioning the qualifications of the appointed individual under federal law. The inquiry highlights concerns about leadership and qualifications within the CDC. The letter emphasizes the importance of adhering to the Vacancies Act in appointing officials.
#Provider
Notable Notes
Biden’s Cancer Diagnosis Leaves Democrats With New Questions
The recent diagnosis of aggressive prostate cancer for former President Biden has raised public concern and speculation regarding his health and the implications for his political future.
#All
ASCO’s new AI tool for cancer treatment guidelines
The American Society of Clinical Oncology (ASCO) has partnered with Google Cloud to create an AI tool aimed at making cancer treatment guidelines more accessible to clinicians. The tool is designed to streamline access to high-quality, consensus-based treatment guidelines for oncologists. Initial demonstrations of the tool showed mixed results, highlighting its potential and limitations in practical applications.
#Device, #Patient, #Provider
Same-day discharge after TAVR linked to positive outcomes
A study indicates that low-risk patients undergoing transfemoral TAVR can safely be discharged on the same day of the procedure, showing promising outcomes. This finding supports advancements in minimally invasive cardiac procedures.
#Device, #Patient, #Provider
Trump administration lays out more details of plan to lower drug prices
The Trump administration has detailed its plan to negotiate drug prices, aiming to align U.S. prices with those in other countries. The initiative targets brand-name drugs without generic competition and seeks to reduce prices significantly. HHS Secretary Robert F. Kennedy Jr. emphasized the commitment to lower drug costs for American patients, with potential reductions of 50% to 90%. The plan is part of a broader strategy to ensure that Americans do not pay more for medications than patients in comparable countries.
#Drug, #Payer
Trump Blames Other Nations for U.S. Drug Prices. Experts Say It’s Not Their Fault.
President Trump attributed high U.S. prescription drug prices to foreign nations while signing an executive order aimed at reducing these costs. Experts argue that this blame is misplaced and that domestic factors play a more significant role in driving up drug prices.
#Drug, #Patient
Maryland governor signs law to expand powers of the state’s prescription drug affordability board
Maryland Governor Wes Moore has signed a law to empower the state’s Prescription Drug Affordability Board to regulate drug prices for all residents, not just state employees. The legislation aims to reduce prescription drug costs and has received support from consumer advocates, although it faces criticism from the pharmaceutical industry. Advocates argue that the law will help lower medication costs for Maryland residents.
#Drug, #Payer
UnitedHealth said it was too dangerous for him to be discharged. Days later, it denied his care
A family faced multiple denials from UnitedHealth regarding their father’s care after brain surgery, highlighting issues with algorithm-based decision-making in healthcare.
#Patient, #Payer
Cigna debuts GLP-1 copay cap
Cigna’s subsidiary, Evernorth Health Services, is automating prior authorizations for GLP-1 weight-loss drugs, introducing a copay cap. This initiative aims to improve patient access to weight-loss medications by simplifying the prior authorization process and capping costs. The automation of prior authorizations is expected to enhance efficiency and reduce barriers for patients seeking treatment.
#Patient, #Provider
Claim denials grew as prior authorization rejections fell in 2024
Health insurance companies initially declined to pay more than one dollar for every $10 providers submitted in claims last year, an increase from 2023. Payers in 2024 initially denied 11.8% of dollars associated with hospital-based claims, according a report from consultant Kodiak Solutions. That compares with 11.53% of dollars denied in 2023.
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