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All posts tagged with “Regulatory News | HHS.”
Trump freezes HHS communications: report
01/23/25 at 03:00 AMTrump freezes HHS communications: report Modern Healthcare Alert; by Bridget Early; 1/22/25 The Health and Human Services Department and its agencies are going silent for now, according to the Washington Post. On Tuesday, the day after President Donald Trump's inauguration, HHS received an order to halt all outbound communications, including health advisories, weekly reports, research, website updates and social media posts, the newspaper reported. The Washington Post reports that the pause has no definitive end date and that the decree does not specify whether exceptions will be made for disease outbreaks or other urgent situations. The directive applies to agencies such as the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Health Resources and Services Administration, the Centers for Disease Control and Prevention, the National Institutes of Health and the Substance Abuse and Mental Health Services Administration.
Hospice agency changes of ownership: An analysis of publicly available ownership data
01/21/25 at 03:00 AMHospice agency changes of ownership: An analysis of publicly available ownership data Assistant Secretary for Planning and Evaluation: Office of Behavioral Health, Disability, and Aging Policy; 1/10/25 ... Over time, the number of both Medicare enrollees receiving hospice care and hospice providers has grown. Between 2010 and 2022, the number of Medicare enrollees receiving hospice care grew by approximately 50%, while the number of hospice agencies grew by 69%. Growth in the hospice provider market was driven predominantly by a 125% increase in for-profit hospices, which represent a growing share (approximately three-quarters in 2021) of the hospice provider market. The shift toward for-profit ownership in the hospice industry has been driven not only by newly enrolling hospices, but also changes of ownership. For example, acquisitions of nonprofit hospice agencies by publicly traded corporations and private equity firms have contributed to the increase in market share of for-profit hospices.
CMS Health Equity Data Book
01/17/25 at 03:00 AMCMS Health Equity Data Book U.S. Centers for Medicare and Medicaid Services - Office of Minority Health; by CMS Office of Minority Health; published December 2024, email notifications 1/15/25 One of the six pillars of the Centers for Medicare & Medicaid Services (CMS) 2023 Strategic Plan is to, “Advance health equity by addressing the health disparities that underlie our health system.” The CMS Office of Minority Health (OMH) aims to advance health equity by providing broader access to data about the state of health equity across CMS’ programs. This Data Book presents summary information on disparities within CMS programs as demonstrated by data related to prevalence. ... This Data Book is intended for use as a readily-available information source on health disparities within the Medicare, Medicaid, and the Health Insurance Marketplace populations. This Data Book is organized into five key sections – CMS at a Glance, Demographics, Chronic Conditions, Behavioral Health, and Social Determinants of Health – so that Data Book users can jump to the section most relevant to their data needs. Within each section, data are presented by each population type.
CMS Call for Nominations: 2025 CMS Health Equity Award
01/17/25 at 02:00 AMCMS Call for Nominations: 2025 CMS Health Equity Award U.S. Centers for Medicare and Medicaid Services; by CMS Health Equity; via CMS email 1/13/25Nominations for the 2025 CMS Health Equity Award are now open to organizations working to advance health equity, showing others how to reduce disparities in health care access, quality, and outcomes. Nominations are due February 18 at 11:59 pm PT. ... Health equity is defined by CMS as the attainment of the highest level of health for all people, where everyone has a fair and just opportunity to attain their optimal health regardless of race, ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography, preferred language, and other factors that affect access to care and health outcomes.
ASTP Rule codifies requirements for TEFCA-Qualified health information networks
01/16/25 at 03:00 AMASTP Rule codifies requirements for TEFCA-Qualified health information networks McDermott Will & Emery, Washington, DC; by James A. Cannatti III, Jennifer S. Geetter, and Nathan Gray; 1/15/25 On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the NationaTl Coordinator for Health Information Technology (ASTP) published the Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA) final rule in the Federal Register as part of its continued focus on improving information sharing among healthcare stakeholders. Rather than codifying comprehensive substantive and procedural requirements for entities participating in TEFCA, the final rule provides a flexible framework establishing how such decisions will be made in current and future subregulatory documents.
Winter snow storm slams into over a dozen states in the East, Midwest
01/07/25 at 02:00 AMWinter snow storm slams into over a dozen states in the East, Midwest USA Today; by Julia Gomez; 1/6/25 The Central Plains and Midwest are getting slammed by a winter storm , according to officials, and it's leaving over a dozen inches of snow in some places. Here's a look at what the storm is leaving behind. Over 60 million people in the Central Plains, Midwest and along the East Coast are being bombarded by heavy snowfall because of the "disruptive" winter storm moving through the area, according to the National Weather Service. Some areas could see snowfall anywhere between 8 to 14 inches. The storm is also expected to impact travel in Kansas City, St. Louis, Indianapolis and Cincinnati and bring the cities to a standstill.Editor's note: Are you ready for emergencies in your service areas? Click here for the CMS.gov Emergency Preparedness Rule. Click here for Wisconsin's CMS Emergency Preparedness Rule Toolkit: Hospices.
MA Special Needs Beneficiaries more likely to receive lower quality hospice care
01/03/25 at 03:00 AMMA Special Needs Beneficiaries more likely to receive lower quality hospice care Hospice News; by Jim Parker; 1/2/25 Medicare Advantage special needs plan (SNP) beneficiaries were more likely to use lower-quality hospices than those enrolled in fee-for-service Medicare. Researchers from the Perelman School of Medicine at University of Pennsylvania in Philadelphia examined Medicare enrollment and claims data for 4.2 million decedents and 2.2 million hospice enrollees from Jan 1, 2018 to Dec. 31, 2019. Among other findings, results indicated that MA SNP beneficiaries were more likely to receive care from hospices with lower Hospice Quality Reporting Program (HQRP) scores. “These results suggest that policymakers should consider incentivizing referrals to high-quality hospices and approaches to educating beneficiaries on identifying high-quality hospice care,” researchers wrote in the study, published in JAMA Network Open. Editor's note: Click here for the CMS.gov Special Needs Plans webpage.
Trends in private equity acquisition of pain management practices
12/28/24 at 03:45 AMTrends in private equity acquisition of pain management practicesJAMA Network Open; Geronimo Bejarano, MPH; James E. Eubanks, MD, MS; Robert T. Braun, PhD; 12/24Pain has the highest health care spending in the US and is expected to increase with the aging population, which may entice private equity acquisitions of pain management practices. Private equity has increasingly acquired physician practices and acquisitions are associated with higher spending, utilization of more expensive treatments, and increasing patient volume. In this cross-sectional study of private equity acquisitions of pain management practices, we found a rise in acquisitions over the last decade with almost 1 in 10 pain management physicians affiliated with a private equity–owned pain management practice. [The] ... high amount of consolidation within certain states poses concerns for private equity to have enough market power to control care delivery of several procedure-based specialties, including pain management. Policymakers and the Federal Trade Commission have taken notice of the harms of increases in both health care consolidation and private equity acquisitions, and there are ongoing efforts to curb their detrimental effects.
Quality of hospices used by Medicare Advantage and traditional fee-for-service beneficiaries
12/21/24 at 03:00 AMQuality of hospices used by Medicare Advantage and traditional fee-for-service beneficiariesJAMA Network Open; Lindsay L. Y. White, PhD, MPH; Chuxuan Sun, MPA; Norma B. Coe, PhD; 12/24In this cross-sectional study including 4 215 648 decedents and 2 211 826 hospice enrollees, regular Medicare Advantage and fee-for-service beneficiaries enrolled in hospices of similar quality. However, beneficiaries in Medicare Advantage special needs plans were significantly more likely than fee-for-service beneficiaries to use hospices of inferior quality, with referral networks playing an important role in hospice quality choice. These results suggest that policymakers should consider incentivizing referrals to high-quality hospices and approaches to educating beneficiaries on identifying high-quality hospice care.
How the downfall of the ‘Chevron Doctrine’ could affect hospices in the courts
12/18/24 at 03:00 AMHow the downfall of the ‘Chevron Doctrine’ could affect hospices in the courts Hospice News; by Holly Vossel; 12/16/24 Recent court rulings have the potential to make significant differences in the landscape of hospice regulatory oversight in coming years, particularly when it comes to audits and the forthcoming Special Focus Program (SFP). In June the U.S. Supreme Court overturned a ruling that in 1984 established the “Chevron Doctrine,” which instructed lower courts to defer to executive branch agencies to resolve ambiguities in laws passed by Congress. The decision marked the end of the practice known as “Chevron deference,” which required that courts must defer to regulatory agencies’ interpretations of “ambiguous” statutes within federal legislation as long as the enforcement activity is deemed “reasonable.” Hospices could potentially see a vastly different outlook in regulatory enforcement activity during a time of tremendous changes already taking place in the industry, [Bryan Nowicki, partner at the law firm Husch Blackwell] said.
Agency Information Collection Activities: Proposed collection; Comment request
12/17/24 at 03:00 AMAgency Information Collection Activities: Proposed collection; Comment request Federal Register - United States Government; A Notice by the Centers for Medicare & Medicaid Services, Health and Human Services; 12/16/24 The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Why repeat offender nursing homes elude accountability
12/11/24 at 03:00 AMWhy repeat offender nursing homes elude accountability Modern Healthcare; by Diane Eastabrook and Tim Broderick; 12/10/24 Fallbrook Rehabilitation and Care Center stands out as one of the worst among the more than 1,200 nursing homes in Texas and the nearly 15,000 facilities nationwide. Over a three-year period at the skilled nursing facility in Houston, one patient died after staff did not notice her ventilator had disconnected. ... The Texas Department of Health and Human Services cited Fallbrook for more than 50 other health and safety violations. Fallbrook was fined about $640,000 between April 2021 and July 2023, according to Modern Healthcare analysis of April 2024 CMS data. The amount was among the top 30 fines paid by nursing homes nationally and was more than six times the average fine other Texas nursing homes with CMS one-star ratings were assessed during that period. Yet the 200-bed nursing home collected more than $20 million in reimbursements from Medicare, Medicaid and health insurance companies in 2021 and 2022, ... The ownership groups can control facilities through convoluted webs of individuals, private equity investors, limited liability companies, real estate investment trusts and other trusts that often transfer money to related companies or third parties with ownership interests in the nursing homes. The Human and Human Services Department Office of Inspector General has identified this as a problem.
HHS OIG's Fall 2024 Semiannual Report to Congress
12/06/24 at 03:00 AMHHS OIG's Fall 2024 Semiannual Report to CongressU.S. Department of Health and Human Services [HHS] - Office of Inspector General [OIG]; by OIG; issued on 12/4/24, posted on 12/4/24 The Fall 2024 Semiannual Report to Congress highlights OIG's work focusing on the most significant and high-risk issues in health care and human services related to HHS programs and operations during the semiannual reporting period of April 1 through September 30, 2024. The semiannual reports are intended to keep the HHS Secretary and Congress informed of OIG’s crucial findings and recommendations. ...
Regulators extend some telemedicine flexibilities, gauge telehealth’s ‘new path forward’ in hospice
12/06/24 at 02:00 AMRegulators extend some telemedicine flexibilities, gauge telehealth’s ‘new path forward’ in hospice Hospice News; by Holly Vossel; 12/4/24 Regulators recently extended certain temporary telemedicine waivers granted during the pandemic, with some flexibilities now sunsetting in 2025 rather than the end of this year. The U.S. Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) have announced the extension of telemedicine flexibilities for the prescribing of controlled medications until Dec. 31, 2025. ... The move was made in response to feedback the agencies received from more than 38,000 comments and two days of public listening sessions. The extension allows for more time to consider a “new path forward” for telemedicine, according to the DEA and HHS. “We continue to carefully consider the input received and are working to promulgate a final set of telemedicine regulations,” the agencies stated in an announcement. “With the end of 2024 quickly approaching, DEA, jointly with HHS, has extended current telemedicine flexibilities through December 31, 2025.” The temporary rule, entitled as the Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, was recently submitted to the Federal Register and will take effect/become effective Jan. 1, 2025.
Hospice Oversight: 2024’s most impactful regulatory actions
11/29/24 at 03:00 AMHospice Oversight: 2024’s most impactful regulatory action Hospice News; by Jim Parker; 11/27/24 The past year has seen a slew of regulatory developments aimed at improving quality and combatting fraud in the hospice industry. The drive by regulators and members of Congress to strengthen oversight is fueled by two main factors. The first was two July 2019 reports on hospice quality from the Office of the Inspector General (OIG) in the U.S. Department of Health and Human Services (HHS). These spurred passage of the Helping Our Senior Population in Comfort Environments (HOSPICE) Act, which mandated the establishment of a hospice Special Focus Program (SFP), among other actions. The second driving force was the emergence of fraudulent actors in the space in relatively large numbers, particularly concentrated in California, Nevada, Arizona and Texas. [Click on the title's link to continue reading this important information.]
What is compliance risk?
11/27/24 at 03:00 AMWhat is compliance risk? TechTarget; by Katie Terrell Hanna and Francesca Sales; 11/26/24 Compliance risk is an organization's potential exposure to legal penalties, financial forfeiture and material loss, resulting from its failure to act in accordance with industry laws and regulations, internal policies or prescribed best practices. Compliance risk is also known as integrity risk. Organizations of all types and sizes are exposed to compliance risk, whether they are public or private entities, for-profit or nonprofit, state or federal. An organization's failure to comply with applicable laws and regulations can affect its revenue, which can lead to loss of reputation, business opportunities and valuation. Types of compliance risk ... An organization might be implicated in the following types of compliance risks:
OIG issues nursing facility industry segment-specific Compliance Program Guidance; first in a series in Furtherance of its Modernization Initiative
11/25/24 at 03:00 AMOIG issues nursing facility industry segment-specific Compliance Program Guidance; first in a series in Furtherance of its Modernization Initiative Butzel - Attorneys and Counselors Client Alerts; 11/22/24 On November 20, 2024, the U.S. Department of Health & Human Services, Office of Inspector General (“OIG”) issued the first Industry Segment-Specific Compliance Program Guidance (“ICPG”), which applies to the Nursing Facility Industry. This follows from the OIG’s Modernization Initiative to update publicly available resources for the healthcare industry first announced in September 20211 and finalized in April 2023. This ICPG comes just over a year after the OIG issued the General Compliance Program Guidance (“GCPG”) that kicked off the OIG’s efforts to modernize and consolidate numerous Compliance Program Guidance documents issued between 1998 and 2008. Editor's note: Click here to download the U.S. HHS OIG's 59-page November 2024 "NURSING FACILITY Industry Segment-Specific Complicance Program Guidance." A word search finds 30 references to "hospice."
The Inflation Reduction Act and patient costs for drugs to treat heart failure
11/23/24 at 03:40 AMThe Inflation Reduction Act and patient costs for drugs to treat heart failureJAMA Network Open; Erin Trish, PhD; Karen Van Nuys, PhD; Joanne Wu, MS; Nihar R. Desai, MD, MPH; 10/24The 2022 Inflation Reduction Act (IRA) contains several provisions to lower Medicare drug costs, including permitting the Centers for Medicare & Medicaid Services (CMS) to limit the prices of certain medicines and altering the standard Part D benefit to limit patient out-of-pocket costs. CMS has set the prices of 10 drugs effective 2026, including 3 commonly prescribed as part of combination therapy for heart failure (HF): dapagliflozin, empagliflozin, and sacubitril/valsartan. Dapagliflozin and empagliflozin also treat other conditions, including diabetes and chronic kidney disease. In this cross-sectional study of Medicare beneficiary costs ... benefit redesign eliminates the coverage gap in 2025, and caps annual out-of-pocket expenditures, [and] ... will reduce and smooth patient out-of-pocket burden.
Seven of thirty hospices reviewed did not comply or may not have complied with terms and conditions and federal requirements for Provider Relief Fund payments
11/19/24 at 03:00 AMSeven of thirty hospices reviewed did not comply or may not have complied with terms and conditions and federal requirements for Provider Relief Fund payments HHS Office of Inspector General; issued on 11/8/24, posted on 11/14/24Why OIG Did This Audit: The Provider Relief Fund (PRF), a $178 billion program, provided funds to eligible providers for health care-related expenses or lost revenue attributable to COVID-19. ... This audit is part of a series reviewing PRF payments to various provider types. Specifically, this audit assessed whether 30 selected hospices expended taxpayer funds in accordance with Federal and program requirements. ... What OIG Found: ... Of the 30 selected hospices, 23 hospices used PRF funds for allowable expenditures and lost revenues attributable to COVID-19; however, 7 hospices did not comply with or may not have complied with Federal requirements. Of these seven hospices, which received $98.1 million in PRF payments, six hospices claimed a total of $8.3 million of unallowable PRF expenditures and inaccurately reported $1.5 million of lost revenues, and one hospice claimed $4 million in expenditures that may not have been allowable. ... What OIG Recommends: We made two recommendations to HRSA, including that it require the selected hospices to return any unallowable expenditures to the Federal Government or ensure that the hospices properly account for these expenditures. ...
Strengthening nondiscrimination protections and advancing civil rights in health care through Section 1557 of the Affordable Care Act: Fact sheet
11/14/24 at 03:00 AMStrengthening nondiscrimination protections and advancing civil rights in health care through Section 1557 of the Affordable Care ActHHS press release; 11/13/24Publisher's note: While the final rule was released this Spring, compliance deadlines begin this month and might be burdensome for some providers to implement. In addition to the link above, guidance can be found here: final rule, press release, fact sheet.
NAHC re-files lawsuit against HHS, CMS over home health cuts
07/02/24 at 03:00 AMNAHC re-files lawsuit against HHS, CMS over home health cuts Home Health Care News; by Joyce Famakinwa; 6/28/24 The National Association for Home Care & Hospice (NAHC) hasn’t given up on efforts to push back on Medicare home health payment calculations. NAHC has re-filled its lawsuit against the U.S. Department of Health and Human Services (HHS). The lawsuit focuses on the home health PDGM budget neutrality adjustment, which imposed both permanent and temporary calculations with a methodology that NAHC believes is noncompliant with the law. The original lawsuit was filed last summer, and in April the case was dismissed by a federal court in Washington D.C. The case was dismissed on the basis that NAHC did not fully exhaust administrative appeal remedies. ... There are a number of factors that made NAHC decide to re-file the lawsuit, according to [NAHC President, William A.] Dombi. “No. 1, it will be faster,” he said. “No. 2, we are highly likely to get the same judge, as there’s a related litigation standard in an assignment of cases,” he said. One of the biggest factors that heavily contributed to NAHC’s decision was the Supreme Court ruling, which upended the Chevron Doctrine.
HHS to impose penalties on providers that block patients’ health information
06/28/24 at 03:00 AMHHS to impose penalties on providers that block patients’ health information McKnights Home Care; by Adam Healy; 6/24/24In a bid to promote easier access and exchange of patients’ health records, the Department of Health and Human Services published a final rule Monday outlining penalties for providers that block access to electronic health information. ... Fragmented and inaccessible patient data can prevent long-term and post-acute care providers from seeing the full picture of a patients’ health. Hospitals, for example, are not required to share updates about a patient’s health with the patient’s post-acute care provider. As a result, home health and home care agencies frequently cannot access patients’ electronic health records to help assess and treat patients. Three disincentives: ... First, hospitals that commit information blocking can be subject to a reduction of three quarters of an annual market basket update. Second, clinicians eligible for the Merit-based Incentive Payment System will receive a zero score in the “promoting interoperability performance” MIPS category, which can be equivalent to roughly a quarter of the clinician’s MIPS score in a given year. Lastly, providers that participate in information blocking can have their Medicare Shared Savings Program or Accountable Care Organization eligibility revoked for at least one year. ...Editor's Note: Almost any solution raises additional challenges. How does HIPAA interface with this? How might a cyberattack at a hospital (or other healthcare agency) affect the patients' other agencies, putting them at risk as well?
National aging framework outlines governmentwide initiatives promoting home-based care
06/05/24 at 03:00 AMNational aging framework outlines governmentwide initiatives promoting home-based careMcKnight's Home Care; by Adam Healy; 6/3/24The Department of Health and Human Services released a new framework for its National Plan on Aging on Thursday. The framework aims to guide a multifaceted, governmentwide approach to help caregivers and home- and community-based service providers enable older adults to age comfortably in place.
HHS puts $50M toward hospitals' ransomware fight
05/23/24 at 03:00 AMHHS puts $50M toward hospitals' ransomware fightBecker's Health IT; by Molly Gamble; 5/20/24A new agency within the National Institutes of Health is launching a $50 million initiative to develop tools for hospital IT teams that enhance their cybersecurity measures and resources to combat ransomware. On May 20, the Advanced Research Projects Agency for Health introduced its Universal PatchinG and Remediation for Autonomous DEfense, or UPGRADE, program. "What if every hospital could autonomously protect itself and patients from cyber threats?" That is the guiding question for the initiative, which aims to develop a tailored and scalable software suite of remediations and patches for hospitals, reducing the patching time for vulnerable healthcare products to days or weeks.
HHS finalizes disability access rule for healthcare providers
05/06/24 at 03:00 AMHHS finalizes disability access rule for healthcare providers Modern Healthcare, by Kara Hartnett; 3/2/24 The Health and Human Services Department finalized a rule that broadens nondiscrimination protections for individuals with disabilities in healthcare environments. ... When the rule takes effect July 1, healthcare organizations will be required to modify facilities and medical equipment to cater to patients' physical and sensory needs. Facilities will have to update features such as elevators and ramps to ensure they are functional and meet federal standards. In addition, healthcare organizations must ensure websites, mobile apps and virtual care programs are user-friendly for people with disabilities and remove disability status as a factor in clinical support tools.