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All posts tagged with “Regulatory News | HHS.”
RFK Jr. continues Opioid Crisis PHE into its eighth year
03/21/25 at 03:00 AMRFK Jr. continues pioid Crisis PHE into its eighth year Inside Health Policy; by Dorothy Mills-Gregg; 3/19/25 HHS Secretary Robert F. Kennedy Jr. recently renewed the department’s longest ongoing public health emergency (PHE) first declared under the first Trump administration: the opioid abuse crisis. While the Centers for Disease Control and Prevention found a 25.5% decrease in overdose deaths in 2024 compared to the previous year, HHS says the opioid PHE needs to be renewed for another 90 days so federal coordination efforts can continue and key flexibilities for HHS will be preserved.Editor's note: How recently have you reviewed your Policies & Procedures for destroying drugs in the patient's home, upon death--in accordance with state laws? For staff education and accountability? For communicating this with family? For assessing possible drug diversion of opioids, with appropriate follow-up actions? Additionally, numerous hospice bereavement programs have been flooded with grief needs of bereaved family members from opioid deaths. Click here for the U.S. Department of Justice's Drug Enforcement Administration - Diversion Control Divsion; more focused, scroll down to their "Home Disposal Methods."
What Trump has done with Medicare so far
03/18/25 at 03:00 AMWhat Trump has done with Medicare so far Kiplinger; by Kathryn Pomroy; 3/17/25 Since President Trump was sworn into office on January 20, he has proposed or initiated changes impacting Medicare. Here's a roundup. ...
OIG Nursing Facility Compliance Program Guidance: Renewed focus on fraud and abuse
03/13/25 at 03:00 AMOIG Nursing Facility Compliance Program Guidance: Renewed focus on fraud and abuse McDermott Will & Emery, Chicago, IL; by Gregory E. Fosheim, Monica Wallace, Dexter Golinghorst, and Brigit Dunne; 3/11/25 The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the importance of billing and coding and fraud and abuse compliance for nursing facilities and skilled nursing facilities (SNFs). This On the Subject is the second in a two-part series summarizing highlights of the Nursing Facility ICPG. This installment focuses on OIG’s recommendation that nursing facilities comply with existing billing rules and analyze referral source arrangements for compliance with fraud and abuse laws. [Click on the title's link for this significant information.]
An opportunity to advance cannabis science—DEA rescheduling
03/08/25 at 03:20 AMAn opportunity to advance cannabis science—DEA reschedulingJAMA Psychiatry; Kevin P. Hill, MD, MHS; Anshul V. Puli, BS; 2/25In 1970, the US Congress enacted the Controlled Substances Act (CSA), establishing a scheduling system for drugs based on their medical use, abuse potential, and safety. The most restrictive classification is Schedule I; cannabis along with other drugs, such as heroin and lysergic acid diethylamide (LSD), have this classification. May 13, 2024, the Drug Enforcement Agency (DEA), the agency regulating substance scheduling, issued a Notice of Proposed Rulemaking to investigate rescheduling cannabis from Schedule I to Schedule III. This was due to a recommendation from the US Department of Health and Human Services (HHS) to reschedule based on its review of the medical and scientific cannabis research. Still, the FDA investigated HHS’ CAMU [cannabis’ current accepted medical use] claim and found some credible scientific support for treating “anorexia related to a medical condition, nausea and vomiting (eg, chemotherapy-induced), and pain.”
HHS scraps transparency practices for policymaking
03/07/25 at 03:00 AMHHS scraps transparency practices for policymaking Modern Healthcare; by Bridget Early; 2/28/25The Health and Human Services Department is abandoning a Nixon-era practice that offered transparency into federal policymaking in a move that limits the public and the healthcare sector's ability to influence government actions. Instead, HHS intends to comply with the bare-minimum requirements of the Administrative Procedures Act of 1946, or APA, and only engage in the traditional notice-and-comment process as expressly dictated by that law, Secretary Robert F. Kennedy Jr. wrote in a policy statement published Friday [2/27]. HHS had followed the now-defunct guidelines for 54 years.
HHS job cuts mount: 4 notes
02/19/25 at 03:00 AMHHS job cuts mount: 4 notes Becker's Hospital Review; Madeline Ashley; 2/18/25 HHS saw further job cuts on Feb. 15 across agencies including the CDC, FDA and National Institutes of Health, including around 1,000 NIH terminations, after a Trump administration order to eliminate "nearly all" HHS probationary employees, Bloomberg reported Feb. 16. Here are four things to know: [click on the title's link to continue reading]
5,200 job cuts at HHS: What to know
02/18/25 at 03:00 AM5,200 job cuts at HHS: What to know Becker's Hospital Review; by Madeline Ashley; 2/14/25 The Trump administration on Feb. 13 ordered HHS to lay off "nearly all" of its 5,200 probationary employees, The Associated Press reported Feb. 14. In a National Institutes of Health department meeting recording obtained by the AP, an NIH office director said some probationary employees with specialized skills might be retained. Affected employees were notified via email on the afternoon of Feb. 13. Many probationary employees are people who have worked for the federal government for about one to two years, before gaining civil service protections. Some probationary employees are veteran staffers who may have been recently promoted, according to the AP.
U.S. Attorney’s Office recovers more than $55 million in civil settlements and judgments in calendar year 2024
01/30/25 at 03:00 AMU.S. Attorney’s Office recovers more than $55 million in civil settlements and judgments in calendar year 2024United States Attorney's Office - Western District of Texas, San Antonio, TX; 1/28/25U.S. Attorney Jaime Esparza announced today that the Western District of Texas recovered $55,969,678.60 in settlements and judgments in over 25 affirmative civil enforcement cases between January 1, 2024, and December 31, 2024. ... The office’s largest civil recoveries were obtained in False Claims Act (FCA) matters. The most significant FCA recoveries include: ...
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."