Literature Review

All posts tagged with “Regulatory News.”



Vital Signs: Digital Health Law Update | Spring 2024

07/24/24 at 03:00 AM

Vital Signs: Digital Health Law Update | Spring 2024 Jones Day - Vital Signs; by Vital Signs' Editors; July 2024Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health.  [Topics include the following:]

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Texas pharmaceutical marketer sentenced for $59 million medications fraud conspiracy

07/23/24 at 03:00 AM

Texas pharmaceutical marketer sentenced for $59 million medications fraud conspiracy ArentFox Schiff; by  D. Jacques Smith, Randall A. Brater, Michael F. Dearington, Nadia Patel, Hillary M. Stemple, Mattie Bowden, Elizabeth Satarov; 7/19/24 On July 12, Quintan Cockerell, a Texas pharmaceutical marketer, was sentenced to over two years in prison and ordered to pay more than $59 million for receiving illegal kickbacks in exchange for prescription referrals for compounded medications intended to be made specific for individual patient needs. ... Court documents and evidence presented at trial demonstrated that Cockerell used preloaded prescription pads and “standing orders” for doctors to easily select expensive compounded medications. The pharmacy could then switch ingredients in the medications actually prescribed by doctors to maximum insurance reimbursements.

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How well does Medicare cover end-of-life care? It depends on what type

07/23/24 at 03:00 AM

How well does Medicare cover end-of-life care? It depends on what type Medical Xpress; by Mark Harden, CU Anschutz Medical Campus; 7/19/24 Not all versions of Medicare are created equal—and when it comes to end-of-life care, some versions may serve a patient's needs better than others. That's the focus of newly published research by Lauren Hersch Nicholas, Ph.D., MPP, a University of Colorado Department of Medicine and CU Cancer Center health economist, and her colleagues. The researchers analyzed the experiences of more than a million people receiving Medicare-funded services in the last six months of their lives. ... Their paper was published July 19 in JAMA Health Forum. What Nicholas and her colleagues found is that the kind of Medicare a patient is enrolled in can make a difference in whether that patient gets certain treatments, and whether the patient dies in a hospital or in hospice care.

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‘Bad apples in a barrel’: How fraudsters in home health care impact the entire space

07/23/24 at 02:00 AM

‘Bad apples in a barrel’: How fraudsters in home health care impact the entire space Home Health Care News; by Joyce Famakinwa; 7/19/24 The home health industry has its very own boogeyman--the bad actor. However, there's a difference between providers that had made errors in claims ... [Subscription required to continue reading]

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Does Medicare pay for dementia care? Here’s what coverage you can expect for treatments and therapies

07/22/24 at 03:00 AM

Does Medicare pay for dementia care? Here’s what coverage you can expect for treatments and therapies Aol - Fortune; by Margie Zable Fisher; 7/18/24 Age-related memory loss is common, but more serious memory problems may be a sign of dementia, which is not a normal part of aging. ... Dementia patients have a variety of medical issues. “In addition to symptoms related to dementia, the overwhelming majority of dementia patients have one or more chronic health conditions,” says Matthew Baumgart, Vice President of Health Policy, at the Alzheimer's Association. Medicare (and Medicare Advantage) provide some coverage for dementia, beginning with the diagnosis, says Baumgart. [Click on the title's link for practical, user-friendly information about what Medicare provides arose the trajectory of dementia's progression. CMS's new GUIDE pilot program is described.]

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Glitzy Scottsdale couple jailed in $900M fraud

07/16/24 at 03:15 AM

Glitzy Scottsdale couple jailed in $900M fraud Gilbert Sun News; by Tom Scanlon; 7/14/24 ... According to a federal indictment, “Alexandra Gehrke and Jeffrey King were charged for targeting elderly Medicare patients, many of whom were terminally ill in hospice care, for medically unnecessary wound grafts.” Gehrke – known to friends and associates as “Lexie” – and King allegedly filed $900 million in fraudulent claims, pocketing “$330 million in illegal kickbacks as a result of their fraudulent scheme.” According to the indictment, they were responsible for “allograft” bandages being applied frivolously to hundreds of patients, many of them dying. According to Gehrke’s LinkedIn profile, “APEX Medical is a national medical device distribution company. 

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The Medicare Post-Acute Care and Hospice Provider Public Use File (PAC PUF)

07/16/24 at 03:00 AM

The Medicare Post-Acute Care and Hospice Provider Public Use File (PAC PUF)CMS press release; 7/10/24[This file] provides information on services provided to Medicare beneficiaries by home health agencies (HHAs), hospices, skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), and long-term care hospitals (LTCHs).  It contains information on demographic and clinical characteristics of beneficiaries served, professional and paraprofessional service utilization, submitted charges, and payments at the provider, state, and national levels.  Additionally, the PAC PUF includes payment information at the case-mix grouping level for HHAs, SNFs, and IRFs.

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Chevron deference derailed

07/15/24 at 03:00 AM

Chevron deference derailed The Rowan Report; by Kristin Rowan; 7/12/24 ... Chevron Deference in Home Health: Since the advent of the PDGM model, CMS has calculated payment rates based on its interpretation of budget neutrality. The National Association for Home Care and Hospice [NAHC] has disputed the validity of both the interpretation of budget neutrality and the formulas used to calculate it. Last year’s 2024 CMS Proposed Rule cut payment rates even further with a 2.890% Budget Neutrality permanent payment rate adjustment and a temporary rate adjustment to account for alleged overpayments from 2020-2022. The lawsuit filed against CMS in response to the 2024 Final Rule was dismissed. NAHC began pursuing an administrative review with CMS. [Click on the title's link to continue reading the discourse between CMS and NAHC, specific to home health.]

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[CMS CAHPS Hospice Survey] Agency Information Collection Activities: Submission for OMB Review; Comment Request

07/15/24 at 03:00 AM

[CMS CAHPS Hospice Survey] Agency Information Collection Activities: Submission for OMB Review; Comment Request Federal Register; A Notice by the Centers for Mediare & Medicaid Services; 7/9/24 Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: CAHPS Hospice Survevy; Use: CMS launched the development of the CAHPS Hospice Survey in 2012. Public reporting of the results on Hospice Compare started in 2018. The goal of the survey is to measure the experiences of patients and their caregivers with hospice care. 

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C-TAC: CMS’ ‘Palliative’ Definition in 2025 Proposed Hospice Rule ‘Misaligned, Problematic’

07/15/24 at 03:00 AM

C-TAC: CMS’ ‘Palliative’ Definition in 2025 Proposed Hospice Rule ‘Misaligned, Problematic’ Hospice News; by Holly Vossel; 7/12/24 Efforts to establish potential payment mechanisms for high-acuity palliative services within the Medicare Hospice Benefit will require greater clarity from regulators, according to the Coalition to Transform Advanced Care (C-TAC). The U.S. Centers for Medicare & Medicaid Services’ (CMS) 2025 proposed hospice payment rule contained a request for information (RFI) on the potential implementation of reimbursement pathways for “high intensity palliative care services,” such as chemotherapy, blood transfusion and dialysis. CMS in its proposed rule indicated that, “Hospice care changes the focus of a patient’s illness to comfort care (palliative care) for pain relief and symptom management from a curative type of care.” C-TAC’s recommendations are as follows: [Click on the title's link to read more.]

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All the payment factors included in the 2025 Home Health Proposed Rule

07/11/24 at 03:00 AM

All the payment factors included in the 2025 Home Health Proposed Rule Home Health Care News; by Joyce Famakinwa; 7/8/24 Providers examining the 2025 home health proposed payment rule may be experiencing some déjà vu, according to William A. Dombi, the president of the National Association for Home Care & Hospice’s (NAHC). “Much of what we see in the rule is just, on the payment side of it in particular, an update from ‘23 and ‘24,” he said during a recent webinar hosted by NAHC. On June 26, the U.S. Centers for Medicare & Medicaid Services (CMS) unveiled its home health proposed payment rule for 2025. The proposal includes a payment decrease in the aggregate by 1.7%, or by about $280 million. “That needs qualification,” Dombi said. “That’s $280 million, not to what it would otherwise have been, but rather, in contrast to what it’s expected to be for 2024.” Providers examining the proposed rule will also see a 2.5% net inflation rate update. ... 

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Home health providers to pay $4.5M to resolve alleged false claims act liability for providing kickbacks to assisted living facilities and doctors

07/10/24 at 03:00 AM

Home health providers to pay $4.5M to resolve alleged false claims act liability for providing kickbacks to assisted living facilities and doctorsDOJ press release; 7/1/24Guardian Health Care Inc., Gem City Home Care LLC and Care Connection of Cincinnati LLC, home health agencies operating in Texas, Ohio and Indiana, along with their owner Evolution Health LLC, have agreed to pay $4,496,330 to resolve allegations that they violated the False Claims Act by knowingly providing illegal kickbacks to assisted living facilities and physicians in exchange for Medicare referrals.

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Long-term care providers among 193 criminally charged, $2.75 billion in fraud recoveries so far in 2024

07/10/24 at 02:00 AM

Long-term care providers among 193 criminally charged, $2.75 billion in fraud recoveries so far in 2024McKnight's Senior Living; by Kathleen Steele Gaivin; 7/1/24The Justice Department has recovered more than $2.75 billion in false claims against healthcare providers and charged 193 defendants so far this year in criminal cases through its 2024 National Health Care Fraud Enforcement Action, and many of the cases involve nursing homes, home health or hospice agencies, and assisted living providers, according to a Thursday report from the department’s criminal division.

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10 key Medicare Advantage updates in 2024

07/08/24 at 03:00 AM

10 key Medicare Advantage updates in 2024 Becker's Payer Issues; by Rylee Wilson; 6/27/24 The first half of 2024 brought shifting trends for Medicare Advantage. Payers continued to warn of rising medical costs in the MA population, and some are predicting they will lose members next year. Insurers picked up a win in June when CMS said it would recalculate star ratings for 2024. Here are 10 key Medicare Advantage updates to know: 

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Survey: Adults dropped from Medicaid after pandemic faced healthcare access, affordability issues

07/08/24 at 03:00 AM

Survey: Adults dropped from Medicaid after pandemic faced healthcare access, affordability issues CIDRAP - Center for Infectious Disease Research & Policy Research and Innovation Office, University of Minnesota; by Mary Van Beusekom, MS; 7/2/24 A survey of low-income adults in four southern US states shows that nearly half of those disenrolled from Medicaid after COVID-19 pandemic protections ended had no insurance in late 2023, leading to struggles to afford healthcare and prescription drugs and threatening to broaden a gap that had narrowed during expanded governmental benefits. The data were derived from 89,130 adult residents of Arkansas, Kentucky, Louisiana, and Texas participating in the National Health Interview Survey in 2019, 2021, and 2022. In 2023, states rechecked Medicaid eligibility after COVID-19 governmental protections expired, disenrolling millions. The average participant age was 48.0 years, and 51.6% were women. Researchers from Beth Israel Medical Center and Harvard Medical School published the results late last week in JAMA Health Forum.

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Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, etc.

07/08/24 at 03:00 AM

Medicare Program: End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, etc. Federal Register; Proposed Rule by the Centers for Medicare & Medicaid Services; 7/5/24

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CMS Office of Minority Health: Advance health equity through accessibility

07/08/24 at 03:00 AM

CMS: Advance health equity through accessibility CMS.gov; posted for July 2024 Throughout July, the Center for Medicare & Medicaid Services Office of Minority Health (CMS OMH) celebrates Disability Pride Month and the anniversary of the Americans with Disability Act (ADA). Twenty-seven percent of adults in the United States have some type of disability, with mobility (serious difficulty walking or climbing stairs) and cognitive (serious difficulty concentrating, remembering, or making decisions) disabilities being the most prominent types. Individuals living with disabilities often face worse overall health outcomes, including likelihood of obesity (41.6%), diabetes (15.9%), and heart disease (9.6%). ... Find these resources on our health observance page this month or our Improving Access to Care for People with Disabilities page all year long.

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States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model

07/08/24 at 02:00 AM

States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model CMS.gov; 7/2/24 On July 2, 2024 CMS announced that Connecticut, Maryland, and Vermont will be the first state participants in the States Advancing All-Payer Health Equity Approaches and Development (AHEAD) Model. Hawaii will also participate, pending satisfaction of certain requirements. Applications to participate in Cohort 3 of the model are due August 12, 2024 at 3:00 p.m. EST (Cohort 3). Eligibility requirements and additional model details can be found in the NOFO.  To stay up to date on model announcements, events, and resources, please sign up for the AHEAD Model listserv.

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DOJ slaps $20M opioid prescription penalty on OptumRx

07/05/24 at 03:00 AM

DOJ slaps $20M opioid prescription penalty on OptumRx Fierce Healthcare; by Noah Tong; 7/2/24 OptumRx will pay $20 million to resolve claims the company violated the Controlled Substances Act by improperly filling certain opioid prescriptions, the Department of Justice recently announced. The agency claims OptumRx did not fill prescriptions correctly for "trinity prescriptions" like benzodiazepines and other muscle relaxants from April 2013 to April 2015. These prescriptions, which are addictive, may not have been “intended for legitimate medical use” and carry “significant risk of harm,” according to a news release. “Pharmacies providing opioids and other controlled substances have a duty under the Controlled Substances Act to ensure that they fill prescriptions only for legitimate medical purposes,” said Principal Deputy Attorney General Brian Boynton, head of the Justice Department’s Civil Division, in a statement. “The department will continue to work with its law enforcement partners to ensure that pharmacies do not contribute to the opioid addiction crisis.”

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2024 Home Health and Hospice Medicare Administrative Contractor Collaborative Summit: Oct. 2-4, 2024

07/04/24 at 03:00 AM

2024 Home Health and Hospice Medicare Administrative Contractor Collaborative Summit: Oct. 2-4, 2024Press release; 7/2/24The Summit is a collaboration of three Medicare Administrative Contractors (MACs): National Government Services, Inc. (NGS); Palmetto GBA; and CGS Administrators; and it's a unique learning and networking opportunity for HH+H providers from every state and Medicare jurisdiction. [Occurring in Las Vegas, NV.]

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Lawmakers say CMS should ban Medicare Advantage’s use of AI to deny care

07/03/24 at 03:00 AM

Lawmakers say CMS should ban Medicare Advantage’s use of AI to deny care McKnights Long-Term Care News; by Josh Henreckson; 6/26/24 The Centers for Medicare & Medicaid Services should consider banning artificial intelligence from being used to deny Medicare Advantage coverage pending a “systematic review,” a group of 49 congressional leaders is urging. ...  Skilled nursing providers have been sounding the alarm for years on Medicare Advantage coverage access, especially when informed by AI and other algorithms. Sector leaders have frequently noted that these methods can deny or prematurely end coverage for patients who need it to afford necessary long-term care. Providers and consumer advocates both spoke out in favor of the lawmakers’ letter this week. “LeadingAge’s nonprofit and mission driven members … have firsthand experience of Medicare Advantage (MA) plans’ inappropriate use of prior authorization to deny, shorten and limit MA enrollees’ access to medically necessary Medicare benefits,” wrote Katie Smith Sloan, president and CEO of LeadingAge. ... “Implementation by [the] Centers for Medicare and Medicaid Services (CMS), which we fully support, would ensure MA plans fulfill their obligation to provide enrollees equitable access to Medicare services.”

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National Health Care Fraud Enforcement Action results in 193 defendants charged and over $2.75 billion in false claims

07/02/24 at 03:00 AM

National Health Care Fraud Enforcement Action results in 193 defendants charged and over $2.75 billion in false claims United States Attorney's Office - Western District of Virginia, Charlottesville, VA; 6/27/24 The Justice Department today announced the 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants, including 76 doctors, nurse practitioners, and other licensed medical professionals in 32 federal districts across the United States, for their alleged participation in various health care fraud schemes involving approximately $2.75 billion in intended losses and $1.6 billion in actual losses. In connection with the coordinated nationwide law enforcement action, and together with federal and state law enforcement partners, the government seized over $231 million in cash, luxury vehicles, gold, and other assets. 

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Optum to pay $20M to settle improper prescription allegations

07/02/24 at 03:00 AM

Optum to pay $20M to settle improper prescription allegations Becker's Hospital Review; by Rylee Wilson; 6/28/24 OptumRx will pay $20 million to settle allegations it improperly dispensed some opioid medications, the Justice Department said June 27. The settlement resolves an investigation into if OptumRx improperly filled certain opioid prescriptions between 2013 and 2015. The Justice Department alleged the pharmaceutical benefit manager improperly dispensed opioids in combination with other drugs, including benzodiazepines and muscle relaxants, from its mail-order pharmacy operations in Carlsbad, Calif. Opioids prescribed alongside benzodiazepines and muscle relaxants are commonly referred to as "trinity" prescriptions. These prescriptions raise red flags that the drugs may not be for legitimate medical use, and could lead to the diversion of controlled substances, the Justice Department said. In its investigation, the department alleged OptumRx dispensed trinity prescriptions without resolving red flags. OptumRx does not admit liability as part of the settlement.

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HHS to impose penalties on providers that block patients’ health information

06/28/24 at 03:00 AM

HHS 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?

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‘Lot of work to be done’: What home health leaders expect from payment rulemaking in 2024

06/27/24 at 03:00 AM

‘Lot of work to be done’: What home health leaders expect from payment rulemaking in 2024Home Health Care News; by Joyce Famakinwa; 6/24/24 In recent years, home health care has faced relentless cuts from the Centers for Medicare & Medicaid Services (CMS). It has plagued the industry, but providers and advocates alike are still hopeful a light at the end of the tunnel is ahead. ... Home Health Care News recently caught up with PQHH CEO Joanne Cunningham and David Totaro, the president and executive director of Hearts for Home Care. ... [Cunningham said,] "I anticipate that what we will see, given CMS’s posture and prior rulemaking cycles, is the continuation of the policy that will put in place permanent cuts to the Medicare home health program. We’re bracing ourselves for an additional sizable permanent cut. We don’t know exactly what CMS has planned for the temporary cuts, otherwise known as the clawback cuts. We will certainly see, at a minimum, CMS identify what their new projected value of the temporary cuts are. ...

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