Regulatory roundup: DOJ to publish final rule to improve care access for people with disabilities; CMS final rule increases Medicare hospice payment rates; and more

RISE summarizes recent regulatory-related news headlines.

DOJ to publish final rule to improve care access for people with disabilities

Attorney General Merrick B. Garland last week signed a final rule under Title II of the Americans Disabilities Act (ADA) to improve access to medical diagnostic equipment (MDE) for people with disabilities. Accessible equipment, such as medical examination tables, weight scales, dental chairs, x-ray machines and mammography machines, are essential for people with disabilities to have equal access to medical care.

The Department of Justice (DOJ) said the final rule will soon be available for review on the Federal Register’s website.

 “Thirty-four years after passage of the ADA, people with disabilities should not have to forgo needed medical care due to inaccessible medical diagnostic equipment,” said Assistant Attorney General Kristen Clarke of the Civil Rights Division in the announcement. “This rule marks a significant milestone in our ongoing efforts to ensure that people with disabilities can get the medical treatment they need. Whether you are talking about access to mammograms or access to general OB/GYN services, it is critical that hospitals and doctors’ offices provide equipment that is accessible to patients with disabilities.”

The rule clarifies how public entities that use MDE, such as hospitals and health care clinics operated by state or local governments, can meet their obligations to ensure accessibility under the ADA. In the announcement, DOJ said it has heard from many individuals with disabilities who have been denied basic, critically important health care services because medical providers lacked accessible MDE. For example, patients with disabilities reported receiving only a cursory physical examination in their wheelchair because they could not be transferred to the examination table for a full examination. Other patients reported forgoing basic preventive health care, such as dental examinations and mammograms, because providers did not have accessible MDE.

 The rule adopts a technical standard for accessible MDE and establishes requirements that will help make accessible examination tables and weight scales more available. This will make it easier for people with disabilities—especially people who use wheelchairs—to receive medical care.

CMS final rule increases Medicare hospice payment rates

The Centers for Medicare & Medicaid Services (CMS) issued a final rule this week, updating Medicare hospice payment rates and the aggregate cap amount for fiscal year (FY) 2025. The fiscal year (FY) 2025 hospice payment update percentage is 2.9 percent (an estimated increase of $790 million in payments from FY 2024). In a fact sheet, CMS explained the increase results from the 3.4 percent inpatient hospital market basket percentage increase, reduced by a 0.5 percentage point productivity adjustment. The FY 2025 payment rates for hospices that do not submit the required quality data would reflect the finalized FY 2025 hospice payment update percentage of 2.9 percent minus four percentage points, which results in a -1.1 percent update.

The rule also finalizes that Hospice Quality Reporting Program (HQRP) measures be collected through a new collection instrument, the Hospice Outcomes and Patient Evaluation (HOPE), and finalizes two HOPE-based measures and discusses the anticipated trajectory for future refinement. The rule summarizes public comments received on the request for information regarding potential social determinants of health (SDoH) elements and provides updates on health equity, future quality measures, and public reporting requirements. In addition, the rule changes the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey.

AHIP study: MA outperforms FFS Medicare in 9 out of 10 quality measures

Medicare Advantage (MA) members receive higher quality of care and access more preventive services compared to fee-for-service (FFS) Medicare, according to a new AHIP report.

The research found that MA outperformed FFS Medicare in nine out of 10 quality measures focused on preventive and chronic disease care for seniors and people with disabilities. The report compared performance results for 10 Healthcare Effectiveness Data and Information Set (HEDIS®) measures in FFS Medicare and MA in 2021.

“Medicare Advantage continues to outperform FFS Medicare on preventive care and chronic care, all while saving seniors more than $2,500 a year. The compelling combination of better care at lower costs is why 33 million Medicare beneficiaries have chosen Medicare Advantage,” said Mike Tuffin, AHIP President and CEO, in an announcement.

The report compared performance results for 10 HEDIS measures in FFS Medicare and MA in 2021. The measures are based on administrative claims data from 2020 and 2021; they compare the quality of care delivered during the COVID-19 pandemic. Analysts found:

  • A higher share of MA enrollees were screened for two common forms of cancer than the share in FFS Medicare. Compared to those enrolled in FFS Medicare, a higher share of MA beneficiaries received screenings for breast cancer (67.6 percent vs 67.3 percent) and colorectal cancer (32.2 percent vs 29 percent).
  • ·       A higher share of MA enrollees completed a course of beta-blockers after a heart attack (85.6 percent vs 79.4 percent) and were prescribed (84.9 percent vs 82.8 percent) and completed statin therapy (83.4 percent vs 82.3 percent) in cases of cardiovascular disease.

    ·       A higher share of MA enrollees with diabetes had at least one blood sugar level (HbA1c) test (91.8 percent vs 90.4 percent) and were prescribed (78.8 percent vs 74.5 percent) and completed statin therapy (85 percent vs 83.5 percent).

    ·       A higher share of MA enrollees received disease-modifying antirheumatic drugs (DMARD) therapy for rheumatoid arthritis (87.7 percent vs 87.3 percent) and osteoporosis management after a fracture (38.5 percent vs 22.6 percent), although the difference in DMARD treatment was not statistically significant.

    ·        A higher share of MA enrollees with chronic obstructive pulmonary disease (COPD) were prescribed systemic corticosteroids (72.6 percent vs 68.4 percent) and bronchodilators (73.3 percent vs 67.2 percent) following COPD exacerbation. In contrast, for newly diagnosed COPD patients, a lower share of MA enrollees received spirometry testing to confirm the diagnosis (38.3 percent vs 40.3 percent); however, the difference was not statistically significant.

    KFF: ACA marketplace enrollees will see steep increases in premium payments in 2026 if enhanced subsidies expire

    Enrollees in 12 HealthCare.gov states would see their annual payments at least double on average without enhanced subsidies, according to a new KFF analysis.

    The issue brief found that without the enhanced subsidies in the Inflation Reduction Act (IRA), Affordable Care Act (ACA) marketplace enrollees in 12 of the states that use HealthCare.gov would see their annual premium payments at least double on average.

    Enrollees in three states would see the steepest annual increases: Wyoming (195 percent or $1,872), Alaska (125 percent or $1,836), and West Virginia (133 percent or $1,404), and premiums would rise by an average of 93 percent or $624 overall in HealthCare.gov states.

    Nationally, enhanced subsidies have cut premium payments by an estimated 44 percent ($705 annually) on average for people receiving a subsidy. If they expire, almost all subsidized ACA marketplace enrollees, including those in state-run marketplaces, would experience steep increases in premium payments in 2026. Because enhanced subsidies have made marketplace coverage more affordable for low- and middle-income people, they would be the most impacted by a potential subsidy expiration.

    Enrollees with low incomes would see the greatest jump in their premium payments. For example, a 45-year-old enrollee earning $25,000 on average would pay 573 percent ($917) more annually for a benchmark silver plan (from $160 with enhanced subsidies to $1,077 without them).

    The number of people with marketplace coverage nearly doubled since the enhanced subsidies began in 2021, from 11.4 million in 2020 to 21.4 million in 2024. This enrollment growth has been concentrated among low-income individuals, spurred by the availability of low-cost (and in some cases, zero-premium) plans made available by the enhanced subsidies.

     Zero-premium plans are available to a larger share of ACA marketplace enrollees in the 10 states that have not expanded Medicaid. Among states that use HealthCare.gov, enrollees in Florida and Texas received the most ($2.2 and $1.5 billion respectively) in enhanced IRA subsidies in 2024.

    Admera Health to pay $5M to settle FCA kickback allegations to third-party marketers 

    Admera Health LLC, a New Jersey-based company that provides biopharmaceutical research services for health care institutions and provided clinical laboratory testing services to health care providers, has agreed to pay the United States more than $5 million to resolve allegations that it violated the False Claims Act by paying commissions to third party independent contractor marketers in violation of the anti-kickback statute. Admera will pay an additional $147,851 to individual states for claims paid to Admera by state Medicaid programs.

    The settlement resolves allegations that, from Sept. 1, 2014, through May 21, 2021, Admera made commission-based payments to independent contractor marketers in return for recommending or arranging for the ordering of genetic testing services in violation of the anti-kickback statute. The law prohibits offering or paying remuneration in return for arranging for or recommending items or services covered by Medicare and other federally funded programs.

    As part of the settlement, Admera has admitted that it made millions of dollars of commission payments to independent-contractor marketers (the marketers) to induce them to arrange for or recommend that health care providers order and refer clinical laboratory services to Admera, including genetic tests, that were reimbursable by Medicare and/or Medicaid; that it paid marketers through arrangements that took into account the volume and value of genetic testing referrals; and that Admera was informed that the payment of commissions to independent contractors did not comply with the anti-kickback statute but continued to enter into such contracts.

    The civil settlement includes the resolution of claims brought under the qui tam or whistleblower provisions of the False Claims Act by relators, Sunil Wadhwa and Ken Newton, co-founders of Financial Halo LLC/MedXPrime, a former third-party marketer for Admera. They will receive $862,343 of the proceeds from the settlement.

    Mental health services providers pay over a million to settle false claims liability

    Two mental health care providers in the South Texas area have agreed to pay over $1 million to resolve False Claims Act (FCA) allegations regarding the submission of claims to Medicare, TRICARE and Medicaid that non-physician personnel rendered, according to the U.S. Attorney’s Office, Southern District of Texas.

    From 2017 through 2020, Texas Behavioral Health PLLC (TBH) and United Psychiatry Institute LLC (UPI) allegedly engaged in a pattern and practice of falsely billing Medicare Part B.

    According to the allegations, the providers submitted claims for mental health services that physicians had not rendered or not directly supervised as Medicare regulations require. Some services occurred on dates when the physicians were traveling outside of the United States and thus unable to provide the services. Others allegedly occurred at times when it was not logistically possible for the physicians to have rendered them or directly supervised the services themselves due to the sheer volume of patients at multiple office locations located in and around the Houston area. As a result of the alleged improper billing, Medicare, TRICARE and Medicaid reimbursed TBH and UPI at a higher physician rate.

    The settlement stems from a qui tam or whistleblower complaint. The whistleblower will receive 17 percent of the proceeds from the settlement.

    Doc pleads guilty to health care fraud for hospice scam that bilked Medicare out of $3.2M

    The U.S. Attorney's Office, Central District of California, announced that a Ventura County physician who worked for two Pasadena hospices pleaded guilty to defraud Medicare out of more than $3 million by billing the public health insurance program for medically unnecessary hospice services.

    Dr. Victor Contreras, 68, of Santa Paula, pleaded guilty to one count of health care fraud.

    According to his plea agreement, from July 2016 to February 2019, Contreras and Juanita Antenor, 61, formerly of Pasadena, schemed to defraud Medicare by submitting nearly $4 million in false and fraudulent claims for hospice services submitted by two hospice companies: Arcadia Hospice Provider Inc., and Saint Mariam Hospice Inc. Antenor controlled both companies. Medicare only covers hospice services for patients who have a life expectancy of six months or less if their illness ran its normal course.

    Contreras falsely stated on claims forms that patients had terminal illnesses to make them eligible for hospice services covered by Medicare, typically adopting diagnoses provided to him by hospice employees whether they were true. Contreras did so even though he was not the patients’ primary care physician and had not spoken to those primary care physicians about the patients’ conditions. Medicare paid on the claims supported by Contreras’ false evaluations and certifications and recertifications of patients.

    In total, approximately $4 million in fraudulent claims were submitted to Medicare, of which a total of approximately $3.2 million was paid.

    According to Medical Board of California records, Contreras is a licensed physician in California, but has been on probation with the Board since 2015 and is subject to limitations on his practice. His sentencing hearing is scheduled for October 25. He faces a statutory maximum sentence of 10 years in federal prison. Antenor remains at large. Co-defendant Callie Black, 65, of Lancaster, who allegedly recruited patients for the hospice companies in exchange for illegal kickbacks, has pleaded not guilty and is currently scheduled to go on trial on October 15.

    Substance use disorder treatment clinics to pay $850K to resolve fraud allegations

    The United States and the Commonwealth of Virginia have reached an $863,934 civil settlement with certain substance use disorder treatment clinics serving patients from Virginia to resolve allegations that these clinics submitted false and fraudulent claims to the Medicaid program. The clinics–Crossroads Treatment Center of Petersburg P.C., ARS Treatment Centers of New Jersey P.C., Crossroads Treatment Center of Greensboro P.C. and Starting Point of Virginia P.C. – are part of a chain called Crossroads, which is headquartered in Greenville, S.C.

    The United States and the Commonwealth contended that, from 2016 through mid-2023, the clinics submitted claims to Virginia Medicaid containing code 99215, which signifies a meeting with a patient involving at least two of the following three components: a comprehensive medical history, a comprehensive medical examination, and medical decision-making of high complexity. However, the clinics knew the meetings were regular check-ins during substance use disorder treatment and did not meet those criteria. Of the $863,934 civil settlement, the United States will receive $356,891 and the Commonwealth will receive $507,043.

    The United States’ investigation was prompted by a lawsuit filed under the whistleblower provisions of the False Claims Act. Diana France, a former director of network management and contracting for Crossroads, will receive $60,671 as her share of the federal recovery. The settlement agreement also provides for the whistleblower to receive a share of the Commonwealth’s recovery.