https://www.morganlewis.com/rss/blogsBlogs RSS Feed25https://www.morganlewis.com/blogs/healthlawscan/2026/04/major-government-updates-from-ahla-medicare-and-medicaid-conferenceFrom March 18–20, 2026, the American Health Law Association (AHLA) hosted its annual Institute on Medicare and Medicaid Payment Issues conference in Baltimore, Maryland, focused on the full range of risks and opportunities relating to participation in federal health care payment programs. The schedule provided a formal blueprint for addressing updates in Medicare Parts A & B, Medicaid program changes, supplemental payments, cost reporting, appeals, fraud and abuse, compliance obligations, and health equity requirements. Partners Scott McBride and Greg Etzel made presentations on the underpinnings of overpayments and on Medicare cost reporting and appeals, respectively.Thu, 02 Apr 2026 00:00:00 -0500a6cf5039-4efc-45ba-8603-ba81eb3f0168United StatesHealthcareTesch Leigh WestGregory N. EtzelB. Scott McBridehttps://www.morganlewis.com/blogs/healthlawscan/2026/02/favorable-oig-advisory-opinion-underscores-ongoing-scrutiny-of-ancillary-service-referralsThe US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion No. 26-02, concluding that a proposed arrangement under which an urgent care management entity would operate an affiliated clinical laboratory would not generate prohibited remuneration under the federal Anti-Kickback Statute.Thu, 26 Feb 2026 00:00:00 -06005737d0e4-dabe-41bb-aaef-9d5241b451fdFDA & HealthcareUnited StatesHealthcareFDAB. Scott McBrideAlbert W. ShayJeanna Palmer GunvilleSydney Menackhttps://www.morganlewis.com/blogs/healthlawscan/2026/02/virtual-direct-supervision-allowed-for-incident-to-medicare-billing-and-other-telehealth-updatesThe Centers for Medicare & Medicaid Services (CMS) allows the use of real-time, two-way audio/video communications technology to satisfy the direct supervision requirement for most Medicare Part B services. This development, stemming from flexibilities first introduced during the COVID-19 public health emergency, is now permanent. Additionally, the Consolidated Appropriations Act, 2026 extended and permanently implemented certain Medicare telehealth flexibilities.Thu, 12 Feb 2026 00:00:00 -060045ae2b83-5751-49d1-adef-0f3a3c050f3bFDA & HealthcareUnited StatesHealthcareFDATesch Leigh WestGregory N. Etzelhttps://www.morganlewis.com/blogs/healthlawscan/2026/02/medicare-advantage-agent-and-broker-agreements-2025-in-review2025 was an important year for Medicare Advantage (MA) plans that pay state-licensed agents and brokers to market their plans and engage in lead generation, subject to complex federal regulations. As we previously discussed on Health Law Scan , improper broker arrangements were identified as a 2025 focus area by the whistleblower bar and the US Department of Justice (DOJ), particularly the US Attorney’s Office for the District of Massachusetts.Fri, 06 Feb 2026 00:00:00 -0600b6fc83e6-53c1-4fdc-8dea-98f25d7dd279United StatesHealthcareTesch Leigh WestScott A. Memmotthttps://www.morganlewis.com/blogs/healthlawscan/2026/01/cms-expands-hospice-oversight-to-georgia-and-ohio-as-dea-extends-telemedicine-flexibilitiesRecent regulatory actions by the Centers for Medicare and Medicaid Services (CMS), the US Drug Enforcement Administration (DEA), and the US Department of Health and Human Services (HHS) highlight heightened federal scrutiny of hospice providers in higher-risk states and continued uncertainty about the future regulation of controlled substance prescribing.Mon, 12 Jan 2026 00:00:00 -06004c7f6f50-a487-4a3a-acab-9155c8b72358Healthcare TransactionsFDA & HealthcareHealthcare & Life Sciences LitigationUnited StatesHealthcareLife SciencesDigital HealthFDAHoward J. YoungRoshni EdalurRachel L. LamparelliJonathan P. Yorkhttps://www.morganlewis.com/blogs/healthlawscan/2025/11/applied-behavioral-analysis-key-service-for-children-with-autism-is-under-payment-scrutinyIn the past decade, there has been a significant increase in the utilization of Applied Behavioral Analysis (ABA) therapy, in large part because of expanded coverage under all Medicaid programs since 2022. Both federal and state regulators and enforcement authorities have turned their attention to the coverage and payment of these ABA services and potential fraud and abuse. This blog provides some quick takeaways for stakeholders.Fri, 14 Nov 2025 00:00:00 -06005bb5b93b-8c3c-47f6-9926-d0adc30e171aFDA & HealthcareUnited StatesHealthcareFDAHoward J. YoungTesch Leigh WestJonathan P. Yorkhttps://www.morganlewis.com/blogs/healthlawscan/2025/10/double-dose-of-regulation-the-impact-of-sb-351-and-ab-1415-on-california-healthcare-transactionsCalifornia Governor Gavin Newsom recently signed two new bills into law that formalize restrictions on medical and dental practice management platforms operated by private equity groups and hedge funds and increase the state’s oversight of certain healthcare transactions. SB 351 and AB 1415 reflect California’s increasing attention on private equity and hedge fund participation in the healthcare industry. The changes to the law under each bill will go into effect on January 1, 2026.Tue, 28 Oct 2025 00:00:00 -0500563f6dc1-7d9e-4d7a-a12d-d3fbf34acbabFDA & HealthcareHealthcare TransactionsMergers & AcquisitionsPrivate EquityAntitrust & CompetitionHealthcareHealthcare Private Equity & Strategic TransactionsFDACBTMAPEATRJeanna Palmer GunvilleQian (Susan) ZhuChristina CacioppoRachel L. LamparelliSydney MenackY. Frank RenSydney Reed Swansonhttps://www.morganlewis.com/blogs/healthlawscan/2025/10/remote-control-key-findings-and-implications-of-hhs-oigs-report-on-medicare-billing-for-rpmThe US Health and Human Services Office of Inspector General (OIG) recently released a report by its Office of Evaluation and Inspections highlighting significant trends and recommendations regarding billing for remote patient monitoring (RPM) in Medicare. The report acknowledges the growing adoption of RPM as a technology-based healthcare service while underscoring the importance of providers and the Medicare program adopting compliance-oriented safeguards when billing and paying for RPM services.Tue, 21 Oct 2025 00:00:00 -0500018029fb-83c6-4f1e-be7a-238f436fbaabFDA & HealthcareHealthcareFDAHoward J. YoungRachel L. LamparelliRoshni Edalurhttps://www.morganlewis.com/blogs/healthlawscan/2025/10/enforcement-notes-from-american-health-law-associations-fraud-and-compliance-forumRepresentatives from the defense bar and the healthcare and life sciences industry recently met for the American Health Law Association’s Fraud and Compliance Forum. The conference programming covered an array of topics for practitioners, ranging from the practical risks of and guidance for using artificial intelligence (AI) in clinical operations to discussions of commercial reasonableness and fair market value in compensation.Thu, 16 Oct 2025 00:00:00 -0500f99cee2a-1054-45de-b3f1-26168f6721e5FDA & HealthcareUnited StatesHealthcareFDAJonathan P. YorkB. Scott McBrideScott A. Memmotthttps://www.morganlewis.com/blogs/healthlawscan/2025/08/ninth-circuit-ruling-confirms-strength-of-the-eliminating-kickbacks-in-recovery-actSince its enactment in 2018, the Eliminating Kickbacks in Recovery Act (EKRA) has rapidly gained momentum as a powerful tool against healthcare kickbacks. By 2020, the US Department of Justice (DOJ) had already secured its first EKRA conviction. This relatively young law, aimed at curbing patient brokering in laboratories, recovery centers, and treatment facilities, carries hefty penalties and, unlike older statutes, applies even to services billed to private insurance.Wed, 06 Aug 2025 00:00:00 -050043c089f3-1d9c-4d07-81a9-b324cabafc4aFDA & HealthcareLife Sciences TransactionsHealthcareFDALSScott A. Memmotthttps://www.morganlewis.com/blogs/healthlawscan/2025/07/oigs-advisory-opinion-no-25-08-negative-opinion-highlights-potential-broad-reach-of-aksIn a relatively rare move, the US Department of Health and Human Services Office of Inspector General (OIG) recently issued an unfavorable Advisory Opinion (No. 25-08) (Opinion) reinforcing the agency’s expansive view of the federal Anti-Kickback Statute (AKS).Thu, 31 Jul 2025 00:00:00 -050015070886-e6bc-4bbf-87ab-f61777f78104FDA & HealthcareHealthcareFDAJonathan P. YorkRachel L. Lamparellihttps://www.morganlewis.com/blogs/healthlawscan/2025/05/mass-usao-focuses-on-healthcare-fraud-in-private-equity-investments-broker-arrangements-at-annual-conferenceOn May 8, 2025, the Boston Bar Association hosted its annual White Collar Crime Conference, a reoccurring theme of which was the recognition of changing times, while also maintaining that the core principles of criminal and civil fraud enforcement remain the same. An anticipated highlight from the conference came from the panel addressing federal and state False Claims Act (FCA) and Anti-Kickback Statute (AKS) enforcement priorities.Mon, 19 May 2025 00:00:00 -0500e2368a27-8ff6-40c9-b592-f620cd48781dFDA & HealthcareHealthcareLife SciencesPharmaceuticals & BiotechnologyMedical DevicesFDATesch Leigh WestScott A. Memmotthttps://www.morganlewis.com/blogs/healthlawscan/2025/04/courts-diverge-in-challenges-to-cmss-minimum-staffing-requirements-for-ltc-facilitiesOn May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our prior blog post, the Final Rule was immediately challenged under the Administrative Procedure Act (APA) in two major lawsuits. These cases have resulted in divergent rulings, injecting more uncertainty across the LTC industry about the future of the application and validity of the Final Rule.Tue, 29 Apr 2025 00:00:00 -0500fc03f748-f3da-40dc-91a6-4cd846ae3f50FDA & HealthcareHealthcareFDAJonathan P. YorkSydney MenackHoward J. YoungScott A. MemmottKayla Stachniak Kaplan https://www.morganlewis.com/blogs/healthlawscan/2025/02/hhs-oig-sets-out-limited-guardrails-for-patient-assistance-arrangementsIn honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan , focusing on issues impacting the rare disease community.Tue, 04 Feb 2025 00:00:00 -0600eea1cbd2-c40b-4cdc-b759-3061613e38c1FDA & HealthcareHealthcareLife SciencesFDAScott A. MemmottJonathan P. Yorkhttps://www.morganlewis.com/blogs/healthlawscan/2025/01/affordable-care-act-section-1557-new-language-accessibility-requirementsSection 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain healthcare activities. Among other requirements, all healthcare providers that receive, directly or indirectly, federal financial assistance, including but not limited to participation in Medicare or Medicaid must now provide a notice of availability of language assistance services free of charge. The US Department of Health and Human Services’ (HHS) new set of requirements was finalized in April 2024.Thu, 30 Jan 2025 00:00:00 -0600835a8ac3-9a73-4574-82de-5dd91a40ba5eFDA & HealthcareHealthcareFDAAmy M. MagnanoMichael J. MadderraRoshni Edalurhttps://www.morganlewis.com/blogs/healthlawscan/2025/01/trump-executive-order-signals-drug-pricing-reforms-likely-on-the-horizonThrough the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a comprehensive overhaul of existing reforms in the near term.Tue, 28 Jan 2025 00:00:00 -0600b89237e1-e718-4d98-945c-5d92769f98ceFDA & HealthcareFDARachel L. LamparelliSydney Menackhttps://www.morganlewis.com/blogs/healthlawscan/2024/12/2024-year-end-recap-of-california-consumer-privacy-act-activityFirst passed into law in 2018, the California Consumer Privacy Act (CCPA) received its first major update in 2020 by way of the California Privacy Rights Act (CPRA), through which the California Privacy Protection Agency (CPPA) was established. Now, in 2024, the CPPA and California Attorney General (AGO) have swung into action with advisory and enforcement activity.Mon, 30 Dec 2024 00:00:00 -0600e96a2a01-78fb-412a-a822-a7108f41c202FDA & HealthcareCybersecurity, Incident Response & PrivacyHealthcareFDAACCPLITMichael J. MadderraKristin M. Hadgishttps://www.morganlewis.com/blogs/healthlawscan/2024/12/congress-temporarily-extends-hospice-telehealth-face-to-face-flexibilityUS Congress on December 20, 2024 passed a last-minute temporary government funding bill that keeps the government open for three months. As part of this package, a number of existing telehealth flexibilities were also extended to March 31, 2025. This includes the flexibility permitting the use of audio/video telehealth technologies to conduct hospice face-to-face visits, which many hospices and their physicians and nurse practitioners have come to rely upon since Medicare allowed that flexibility during the COVID public health emergency.Tue, 24 Dec 2024 00:00:00 -0600d55f3cf1-cc45-4e46-8301-d99ea6a9e668HealthcareHoward J. Younghttps://www.morganlewis.com/blogs/healthlawscan/2024/11/falling-star-ratings-in-medicare-advantage-lead-to-meteoric-payment-lossesThe enormous impact of Medicare Star Ratings on payments received by Medicare Advantage plans cannot be overstated. And with billions of dollars in bonus payments at stake, it may come as no surprise that stringent standards set out by the Centers for Medicare and Medicaid Services (CMS) have led to plans to push back against agency interpretations and seek judicial redress. We discuss the issues here.Wed, 27 Nov 2024 00:00:00 -060082b9d8d7-293a-4a91-92c5-0e30774eb3f0FDA & HealthcareHealthcareFDATesch Leigh WestBryan M. Killianhttps://www.morganlewis.com/blogs/healthlawscan/2024/10/cms-announces-updated-list-of-drugs-under-the-inflation-rebate-programBipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its coinsurance savings program under the Medicare Prescription Drug Inflation Rebate Program.Wed, 23 Oct 2024 00:00:00 -050017032805-c3d3-49c7-97e9-8d6d39923aecFDA & HealthcareHealthcareLife SciencesFDARachel L. Lamparellihttps://www.morganlewis.com/blogs/healthlawscan/2024/08/the-ins-and-outs-of-medicares-prescription-payment-planThrough its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government. Included in these reforms is the establishment of the Medicare Prescription Payment Plan (M3P), a monthly installment plan that allows enrollees to pay back prescription drug costs overtime instead of all at once at the pharmacy. While M3P will reduce monthly out-of-pocket costs for enrollees, it requires plan sponsors to cover all up-front costs until payments are collected. Given the potential for non-payment, Medicare Part D plans would be well advised to prepare and account for potential financial losses.Fri, 16 Aug 2024 00:00:00 -05000d63df66-615c-48d6-8e1e-1157274d1405FDA & HealthcareHealthcareLife SciencesFDARachel L. Lamparellihttps://www.morganlewis.com/blogs/healthlawscan/2024/07/manufacturers-should-carefully-evaluate-oigs-approval-of-medicare-cost-sharing-subsidies-in-clinical-trialsAt the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial.Fri, 26 Jul 2024 00:00:00 -0500ac161966-3caa-4309-b06d-1b1f087bd4e9FDA & HealthcareHealthcareLife SciencesFDAJonathan P. YorkScott A. Memmotthttps://www.morganlewis.com/blogs/healthlawscan/2024/07/hhs-and-fbi-release-joint-cybersecurity-advisory-statement-for-healthcare-providersShortly after our prior blog post discussing the need for healthcare entities to shore up protections against phishing attacks, the Department of Health and Human Services (HHS) and the Federal Bureau of Investigation (FBI) released a joint cybersecurity advisory (CSA) to alert members of the healthcare industry of indicators of compromise and tactics, techniques, and procedures used in phishing social engineering campaigns. This recent guidance underscores that phishing attacks have the attention of the FBI and HHS, and that health systems should proactively update their policies, procedures, and security to remain compliant with industry standards.Wed, 17 Jul 2024 00:00:00 -05004ce45239-9628-4aef-a44b-d15b0b6d885eFDA & HealthcareCybersecurity, Incident Response & PrivacyHealthcareFDAACCPLITAmy M. MagnanoMichael J. MadderraRoshni Edalurhttps://www.morganlewis.com/blogs/healthlawscan/2024/06/ocr-increases-focus-on-phishing-attacks-against-healthcare-providersPhishing, the act of impersonating a person or business to deceive a target into revealing sensitive information, has quickly become the tool of choice for scammers and cybercriminals. In 2023, the Federal Bureau of Investigation’s (FBI’s) Internet Crime Complaint Center noted that there were 298,878 complaints of phishing, a significant increase from the 114,702 cases reported in 2019.Thu, 20 Jun 2024 00:00:00 -0500de60c68a-534f-46d4-a12f-d7bed221f9fcFDA & HealthcareCybersecurity, Incident Response & PrivacyHealthcareFDAACCPLITAmy M. MagnanoMichael J. Madderrahttps://www.morganlewis.com/blogs/healthlawscan/2024/05/cms-publishes-final-rule-for-minimum-staffing-standards-for-long-term-care-facilitiesThe Centers for Medicare & Medicaid Services (CMS) published its Final Rule today to implement a minimum staffing “floor” for nursing homes in the United States, as first announced on April 22. The Final Rule, which as proposed garnered significant attention and opposition, with over 46,000 public comments submitted, reflects the Biden administration’s efforts to implement staffing mandates to ensure quality of care for long-term care (LTC) nursing home residents.Fri, 10 May 2024 00:00:00 -050077fdfc7d-e8a5-45ca-9bd3-ff007c622f7eFDA & HealthcareHealthcareFDAJonathan P. YorkKayla Stachniak Kaplan