Duane Morris Health Law

November 4, 2025 by Duane Morris

Medicare Telehealth Claims Reimbursement and Flexibilities Face Limits During the Government Shutdown

By Erin Duffy, Neville Bilimoria and Victoria (Tori) Hawekotte

Due to the U.S. government shutdown, the Centers for Medicare and Medicaid Services have paused reimbursement payments for nonbehavioral health telehealth Medicare claims, pending congressional action. Further, a new congressional bill, Section 207 of the Continuing Appropriations Act 2026, would have statutorily extended certain telehealth flexibilities, mainly for nonbehavioral healthcare services. Given the bill’s failure in the Senate, pre-COVID-19 restrictions for Medicare telehealth coverage will continue to be in effect until congressional action further extends the telehealth flexibilities.

Read the full Alert on the Duane Morris website.

February 26, 2025February 26, 2025 by Duane Morris

CMS Issues Final Rule on Returning Medicare and Medicaid Overpayments

By Daniel R. Walworth, Christopher H. Casey, Frederick R. Ball, Erin M. Duffy and Arti Fotedar

The Centers for Medicare & Medicaid Services (CMS) issued a Final Rule as part of the 2025 Physician Fee Schedule, which revises requirements for reporting and returning overpayments of Medicare and Medicaid funds. The Final Rule, which took effect January 1, 2025, amends CMS’s regulation interpreting the federal overpayment statute in two key ways: It revises the definition of when an overpayment is “identified” to trigger the 60-day return period and establishes a 180-day timeframe for investigating additional related overpayments.

Read the full story on the Duane Morris LLP website.

February 25, 2025 by Duane Morris

First Circuit Embraces More Restrictive View of False Claims Act Kickback Enforcement Provision

By Daniel R. Walworth, Christopher H. Casey, Frederick R. Ball, Erin M. Duffy and Joseph R. Welsh

The United States Court of Appeals for the First Circuit’s opinion in United States v. Regeneron Pharmaceuticals, Inc. has sharpened the circuit split for demonstrating the effect of a kickback on healthcare decisions under the False Claims Act (FCA). The Regeneron court held that an FCA claim based on an alleged violation of the Anti-Kickback Statute requires demonstrating that an alleged unlawful kickback was the “but-for” cause of a submitted claim.

Read the full story on the Duane Morris LLP website.

January 18, 2025January 18, 2025 by Taylor Hertzler

U.S. Drug Enforcement Administration Proposes Permanent Tele-Prescribing Rules, Offering Registration Framework for Remote Prescription of Controlled Substances

On January 17, 2025, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (Notice) to allow for remote prescription of certain controlled substances within the telemedicine exception provided by the Ryan Haight Act (Act). The Act generally prohibits prescribing drugs without at least one “in-person medical evaluation” with a healthcare provider, but it excepts from this requirement providers “engaged in the practice of telemedicine.” During the COVID-19 public health emergency, DEA used this telemedicine exception to allow providers to tele-prescribe Schedule II-V controlled substances, implementing temporary flexibilities to that effect via a March 25, 2020, letter and a March 31, 2020, letter. DEA, the Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration have extended those temporary measures three times since, with minor modifications, all while seeking industry comments on how to make the measures permanent. The regulations proposed in the Notice would create permanent tele-prescribing exceptions by constructing a framework for different providers to obtain special registration to tele-prescribe controlled substances. As these rules differ from the exceptions granted in the 2020 letters—exceptions that will expire December 31, 2025—affected providers should review the proposed regulations and prepare to register accordingly in the event the rules are finalized.

The March 25, 2020, letter permitted providers to tele-prescribe controlled substances to patients without an in-person encounter in states where they are not registered to dispense, and the March 31, 2020, letter permitted providers to tele-prescribe buprenorphine to opioid use disorder patients without an in-person encounter. The regulations proposed in the Notice offer a broader, more-segmented scheme for granting exceptions to the Act but also limit some of those permissions. The proposed regulations recognize two types of “Special Registrants”: clinician practitioners (physicians and mid-level practitioners) and platform practitioners (covered online telemedicine platforms). These Special Registrants could apply for three types of Special Registrations for Telemedicine:

a Telemedicine Prescribing Registration, authorizing qualified clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine,
an Advanced Telemedicine Prescribing Registration, authorizing qualified, specialized clinician practitioners (e.g., psychiatrists, hospice care physicians) to prescribe Schedule II-V controlled substances via telemedicine, and
a Telemedicine Platform Registration, authorizing covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances.

Unlike the exceptions in the 2020 letters, however, these proposed regulations would require Special Registrants to obtain Special Registrations in each state where they prescribe. They would also require Special Registrants to conduct nationwide background checks of all patients prescribed controlled substances through this program.

Providers currently tele-prescribing under the exceptions granted by the 2020 letters have time to comply. Further, the change of administration on January 20, 2025, may result in further changes to these rules. Nonetheless, given the significant differences proposed by the Notice, and the fact that the existing exceptions will expire at the end of 2025, affected providers are encouraged to consider now what would be required for them to register under the proposed regulations.

February 23, 2024 by Sean P. McConnell

Federal and State Antitrust Enforcers Reiterate Focus on Healthcare

Federal and state antitrust enforcers are keenly focused on potential anticompetitive conduct in the healthcare space.

Federal Trade Commission Chair Lina Kahn recently noted that “the FTC is squarely focused on tackling illegal business practices that deprive Americans of access to affordable and innovative healthcare” in a speech to the American Medical Association’s national advocacy conference. According to Chair Kahn, medical professional consistently express frustration to the FTC “about how the business of healthcare today forces many [medical providers] to subordinate [their] own medical judgment to corporate decision-makers at the expense of patient health.” In response to those complaints, Chair Khan highlighted a few recent enforcement efforts, including scrutiny of group purchasing organizations, drug wholesalers, and pharmacy benefit managers; tackling unlawful consolidation in healthcare markets and roll-ups of healthcare providers. She also touted the FTC’s work protecting healthcare workers, tackling unlawful practices by pharmaceutical companies, including suits to block two major pharmaceutical mergers, and protecting patient privacy and data.

Continue reading “Federal and State Antitrust Enforcers Reiterate Focus on Healthcare”

April 26, 2023April 26, 2023 by Duane Morris

CMS Rules for Coding Emergency Department Claims

By Gregory A. Brodek and Arti Fotedar

The Centers for Medicare and Medicaid Services (CMS) has consistently authorized hospitals to establish and utilize their own coding guidelines for emergency department facility claims. CMS makes clear that “[a]s long as the services furnished are documented and medically necessary and the facility is following its own system, which reasonably relates the intensity of hospital resources to the different levels of HCPCS codes, we will assume that it is in compliance with these reporting requirements as they relate to the clinic/ emergency department visit code reported on the bill.” 65 Fed. Reg. 18433, 18451 (Apr. 7, 2000). CMS also makes clear that “[t]he coding guidelines should be applied consistently across patients in the clinic or emergency department to which they apply” and should be verifiable by hospital staff and outside sources. 72 Fed. Reg. 66759, 66805 (Nov. 27, 2007). Continue reading “CMS Rules for Coding Emergency Department Claims”

February 8, 2023 by Duane Morris

FTC Wields Health Breach Notification Rule for First Time in Quest to Protect Consumer Health Information

By Samantha Dalmass and Melissa Sobel Snyder

The Federal Trade Commission (“FTC”) is seeking enforcement under the Health Breach Notification Rule for the first time since the rule was adopted in 2009. The Health Breach Notification Rule (16 C.F.R. Part 318) requires vendors of personal health records, PHR-related entities, and third party service providers that are not otherwise subject to the Health Insurance Portability and Accountability Act (“HIPAA”) to notify their customers and individuals whose personal health records are disclosed in the event of a breach or unauthorized disclosure. In its complaint filed against GoodRx on January 1, 2023, the FTC targets the digital health platform, alleging that it repeatedly violated the promises it has made to its customers regarding its protection of their personal health information, including that such information would be shared only with limited third parties and for limited purposes; that GoodRx would restrict such third parties’ use of customer information; and that it would never share personal health information with advertisers or other third parties. Continue reading “FTC Wields Health Breach Notification Rule for First Time in Quest to Protect Consumer Health Information”

January 18, 2023 by Duane Morris

340B Hospital Reimbursement Update: D.C. District Court Remands Underpayment Remedy to HHS

On Tuesday, January 10, 2023, the United States District Court for the District of Columbia issued an important ruling allowing the U.S. Department of Health and Human Services (HHS) to propose an appropriate retrospective remedy for underpayments made from 2018 through September 27, 2022, to hospitals participating in the 340B drug pricing program.

To read the full text of this Duane Morris Alert, please visit the firm website.

January 13, 2022 by Duane Morris

Revised Code of Pharmaceutical Research and Manufacturers of America Takes Effect

On January 1, 2022, the updated Code on Interactions with Health Care Professionals, published by the Pharmaceutical Research and Manufacturers of America (PhRMA), became effective. The updates reflect fraud and abuse concerns voiced by the Department of Health and Human Services’ Office of Inspector General in its November 2020 Special Fraud Alert. While it is not a legal document, companies that adopt the code’s rules are more likely to comply with federal fraud and abuse laws like the Anti-Kickback Statute.

To read the full text of this Duane Morris Alert, please visit the firm website.

December 2, 2021December 2, 2021 by Duane Morris

CMS Mandate Blocked Nationwide

By Erin M. Duffy and Samantha Dalmass

A federal judge in New Orleans blocked the Interim Final Rule with Comment requiring the vaccination of all staff of health care facilities subject to the health and safety standards under the Medicare Conditions of Participation (“CoPs”) issued by the Centers for Medicare and Medicaid Services (“CMS”) earlier this month. The nationwide block was issued on November 30, 2021, less than one week before the December 6, 2021 deadline for all staff of covered facilities to have received at least their first dose of a two-dose COVID-19 vaccine series, and only one day after a federal court in Missouri blocked the CMS vaccination requirement in Missouri, Arkansas, Alaska, Iowa, Kansas, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.

Notwithstanding the broad authority of CMS to regulate the health and safety of facilities subject to Medicare CoPs, the order issued by the U.S. District Court for the Western District of Louisiana blocking implementation of the CMS mandate set forth in 86 Fed. Reg. 61555-01 (November 5, 2021) will remain in effect pending final resolution of the case. The Biden Administration will likely appeal to the Supreme Court, but in the meantime facilities covered by the mandate should plan accordingly and ensure they are prepared to implement the required plans and processes for vaccinating staff, providing exemptions and accommodations for those who are exempt, and tracking and documenting staff vaccinations.