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In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.Continue Reading The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services

Throughout the COVID-19 pandemic, the Centers for Medicare and Medicaid Services (CMS) issued a number of waivers and flexibilities to help healthcare providers manage the influx of patients during the Public Health Emergency (PHE). The implementation of the Acute Hospital Care at Home (AHCaH) individual waiver in 2020 allowed qualifying hospitals to provide hospital at home (H@H) programs. These programs provide similar services as those administered during inpatient visits, such as physician visits and monitoring, drug prescription, nursing services, diagnostics, etc. Since its employment, 144 systems including 260 hospitals across 37 states have utilized the AHCaH waiver, rapidly increasing the number of H@H programs in the United States. While the initiative was originally set to expire with the end of the PHE, the AHCaH waiver program was extended until December 31, 2024, with the passing of the Consolidated Appropriations Act, 2023 (CAA 2023). The extension of this program sends a strong message about the importance of permanently integrating home-based care delivery models into our healthcare system. Despite the lengthy extension, the nature of this waiver program remains temporary and the concerns about the expiration effects on relevant stakeholders continue to be pertinent.Continue Reading Hospital at Home Programs Extended, But Final Push Is Needed

On December 29, President Joe Biden signed into law the Consolidated Appropriations Act, 2023 (P.L. 117-164) (the “Act”)—an approximately $1.7 trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes.  Continue Reading President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

The final rule implementing “Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs” is now available for review, and set for publication in the May 9, 2022 Federal Register.   The final rule adopts the proposed change that requires initial and service area expansion applicants to submit their…

On April 30, 2020, the Centers for Medicare and Medicaid Services (CMS) announced a second round of regulatory waivers and rule changes in an interim final rule with comment (IFC) that added significant flexibilities for the coverage of telehealth services furnished by a broader set of eligible clinicians and in nontraditional health settings during the…

Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s biweekly health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and investors. In this “deep dive” episode, hosts Payal Nanavati and Joe Records talk to Barbara Ryland about benefits under Medicare Part C.

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As of October 3, 2019, the Office of Management and Budget completed its review of the proposed rules for “modernizing and clarifying” the Physician Self-Referral Regulations and revising the safe harbors under the Anti-Kickback Statute and rules regarding the Beneficiary Inducement Civil Monetary Penalties Law.

These regulations were the subject of two Requests for Information…

On Nov. 29, 2018, Deputy Attorney General Rod J. Rosenstein announced several amendments to policies on individual accountability set forth in the 2015 Yates Memo. As a result, companies facing FCA actions—especially defendants in health care cases—should consider following three strategy tips:  (1) Establish clear benchmarks for cooperation.  (2) Advocate for individual releases.  And (3)…

CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market.

Virtual Check-Ins

CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”
Continue Reading Digital Health Updates in the 2019 Physician Fee Schedule (PFS) Rule

CMS has issued its 2019 Physician Fee Schedule Proposed Rule, containing highly anticipated new reimbursement policies for telehealth, remote monitoring, and other uses of digital tools, as well as updates to health IT requirements in the Quality Payment Program, with a stronger focus on patient access to health information. Comments are due September 10 at 5pm.
Continue Reading New CMS Incentives for Remote Patient Monitoring and Patient Access