On June 30, 2022, Governor Gavin Newsom signed legislation to stabilize and promote the retention of California’s healthcare workforce in response to the COVID-19 pandemic. This response included the allocation of $1.3 billion for retention payments to physicians and other clinical and non-clinical healthcare workers. California’s Department of Health Care Services (“DHCS”) will administer the
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CMS Pushes Publication of Final FFS Adjuster for RADV Audits Rule to February 1, 2023
CMS announced today a further extension until February 1, 2023, of the deadline for its publication of the long-awaited final rule on the use of extrapolation and the application of a fee-for-service adjuster (FFS Adjuster) in risk adjustment data validation (RADV) audits of Medicare Advantage organizations (MAOs).
On November 1, 2018, CMS issued a…
How Healthcare Employers Can Prepare for Employee Unionization Efforts
Increasing Unionization Efforts in the U.S. Labor Market and Healthcare Sector
In recent months, the United States has seen workers’ unionization and collective bargaining efforts gain momentum across industries, including healthcare. Current reporting attributes this growth in organized labor activities to the tight labor market, heightened risks to some workers during the pandemic, a favorable…
OIG Limits Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part D”) beneficiaries via 501(c)(3) charities without running afoul of the Federal Anti-Kickback Statute (the “AKS”).
In the Opinion, OIG determined that a…
U.S. Congressional Committee Takes Aim at For-Profit Nursing Homes
On September 21, 2022, the Select Subcommittee on the Coronavirus Crisis held public hearings and issued a report assessing the performance of large, for-profit nursing home chains during the early phase of the Coronavirus pandemic. The Subcommittee’s ongoing investigation began in June 2020, and focused on five for-profit nursing home chains that collectively operated over…
EMTALA in the Post-Dobbs World
The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and transfer for patients with emergency medical conditions (EMCs) or women in labor.[1] EMTALA, which was enacted in 1986 to address concerns about patient dumping,…
CMS Issues a “Roadmap” for the End of the COVID-19 Public Health Emergency and Blanket Waivers
In response to the COVID-19 Public Health Emergency (the “PHE”), the Centers for Medicare and Medicaid Services (“CMS”) issued numerous “blanket waivers” to increase access to medical services, and ease the regulatory burden on providers across the health care industry. In order to help providers understand the current status of the various waivers – some of…
OIG Issues Favorable Advisory Opinion For Federally Qualified Health Center’s Smartphone Loan Program
The Office of the Inspector General (“OIG”) recently issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the provision of limited use smartphones by a federally qualified health center (“FQHC”) to existing, low-income patients (the “Arrangement”) lacked the intent required to violate the federal Anti-Kickback Statute (“AKS”)[1] and was not likely to generate remuneration…
Statute of Limitations for PPP and EIDL Fraud Extended to Ten Years
On August 5, President Biden signed two bills into law that extend to ten years the statute of limitations for civil and criminal enforcement actions for fraud on the Paycheck Protection Program (“PPP”) and Economic Injury Disaster Loans (“EIDL”). These two bills—the PPP and Bank Fraud Enforcement Harmonization Act of 2022 and the COVID-19 EIDL…
CMS ADOPTS MAJOR CHANGES TO LTC FACILITY SURVEYOR GUIDANCE
On June 29, 2022, the Centers for Medicare and Medicaid Services (CMS) announced it issued significant changes to surveyor guidance for Long Term Care (LTC) facility health, quality and safety standards.[1]
Some of the changes reflect clarifications to requirements that become effective during Phase 2 of the revised Requirements for Participation for LTC facilities…
Recap of AHLA’s Annual Meeting
The AHLA’s Annual Meeting held June 27-29 in Chicago reunited healthcare attorneys across the country. The diverse group of attendees were eager not only to reconnect in-person, but also to process the changes that the now-easing pandemic has brought to all corners of the healthcare industry. The conference presenters grappled in real-time with the transitory…
California District Court Finds that EKRA Applies to Compensation Methodologies for Labs’ Employed Marketers Who Market to Physicians
Since its passage in late 2018, the Eliminating Kickbacks in Recovery Act (EKRA) (18 U.S.C. § 220) has posed interpretive challenges. Our detailed critical analysis of EKRA is available here. EKRA prohibits, among other things, the exchange of remuneration for referrals of patients or patronage to a clinical laboratory, or an individual’s use of…
Office of Civil Rights Publishes Guidance on Use of Audio-Only Telehealth Services
As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would exercise its enforcement discretion by declining to impose penalties against covered health care providers for instances of good faith noncompliance with the requirements of…
CMS Issues Contract Year 2023 Final Rule for Medicare Advantage Organizations and Prescription Drug Sponsors
On April 29, 2022, the Centers for Medicare and Medicaid Services (“CMS”), issued the final rule on Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Final Rule”). CMS promotes the Final Rule as advancing “CMS’ strategic vision of expanding access to affordable health care…
7 Things to Know About the New AdvaMed Code Updates
On March 18, 2022, AdvaMed announced updates to the Code of Ethics on Interactions with Health Care Professionals (“Code”), a voluntary code that provides medical technology companies with guidance on ethically compliant interactions and relationships with healthcare professionals. The changes will take effect on June 30, 2022. The updates are part of a concerted effort…
Alert to Providers: Another Shot to Comply with Provider Relief Fund Reporting Requirements
As of April 11, 2022, the Health Resources & Services Administration (“HRSA”) is now offering providers who missed the original Provider Relief Fund (“PRF”) reporting deadlines the opportunity to request the ability to report in compliance with the PRF Terms and Conditions. Request submissions for Reporting Period 1 are due by Friday, April 22,…