Required Coverage of COVID-19 Testing for Essential Workers in California
On July 17th, the California Office of Administrative Law (“OAL”) approved an emergency regulation (effective until January 14, 2021) from the California Department of Managed Health Care (“DMHC”) that...
View ArticlePodcast: ERISA Preemption of State PBM Regulation
Payers, Providers, and Patients – Oh My! Is Crowell & Moring’s health care podcast, discussing legal and regulatory issues that affect health care entities’ in-house counsel, executives, and...
View ArticleHHS Proposes a New Rule to Govern Release and Maintenance of Agency’s...
On August 20, 2020 the Department of Health and Human Services (HHS) published a notice of proposed rulemaking (85 Fed. Reg. 51397) on good practices for the release and maintenance of agency guidance...
View ArticleONC Issues Interim Final Rule Extending Compliance Dates for the Information...
Last week, the Office of the National Coordinator for Health Information Technology (ONC) published an Interim Final Rule: Information Blocking and the ONC Health IT Certification Program: Extension...
View ArticleHHS Approves Telecommunications for Providing Medicare Home Health Services,...
On October 29, 2020, CMS issued the Home Health Prospective Payment System final rule [CMS-1730-F, CMS-1744-IFC, and CMS-5531-IFC], which permanently authorizes use of telecommunications technology as...
View ArticleHHS Finalizes Health Plan Price Transparency Rule
On October 29, 2020, the Departments of Health and Human Services, Labor, and the Treasury (“the Departments”) issued a final rule requiring private-sector health insurers and self-insured health plans...
View ArticleOIG Sends a Special Fraud Alert on Speaker Programs
Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker...
View Article2020 Medicaid Managed Care Rule Summary
On November 13, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule, demonstrating long-awaited efforts to streamline the regulatory framework governing the Medicaid...
View ArticleCMS Issues First FAQs on the CMS Interoperability and Patient Access Rule
On May 14, 2021, CMS published FAQs addressing questions that have been raised regarding the Interoperability and Patient Access final rule published May 2020. CMS is careful to note that the FAQs “do...
View ArticleIs Your Data Supply Chain Ethical? Don’t Restrict Due Diligence to Physical...
This article was originally published in Corporate Compliance Insights. Both your company’s data supply chain and its physical version have fundamentally similar business risks. Given the consequences...
View ArticleFDA Finalizes Guidance on Combination Products
On January 31, 2022, the U.S. Food & Drug Administration (FDA) published a notice in the Federal Register announcing the availability of a final guidance for industry and FDA staff entitled...
View ArticleONC Releases a Framework for Nationwide Health Information Exchange
On January 18, 2022, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the entity chosen as a contracting partner,...
View Article2022 MHPAEA Annual Report Illuminates Tri-agency Review and Enforcement...
The Departments of Labor, Health and Human Services (“HHS”), and the Treasury (the “Tri-agencies”) released their 2022 annual report to Congress on the Mental Health Parity and Addiction Equity Act...
View ArticleIncreased Cyber Risk for Health Care Organizations Due to the Russia-Ukraine...
The Russia-Ukraine conflict is increasing the risk of ransomware attacks and other cyber threats for U.S. companies, and those in the health care industry may be targeted. In a recent analyst note from...
View ArticleCMS Innovation Center Redesigns Direct Contracting Entity Model, Launches ACO...
CMS Administrator Chiquita Brooks-LaSure and CMS Innovation Center Director Elizabeth Fowler continue to forge ahead with the Biden-Harris Administration’s plans to evaluate and streamline the...
View ArticleState PBM Regulation: The Struggle Continues – Oklahoma District Court Latest...
On April 4, 2022, in Pharmaceutical Care Management Association (PCMA) v. Mulready, Case No. CIV-19-977-J (W.D. Okla. 2022), the U.S. District Court for the Western District of Oklahoma ruled on PCMA’s...
View ArticleMental Health Parity: What’s Next for Plans and Issuers?
Now that the Tri-agencies have drawn back the curtains to reveal some of the inner workings of their developing Mental Health Parity and Addiction Equity Act (MHPAEA) comparative analysis enforcement...
View ArticleNot-So-Charitable Donations: DOJ Achieves a $20 Million Settlement for a...
On April 6, 2022, BayCare Health System Inc. (BayCare) entered into a $20 million settlement under the False Claims Act with the U.S. Department of Justice (DOJ) to resolve allegations that it had made...
View ArticleCMS Delays but Finalizes Changes on Network Adequacy
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...
View ArticleChanging Hands, Not Washing Them: CMS’ First Report on Nursing Home M&A Data
Last week, the Centers for Medicare & Medicaid Services (CMS) released data—for the first time—reporting on mergers, acquisitions, consolidations, and changes of ownership of Medicare enrolled...
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