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HHS Proposes to Rein In Its Use of Regulatory “Dark Matter”

- HHS is overhauling its process for developing interpretive guidance documents under a new Proposed Rule. - HHS proposes to no longer use “guidance documents” to establish broadly applicable legal obligations on the...more

CMS Proposes to Streamline Medicare Coverage Process for Innovative Technology and Consider Commercial Coverage in “Reasonable and...

- The proposed rule seeks to “demolish the existing bureaucratic barriers that have created a ‘valley of death’ for innovative products.” - A new Medicare Coverage of Innovative Technology (MCIT) pathway would allow...more

Health Care Providers and the State of Liability Protections in the COVID-19 Era

- As the COVID-19 pandemic continues, the clamor for liability protections for the nation’s health care providers continues. - Although there are serious political divisions, the COVID Phase 4 relief legislation may...more

New Executive Order Calls for Greater Regulatory Flexibility, Compliance Assistance and Enforcement Discretion for Businesses

On May 19, 2020, President Trump signed an Executive Order entitled “Regulatory Relief to Support Economic Recovery.” The Order calls on agencies to provide or extend regulatory flexibilities that promote job creation and...more

CMS Proposes New Hospital Reporting Requirements and Signals Major Shift in Hospital Rate-Setting Methods

- Tucked into a massive Medicare payment rule is a proposal to fundamentally change how CMS sets hospital payment rates. - Recognizing that a hospital’s chargemaster rarely reflects true market costs, CMS seeks to use...more

Interoperability and Information Blocking: What Providers, Payers and IT Developers Need to Know about New Enforcement Timelines

- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...more

EPA IG's Concerns About Oversight of Hospital Disinfectants Reinforces Need for Robust Infection Control Programs

On September 19, 2016, the Inspector General (IG) for the Environmental Protection Agency (EPA) issued the latest in a long line of reports identifying flaws in EPA’s process for ensuring the efficacy of hospital-grade,...more

OIG Releases New Proposals on Anti-kickback Statute Safe Harbors, Exceptions to the CMP Law and the Gainsharing Prohibition

On October 3, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a long-awaited proposed rule for implementing amendments to safe harbors under the Anti-kickback Statute and...more

Fire Safety Requirements for Hospitals and Other Health Care Facilities: How CMS Is Interpreting Occupancy Classifications and...

On April 16, 2014, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule amending the fire safety standards for hospitals and other types of health care facilities. Compliance with the fire safety...more

Senate Finance And House Ways & Means Committees Release Bicameral, Bipartisan Proposal To Reform Physician Payment System

On October 30, 2013, the Senate Finance Committee and the House Ways & Means Committee released a bicameral, bipartisan discussion draft outlining a proposal to permanently repeal the sustainable growth rate (SGR) mechanism...more

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