News & Analysis as of

Hospitals Medicare New Guidance

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Dorsey & Whitney LLP

CMS’ COVID-19 Vaccine Mandate: What Health Care Providers Need to Know

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Last week, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) published their much-anticipated rules mandating COVID-19 vaccinations. ...more

ArentFox Schiff

Hospitals: Be Ready for the CMS Survey

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Hospitals everywhere in the United States should take note: CMS announced on March 26, 2020, that it is lifting its extended 30-day survey suspension for hospitals. Survey activity will now resume. COVID-19’s impact on...more

King & Spalding

CMS Announces 14-Week Timeline for Hospitals to Comply with Daily COVID-19 Reporting Requirements or Risk Termination from...

King & Spalding on

On October 6, 2020, CMS announced new enforcement measures to ensure hospitals report daily COVID-19 data, with the exception of psychiatric and rehabilitation hospitals that must report weekly, to the federal government...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

ArentFox Schiff

Hospitals Be Ready: CMS Announces Return to Routine Surveys

ArentFox Schiff on

On August 17, 2020, CMS encouraged State Survey Agencies to resume some of their normal enforcement activities. Maintaining a Medicare provider agreement is paramount for acute care hospitals, and that process includes...more

Baker Donelson

A Flurry of Recent Activity Highlights Continued Interest in 340B Program Oversight

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Four separate government releases coming over a three-week period have once again highlighted the intense interest in the 340B drug pricing program, with a federal agency and two government watchdog groups issuing guidance...more

McDermott Will & Schulte

[Webinar] 2019 Q4 Healthcare Enforcement Roundup - February 5th, 2:30 pm ET

The final quarter of 2019 brought forward new guidance and proposed rules with major implications for healthcare companies, enforcement developments in healthcare private equity investing and opioid litigation matters, among...more

Baker Donelson

CMS Issues Updated Medicare Payment and Billing Policies for 340B Hospitals

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On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more

Tucker Arensberg, P.C.

CMS Issues Billing Guidance for Major Joint Replacement (Hip or Knee)

Tucker Arensberg, P.C. on

In the January 11, 2018 issue of MLN Connects, CMS has now widely publicized that it issued billing guidance for major joint replacements (hip or knee) in May 2017 at ICN909065. CMS reports that major joint replacement is...more

Bass, Berry & Sims PLC

New CMS Guidance on Information Blocking

Bass, Berry & Sims PLC on

Centers for Medicare & Medicaid Services (CMS) recently published two important guidance statements on so-called "information blocking," i.e., knowingly and willfully limiting or restricting the compatibility or...more

Baker Donelson

Will CMS Consider Your Institution to Be a Hospital? Guidance on the "Primarily Engaged In" Standard

Baker Donelson on

Recent guidance from CMS suggests that some hospitals, and particularly specialty hospitals that provide mostly outpatient care, may soon find themselves the focus of surveyors' scrutiny. In early September, CMS issued...more

Bradley Arant Boult Cummings LLP

What Exactly Is a Hospital, Anyway? CMS Issues Guidance on “Primarily Engaged” Medicare Certification Requirement

The rules that govern participation in the Medicare program are notoriously voluminous and complex. Indeed, courts have described them as akin to a “[body of] law written by James Joyce and edited by E.E. Cummings” and “among...more

King & Spalding

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

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Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

Foley & Lardner LLP

Omnibus 340B Guidance Raises New Issues for Covered Entities

Foley & Lardner LLP on

The Department of Health and Human Services (HHS) released its proposed 340B Drug Pricing Program Omnibus Guidance (Omnibus Guidance) on August 28, 2015. The Omnibus Guidance offers comprehensive – and, in some cases, new –...more

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