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Mintz - Health Care Viewpoints

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

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The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Goodwin

Government Continues to Explore Role of 340B Contract Pharmacies

Goodwin on

The 340B Drug Pricing Program (the “Program”) allows certain healthcare providers (“covered entities”) to purchase pharmaceuticals from drug manufacturers at discounted rates. Some covered entities do not have an internal...more

Zuckerman Spaeder LLP

Whither Insurance Coverage for Preventive Health Services? District Court Decision Striking Down Affordable Care Act’s Preventive...

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On May 15, 2023, the Fifth Circuit temporarily stayed a district-court ruling that struck down a key part of the Affordable Care Act (ACA). As a result of the stay, the ACA’s health insurance coverage requirements for...more

Polsinelli

Flattening the Curve: Are Vaccination Mandates a Viable Strategy for Hospitals?

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic and help restore normal social and economic life, even as variant threats loom. ...more

Carlton Fields

Health Care Price Transparency: CMS Says No Hiding the Ball Containing Pricing Information

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CMS Hospital Price Transparency Rule - After years of policy debate on health care price transparency, the Centers for Medicare & Medicaid Services (CMS) has issued a game-changing hospital price transparency regulation....more

Hogan Lovells

No Surprises Act prohibits balance billing, creates arbitration process for out-of-network providers

Hogan Lovells on

Effective January 1, 2022, the “No Surprises Act” signed into U.S. law as part of H.R. 133, “Consolidated Appropriations Act, 2021,” implicates (1) emergency services provided by non-participating providers at participating...more

Alston & Bird

Alston & Bird Healthcare Week in Review - April 2020 #1

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Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Katten Muchin Rosenman LLP

FDA Reduces Regulatory Uncertainty with New Finalized Rule Defining "Biological Product" under BPCIA to Include Insulin and Other...

Katten Muchin Rosenman LLP on

Key Points - In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more

Jones Day

Proposed Revisions to Stark Law and AKS Protections for Electronic Health Records Donations

Jones Day on

The Situation: Though not universal, Electronic Health Records ("EHR") technology adoption is now widespread in the health care industry. And, while an existing safe harbor under the federal Anti-Kickback Statute ("AKS") and...more

Troutman Pepper Locke

CMS Issues Controversial Health Care Pricing and Insurance Coverage Transparency Rules

Troutman Pepper Locke on

On November 15, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring public disclosure of hospital charges. Along with the Departments of Health and Human Services, Labor and the Treasury, CMS...more

Alston & Bird

CMS Finalizes Price Transparency Hospital Requirements and Proposes Requirements for Health Plans

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Our Health Care Group explains new rules (final and proposed) from the Centers for Medicare & Medicaid Services on pricing transparency for hospitals and cost-sharing information for health plans....more

Hogan Lovells

What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing...

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FDA authority to crack down on illegally marketed stem cell treatments confirmed - On Monday, a federal District Court in Florida issued a decisive blow against US Stem Cell Clinic, LLC, granting the U.S. Food and Drug...more

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

Franczek P.C.

Departments Issue FAQs on Cost-Sharing and Restated Enforcement Approach on Provider Nondiscrimination Rules under ACA

Franczek P.C. on

The Departments issued FAQs clarifying prior guidance on the ACA’s cost-sharing limitations applicable to non-grandfathered plans, and restating their enforcement approach with respect to the ACA’s provider nondiscrimination...more

Mintz - ML Strategies

Telehealth, Health IT, and mHealth Policy: Considerations for Stakeholders

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In recent months, as the conversation about reforming the health care system has shifted from websites and coverage expansion to achieving greater delivery system efficiencies, cost containment, and quality improvement, the...more

Mintz - ML Strategies

Telehealth and Health IT Policy: Considerations for Stakeholders

Mintz - ML Strategies on

In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more

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