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Centers for Medicare & Medicaid Services (CMS) Public Health Service Act

Baker Donelson

60 Days After Loper: Health Care Impact of Chevron Deference's End

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The Supreme Court of the United States issued its highly anticipated ruling in a pair of cases challenging the long-standing Chevron doctrine on June 28, 2024. Foreshadowed by decisions in recent years slighting Chevron, it...more

Stevens & Lee

Gag Clause Prohibitions in ERISA, the Internal Revenue Code and the Public Health Service Act

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If you work for or represent group health plans or issuers of group health plans, it is important that you take a look at the contracts they have with health care providers before the end of 2023. The Internal Revenue Code...more

Holland & Knight LLP

CMS Proposes Returning $9 Billion to More Than 1,600 Hospitals

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) released the Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased in Cost Years 2018-2022 Proposed Rule on July 7, 2023. CMS has published...more

Foley Hoag LLP

Information Collection Request for Drug Price Negotiation Program Data Elements

Foley Hoag LLP on

On March 21, 2023, CMS published in the Federal Register the Information Collection Request (ICR) Form, as required by the Paperwork Reduction Act, for Negotiation Data Elements under Sections 11001 and 11002 of the Inflation...more

Brownstein Hyatt Farber Schreck

Colorado Raises Stakes for Hospitals That Don’t Comply With Price Transparency Law

In an effort to push hospitals toward compliance with federal hospital price transparency laws, Gov. Jared Polis signed HB 22-1285, “Prohibit Collection Hospital Not Disclosing Prices,” into law on June 8, 2022. Specifically,...more

ArentFox Schiff

HHS COVID-19 Public Health Emergency Persists as California COVID-19 Policies Are Set To Expire

ArentFox Schiff on

The US Department of Health and Human Services’ (HHS) declaration that COVID-19 remains a public health emergency (PHE) will continue through July 15, 2022, and is expected to be renewed again through October 13, 2022....more

McDermott Will & Emery

HHS Signals Commitment to “Predictability and Stability,” Extends Public Health Emergency Declaration “Likely” for Entirety of...

McDermott Will & Emery on

In a recent letter to state governors, Acting Secretary of Health and Human Services Norris Cochran signaled the US Department of Health and Human Services’ (HHS’s) commitment to “predictability and stability” in the ongoing...more

Manatt, Phelps & Phillips, LLP

HHS Renews the COVID-19 Public Health Emergency Through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more

Manatt, Phelps & Phillips, LLP

President Trump Signs Drug Pricing Executive Orders: How Will They Impact Pharma and Providers?

Prescription drug pricing is emerging as one of several healthcare issues that may become a focus of the presidential race as well as contested congressional races this fall. With pending legislative attempts to control drug...more

Manatt, Phelps & Phillips, LLP

HHS Renews COVID-19 Public Health Emergency, Extending Flexibilities and Funding for Another 90 Days

On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more

King & Spalding

Hospital Associations Appeal Decision Upholding Price Transparency Rule; King & Spalding Price Transparency Working Group Helping...

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On July 17, 2020, the American Hospital Association and several additional associations and individual hospitals filed their opening brief in their appeal of a decision of the district court, which, had upheld CMS’s price...more

King & Spalding

D.C. District Court Upholds Price Transparency Rule

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On June 23, 2020, Judge Carl Nichols of the United States District Court for the District of Columbia issued a decision upholding CMS’s price transparency rule, which was adopted late last year. The case is cited as American...more

Seyfarth Shaw LLP

FDA and NCI to Review COVID-19 Antibody Tests Marketed Under FDA Guidance Permitting Sale Without FDA Authorization

Seyfarth Shaw LLP on

In mid-March, the US Food and Drug Administration announced via press release an “unprecedented policy” to increase testing capacity for COVID-19 in the United States. As part of its Policy for Diagnostic Tests for...more

Arnall Golden Gregory LLP

Patients Over Paperwork: CMS Issues Blanket Waivers on Stark Law Sanctions in Response to COVID-19

Extraordinary times call for extraordinary measures – this is the approach the Centers for Medicare and Medicaid Services (“CMS”) has taken with respect to the federal Physician Self-Referral Law (the “Stark Law”) by issuing...more

Hogan Lovells

Senate bill proposes laboratory developed tests to be regulated under CLIA process

Hogan Lovells on

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more

King & Spalding

American Hospital Association’s Lawsuit Challenging CMS’s Price Transparency Final Rule Set for Summary Judgment Hearing in April

King & Spalding on

On December 4, 2019, the American Hospital Association and several hospital associations and hospitals (“Plaintiffs”) filed suit against the Secretary of Health and Human Services (“HHS”) to challenge the Centers for Medicare...more

Bass, Berry & Sims PLC

CMS Finalizes Highly Anticipated Hospital Price Transparency Rule

Bass, Berry & Sims PLC on

On November 15, 2019, the Centers for Medicare & Medicaid Services (CMS) finalized a rule requiring hospitals to make public a list of standard charges for items and services provided by such hospitals (the Rule). (The...more

Wilson Sonsini Goodrich & Rosati

CMS Releases Key 2020 Payment and Policy Proposals

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) issued three proposed rules on payment updates and policy changes for calendar year 2020 under 1) the Medicare Hospital Outpatient Prospective Payment...more

ArentFox Schiff

CMS Releases CY 2020 Proposed Hospital Outpatient Payment Rule

ArentFox Schiff on

On July 29, 2019, the Centers for Medicare & Medicaid Services issued the proposed CY 2020 Medicare Hospital Outpatient Prospective System and Ambulatory Surgical Center Payment System (Proposed Rule)....more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

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

Mintz - Health Care Viewpoints

Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid...more

Sheppard Mullin Richter & Hampton LLP

The 340B Drug Pricing Program: New CMS Final Rule Draws a Motion for Preliminary Injunction from Hospital Groups

On November 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the final rule, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting...more

K&L Gates LLP

K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program

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This episode outlines the basics of the 340B Drug Pricing Program and discusses potential changes affecting the program, including CMS’s recent proposal to cut reimbursement for Part B drugs purchased under the 340B program....more

Alston & Bird

A&B Healthcare Week in Review

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I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: CMS Releases Guidance on Fast Track Process for 1115 Waivers for Medicaid and CHIP... Healthcare.gov CEO Sends Letter to State Insurance Commissioners Concerning 2016 Premium Decisions... Medicare Board of Trustees...more

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