News & Analysis as of

Health Care Providers Public Health Service Act

Manatt, Phelps & Phillips, LLP

HRSA Threatens to Sanction J&J Absent Withdrawal of 340B Rebate Plan

On September 17, the Health Resources and Services Administration (HRSA), which administers the prescription drug discount program established under Section 340B of the federal Public Health Service Act, sent a letter to...more

Manatt, Phelps & Phillips, LLP

Johnson & Johnson Announces Rebate Model for Certain 340B Drugs; HRSA Pushes Back

On August 23, Johnson & Johnson (J&J) issued a written notice to disproportionate share hospitals that participate in the prescription drug discount program established under section 340B of the federal Public Health Service...more

Baker Donelson

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

Baker Donelson on

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

Wiley Rein LLP

Manufacturers Are “Winning” in the 340B Drug Discount Dispute

Wiley Rein LLP on

Section 340B of the Public Health Service Act has grown significantly since its enactment in 1992 – both in the number of covered entities eligible to participate and in the volume of drugs purchased through the program. The...more

Mandelbaum Barrett PC

The No Surprises Act: A Look at What Dentists Need to Know

Mandelbaum Barrett PC on

The Federal No Surprises Act (“NSA”) was signed into law on December 27, 2020, as part of the Consolidated Appropriations Act of 2021. Since its enactment, the NSA has been supplemented on two occasions by regulations which...more

Stevens & Lee

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

Stevens & Lee on

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

Jones Day

Congress Authorizes Competitive Multivendor Contracts in U.S. Organ Transplant System

Jones Day on

This new legislation supports the Health Resources and Services Administration ("HRSA") modernization initiative announced in March, including several actions to strengthen accountability and transparency in the Organ...more

Hinshaw & Culbertson - Health Care

Federally Qualified Health Center Provider Referral Contracts and Arrangements

Federally Qualified Health Centers (FQHCs) are required to provide all required primary, preventive, and enabling health services as well as additional health services as appropriate and necessary – either directly or through...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

Hinshaw & Culbertson - Health Care

California Appellate Court Rules Federally Qualified Health Center Outreach Expenses Don't Qualify For Cost-Based Reimbursement

Family Health Centers of San Diego (Health Center) operates a federally qualified health center (FQHC) that has 49 locations throughout San Diego County, California, and provides a comprehensive range of primary and...more

Mintz - Health Care Viewpoints

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...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

Jackson Walker

Health Plan Changes in the Consolidated Appropriations Act, 2021

Jackson Walker on

The protections for participants and their beneficiaries in the Patient Protection and Affordable Care Act (ACA) were expanded by the Consolidated Appropriations Act, 2021 (the “Act”). Some of the changes build on concepts in...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

McDermott Will & Emery

FDA Issues Intended Use Proposed Rule, Repealing and Replacing January 2017 Final Rule

McDermott Will & Emery on

On September 23, 2020, the US Food and Drug Administration (FDA) published its Regulations Regarding “Intended Uses” proposed rule (Proposed Rule) to amend its “intended use” regulations at 21 C.F.R. §§ 201.128 and 801.4. The...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

Epstein Becker & Green

In Response to COVID-19, FDA Extends Enforcement Discretion for HCT/Ps Requiring Pre-Market Review

Epstein Becker & Green on

On July 20, 2020, the United States Food and Drug Administration (FDA) announced a six-month extension of its enforcement discretion policy for certain regenerative medicine products requiring pre-market review due to the...more

Pillsbury Winthrop Shaw Pittman LLP

The Limited Pandemic Federal Liability Protections

Businesses await clarity from the federal government on liability protections for injuries resulting from COVID-19. Current federal law provides liability protection to businesses but is limited to COVID-19 related...more

King & Spalding

Strategies for Addressing Reference-Based Plans

King & Spalding on

The move by some employer plans to a “reference-based” pricing model has created a need for healthcare providers to develop a strategy to confront payment challenges that these plans create. A prevalent model of...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

Pullman & Comley - Connecticut Health Law

The Potential Impact of the Conscience Rule on Connecticut Health Care Providers

On May 2, 2019 the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a controversial final rule, referred to as the “Conscience Rule.” If implemented, this rule would expand OCR’s...more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

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

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