News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Office of the Inspector General Prescription Drugs

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

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The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

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Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

McGuireWoods Consulting

Washington Healthcare Update - December 2023

This Week in Washington: House Energy and Commerce subcommittees look at role of AI and CDC respiratory disease preparedness; FDA releases final rule on prescription drug advertisements....more

McGuireWoods Consulting

Washington Healthcare Update - November 2023 #3

McGuireWoods Consulting on

This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more

Alston & Bird

Health Care Week in Review: CMS Releases Three Major Medicare Final Rules

Alston & Bird on

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

Alston & Bird

Health Care Week in Review: Rep. McCarthy Ousted as Speaker of the House; CMS Announces Drug Manufacturer Participation in...

Alston & Bird on

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

Mintz - Health Care Viewpoints

Mintz IRA Update — Other Key IRA Programs and Developments: The Medicare Prescription Drug Inflation Rebate Program and Maximum...

Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - August 2023

Illinois passed S.B. 1913, which requires Medicaid FFS and Medicaid managed care plans to provide coverage of mental health services, substance use disorder treatment, and ‘behavioral telehealth services’. Requires Medicaid...more

Manatt, Phelps & Phillips, LLP

Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 - June 2023 #2

H.R. 4189 / S. 2016: Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act ....more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

Paul Hastings LLP on

While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

Ballard Spahr LLP

HHS OIG to Review CMS Citations

Ballard Spahr LLP on

Summary - The Department of Health and Human Services Office of Inspector General (HHS OIG) has announced its intention to comprehensively review nursing home citations issued by the Centers for Medicare and Medicaid...more

Goodwin

CMS Issues Proposed Guidance on Inflation Rebates Under Medicare Part B

Goodwin on

On February 9, 2023, the Centers for Medicare & Medicaid Services (CMS) released initial program guidance addressing the inflation rebate provisions of the Inflation Reduction Act of 2022 (IRA). These provisions apply to how...more

McGuireWoods Consulting

Washington Healthcare Update - February 2023 #3

Upcoming Hearings - March 22 - Senate Committee on Health, Education, Labor and Pensions Hearing: “Taxpayers Paid Billions For It: So Why Would Moderna Consider Quadrupling the Price of the COVID Vaccine?” 10:00 a.m.,...more

ArentFox Schiff

CMS and OIG Issue Guidance on Implementation of the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) and the US Department of Health and Human Services Office of Inspector General (OIG) continue to issue guidance regarding the implementation of the drug pricing provisions of...more

King & Spalding

OIG Issues Advisory Opinion Permitting Cost-Sharing for Medicare-Reimbursable Items and Services in a Clinical Trial

King & Spalding on

On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more

Hogan Lovells

MDRP and 340B: Updates from last week

Hogan Lovells on

On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more

Health Care Compliance Association (HCCA)

[Event] 2022 Managed Care Compliance Conference - January 30th - February 1st, Phoenix, AZ

Attend our annual event for those who manage compliance at health plan providers. Explore topics and issues that are pertinent to industry professionals like you. Learn the latest practices, share strategies, and connect with...more

Foley & Lardner LLP

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2021 #4

Alston & Bird on

Below is Alston & Bird’s Health Care 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

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

McGuireWoods Consulting

Washington Healthcare Update - October 2020 #2

McGuireWoods Consulting on

This week in Washington: Negotiations for COVID-19 stimulus package are ongoing; House and Senate are in recess....more

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