News & Analysis as of

Office of the Inspector General Department of Health and Human Services (HHS) Prescription Drugs

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Drug Cost Subsidies for Certain Low-Income Medicare Enrollees

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Arnall Golden Gregory LLP

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...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

Arnall Golden Gregory LLP

OIG Announces New Audit Focus on Diabetes Drugs and Weight Loss

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) announced multiple new OIG Work Plan Items, including two audits, focused on identifying and quantifying improper Medicare and Medicaid...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

Bass, Berry & Sims PLC

OIG Approves Free Drug Program for Ultra-Rare Condition in Advisory Opinion 23-02

Bass, Berry & Sims PLC on

On February 23, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion 23-02, approving a pharmaceutical company’s program to provide a free 14-day supply of an...more

Sheppard Mullin Richter & Hampton LLP

OIG Advisory Opinion Alert: Medical Flights for Patient Access

On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug...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

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

MoFo Life Sciences

Supreme Court Denies Review Of Cost Sharing Assistance Program

MoFo Life Sciences on

The U.S. Supreme Court recently declined to review a Second Circuit decision that blocked Pfizer from implementing a cost sharing assistance program. Pfizer had sought to cover out-of-pocket expenses for financially eligible...more

Baker Donelson

OIG Issues Favorable Opinion for Pharmaceutical Manufacturer's Free Drug Program

Baker Donelson on

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has issued Advisory Opinion 2022-22, stating that it would not impose sanctions related to a proposed arrangement where a...more

McDermott Will & Emery

Pandemic Response Accountability Committee Report Highlights Telehealth Program Integrity Concerns

On July 20, 2022, the US Department of Health and Human Services Office of Inspector General (OIG) issued a Special Fraud Alert (Alert) concerning the fraud and abuse risks associated with healthcare practitioners entering...more

Sheppard Mullin Richter & Hampton LLP

Recent Developments in Telehealth Enforcement

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the...more

Sheppard Mullin Richter & Hampton LLP

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

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