News & Analysis as of

Medicare Office of the Inspector General Prescription Drugs

Goodwin

Health Headlines: June 2025

Goodwin on

Welcome to the seventh issue of Health Headlines, a newsletter created by lawyers in our Healthcare practice. Iowa Governor Kim Reynolds signed Senate File 383 into law, placing new restrictions on pharmacy benefit...more

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

Lathrop GPM on

Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Arnall Golden Gregory LLP

OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01

On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s free product offering to...more

Morgan Lewis - As Prescribed

Patient Assistance Programs – The Dos and Don’ts from HHS OIG

Patient assistance programs (PAPs) emerged to help patients who lack health insurance or prescription drug coverage obtain critical, and often, life-saving medications. This is especially true for rare disease patients, whose...more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

King & Spalding on

On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

King & Spalding

OIG Issues a Favorable Advisory Opinion to a Pharmaceutical Manufacturer Regarding Free Transportation, Lodging and Support for...

King & Spalding on

On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more

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

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

Bass, Berry & Sims PLC on

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...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

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

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

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

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

McDermott Will & Schulte

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

Holland & Knight LLP

OIG Advisory Opinion Highlights Further Concerns for Patient Assistance Programs

Holland & Knight LLP on

Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

McDermott Will & Schulte

OIG Issues Special Fraud Alert Warning Providers of Suspect Telemedicine Arrangements

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

Rivkin Radler LLP

NY Pharmacy Owner Sentenced for Healthcare Fraud

Rivkin Radler LLP on

A New York woman was sentenced last month to 78 months in prison for defrauding healthcare programs, including obtaining more than $6.5 million from Medicare Part D plans and Medicaid drug plans....more

Husch Blackwell LLP

Hospice Audit Series: Beyond Part D, OIG Scrutinizes the Hospice Industry to the Tune of $6.6 Billion

Husch Blackwell LLP on

In a follow-up to its recent reports on billing outside the hospice benefit for drugs and durable medical equipment (DME), the Office of Inspector General’s (OIG) new data report identifies billions being billed to Medicare...more

101 Results
 / 
View per page
Page: of 5

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide