News & Analysis as of

Office of the Inspector General Medicare Medicare Part D

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

Alston & Bird

Health Care Week in Review: CMS Finalizes Rules for Medicare Advantage, Part D, and Affordable Care Act (ACA) Marketplaces

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

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

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more

ArentFox Schiff

CMS Issues Revised Guidance Implementing Medicare Inflation Rebates Under the Inflation Reduction Act

ArentFox Schiff on

The Centers for Medicare and Medicaid Services (CMS) continues to take steps implementing the Inflation Reduction Act of 2022 (IRA). Newly revised guidance issued on December 14, 2023, makes notable changes and clarifications...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

Health Care Compliance Association (HCCA)

[Event] 2024 Managed Care Compliance Conference - January 29th - 30th, Coronado, CA

Explore the unique issues that are pertinent to managed care professionals! This annual event dedicated to compliance management for health plan providers is returning to an in-person format for 2024. Join your peers and...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

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

ArentFox Schiff

Investigations Newsletter: OIG Warns That Proposed Drug Discounts May Warrant Sanctions

ArentFox Schiff on

OIG Warns That Proposed Drug Discounts May Warrant Sanctions - On October 5, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued an advisory opinion assessing a proposal that involved...more

Maynard Nexsen

CMS Revocation and Preclusion: The “Secret” Exclusion

Maynard Nexsen on

On April 1, 2019, the Center for Medicare and Medicaid Services (“CMS”) announced a new exclusion sanction: the CMS Preclusion List. This lesser-known sanction is different than placement on the Office of Inspector General...more

King & Spalding

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

King & Spalding on

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...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

King & Spalding

OIG Releases Semiannual Report to Congress

King & Spalding on

On May 28, 2021, OIG released its Semiannual Report to Congress (the Report). The Report describes OIG’s work during the 6-month semiannual reporting period of October 1, 2020, through March 31, 2021 (the Semiannual Reporting...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

Faegre Drinker Biddle & Reath LLP

HHS-OIG: Pharma Manufacturer’s Proposed Copayment Assistance Program ‘Highly Suspect’ Under Federal Anti-Kickback Statute

On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more

Manatt, Phelps & Phillips, LLP

OIG Advisory Opinion Rejects Pharmaceutical Manufacturer’s Proposed Beneficiary Cost-Sharing Program

On September 18, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion, No. 20-05 (the Opinion), that a pharmaceutical manufacturer’s (Requestor) proposed...more

Hogan Lovells

OIG denies proposed manufacturer-sponsored copay support program for Medicare beneficiaries

Hogan Lovells on

On September 23, the HHS OIG published Advisory Opinion No. 20-05, advising that OIG found “highly suspect” a manufacturer’s proposal to create a copay subsidy program to help certain financially eligible Medicare...more

Baker Donelson

OIG to Audit Utilization of Medication-Assisted Treatment for Opioid Use Disorder

Baker Donelson on

The OIG has indicated concern that patients suffering from opioid use disorder may experience difficulty accessing medication-assisted treatment (MAT), resulting in under-utilization of this intervention that offers what the...more

Maynard Nexsen

HHS Office of Inspector General Work Plan Update: News Items Added

Maynard Nexsen on

There are twelve OIG Work Plan updates released for July 2020, all of which are issued by the Office of Evaluation and Inspections, as well as the Office of Audit Services....more

Robinson+Cole Data Privacy + Security Insider

OIG Audit Finds that Majority of Part D Providers Surveyed used E1 Transactions for Potentially Inappropriate Purposes

The Centers for Medicare and Medicaid Services (CMS) requested an audit by the Office of Inspector General of Medicare Part D eligibility transactions (E1) transactions....more

Dorsey & Whitney LLP

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

Dorsey & Whitney LLP on

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

Bricker Graydon LLP

Recent OIG audit report on duplicate Medicare payments for drugs prescribed to hospice patients shows tension between OIG and CMS...

Bricker Graydon LLP on

On August 22, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a report following up to an audit that the OIG performed in 2012 indicating that Medicare Part D paid for...more

Mintz - Health Care Viewpoints

The OIG Urges CMS to Implement Solutions to Reduce Fraud in Medicare Part C and Part D

Recently, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued its 2019 “Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: Top Unimplemented Recommendations.” The OIG...more

Bricker Graydon LLP

OIG says Part D contracts cost Medicare as much as $75 million in lost drug manufacturer rebates in one year

Bricker Graydon LLP on

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report on July 1, 2019, finding that Medicare Part D contracts between Medicare Prescription Drug Plan sponsors and drug...more

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