News & Analysis as of

Office of the Inspector General

OIG Gainsharing Opinion Facilitates P4P

by Tucker Arensberg, P.C. on

Although it has been almost a decade since the OIG has issued a gainsharing opinion, OIG Advisory Opinion No. 17-09 confirms the federal government’s support of the pay for performance concept. OIG 17-09 is the first...more

White House Unveils Proposal on Drug Pricing

by Holland & Knight LLP on

On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more

Third Circuit: False Claims Act Liability Premised on an Anti-Kickback Statute Violation Requires Proof that at Least One Federal...

by Dorsey & Whitney LLP on

Federal scrutiny of charities that assist patients with accessing prescription drugs has increased with rising prescription drug prices. Some prescription drug charities receive funding from medical providers or drug...more

DOJ Enforcement Memorandum Signals Policy Shift in Deference to Agency Guidance Documents for Civil Health Care Enforcement...

by Ropes & Gray LLP on

On January 25, 2018, the U.S. Associate Attorney General issued a memorandum directing civil litigators in the U.S. Department of Justice (“DOJ”) to limit their use of governmental agency guidance documents in affirmative...more

OIG January 2018 Work Plan Update

by Baker Ober Health Law on

The OIG added six new items to its Work Plan with the January 2018 update, as listed in the chart below. Consistent with prior Work Plan missives, the OIG continues to focus its efforts on reducing prescription opioid misuse....more

OIG Offers Additional Guidance on Gainsharing Arrangement in Advisory Opinion 17-09

by Baker Ober Health Law on

A non-profit acute care hospital may share cost savings for certain spinal surgeries with neurosurgeons in a multi-specialty physician group following approval by the U.S. Department of Health & Human Services, Office of...more

The Opioid Crisis: An Emerging False Claims Act Risk Trend

by McDermott Will & Emery on

The government’s focus on the US opioid crisis has been consistently expanding over the past year beyond manufacturers to reach prescribers and health care providers who submit claims to federal health care programs for...more

Nursing Facility Discounts Approved in OIG Advisory Opinion 17-08

by Baker Ober Health Law on

The OIG created an opening for nursing facility discounts to private payors when it approved a startup company's proposal to create a network of nursing facilities willing to offer discounts on the daily rates charged to...more

Stark Law Reform a Focus of Recent Regulatory and Legislative Initiatives; 2018 DHS Code List and CPI-U Updates

by Dorsey & Whitney LLP on

The Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma recently identified federal physician self-referral law (or “Stark Law”) reform as a top policy priority and reported that an inter-agency group is...more

OIG finds incomplete CFPB response to unaccounted-for-laptops

by Ballard Spahr LLP on

The CFPB’s Office of Inspector General has issued a report indicating that, in performing an audit of the CFPB’s encryption of data on mobile devices issued to staff members, the OIG found the CFPB had not yet completed all...more

The Brand Memorandum: DOJ Restricts Reliance on Agency Guidance in Civil Enforcement Actions

by King & Spalding on

On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum significantly restricting Department of Justice (“DOJ” or “the Department”) civil litigating units’ use of executive agency guidance documents...more

DOJ Issues New Memo Limiting Use of Agency Guidance Documents in Civil Enforcement Cases: What It Means for Health Care...

by Foley & Lardner LLP on

On January 25, 2018, the U.S. Department of Justice (DOJ) issued a memorandum limiting the use of agency guidance documents in affirmative civil enforcement (ACE) cases. Stating that “[g]uidance documents cannot create...more

New Year, New Resolution: Build A Stronger Compliance Program

by SmithAmundsen LLC on

The headlines keep coming – chief executives being indicted for fraud and millions being paid by hospitals for improper billing practices and by physician groups for making illegal referrals or billing for unnecessary...more

2017 – The Health Law Year in Review

Uncertain. What better word to describe a year in which a new administration came to power and began to chart a new course for health policy, the fate of the Affordable Care Act (ACA) hung in the balance, and courts grappled...more

OIG Issued a No-Sanctions Letter to PhRMA Following Rescission of OIG Advisory Opinion Regarding a Patient Assistance Charity...

by King & Spalding on

On January 4, 2018, OIG issued a letter to Pharmaceutical Research and Manufacturers of America (PhRMA) addressing OIG’s Final Notice of Rescission of OIG Advisory Opinion No. 06-04 dated November 28, 2017. The OIG’s 2018...more

Gainsharing Guidance: Clarification on Cost-Savings Arrangements Between Hospitals and Physicians

by Polsinelli on

The Office of Inspector General of the U.S. Department of Health and Human Services (OIG) recently posted its first advisory opinion interpreting a gainsharing arrangement – that is, a financial relationship under which...more

OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement

by Dorsey & Whitney LLP on

On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social...more

HHS-OIG Issues Favorable Opinion on Gainsharing Arrangement

by McGuireWoods LLP on

On Jan. 5, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a favorable advisory opinion regarding a nonprofit acute care hospital’s proposed shared savings program involving...more

This Year May be a Game Changer for 340B Drug Discount Program, Take Two

I previously said that the year 2014 may be a game-changer for the 340B Drug Discount Program. Increasing HRSA audits, a lawsuit over the 340B Orphan Drug Rule, and HRSA’s promise to issue a 340B mega-regulation, all pointed...more

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

by Holland & Knight LLP on

On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more

DOT v. FAA: Oversight of regional Air Carriers

by LeClairRyan on

A just-released report by the U.S. Department of Transportation (DOT) Office of Inspector General (OIG) points to the importance of the regional airline industry in safely transporting passengers, economic changes buffeting...more

Blog: OIG Permits Drug Companies To Provide Free Medications in Limited Circumstances to Patients for 2018 Following Advisory...

by Cooley LLP on

As we discussed last month, the Office of Inspector General (OIG) rescinded Advisory Opinion 06-04 (Opinion 06-04), provided to a nonprofit, tax-exempt, charitable patient assistance program (PAP) because it determined that...more

OIG Scrutiny of Patient Assistance Programs

by Shipman & Goodwin LLP on

Last week, one of the largest charity patient assistance programs in the country, Caring Voice Coalition, announced that it would not be offering financial assistance for any of its disease funds in 2018. This announcement...more

OIG Reaffirms Permissibility of Certain Gainsharing Arrangements

The Department of Health and Human Services Office of the Inspector General (OIG) has issued an Advisory Opinion (Opinion) in connection with a hospital’s gainsharing arrangement (Arrangement) with a designated group of...more

United Therapeutics Enters False Claims Act Settlement Pertaining to Patient Assistance Program

by Arnall Golden Gregory LLP on

On December 20, 2017, United Therapeutics Corporation, a Silver Spring, Maryland-based pharmaceutical company that manufactures and sells a number of drugs to treat pulmonary arterial hypertension (PAH), agreed to pay $210...more

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