News & Analysis as of

Office of the Inspector General Anti-Kickback Statute

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

by Pepper Hamilton LLP on

Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

HHS-OIG blesses product replacement program

by Dentons on

The federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (AKS), in addition to prohibiting payments for patient referrals, prohibits one party (such as a manufacturer) from providing anything of value to...more

Pharmacy Chain's Benefit Program Gets OIG Approval in Advisory Opinion 17-05

by Baker Ober Health Law on

The OIG approved a retail pharmacy chain's proposal to expand its benefit program, which allows participating federal health care program beneficiaries to receive discounts and other benefits when purchasing certain products...more

OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

by Polsinelli on

Recently, the U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) issued an Advisory Opinion (17-02) that allows for waivers or reductions of cost-sharing amounts owed by financially needy...more

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

by Baker Ober Health Law on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

OIG Signs Up for Customer Loyalty Program

by BakerHostetler on

In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy’s customer loyalty/discount program (Benefit Program)....more

OIG Issues Advisory Opinion to Pharmacy

On September 7, 2017, the HHS Office of Inspector General (OIG) issued an Advisory Opinion to the owner of a retail pharmacy chain (Pharmacy) that would allow Federal health care program beneficiaries to participate in a paid...more

Healthcare Law Update: September 2017

by Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

OIG’s Expanded Interpretation of Warranty Safe Harbor Portends Well for Value-Based Health Care

by Ropes & Gray LLP on

In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) clarified the scope of the Anti-Kickback Statute (“AKS”) warranty safe harbor (the “Warranty Safe Harbor”). In...more

HHS-OIG Issues Favorable Opinion on Pharmaceutical Spoilage Replacement Program

by McGuireWoods LLP on

On Aug. 25, 2017, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a favorable advisory opinion regarding a pharmaceutical manufacturer’s proposed replacement program for spoiled...more

OIG Approves Cost-Sharing Arrangement Involving Clinical Research Study

by Baker Ober Health Law on

The U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable advisory opinion, No. 17-02, regarding a proposed arrangement under which the cost-sharing amounts owed by...more

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

by Bracewell LLP on

On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

New OIG Advisory Opinion Allows Waiver of Cost Sharing in Research Studies

The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more

New OIG Rules Change Patient Incentive Program Landscape: Where Are the Limits Now?

by McDermott Will & Emery on

With health care becoming more consumer-driven, health care providers and health plans are wrestling with how to incentivize patients to participate in health promotion programs and treatment plans. As payments are...more

New Safe Harbor Permits Some Free Transportation to Patients

by Ruder Ware on

A new safe harbor was recently issued by the Health and Human Services (HHS) Office of Inspector General (OIG) that permits eligible health care providers to offer free or discounted transportation to established patients....more

When to Use the OIG’s Self Disclosure Protocols

by Ruder Ware on

The HHS Office of Inspector General offers providers an opportunity to self-disclose certain violations in exchange for avoiding some of the more draconian penalties that may otherwise apply under applicable regulations. ...more

Healthcare Law Update: March 2017

by Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

OIG Approves Free Lodging and Meals Under "Promotes Access to Care" Exception to Beneficiary Inducement CMP

by Baker Ober Health Law on

In Advisory Opinion 17-01, published March 10, 2017, the Department of Health and Human Services, Office of Inspector General (OIG) approved an academic medical center's proposal to provide free or reduced-cost lodging and...more

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

New OIG Exclusion Regulations About to Go into Effect

by McDermott Will & Emery on

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

OIG Finalizes Expanded Exclusion Authorities under ACA (Updated)

by Reed Smith on

On January 12, 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services issued the final rule implementing its statutory authority under the Affordable Care Act (ACA) to expand the exclusion...more

Stretching the Rules: HHS-OIG Expands its Exclusionary Authority

by Arnall Golden Gregory LLP on

On January 12, 2017, the Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule expanding its authority to exclude providers from participation in federal healthcare programs. This...more

OIG Expands Exclusionary Authority

The Department of Health and Human Services, Office of Inspector General (OIG) published a final rule on January 12, 2017, expanding the OIG’s authority to exclude providers from participation in federal healthcare programs....more

Health Law Insights: January Newsletter

by Roetzel & Andress on

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

Analysis of HHS OIG Final Rule to Amend the Anti-Kickback Safe Harbors and CMP Rules on Beneficiary Inducements

by Reed Smith on

On December 7, 2016, the Office of Inspector General of the Department of Health and Human Services published a final rule amending the safe harbors to the Anti-Kickback Statute (AKS) and the Civil Monetary Penalty (CMP)...more

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