On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a warranty program to hospital customers covering three joint replacement products (“Proposed Arrangement”).

Under the Proposed Arrangement, the manufacturer would refund hospitals for the combined purchase price of three of its products if a patient who received them as part of a joint replacement surgery was readmitted to the hospital within 90 days following the surgery, due to a failure of any of the products to perform as expected (“Warranty Program”). The products include: (1) a total knee or hip implant, (2) a wound therapy system, and (3) an antimicrobial dressing (collectively, the “Product Suite”).
Continue Reading OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

The Office of Inspector General (OIG), Health and Human Services, issued an Advisory Opinion allowing an arrangement between a licensed offeror of Medicare Supplemental Health Insurance policies (Medigap Offeror) and a preferred hospital organization (PHO) having network hospitals across the U.S. (the “Arrangement”).  Under the Arrangement, the PHO’s network hospitals would provide discounts of up

The Office of Inspector General (OIG), Health and Human Services issued an Advisory Opinion allowing an arrangement proposed by a federally qualified health center look-alike (FQHC look-alike) to provide free technology items and services to a clinic run by a county Department of Health (County Clinic), that would facilitate telemedicine encounters (the Arrangement).  Although the OIG found that the Arrangement could potentially implicate the anti-kickback statute (AKS), the OIG concluded that it would not impose administrative sanctions.
Continue Reading OIG Posts Telemedicine Advisory Opinion

On May 7, 2018, the Health and Human Services Office of Inspector General (OIG) issued a  favorable Advisory Opinion in which it permitted a medical device company (Requestor) to provide free sample ostomy products and conduct follow-up customer satisfaction surveys (Arrangement).
Continue Reading OIG Advisory Opinion Allows Medical Device Supplier to Provide Sample Products to Patients

On January 5, 2018, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting an arrangement involving payment by a Medical Center to a multi-specialty physician Group for cost-reduction measures achieved through the efforts of certain Neurosurgeons, relating to the selection and use of products during spinal fusion surgeries (Program).  Payment under the Program was calculated as a percentage of cost savings realized by the Medical Center over a three-year period.  Though not yet paid at the time of the OIG advisory opinion, the amounts were to be paid to the Group through a Medical Center Subsidiary tasked with administering the Program, utilizing a Program Administrator. A portion of the payment made to the Group would be distributed to participating Neurosurgeons based on pre-existing contractual provisions with the Group that provided payment for personally-performed services. The Program Administrator was being paid a fixed monthly fee for services rendered, an amount not tied to cost savings or compensation paid to the Group.
Continue Reading OIG Advisory Opinion Allows Medical Center to Share Cost Savings with Neurosurgeons for Curbing Spinal Fusion Surgery Costs

On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer (the Requestor), a trade association (Association), a Medicare Advantage Part D plan (MA Plan), a Hospital System, and a Vendor.  As proposed, the program would provide new technology to allow real-time access to patient discharge information for use by MA Plan pharmacists who conduct medication therapy management (MTM) services. 
Continue Reading OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions

The Centers for Medicare & Medicaid Services (CMS) issued a rare advisory opinion (CMS-AO-2017-1) under the Stark Law (Section 1877 of the Social Security Act, codified at 42 U.S.C. § 1395) earlier this fall, addressing a proposed arrangement under which a web-based diagnostic testing portal sought to provide referring physicians with free alerts related to test results.
Continue Reading CMS Approves Laboratory Alerts to Physicians in Rare Stark Law Advisory Opinion

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 membership program (Program).  The Program would include discounts and rebates on certain prescriptions and, where offered, on selected clinic services.

The Program was being offered previously to customers who satisfied certain eligibility criteria and paid an annual fee to join, but Federal program beneficiaries had not been permitted to enroll. In seeking the Advisory Opinion, the Pharmacy sought to modify the Program to extend it to Federal program beneficiaries as well.
Continue Reading OIG Issues Advisory Opinion to Pharmacy

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 research studies conducted at a non-profit medical center.  In the advisory opinion, the OIG reiterated its longstanding concern about routine waivers of Medicare beneficiary cost-sharing amounts in the absence of financial hardship, and noted this can lead to liability under the anti-kickback statute (AKS).  The research studies were conducted utilizing protocols under the Medicare Coverage with Evidence Development (CED) framework and involved a wound care system used to treat chronic, non-healing wounds.

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

On December 13, 2016, the Office of Inspector General (OIG) issued a favorable Advisory Opinion to a university health system (the Requestor) for two arrangements relating to a federally-funded clinical research study designed by a physician-employee (the Study):

  1. a proposal to waive the cost-sharing obligations of Study participants (Participants) for medically necessary health care services received under the Study protocol (the Proposed Arrangement), and
  2. payment of a stipend to Participants for the time and effort required to participate (the Current Arrangement).


Continue Reading OIG Issues Favorable Advisory Opinion for Cost-sharing Waivers and Stipends in a Clinical Research Study