On January 24, 2019, the Office of Inspector General (“OIG”) issued a favorable advisory opinion allowing a pharmaceutical manufacturer (“Manufacturer”) to temporarily loan limited-functionality smartphones to financially needy patients who lack the required technology to receive adherence data from a sensor embedded in a prescribed antipsychotic medication (“the Arrangement”). The OIG concluded that the Arrangement did not constitute grounds for penalties under the Civil Monetary Penalties law (“CMP”) and that although the Arrangement could potentially cause remuneration under the Anti-Kickback Statute (“AKS”), the OIG would not impose sanctions on the Manufacturer as related to the Arrangement based on the low-risk nature of the Arrangement.
Continue Reading OIG Advisory Opinion No. 19-02 Allows Pharmaceutical Manufacturer to Temporarily Loan Smartphones to Financially Needy Patients to Receive Data from a Digestible Medication Sensor
Advisory Opinions
OIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory Opinion
On November 16, 2018, the Office of the Inspector General of the Department of Health and Human Services (OIG) posted an unfavorable Advisory Opinion No. 18-14 regarding an arrangement where a vendor (Requestor) of a commonly used drug would supply free doses of the drug to hospitals for treatment of inpatients with a rare and serious form of epilepsy (Proposed Arrangement). The drug is not separately reimbursable in the inpatient setting. As a result, and according to the Requestor, many hospitals do not stock sufficient quantities of the drug and are reluctant to administer the drug due to insufficient reimbursement from government and commercial payers.
Continue Reading OIG Disapproves of Drug Company’s Plan to Provide Hospitals Free Medications in Advisory Opinion
OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities
On November 6, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion regarding a proposed arrangement comprised of substantial donations that were earmarked for biomedical research purposes, made by a charitable trust (“Trust”) to a public-private medical research institute (“Research Institute”). The Research Institute had been formed by a health care system (“Health Care System”) and a public university (“University”). In addition, one of the Trustees planned to make a separate, individual donation to the Research Institute, through the University’s foundation, under substantially identical terms.
Continue Reading OIG Issues Favorable Advisory Opinion for Trust Donations to Public-Private Research Institute Affiliated with a Health System Having Ongoing Business Relationships with Trustee-Owned Long-Term Care Facilities
OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions
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
OIG Advisory Opinion Allows PHO Network Hospitals to Give 100% Discount on Medigap-Covered Inpatient Deductibles, with Savings Shared as a Premium Credit to Patients
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…
OIG Posts Telemedicine Advisory Opinion
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
OIG Reports That CMS Paid Practitioners For Telehealth Services That Failed To Meet Medicare Requirements
On April 5, 2018, the Office of the Inspector General (OIG) announced its findings that the Centers for Medicare and Medicaid Services (CMS) paid practitioners for telehealth services that did not meet Medicare requirements. Certain telehealth services are reimbursable by Medicare as Part B services. According to the OIG, it engaged in a review of telehealth services after finding that Medicare paid a total of $17.6 million in telehealth payments in 2015, compared to just $61,302 in 2001.
Continue Reading OIG Reports That CMS Paid Practitioners For Telehealth Services That Failed To Meet Medicare Requirements
OIG Advisory Opinion Allows Medical Center to Share Cost Savings with Neurosurgeons for Curbing Spinal Fusion Surgery Costs
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
OIG Advisory Opinion Allows Pilot Collaborative Program Proposed by Pharmaceutical Manufacturer for Medication Therapy Management Interventions
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