AKS

Subscribe to AKS via RSS

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

On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published the favorable Advisory Opinion 19-01 allowing a charitable pediatric clinic (“Clinic”) to routinely waive cost-sharing amounts for patients in financial need (“Arrangement”). OIG noted that the Arrangement did not meet the regulatory exception for permitted waivers of cost sharing amounts under the Civil Monetary Penalties Law (CMP), but ultimately decided not to impose administrative sanctions in connection with the Arrangement.
Continue Reading OIG Advisory Opinion Allows Charitable Pediatric Clinic to Provide Routine Cost-Sharing Waivers

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

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 Department of Justice (DOJ) announced two significant False Claims Act (FCA) settlements in recent days that signal continued close government scrutiny of billing, coding and referral practices at hospitals.

On August 2, DOJ announced an $84.5 million dollar settlement with Michigan-based health system William Beaumont Hospital. The settlement resolves allegations of non-compliance with the…

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 February 9, 2018, Congress passed the Bipartisan Budget Act of 2018 (the Act), which included a number of important health law provisions..

AKS and CMP Violations

Under the Act, Congress doubled the statutory civil fines for certain violations of the Anti-kickback Statue (AKS) and adjusted certain fines under the Civil Monetary Penalty (CMP) Law. The Act also increased the maximum criminal penalty from $25,000 to $100,000 and increased the maximum incarceration period from five years to ten years.
Continue Reading Bipartisan Budget Act Revises Stark Law, Increases Penalties for AKS and CMP Law Violations, and Expands Telehealth Coverage

The Department of Justice (DOJ) recently resolved two health care fraud cases – one criminal and one civil – that demonstrate the government’s continued scrutiny of lavish meals and “speaker’s bureaus” sponsored by pharmaceutical and device manufacturers as potential avenues for the payment of kickbacks to physicians for referrals of health care items and services. These cases indicate the criminal and civil risk that providing lavish meals or purported speaker’s bureau payment can pose, and the corresponding need to proactively assess the legitimacy of such programs and events.
Continue Reading Recent Anti-Kickback Cases Emphasize Government Scrutiny of Speaker’s Bureaus and Lavish Meals Funded by Pharmaceutical and Device Manufacturers

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