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
Meaghan Mary Cooper
Meaghan Cooper is a member of Robinson+Cole's Health Law Group, where she advises hospitals, physician groups, community providers, and other health care entities on health care issues and general corporate matters. She provides legal counsel on a full range of transactional and regulatory health law issues, including contracting, tax exemption, licensure, government investigations, medical staff, joint ventures, affiliations, physician recruitment, and privacy and security of medical information. She also works with clients on the regulation of long-term care services, referral and reimbursement rules, and the structuring of physician compensation. Read her full rc.com bio here.
Bipartisan Budget Act Revises Stark Law, Increases Penalties for AKS and CMP Law Violations, and Expands Telehealth Coverage
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
CMS Revises National Coverage Determination for Implantable Cardioverter Defibrillators
On February 15, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a Decision Memo outlining revisions to its 2005 National Coverage Determination (NCD) for Implantable Automatic Defibrillators (ICDs) . The updated NCD includes changes to the covered indications for ICDs, new patient criteria and exceptions to waiting periods for symptomatic patients with certain…
OIG Settles EMTALA Allegations Involving Psychiatric Care
On June 2, 2017, AnMed Health and the Office of Inspector General (OIG) for the United States Department of Health and Human Services agreed to a $1.295 million settlement of allegations that AnMed had violated the Emergency Medical Treatment & Labor Act (EMTALA) (Section 1867 of the Social Security Act). The OIG alleged that AnMed failed to provide appropriate medical screening and stabilizing treatment to individuals presenting to the ED with unstable psychiatric emergency medical conditions.
Continue Reading OIG Settles EMTALA Allegations Involving Psychiatric Care
DOJ Settles Allegations of Fraudulent Loan Program Between Hospital System and FQHC
The U.S. Department of Justice (DOJ) recently announced a settlement with a hospital operated by Indiana University Health, Inc. and a federally qualified health center operated by HealthNet, Inc. to resolve claims that the parties violated the Anti-Kickback Statute, the Federal Claims Act and Indiana law. Each of the parties will pay over $5 million to the United States and approximately $3.9 million to the State of Indiana. The lawsuit was originally brought by a qui tam relator, a physician and former employee of the hospital and HealthNet, and later joined by the DOJ and the State. The Anti-Kickback Statute prohibits, in relevant part, the knowing and willful payment of any remuneration to induce the referral of services or items that are paid for by a federal health care program, such as Medicaid. Claims submitted to federal health care programs in violation of the Anti-Kickback Statute are false claims under the False Claims Act. The government alleges that the parties had, for over a decade, established a series of illegal referral based relationships to guarantee that Medicaid beneficiaries were directed to the hospital for both inpatient and outpatient services and collaborated to provide services focused on collections for patient services, rather than improving health outcomes, in violation of the federal Anti-Kickback Statute and Indiana law. In particular, the government alleges that, in exchange for a no-interest loan to HealthNet, the hospital was guaranteed that high-risk maternity patients would deliver at the hospital, thereby allowing the hospital to benefit from expensive services provided to critically ill infants.
Continue Reading DOJ Settles Allegations of Fraudulent Loan Program Between Hospital System and FQHC