Tag archives: healthcare

Deputy Associate Attorney General Stephen Cox Addresses DOJ’s False Claims Act Enforcement Priorities and Regulatory Reforms

On January 27, Deputy Associate Attorney General Stephen Cox delivered keynote remarks on the False Claims Act (FCA) at the 2020 Advanced Forum on False Claims and Qui Tam Enforcement. Mr. Cox’s remarks described the Department of Justice’s (“DOJ”) ongoing enforcement efforts and priorities, as well as outlined DOJ’s regulatory reform agenda and some of its … Continue reading

DOJ issues guidance on cooperation credit in FCA investigations

On May 7, the Department of Justice (“DOJ”) released an update to its previous 2017 guidance (“Updated Guidance”) outlining when the government will award cooperation credit to defendants in False Claims Act (“FCA”) investigations. Under the Updated Guidance, set forth at Justice Manual Section 4-4.112, defendants can earn cooperation credit in FCA cases in three … Continue reading

Ontario legislature clarifies mandatory privacy breach reporting requirements under the Ontario Personal Health Information Protection Act

In Ontario, the Personal Health Information Protection Act (PHIPA)[1] governs the collection, use and disclosure of personal health information within the health sector. The term “personal health information” is broadly defined in PHIPA and includes identifying information which is not strictly personal health information but is contained in a record containing personal health information. Health … Continue reading

DOJ charges 412 individuals in largest healthcare fraud takedown in US history

On Thursday, the DOJ announced charges against 412 individuals for their alleged participation in healthcare fraud schemes involving approximately $1.3 billion in false billings.  This marks the largest national healthcare fraud takedown in U.S. history—topping the DOJ’s announcement of charges against 301 individuals in June 2016. The enforcement actions spanned across 41 federal districts and … Continue reading

Medical assistance in dying in Canada: one year later

Since the Canadian federal government introduced legislation governing medical assistance in dying (“MAiD”), the provinces and territories, which are responsible for the delivery of health care services in Canada, have adopted a variety of processes and procedures to deal with requests for MAiD. However, some questions and issues which have arisen with the legalization of … Continue reading

No monetary penalties for manufacturer providing physicians with free vaccine refrigeration storage system

In an Advisory Opinion issued on September 23, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) announced that  it would not impose administrative sanctions against the manufacturer of a vaccine refrigeration system (the “Requestor”) for providing the devices to physicians without charge.  This development comes at a critical time … Continue reading

Ninth circuit upholds conviction for physician for re-using single use devices

Last week, the Ninth Circuit affirmed a physician’s conviction for conspiracy to distribute an adulterated device with intent to defraud or mislead in violation of Section 331(k) of the federal Food, Drug and Cosmetic Act (FDCA). The physician – who dubbed his own practice “The McDonald’s of Urology” because of the high volume of patients … Continue reading

Texas supreme court temporarily halts state Medicaid cuts for home health therapy programs for disabled children

The Texas Supreme Court has temporarily blocked the Texas Health and Human Services Commission’s planned rate reductions for Medicaid home health services for severely disabled children, holding that a temporary injunction issued by a trial court enjoining the rate cuts from taking effect remains binding pending the issuance of a mandate by the Texas Third … Continue reading

DOJ charges over 300 people in largest healthcare fraud “takedown” in U.S. history

On Wednesday, the Justice Department announced that it had brought criminal and civil charges against 301 healthcare professionals as part of the largest national healthcare fraud “takedown” in history. A nationwide investigation spearheaded by the Medicare Fraud Strike Force revealed claims amounting to $900 million in the form of alleged kickbacks, money laundering, and other … Continue reading

New ethical guidelines from the AMA: Telemedicine

On June 13, 2016, the American Medical Association (AMA) at its annual meeting approved new ethical guidelines for physicians providing telemedicine services, which will be incorporated in the full publication of the AMA Code of Medical Ethics this fall. Although the ethical guidelines do not place legal limitations on the provision of telemedicine for any … Continue reading

New USPTO subject matter eligibility (35 USC § 101) examiner guidance and life science examples

On May 5, 2016, the United States Patent and Trademark Office issued six new examples that provide guidance to Examiners and patent applicants prosecuting claims directed to life sciences subject matter (Subject Matter Eligibility Examples: Life Sciences).  These examples analyze claims that are directed to several of the most contentious areas of patentable subject matter … Continue reading

May 1st letter from CMS temporarily extends Texas’ 1115 Transformation Waiver

The Texas Health and Human Services Commission (“HHSC”) has been actively trying to reach an agreement with the Centers for Medicare and Medicaid Services (“CMS”) to extend or renew the Texas 1115 Transformation Waiver (the “Waiver”)since March 2015, when HHSC submitted its first iteration of a transition plan focused on a 5-year renewal. The result … Continue reading

FY 2017 Medicare Acute Care Hospital IPPS and LTCH PPS proposed rule policy highlights

On April 27, 2016, CMS published the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital Prospective Payment System (LTCH PPS) proposed rule for fiscal year (FY) 2017 in the Federal Register. Highlights from the proposed rule are explained in further detail below. Completion of Medicare Severity-Diagnosis Related Group (MS-DRG) $11 Billion Overpayment Recoupment … Continue reading

CMS publishes final rule addressing the reporting and returning of self-identified overpayments; detailed post to follow

This morning the Centers for Medicare and Medicaid Services issued a final rule that addresses the obligation of health care providers and suppliers to report and return overpayments by the later of 60 days from the date an overpayment is identified or the due date of any corresponding cost report. According to the CMS Fact … Continue reading

Increased focus on data analysis by government agencies

At a recent DC Bar program called “The Use of Data by the OIG-DHHS and CMS/CPI in Medicare Program Integrity, Investigations and Compliance,” representatives from CMS and the OIG provided their perspectives on the evolving capabilities of government agencies to review and analyze large datasets related to the provision and reimbursement of healthcare services.… Continue reading

DOJ announces US$3.5bn of FCA recoveries in FY 2015

Biggest year ever for declined qui tams   On December 3, 2015, the Department of Justice announced that it had recovered more than US$3.5 billion in settlements and judgments from civil cases involving fraud and false claims against the government in the fiscal year ending Sept. 30.  According to DOJ’s press release, “US$1.9 billion came … Continue reading