Tag archives: healthcare

COVID-19 update: Trump issues Telehealth Executive Order

President Trump issued an Executive Order on August 3, 2020 that will continue the momentum for telehealth in rural areas.… Continue reading

Court of Appeals upholds 340B Reductions

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in News from DC

On Friday July 31, 2020 the U.S. Circuit Court of Appeals for the District of Columbia Circuit reversed the federal district court and permitted reimbursement cuts for drugs purchased through the 340B Drug Discount Program.… Continue reading

CMS publishes FY 2021 Skilled Nursing Facility, Inpatient Psychiatric Hospital, and Hospice Medicare Payment final rules

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 4, 2020 Posted in Enforcement, News from DC, Regulatory

All three of these Medicare payment final rules will become effective on October 1, 2020.… Continue reading

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

By Chandra Westergaard (US), Keith Rosen (US) and Rachel Park (US) on February 19, 2020 Posted in Enforcement, General

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

By Michael Koon (US), Carol Poindexter (US) and Zach Smith (US) on May 9, 2019 Posted in Enforcement

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

By Melissa Perry (CA) on July 21, 2017 Posted in International

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

By on July 17, 2017 Posted in Enforcement

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

By Melissa Perry (CA) on April 27, 2017 Posted in International

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

By on September 26, 2016 Posted in Enforcement

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

Withdrawal of life support from child in his best interests (UK)

By Sandra Sithole (ZA) on September 21, 2016 Posted in International

The mother of a 2-year old child who suffered grave injuries in a road traffic accident appealed against the court order obtained by the grandmother to withdraw all respiration and to treat the child only with pain relief, sedation and nursing as appropriate.… Continue reading

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

By Savannah Wiseman (US) on September 14, 2016 Posted in Enforcement

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

Australia trials “Health Care Homes”, a new model of primary health care

By Rohan Sridhar (AU) on August 15, 2016 Posted in International

Australia is set to trial a new model of primary health care based on the successful “Health Care Homes” programs in Canada and the United States. Australia’s version of the Health Care Homes scheme was proposed in broad terms in December 2015 by the Primary Health Care Advisory Group, in its Better Outcomes for People … Continue reading

CMS investment in preventing healthcare fraud brings $42 billion return

By Savannah Wiseman (US) on July 28, 2016 Posted in Enforcement

CMS’s annual report demonstrates that the government is becoming increasingly effective at ferreting out fraud and abuse from the healthcare system. With a 12-to-1 return on investment, the government will likely continue to make fighting healthcare fraud a priority.… Continue reading

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

By Yvonne Puig (US) and Eric Hoffman (US) on July 12, 2016 Posted in Regulatory

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

By on June 23, 2016 Posted in Enforcement

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

By Frances Morgan (US) on June 15, 2016 Posted in Regulatory

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

By Tamsen Barrett (US) on May 9, 2016 Posted in Regulatory

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

By Frances Morgan (US) on May 3, 2016 Posted in News from DC, Regulatory

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

By Thomas Dowdell (US) and Mark Faccenda (US) on April 28, 2016 Posted in Regulatory

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

Government healthcare fraud-and-abuse recovery drops to $2.4 billion in FY 2015

By on March 2, 2016 Posted in Enforcement

In a report released on February 26, 2016, the federal government announced that it recovered $2.4 billion through its Health Care Fraud and Abuse Control Program (HCFAC) during FY 2015. The $2.4 billion is almost $1 billion lower than the recovery of $3.3 billion in FY 2014. Over the last three years, the return on … Continue reading

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

By Thomas Dowdell (US) and Mark Faccenda (US) on February 11, 2016 Posted in Regulatory

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

By on January 20, 2016 Posted in Enforcement

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

Australian health and life insurers race into wearable technology

By Matthew Ellis (AU), Victoria Vilagosh (AU) and Zein El Hassan (AU) on December 8, 2015 Posted in International

Just as telematics has been supplementing motor vehicle insurance underwriting, Australia’s health and life insurance markets are embracing innovative technologies in the form of “wearables”.… Continue reading

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

By on December 4, 2015 Posted in Enforcement

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