Tag archives: physicians

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

FTC and DOJ side with Texas-based Teladoc

The Federal Trade Commission (“FTC”), in a joint amicus brief with the Department of Justice filed on September 9, 2016, petitioned the Fifth Circuit to dismiss the Texas Medical Board (“TMB”) appeal of the district court ruling holding that TMB regulations restricting the prescribing rights of physicians providing professional services through telemedicine may be challenged … 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

FDA now demands its strongest black box warnings for certain opioid and other drugs

On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid medicines and benzodiazepines. FDA prepared a Drug Safety Communication directed to health care professionals and … Continue reading

Judge declines to certify order for appeal in Texas Teladoc case

On August 15, 2016, United States District Judge Robert Pitman denied the motion of the Texas Medical Board (“TMB”) to certify order for an immediate appeal of the court’s decision not to dismiss the Teladoc case.  The court previously denied the TMB’s attempt to have the case against it dismissed, which was brought by Teladoc … Continue reading

Physicians’ compensation structure results in $17M Stark Law fine and CIA for hospital

Lexington Medical Center (“LMC”), a 428-bed hospital in South Carolina, has agreed to pay $17 million to resolve allegations that it violated the federal False Claims Act (“FCA”), 31 U.S.C. §§ 3729 et seq., and Physician Self-Referral Law (“Stark Law”), 42 U.S.C. § 1395nn, by allegedly providing improper financial incentives to 28 physicians for referrals.… 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

House passes comprehensive opioid legislation in advance of negotiations with the Senate

During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016.  This bill authorizes … Continue reading

FDA establishes bright-line recommendations for human drug compounding

On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition … Continue reading

Paxil birth defect lawsuit cannot survive exclusion of evidence of later FDA warnings

Last week, the first of nine Paxil birth defect lawsuits in line for trial in Pennsylvania was dismissed after a judge excluded evidence of the drug’s later heightened FDA warning. Judge Kenneth Powell of the Philadelphia County Court of Common Pleas granted a compulsory nonsuit in favor of defendant GlaxoSmithKline PLC (“GSK”) after portions of … Continue reading

CMS issues final rule requiring face-to-face encounters for Medicaid home health services

On January 27, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule requiring documentation of face-to-face encounters for physicians ordering home health services and certain medical equipment for Medicaid beneficiaries as required by the Patient Protection and Affordable Care Act of 2010. While the final rule becomes effective on July 1, … Continue reading

GAO recommends the same Medicare payment rates for evaluation and management services performed in all provider settings

The United States Government Accountability Office (GAO) has recommended that Congress consider directing the Secretary of the Department of Health and Human Services (Secretary) to equalize Medicare payment rates for evaluation and management (E/M) services, and other services that the Secretary deems appropriate, performed in all provider settings. … Continue reading

CMS proposes Stark Law liberalizations

On July 8, CMS proposed significant changes to the Stark Law via a far-reaching proposed rule and commentary that would—and in a few cases may already—eliminate numerous technical traps under the current regulatory scheme. From eliminating time limitations in connection with ‘holdovers’ of existing arrangements, to affording greater flexibility in signature timing, to clarifying that … Continue reading

CMS proposes changes to the 2-midnight rule and updates to Medicare outpatient payments for CY 2016

On July 1, the Centers for Medicare & Medicaid Services (CMS) issued the proposed calendar year (CY) 2016 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule (collectively, OPPS rule). In the proposed OPPS rule, CMS (1) provides changes to its inpatient short hospital stay policy known as the 2-midnight … Continue reading

$237 million judgment against Tuomey stands

Tuomey Healthcare System Inc. owes the government $237.4 million after losing its Fourth Circuit appeal of a judgment imposed after a jury found the hospital liable for violations of the Stark self-referral law and the False Claims Act. Tuomey has stated that it would likely need to file for bankruptcy based on the damages imposed in … Continue reading

CMS releases 2014 Sunshine Act data

On schedule, CMS released the 2014 Sunshine Act data, which shows $6.49 billion in transfers of value by pharmaceutical and medical-device manufacturers to physicians and teaching hospitals.  The data covers 11.4 million financial transactions attributed to over 600,000 physicians and more than 1,100 teaching hospitals. Join us on July 8 or July 14 for a … Continue reading

Obamacare saved by Supreme Court

In a 6-3 decision credited with saving Obamacare, the Supreme Court ruled on Thursday that the premium subsidies offered to qualifying enrollees of insurance plans offered on federal exchanges, which help more than 6 million Americans pay for their health plans under Obamacare, are legal. The Court declined to apply Chevron [i] deference to an IRS … Continue reading

Two new OIG reports signal intensified scrutiny on Medicare Part D fraud

On the heels of the largest nationwide health care fraud takedown in history announced last week, the federal government on Tuesday issued two new reports detailing what it believes to be extensive evidence of suspicious billing under Medicare Part D. The move signals that the prescription drug benefit program can expect significant enforcement actions in … Continue reading