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 individual physician or State, they are designed to guide a physician in his or her practice. Allegations of any violations of the Code of Medical Ethics, after a disciplinary hearing, could ultimately result in suspension or revocation of a physician’s AMA membership. Individual State agencies are responsible for issuing licenses and enforcing State law governing the practice of medicine, including ramifications of unethical behavior.
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 US $103 million dollars in grant funding for fiscal years 2017 through 2021, and makes the U.S. Department of Justice (DOJ) responsible for administering grants to state, local, and tribal governments to provide a range of opioid abuse services. These services include developing and expanding existing programs to combat opioid abuse, training first responders in administering opioid overdose reversal medication, and providing dedicated opioid treatment and prevention services for veterans. In March 2016, the Senate passed a similar measure, titled the Comprehensive Addiction and Recovery Act of 2016 (S. 524), which authorizes the Attorney General to award similar grants.
CMS proposed rule establishes new MACRA physician payment models
On April 27, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would implement changes to reimbursement under the Medicare Physician Fee Schedule (PFS) as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The proposed rule contains the following key elements: (i) a framework for the new Merit-based Incentive Payment System (MIPS), (ii) a methodology for making incentive payments for participation in alternative payment models (APMs), and (iii) proposed criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making recommendations on physician-focused payment models (PFPMs).
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 in section 503B of the FDCA. The FDA intends that its clarifying policies will ensure greater protections for patients whose needs cannot be met by an FDA-approved drug product.
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
NJ judge holds no causation where doctors testified they would prescribe again
A New Jersey state court judge recently found that plaintiffs could not establish proximate cause in 31 failure to warn claims where the prescribing physicians testified that their decision to prescribe the drug would not change even if the manufacturer had given a stronger warning regarding irritable bowel disease. See January 29, 2016 Order. Judge Nelson Johnson dismissed each of the inadequate warning cases relating to Defendant Hoffmann-La Roche Ltd.’s acne drug Accutane.
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, 2016, CMS is delaying compliance until July 1, 2017 for states whose legislatures meet in 2016 or until July 1, 2018 for all other states.
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.
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
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,