The Centers for Medicare and Medicaid Services (CMS) has promulgated a proposed rule that makes numerous revisions to the appeals process for Medicare claims. If finalized, this proposed rule will mainly clarify the existing regulations regarding the Medicare appeals process. It will, however, also add two key concepts to help streamline the appeals process.
In one of the most closely watched cases of this term, a divided Supreme Court struck down Texas’s abortion law, finding that it constituted an undue burden on a woman’s right to obtain an abortion.
On June 23, 2016, the Senate Agriculture Committee agreed to a bipartisan deal that would set a national standard for GMO labeling. The National Bioengineered Food Disclosure Standard would amend The Agricultural Marketing Act of 1946 by setting forth mandatory disclosure requirements for GMO food products, while providing a variety of options to the industry on how to provide consumers with this required information. The deal comes a week before Vermont’s own version of a mandatory GMO labeling law is set to take effect. If the bipartisan bill is passed, then the national standards would pre-empt Vermont’s law. Industry groups are showing support for the bill as they want to avoid the challenges of complying with varying state GMO labeling requirements. The race is now on to get the bill passed in the Senate before the July 1 effective date of the Vermont law; however, the House of Representatives is on break until July 5, which guarantees delaying the possibility of any passage of the bill into law until after the Vermont law goes into effect.
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 false billings.
On June 17, 2016, CMS published the “Medicare Clinical Diagnostic Laboratory Tests Payment System” final rule. Among the key changes in this final rule, CMS has revised the Medicare Clinical Laboratory Fee Schedule (CLFS) such that payment for clinical diagnostic laboratory tests (CDLTs) beginning January 1, 2018 will reflect the weighted median of private payor rates.
On June 17, 2016, the Department of Health and Human Services’ Office of Inspector General (OIG) released a report entitled “CMS Is Taking Steps to Improve Oversight of Provider-Based Facilities, But Vulnerabilities Remain” (OEI-04-12-00380).
The OIG reviewed oversight by the
In a closely watched decision, the U.S. Supreme Court has unanimously endorsed a version of the “implied false certification” theory of liability under the False Claims Act (“FCA”). In a decision that leaves almost as many questions unanswered as it resolved, the Court held that a material omission on a claim for payment may give rise to liability where two conditions are met:
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.
On June 13, 2016, CMS published a proposed rule intended to revise the conditions of participation (CoPs) required for hospitals and critical access hospitals (CAHs) to participate in the Medicare and Medicaid programs, with a focus on quality of care.
Highlights from the proposed rule are outlined in further detail below.
On May 4, 2016, the U.S. Food and Drug Administration (FDA) signed a “systems recognition arrangement” with the Canadian Food Inspection Agency (CFIA) and Health Canada recognizing the comparability of the U.S. and Canadian food safety systems. This is only the second time that the FDA has recognized a foreign food safety system as comparable, with the only other recognized system being New Zealand signed in 2012. However, similar systems recognition arrangements are underway between the FDA and Australia and the European Commission.