On March 1, 2017, the Joint Commission issued a Sentinel Event Alert warning of the link between inadequate safety cultures within health care organizations and a rise in the occurrence of adverse events, and further urging health care organization leadership to adopt a culture of safety through formal initiatives and a top-down model behavioral approach. … Continue reading
On February 15, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to stabilize the individual and small group health insurance market by increasing incentives for individuals to maintain enrollment in health plans, decreasing incentives to enroll in coverage only after healthcare services are needed, and reducing the regulatory burdens for … Continue reading
On January 17, 2017, the Centers for Medicare & Medicaid Services (“CMS”) finalized certain changes to the Medicare appeals process, with the intent to provide increased transparency and efficiency to cure the current backlog in pending appeals. According to CMS, the number of requests for an Administrative Law Judge (“ALJ”) hearing or review pending at … Continue reading
On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. (“Egalet”) for use in the management of pain severe enough to require long-term opioid treatment, and where alternative treatment options are inadequate. In its approval, FDA explains that typical post-marketing surveillance of adverse … Continue reading
CMS announced on December 15, 2016 that it will not pursue its plans to finalize a proposed rule that would have created a pilot program to test a new Medicare Part B prescription drug reimbursement model. CMS explained that while the rule garnered some support, numerous stakeholders “expressed strong concerns” about the proposed reimbursement model. … Continue reading
On November 16, 2016, the Centers for Medicare & Medicaid Services (“CMS”) hosted a 2016 MLN Connects National Provider Call (“Provider Call”) for purposes of outlining the parameters of the 2016 Hospital Appeals Settlement Process, which CMS initially launched in August 2014 for certain eligible inpatient provider types. During the 2014 Hospital Appeals Settlement Process, … Continue reading
On November 7, 2016, the U.S. District Court for the Northern District of Mississippi granted a preliminary injunction against CMS’s enforcement of the mandatory pre-dispute arbitration agreement ban, which has recently triggered a flurry of litigation. As the Order explains, in enacting the final rule promoting the pre-dispute arbitration ban, CMS relied fundamentally upon disparities in … Continue reading
On November 1, 2016, CMS issued its Calendar Year (CY) 2017 Outpatient Prospective Payment System (OPPS) final rule with comment period. CMS also issued an interim final rule with comment period that establishes Medicare Physician Fee Schedule (MPFS) rates for certain items and services furnished by certain hospital off-campus outpatient departments. Significant provisions of the … Continue reading
On October 28, 2016, the U.S. Supreme Court accepted review of a case involving the enforceability of pre-admission arbitration agreements. The case is brought by Kindred Nursing Centers, who filed a petition for writ of certiorari on July 1, 2016, challenging the Kentucky Supreme Court’s refusal to enforce the parties’ arbitration agreements on the basis … Continue reading
On October 14, 2016, CMS issued the “Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models” final rule with comment period. MIPS and Advanced APMs are the two ways for health care providers to participate in the CMS Quality Payment Program that … Continue reading
In response to the recent Centers for Medicare & Medicaid Services (“CMS”) final rule prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with its residents (the “Arbitration Rule”), several plaintiffs (including the American Health Care Association and other long-term care facility (“LTC”) providers) collectively filed a complaint on October 17, 2016 against CMS … Continue reading
On October 4, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule that implements sweeping changes to the requirements long-term care facilities (“LTCs”) must meet to participate in the Medicare and Medicaid programs. These new and modified requirements offer heightened protections for residents. Most notably, the final rule prohibits Medicare and … Continue reading
The Department of Health and Human Services and its Office of Civil Rights (OCR) are capping off a very active 2016. In the last 6 months, the OCR has released a new audit protocol, announced new rounds of HIPAA audits, and stepped up enforcement. The flurry of activity comes after a prolonged period of anticipation in … Continue reading
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
On July 26, 2016, the FDA issued draft guidance to help clarify the form and content requirements of the Unique Device Identifier (UDI). Industry groups have 60 days to comment on the draft guidance. Background The UDI final rule, which established the UDI system, was published on September 24, 2013. The rule aims to develop … Continue reading
In response to the most recent Zika virus outbreak in the Wynwood neighborhood of Miami, Florida, the Centers for Disease Control and Prevention (“CDC”) issued an immediate travel warning advising all pregnant women against traveling to the Wynwood neighborhood at this time.… Continue reading
On July 13, 2016, the Senate passed by 92-2 vote the Comprehensive Addiction and Recovery Act of 2016 (S. 524), a comprehensive set of 18 bills targeting the opioid crisis, which bill the U.S. House of Representatives approved in a 407-5 vote on July 8, 2016.… Continue reading
On June 12, 2016, the HHS Office of Civil Rights (OCR) released guidance, entitled “FACT SHEET: Ransomware and HIPAA,” in response to the rising number of ransomware attacks perpetrated against healthcare entities. The guidance addresses Health Insurance Portability and Accountability Act (HIPAA) issues that may arise when medical records containing Protected Health Information (PHI) are compromised … Continue reading
On July 6, 2016, CMS published its Calendar Year (CY) 2017 Outpatient Prospective Payment System (OPPS) Proposed Rule. We provide a more detailed analysis of the significant proposals to our July 6 post below.… Continue reading
On July 6, 2016, the Centers for Medicare & Medicaid Services (CMS) published its Calendar Year (CY) 2017 Outpatient Prospective Payment System Proposed Rule. We will be providing an in-depth analysis of all significant proposals shortly. In the interim, we note that significant provisions of the rule would implement Bipartisan Budget Act of 2015 Section … Continue reading
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. … Continue reading
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 … Continue reading
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.… Continue reading
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act. MAT involves the use of medication in combination with certain behavioral … Continue reading