On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates the Medicare Physician Fee Schedule (PFS) rates and policies for calendar year (CY) 2020 and expands Medicare coverage to opioid treatment programs (OTPs) that treat beneficiaries with opioid use disorder (OUD). In a fact sheet accompanying the final rule, CMS explains that “this final rule is one of several rules that reflect a broader Administration-wide strategy to…

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) published its CY 2020 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule.  The final rule implements a number of significant changes to payment policies and rates for services furnished to Medicare beneficiaries in hospital outpatient departments and ambulatory surgical centers. Updates to OPPS Payment Rates In the final rule CMS increases Medicare OPPS payment…

On October 21, 2019, U.S. District Judge Rosemary M. Collyer denied the government’s request to modify the Court’s previous ruling on September 17, 2019, that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority when it reduced Medicare payment rates for clinic visit evaluation and management (E&M) services provided to Medicare patients in hospital excepted off-campus provider-based departments. Congress in the Bipartisan Budget Act of 2015 generally reduced Medicare payments for services…

On August 2, 2019, the Centers for Medicare & Medicaid Services (CMS) published its Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System (PPS) final rule (CMS-1716-F). The final rule is scheduled to be published in the Federal Register on August 16, 2019. CMS also published a fact sheet describing the proposed rule, which may be found here. This final rule…

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices.  A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, device manufacturers rely on predicate devices to demonstrate the safety and efficacy of a new device.  The guidance expands the…

On June 5, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to revise requirements established by the Reform of Requirements for Long-Term Care Facilities final rule (2016 Final Rule). Specifically, the proposed rule would remove regulations prohibiting long-term care facilities from entering into pre-dispute arbitration agreements with residents or their caretakers and revise the requirements arbitration agreements must meet. CMS reviewed the 2016 final rule for consistency with the 2017…

Following a series of thwarted efforts and delays, on May 4, 2017, the U.S. House of Representatives passed by a narrow margin of 217-213 the American Health Care Act of 2017 (H.R. 1628) (AHCA), a plan to repeal and replace the Affordable Care Act. The Congressional Budget Office and Joint Committee on Taxation first estimated that the initial version of the bill would reduce the federal budget deficit by $337 billion from 2017-2026,…