In a 6-3 decision handed down on Thursday, January 13, 2022, the US Supreme Court ordered a stay on the federal OSHA COVID “vaccine-or-test” Emergency Temporary Standard (ETS). The stay is predicated on the Court’s finding that the petitioners’ challenges to the ETS are likely to succeed and will remain in effect until a final … Continue reading
On November 12, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued its final guidance for hospitals to clarify how CMS and state agency surveyors will evaluate space-sharing or contracted staff and service arrangements with other hospitals or healthcare providers for compliance with the Medicare Conditions of Participation (“CoPs”). According to CMS, “[c]o-location occurs … Continue reading
On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring that Medicare-certified providers implement policies for vaccination of all health care workers against COVID-19. Compliance with the requirement will be a Condition of Participation in the Medicare program, and providers may be subject to survey, requests for … Continue reading
On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”)released its Calendar Year (“CY”) 2022 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System final rule. This final rule is scheduled to be published in the Federal Register on November 16, 2021. In the final rule, CMS implements … Continue reading
On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts A and B scheduled to go into effect on December 15, 2021. Proposing to repeal … Continue reading
On Monday, July 19, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released its Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) proposed rule for Calendar Year (“CY”) 2022. In the proposed rule, CMS proposes a net increase of 2.3 percent in Medicare OPPS rates from CY 2021 to 2022 for … Continue reading
On Thursday, June 17, 2021, in a 7-2 opinion, the U.S. Supreme Court upheld the Affordable Care Act (“ACA”) in the case California v. Texas. The Court held that Texas, the other plaintiff states, and the two individual plaintiffs did not have standing to challenge as unconstitutional the ACA’s minimum essential coverage provision. The plaintiffs … Continue reading
On Friday, January 8, 2021, the Department of Health and Human Services (“HHS”) released a final rule that would provide HHS with five years to review existing regulations that are more than ten years old, subject to certain exceptions, to determine if each regulation is still necessary. HHS will be permitted to extend this deadline … Continue reading
On December 27, 2020, President Trump signed into law the fourth round of COVID-19 emergency relief that passed both the U.S. Senate and the U.S. House of Representatives. The Consolidated Appropriations Act, 2021 (“Act”) includes approximately $900 billion in pandemic relief and is reportedly the longest bill (5,593 pages) to be passed in Congress’s history. … Continue reading
On December 29, 2020, three days before the implementation date, the U.S. Court of Appeals for the D.C. Circuit upheld the Centers for Medicare & Medicaid Services (“CMS”) price transparency final rule. Beginning January 1, 2021, hospitals will be required to make public their standard charges for 300 shoppable services, including 70 services identified by … Continue reading
After two years of negotiations Congress has enacted legislation to protect patients from certain surprise medical bills as part of Consolidated Appropriations Act, 2021. The No Surprises Act (the “Act”) amends the Public Health Services Act and will take effect on January 1, 2022. While several states have passed surprise billing protections in recent years … Continue reading
On Friday, December 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a special alert to remind hospitals that the Hospital Price Transparency final rule (“final rule”) requirements are effective starting January 1, 2021 and that CMS will monitor a “sample of hospitals” when the final rule goes into effect to determine compliance … Continue reading
On December 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the prior authorization process and to add new requirements for state Medicaid and Children’s Health Insurance Program (“CHIP”) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges … Continue reading
On Wednesday, October 28, 2020, the Centers for Medicare & Medicaid Services (“CMS”), with the Departments of Treasury and Labor, issued a fourth interim final rule (“IFR”) with comment period addressing the public health emergency (“PHE”). The policies in the IFR will become effective upon publication in the Federal Register. The IFR’s stated goal is … Continue reading
On October 2, 2020, Secretary Azar of the Department of Health and Human Services (“HHS”) renewed his public health emergency (“PHE”) declaration because of “the continued consequences” of the COVID-19 pandemic. This renewal will become effective on October 23, 2020 when the previous July 23 renewal was set to expire and will continue to January … Continue reading
On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would establish a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (“MCIT”), for medical devices that are designated by the Food and Drug Administration (“FDA”) as breakthrough devices. Under the proposed MCIT pathway, CMS would provide national … Continue reading
On Wednesday, September 2, the Centers for Medicare & Medicaid Services (CMS) issued the FY 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule. The final rule is scheduled to be published in the Federal Register on September 18 and most of its provisions will be effective … Continue reading
On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … Continue reading
On Tuesday, August 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published the calendar year (“CY”) 2021 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System proposed rule. The proposed rule would increase hospital Medicare OPPS payment rates by 2.6 percent and ASC payment rates by 2.6 percent … Continue reading
On Monday, August 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the CY 2021 Physician Fee Schedule (PFS) proposed rule. We describe certain material provisions from the proposed rule below. Telehealth CMS proposes to add services to the Medicare telehealth list on a Category 1 basis. The additional services include group psychotherapy, … Continue reading
On Friday July 31, 2020 the U.S. Circuit Court of Appeals for the District of Columbia Circuit reversed the federal district court and permitted reimbursement cuts for drugs purchased through the 340B Drug Discount Program.… Continue reading
On Friday, July 24, 2020, President Trump issued three executive orders, and announced a potential fourth executive order, with the stated intention of lowering the cost of prescription drugs in the United States. The general consensus among legal commentators is that the executive orders are not self-executing and implementation of the policies therein will, therefore, … Continue reading
On Friday, July 17, 2020, the Court of Appeals for the District of Columbia found in favor of the U.S. Department of Health and Human Services (“HHS”) by holding that Medicare Part B payment cuts to certain services provided to Medicare beneficiaries in off-campus provider-based departments (“PBDs”) are within the agency’s statutory authority. More specifically, … Continue reading