Hayley Coley (US)

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COVID-19 Update: US Supreme Court decisions stay OSHA ETS, uphold CMS vaccine mandate

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

CMS Publishes Final Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities

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

CMS issues proposed rule repealing Medicare pending new “reasonable and necessary” definition and HHS issues proposed rule implementing provisions of the No Surprises Act

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

CMS issues 2022 OPPS proposed rule

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

ACA Survives “[T]hird Installment in [U.S. Supreme Court’s] epic Affordable Care Act [T]rilogy”

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

HHS Issues Final Rule Requiring Retrospective Review of Regulations

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

COVID-19 Update: Healthcare provisions (Including Medicare GME Revisions) in the Consolidated Appropriations Act, 2021

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

D.C. Circuit Upholds CMS Price Transparency Rule

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

Congress Passes Surprise Medical Bill Legislation

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

CMS releases special alert on monitoring hospital compliance with price transparency requirements

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

CMS releases proposed interoperability rule to improve prior authorizations and the electronic exchange of healthcare data

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

COVID-19 Update: CMS Releases Fourth COVID-19 Interim Final Rule with Comment Period

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

COVID-19 Update: HHS Renews COVID-19 Public Health Emergency Declaration

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

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda. The MFAR, which was proposed in November of 2019, would have added new reporting requirements for state governments to receive state … Continue reading

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies 

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

CMS Issues FY 2021 IPPS and LTCH PPS Final Rule

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

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

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

HHS Issues Proposed Rule on Good Guidance Practices

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

CMS Publishes CY 2021 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule

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

President Trump unveils executive orders on lowering drug prices

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

Court of Appeals Upholds HHS Site-Neutral Payment Cuts to Off-Campus Provider Based Departments

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

COVID-19 Update: CMS releases guide encouraging patients to seek in-person healthcare

On Tuesday, June 9, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a guide for patients who are considering their in-person care options following certain healthcare facilities re-opening for all medical services. As COVID-19 cases decline in some areas of the country, CMS created this guide to give patients recommendations, and to help … Continue reading

U.S. Supreme Court Rules that the Federal Government “Shall” Pay Health Insurers $12 Billion Under the Risk Corridors Program

On Monday, April 27, 2020, the U.S. Supreme Court ruled, in an 8-1 decision, that the federal government is required to pay health insurers $12 billion under the Patient Protection and Affordable Care Act’s (ACA) risk corridors program. Background of the Case Congress in the ACA created three premium stabilization programs to support insurers during … Continue reading
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