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COVID-19 Update: Secretary Azar Extends Pubic Health Emergency

On January 6, 2021 U.S. Department of Health and Human Services Secretary Alex Azar renewed the Public Health Emergency declaration, effective January 21, 2021.  In a tweet, Secretary Azar announced the renewal and stated that “[o]ur work to combat the virus will continue, as will our work to ensure a peaceful and orderly transition.”  The … 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

CMS Announces New Acute Hospital Care At Home Program and Additional Flexibility in the Hospitals Without Walls Program

On Wednesday, November 25, the Centers for Medicare & Medicaid Services (CMS) announced its new Acute Hospital at Home program and additional regulatory flexibility in its Hospitals Without Walls program. The Acute Hospital Care at Home program is for beneficiaries who require acute inpatient admission to a hospital and who require at a minimum daily … Continue reading

Healthcare Regulatory Landscape Transformed by Stark, AKS Final Rules

In what may prove to be the most substantial fraud and abuse rulemaking in over a decade, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) and Centers for Medicare & Medicaid Services (“CMS”) published on November 20, 2020 long-awaited final rules changing the regulations addressing the Anti-Kickback Statute (“AKS”) and … 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: CDC Updates Guidance on Public Transportation and Close Contacts

The U.S. Centers for Disease Control (“CDC”) continues to update COVID-19 guidance as more information is known about how the coronavirus spreads.   On October 21, 2020, the CDC made a significant update to the definition of “close contact”.  Individuals that have spent 15 cumulative minutes within six feet of an infected individual during a 24-hour … 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

COVID-19: OSHA Updates and Reporting Requirements

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19.  Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic.   OSHA recently updated its COVID-19 … Continue reading

President Trump Signs Most Favored National Executive Order

President Trump signed a controversial Executive Order on September 13, 2020  entitled Executive Order on Lowering Drug Prices by Putting America First  with the intention of tying drug costs paid by the Medicare program to the costs borne by countries that have national health systems.   The Executive Order provides that “[i]t is the policy of … Continue reading

Supreme Court to Hold Oral Arguments on Certain Republican States’ Challenge to the ACA on November 10

The U.S. Supreme Court will hear oral arguments on certain red states’ challenge to the Affordable Care Act on November 10, one week after the November 3 presidential election, according to the court’s online docket released on Wednesday, August 19.  The central argument in the case is whether the entire ACA is invalid without a … Continue reading

COVID-19 Update: Trump Issues ‘Buy American’ Executive Order Related to Drugs

On August 6, 2020 President Trump signed an Executive Order on Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States.  The Executive Order states that “the domestic supply chains must be capable of meeting national security requirements for responding to threats arising from CBRN (chemical, biological, radiological, and nuclear) threats … Continue reading

COVID-19 Update: Senators Release Liability Protection Draft Legislation

On July 27, 2020, Senators Mitch McConnell (R-KY) and John Cornyn (R-TX) released the SAFE TO WORK Act (“the Act”).   The Act was released as part of the Senate Republicans draft coronavirus legislation, the HEALS Act, which stands for Health; Economic Assistance; Liability protection; and Schools.  The Act seeks to limit liability for healthcare providers … 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

COVID-19 Update: CDC Issues Guidelines for Events and Gatherings

On Friday June 12 the U.S. Centers for Disease Control and Prevention (CDC) published guidelines for events and gatherings ranging from lowest risk (virtual-only) to highest risk (large, in-person, where difficult to space at least six feet apart and attendees come from other areas).  The guidelines arrive at a time when cities and states have … Continue reading

CMS Announces COVID-19 Adjustments for CMMI Models

On June 3, 2020, Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced adjustments to the Center for Medicare and Medicaid Innovation (“CMMI”) models in light of the COVID-19 public health emergency.  Despite the accommodations being provided, Administrator Verma praised value-based incentives in a Health Affairs blog post, stating that “[t]hese models are … Continue reading

COVID-19 Update: CDC Releases Interim Guidelines on Antibody Testing

On May 24, 2020 the U.S. Centers for Disease Control (“CDC”) issued interim guidelines for COVID-19 antibody tests.  The CDC states that data on serologic testing is “rapidly evolving” and “will have an important public health and clinical uses to monitor and respond to the COVID-19 pandemic.”  The interim guidelines specifically address: Development of Antibodies … Continue reading

CMS Proposed Rule Includes Significant Changes to Medicare GME Funding

On May 11, 2020, the Centers for Medicare & Medicaid Services (CMS) issued its Fiscal Year (FY) 2021 hospital inpatient prospective payment system (IPPS) and long term care hospital (LTCH) prospective payment system (PPS) proposed rule. We previously reported on the hospital IPPS and LTCH PPS proposed changes. See link here . In this rulemaking, … Continue reading
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