Topic: News from DC

President Biden declares monkeypox a public health emergency

By Yvonne Puig (US) and Daphne Calderon (US) on August 5, 2022 Posted in News from DC, Regulatory

The US is approaching 7,000 cases, the largest number of any country around the world. Of concern to the Administration is the nearly 80 percent increase in cases over the last 7 days. Of equal concern is the lack of more widespread availability of the vaccine and testing locations. Workplace safety is at the forefront … Continue reading

Congress Amends Federal Arbitration Act for Claims of Sexual Assault

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on February 25, 2022 Posted in General, News from DC

On February 10, 2022, senators observed that “[i]t has become increasingly clear that forced arbitration clauses have enabled sexual abusers to escape scrutiny while their victims are compelled to stay silent.” This is because “[f]orced arbitration clauses not only deny survivors their right to a day in court, they also conceal their allegations from public … Continue reading

FTC announces 2022 HSR thresholds

By Robin Adelstein (US), Amanda Wait (US), Vic Domen (US) and Gerald Stein (US) on January 26, 2022 Posted in General, News from DC, Regulatory

On January 24, 2022, the Federal Trade Commission (FTC) announced increased reporting thresholds under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Most importantly, the minimum “size-of-transaction” threshold will be increased from US $92 million to US $101 million; acquisitions below this threshold will not be reportable. The increases will apply to all transactions that close … Continue reading

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

By Kevin Mayer (US), Mark Faccenda (US) and Hayley White (US) on January 19, 2022 Posted in Coronavirus, General, News from DC

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

US OSHA issues COVID vaccine and testing Emergency Temporary Standard

By Kevin Mayer (US) on November 8, 2021 Posted in Coronavirus, News from DC, Regulatory

On Friday, November 5, 2021, the federal Occupational Safety and Health Administration (“OSHA”) published an Emergency Temporary Standard (“ETS”) “to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination.” The ETS compels covered employers to develop and enforce a mandatory COVID-19 vaccination policy unless … Continue reading

CMS issues Calendar Year 2022 OPPS/ASC Payment System final rule

By Mark Faccenda (US) and Thomas Dowdell (US) on November 4, 2021 Posted in General, News from DC, Regulatory

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

COVID-19 update: White House recommends COVID-19 booster shot for most Americans

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on August 18, 2021 Posted in Coronavirus, News from DC

On August 18, 2021, the Biden Administration announced with top US health officials a recommendation that Americans receive a COVID-19 booster shot eight months after their second dose was administered. The Administration is not recommending a booster for the one-dose Johnson & Johnson vaccine pending additional data. The statement began, “The COVID-19 vaccines authorized in … Continue reading

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

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on June 17, 2021 Posted in Enforcement, General, News from DC

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

COVID-19 Update – HHS OCR Releases Legal Guidance for Expanding Vaccine Access to People with Disabilities and Older Adults

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 14, 2021 Posted in Coronavirus, General, News from DC

On April 13, 2021, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) published a press release with resources, including from the Administration for Community Living (“ACL”) and the Office of the Assistant Secretary for Planning and Evaluation (“ASPE”), to improve access to vaccinations for individuals with disabilities and older adults. … Continue reading

Xavier Becerra Confirmed as HHS Secretary – Implications for Health System “all-or-nothing” clauses

By Marc Collier (US), Vic Domen (US) and Jeff Wurzburg (US) on March 19, 2021 Posted in General, News from DC

Xavier Becerra was confirmed as U.S. Secretary for Health and Human Services (“HHS”) on March 18, 2021. While the parameters of the Biden administration’s antitrust policy priorities and objectives are not yet clear, a groundbreaking lawsuit brought by Xavier Becerra while Attorney General of California offers important insight and warrants a close reexamination of managed … Continue reading

COVID-19 Update: Biden Executive Order Creates Special Enrollment Period

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 1, 2021 Posted in Coronavirus, General, News from DC

On January 28, 2021, President Biden issued an Executive Order entitled Executive Order on Strengthening Medicaid and the Affordable Care Act (“Executive Order”). “In light of the exceptional circumstances caused by the ongoing COVID-19 pandemic”, the Executive Order creates a special enrollment period in states that operate Federally-facilitated exchanges from February 15, 2021 – May … Continue reading

COVID-19 Update: US President Joe Biden Releases COVID-19 Roadmap and Executive Orders

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on January 22, 2021 Posted in Coronavirus, News from DC, Regulatory

On January 20, 2021, Joseph R. Biden was sworn in as the 46th President of the United States. Within hours of taking the oath, President Biden signed an executive order entitled Executive Order on Protecting the Federal Workforce and Requiring Mask-Wearing that requires wearing masks and encouraging social distancing in Federal buildings and on Federal … Continue reading

COVID-19 Update: Secretary Azar Extends Pubic Health Emergency

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 8, 2021 Posted in Coronavirus, General, News from DC

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

By Mark Faccenda (US), Andrew Roth (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 4, 2021 Posted in Coronavirus, General, News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 29, 2020 Posted in General, News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 22, 2020 Posted in News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 21, 2020 Posted in General, News from DC, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on December 14, 2020 Posted in General, News from DC, Regulatory

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

By Thomas Dowdell (US) on November 25, 2020 Posted in General, News from DC, Regulatory

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

By Joseph Keillor (US) and Jeff Wurzburg (US) on November 23, 2020 Posted in Enforcement, General, News from DC, Regulatory

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on November 4, 2020 Posted in Coronavirus, General, News from DC, Regulatory

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 23, 2020 Posted in Coronavirus, General, News from DC

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

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on October 12, 2020 Posted in Coronavirus, General, News from DC

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

By Yvonne Puig (US), Kevin Mayer (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 5, 2020 Posted in Coronavirus, News from DC, Regulatory

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