Tag archives: HHS

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

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

COVID-19 Update: CDC Increasing Sequencing for Virus Variants

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 26, 2021 Posted in Coronavirus, General

The Biden Administration recently announced additional funding to increase genomic sequencing of COVID-19 to 25,000 samples a week. In a recent article in the Journal for the American Medical Association, U.S. Centers for Disease Control and Prevention (“CDC”) Director Rochelle Walensky and Dr. Anthony Fauci of the U.S. National Institute of Allergy and Infectious Diseases … Continue reading

HHS Issues Final Rule Requiring Retrospective Review of Regulations

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on January 11, 2021 Posted in General, Regulatory

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

CMS Publishes 2021 Hospital OPPS and ASC Final Rule

By Jeff Wurzburg (US) and Thomas Dowdell (US) on December 4, 2020 Posted in General, Regulatory

The Centers for Medicare & Medicaid Services (“CMS”) has published the Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) final rule for CY 2021. CMS finalized an annual increase OPPS and ASC rates of 2.4 percent for CY 2021, based on a 2.4 percent market basket update and without a cut for … 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: 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

HHS Issues Proposed Rule on Good Guidance Practices

By Jeff Wurzburg (US), Thomas Dowdell (US) and Hayley White (US) on August 25, 2020 Posted in Coronavirus, General, Regulatory

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

Court of Appeals upholds 340B Reductions

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in News from DC

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

President Trump unveils executive orders on lowering drug prices

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 30, 2020 Posted in Coronavirus, Enforcement, General, News from DC

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

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on July 20, 2020 Posted in Coronavirus, Enforcement, General

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

CMS Administrator Publishes Blog Post on Expansion of Medicare Telehealth Services

By Thomas Dowdell (US), Jeff Wurzburg (US) and Rachel Park (US) on July 17, 2020 Posted in Coronavirus, General, Regulatory

On Wednesday, July 15, 2020, Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, published a blog post on the Health Affairs Blog discussing CMS’ efforts to expand telehealth for Medicare beneficiaries during the COVID-19 pandemic and reviewing the potential of adopting some flexibilities as permanent measures. Historically Medicare has covered telehealth … Continue reading

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

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on May 6, 2020 Posted in Enforcement, General, News from DC

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

COVID-19 Update: Highly-Impacted and Rural Hospital Distribution Imminent

By Jeff Wurzburg (US) and Frances Morgan (US) on May 3, 2020 Posted in Coronavirus, General

On the evening of May 1, 2020, HHS announced that it will distribute an additional $22 billion in payments from the Provider Relief Fund to hospitals with high volumes of COVID-19 patients ($12 billion) and rural hospitals ($10 billion) in the coming days. Qualifying hospitals will receive funds via direct deposit and will likely be … Continue reading

COVID-19 Update: HHS Issues Omnibus Advisory Opinion Regarding PREP Immunity

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

The HHS Office of the General Counsel has released an important Advisory Opinion that provides insight regarding the interpretation and application of the Secretary’s March 17, 2020 Declaration, which is retroactively effective beginning February 4, 2020. (HL Pulse discussion here). The Declaration provides immunity to certain individuals and entities for liability against “all claims for … Continue reading

HHS Releases Information on Remaining CARES Act Provider Relief Fund Payments

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on April 22, 2020 Posted in Coronavirus, General, News from DC

On April 21, 2020, the U.S. Department of Health and Human Service (“HHS”) announced how the remaining $70 billion of CARES Act funds in the Public Health and Social Services Emergency Fund (“Relief Fund”) will be distributed. HHS explained that $50 billion of the Relief Fund is allocated for general distribution. Between April 10 and … Continue reading

Healthcare and Coronavirus Testing Funding in the $484 Billion Relief Package

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 22, 2020 Posted in Coronavirus, General, News from DC

On Tuesday, April 21, the U.S. Senate approved a $484 billion coronavirus relief package aimed at reviving the depleted loan program for small businesses and providing funds for hospitals and coronavirus testing. The House of Representatives is expected to vote on the legislation as soon as Thursday morning. On top of the $100 billion allotted … Continue reading

COVID-19 Update: Behavioral healthcare regulatory changes and considerations during the COVID-19 outbreak

By Purvi Maniar (US), Sarah Jean Kilker (US) and Hayley White (US) on April 17, 2020 Posted in Coronavirus, General, Regulatory

Throughout the COVID-19 pandemic, there have been a multitude of regulatory changes and strategies adopted in an effort to provide the American healthcare system with added flexibilities during this public health crisis. With the stress of these uncertain and isolating times, mental health and substance-use disorder (SUD) patients are particularly at risk. In a recent … Continue reading

COVID-19 Update: HHS Releases Details of CARES Act Provider Relief Fund

By Jeff Wurzburg (US), Thomas Dowdell (US) and Mark Faccenda (US) on April 10, 2020 Posted in Coronavirus, General, News from DC

On Friday morning April 10, the U.S. Department of Health and Human Services (“HHS”) released details regarding the first $30 billion in payments under the CARES Act. The CARES Act provides a total of $100 billion in relief funds to providers “to support healthcare-related expenses or lost revenue attributable to COVID-19 and to ensure uninsured … Continue reading

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 31, 2020 Posted in Coronavirus, General, Regulatory

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients. However, this “strategy should only be … Continue reading

COVID-19 Update: Senate Unanimously Passes Emergency Stimulus Package

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, News from DC

The United States Senate has passed a $2 trillion phase three emergency package, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The Senate approved the CARES Act on a unanimous vote of 96-0, with three Senators in self-quarantine and another returning home out of an abundance of caution. The CARES Act, assuming it … Continue reading

AHA seeks clarification from HHS regarding EMTALA and HIPAA waivers

By Thomas Dowdell (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, Regulatory

In a letter dated March 25, 2020, the American Hospital Association (AHA) has requested that the U.S. Department of Health & Human Services (HHS) consider clarification for waivers relating to the Emergency Medical Treatment and Labor Act (EMTALA) and the Health Insurance Portability and Accountability Act (HIPAA). HHS recently published two waivers specific to EMTALA … Continue reading

COVID-19 Update: HHS Issues Notice of Designation to Prevent Hoarding and OIG launches COVID-19 Portal

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 26, 2020 Posted in Coronavirus, General, Regulatory

On March 25, in response to President Trump’s Executive Order, HHS issued a Notice of Designation a list of health and medical resources necessary to respond to COVID-19 that are necessary to combat the spread of the disease. The Defense Production Act “prohibits any person from accumulating designated materials (1) in excess of the reasonable … Continue reading