Tag archives: HHS

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

COVID-19 Update: President Trump Issues Executive Order on Hoarding

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 24, 2020 Posted in Coronavirus, General, News from DC

On March 23, 2020 President Trump signed an Executive Order directing the Secretary of HHS, under the authority of the Defense Production Act, to “prevent hoarding of health and medical resources necessary to respond to the spread of COVID-19 within the United States.” It also delegates to the Secretary of HHS the: [A]uthority to prescribe … Continue reading

COVID-19 Update: HHS Declaration Provides Liability Immunity Related to Certain COVID-19 Countermeasures

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

The Public Readiness and Emergency Preparedness Act provides the Secretary of HHS authority to issue a declaration providing immunity to certain individuals and entities during a public health emergency. On March 17, 2020, the U.S. Secretary of Health and Human Services published a Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures … Continue reading

COVID-19 Update: Trump administration expands access to telehealth services for Medicare beneficiaries to combat COVID-19

By Yvonne Puig (US), Daphne Calderon (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on March 17, 2020 Posted in Coronavirus, General, Regulatory

On Tuesday, March 17, 2020, the Trump administration announced that it will immediately expand access to telehealth services for all Medicare beneficiaries during the COVID-19 outbreak. In coordination with this announcement, the Office for Civil Rights at the Department of Health & Human Services (HHS) released a notification stating that HHS has temporarily suspended certain … Continue reading

COVID-19 Update: US Expands Travel Restrictions After First Fatality

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on March 2, 2020 Posted in Coronavirus, General

On Saturday, the State of Washington announced the first fatality in the United States arising from the coronavirus, with a second announced on Sunday. Washington Governor Jay Inslee has declared a state of emergency. As of Monday March 2, 2020, there were 89,197 total confirmed cases of COVID-19 worldwide and 3,048 resulting deaths. U.S. Secretary … Continue reading

COVID-19 Update: Over 60,000 Confirmed Cases

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on February 14, 2020 Posted in Coronavirus, General, International

Earlier this week the WHO announced that COVID-19 would be the name for the disease caused by the coronavirus. On Wednesday, China announced 14,840 new cases of the coronavirus after changing the way cases are confirmed to include where a test was negative but other methods such as symptoms and x-rays show evidence of the … Continue reading

HHS Memorandum Addresses Implications of Allina Decision

By Chandra Westergaard (US) and Jeff Wurzburg (US) on November 26, 2019 Posted in News from DC

On November 21, an internal HHS memorandum addressed to Centers for Medicare & Medicaid Services (CMS) Principal Deputy Administrator Demetrios Kouzoukas entitled “Impact of Allina on Medicare Payment Rules” became publicly available. The memorandum addresses the HHS Office of the General Counsel’s (OGC) “views on the impact of Azar v. Allina Health Services, 139 S. … Continue reading

Allina Update: Supreme Court holds Medicare statute requires notice and comment for DSH payment change

By Yvonne Puig (US), Thomas Dowdell (US), Frances Morgan (US) and Jeff Wurzburg (US) on June 4, 2019 Posted in News from DC

In a decision with potentially far reaching implications for Medicare hospital reimbursement, on June 3 the U.S. Supreme Court ruled 7-1 against the U.S. Department of Health and Human Services (“HHS”) in Azar v. Allina Health Services. The Court affirmed the U.S. Court of Appeals for the D.C. Circuit decision that vacated a rate calculation … Continue reading

MEDICAID ALERT: Work and community engagement requirements blocked by federal court

By Jeff Wurzburg (US) on March 28, 2019 Posted in News from DC

“As Opening Day arrives, the Court finds its guiding principle in Yogi Berra’s aphorism, “It’s déjà vu all over again.”” – Judge James Boasberg, Gresham v. Azar. On March 27, United States District Court for the District of Columbia Judge James Boasberg ruled that Department of Health & Human Services Secretary Azar’s approval of work … Continue reading