Topic: News from DC

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

By Thomas Dowdell (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in General, News from DC, Regulatory

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 7, 2020 Posted in Coronavirus, General, News from DC

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: Trump issues Telehealth Executive Order

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 4, 2020 Posted in Coronavirus, Enforcement, News from DC

President Trump issued an Executive Order on August 3, 2020 that will continue the momentum for telehealth in rural areas.… 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

CMS publishes FY 2021 Skilled Nursing Facility, Inpatient Psychiatric Hospital, and Hospice Medicare Payment final rules

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

All three of these Medicare payment final rules will become effective on October 1, 2020.… Continue reading

COVID-19 Update: Senators Release Liability Protection Draft Legislation

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on July 31, 2020 Posted in Coronavirus, General, News from DC

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

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

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 15, 2020 Posted in Coronavirus, General, News from DC

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

By Jeff Wurzburg (US) and Thomas Dowdell (US) on June 3, 2020 Posted in Coronavirus, General, News from DC

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 27, 2020 Posted in Coronavirus, General, News from DC

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

By Andrew Roth (US) and Thomas Dowdell (US) on May 20, 2020 Posted in General, News from DC, Regulatory

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

COVID-19 Update: CDC Releases Guidance for Reopening

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 14, 2020 Posted in Coronavirus, General, News from DC

On May 14, 2020, the U.S. Centers for Disease Control (“CDC”) published voluntary guidance that provides checklists for reopening certain workplaces and activities. The decision tools state that “[i]t is important to check with state and local health officials and other partners to determine the most appropriate actions while adjusting to meet the unique needs … Continue reading

COVID-19 Update: FBI Warns of Hackers Targeting COVID-19 Research

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 13, 2020 Posted in Coronavirus, General, News from DC

In a Public Service Announcement issued May 13, 2020, the U.S. Federal Bureau of Investigation (“FBI”) and Cybersecurity and Infrastructure and Security Agency (“CISA”) warned of the targeting and compromise of U.S. organizations conducting COVID-19 research. More specifically, the announcement warns that “actors have been observed attempting to identify and illicitly obtain valuable intellectual property … 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: Senate Committee Announces “Aggressive Oversight” of Small Business Paycheck Protection Program loans

By Jeff Wurzburg (US) and Hayley White (US) on April 23, 2020 Posted in Coronavirus, General, News from DC

On Monday, April 20, 2020, Senator Marco Rubio (R-FL) announced, in his role as Chairman of the Committee on Small Business and Entrepreneurship, that “the Committee would conduct aggressive oversight” of loans already made pursuant to the Paycheck Protection Program (PPP). Under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, the PPP authorizes qualified … 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: Provider Relief Fund Attestation Portal Opens

By Mark Faccenda (US), Frances Morgan (US) and Jeff Wurzburg (US) on April 17, 2020 Posted in Coronavirus, General, News from DC

On April 10, 2020, CMS made $30 billion in aggregate Public Health and Social Services Emergency Fund (“Relief Fund”) payments to providers, with each provider receiving a proportionate distribution based on how much that provider billed Medicare fee-for-service in 2019. Providers receiving Relief Fund payments authorized by the CARES Act must submit an attestation to … 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: New CDC Guidance on Critical Workforce

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 9, 2020 Posted in Coronavirus, General, News from DC

On April 8, 2020, the U.S. Centers for Disease Control (“CDC”) issued updated guidance for critical infrastructure workers returning to work. Previously, the CDC had provided that an individual exposed to the coronavirus should self-quarantine for fourteen days. The CDC now recommends that critical infrastructure workers “may be permitted to continue to work following a … Continue reading

New Facility-Specific Guidance for Providers for COVID-19: Infection Control, Supply Shortages, and Staff Management

By Frances Morgan (US) on April 9, 2020 Posted in Coronavirus, General, News from DC

On April 8, 2020, CMS issued follow up guidance to healthcare providers to address infection control for COVID-19 patients, including patient monitoring, isolation techniques, supply shortage guidance, and staff training to avoid infection. CMS intends this guidance to “empower hospitals and healthcare systems… by equipping providers and clinicians with clear guidance based on CDC recommendations.” … Continue reading

COVID-19 Update: CDC Recommends Use of Cloth Face Coverings and President Issues Executive Order on PPE

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 4, 2020 Posted in Coronavirus, General, News from DC

On Friday April 3, the U.S. Centers for Disease Control (“CDC”) recommended “the wearing of cloth face coverings in public settings where other social distancing measures are difficult to maintain (e.g., grocery stores and pharmacies) especially in areas of significant community-based transmission.” The CDC provides citations for several studies finding that individuals with coronavirus may … Continue reading