Topic: Regulatory

COVID-19 Update: CMS releases guide encouraging patients to seek in-person healthcare

By Thomas Dowdell (US) and Hayley White (US) on June 11, 2020 Posted in Coronavirus, Regulatory

On Tuesday, June 9, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a guide for patients who are considering their in-person care options following certain healthcare facilities re-opening for all medical services. As COVID-19 cases decline in some areas of the country, CMS created this guide to give patients recommendations, and to help … Continue reading

COVID-19 Update: The Joint Commission to Resume Hospital Surveys

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 10, 2020 Posted in Coronavirus, General, Regulatory

The Joint Commission (TJC) is resuming regular surveys and reviews after suspending them at the outset of the COVID-19 pandemic. Safety will be “the first and foremost priority” as surveys and reviews are resumed and the survey’s will “assess the impact that the coronavirus pandemic had on their operations and their current state.” The surveys … Continue reading

FTC Submits Comment Supporting Telehealth Provisions in CMS Interim Final Rule

By Amanda Wait (US), Jeff Wurzburg (US) and Rachel Park (US) on June 8, 2020 Posted in Coronavirus, General, Regulatory

On June 2, 2020, the staffs of the Federal Trade Commission’s (FTC) Office of Policy Planning, Bureau of Economics, Bureau of Competition and Office of the General Counsel submitted a comment to the Centers for Medicare & Medicaid Services (CMS) on its Interim Final Rule regarding policy and regulatory revisions in response to the COVID-19 … Continue reading

COVID-19 Update: CDC Publishes Additional Guidance on Reopening

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on May 21, 2020 Posted in Coronavirus, General, Regulatory

The U.S. Centers for Disease Control and Prevention (“CDC”) has quietly released more expansive guidance regarding the reopening of different types of organizations. The document, entitled CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again, builds upon the decision tools issued by the CDC last week. The … 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

CMS Issues FY 2021 Hospital IPPS and LTCH PPS Proposed Rule

By Thomas Dowdell (US) on May 13, 2020 Posted in Coronavirus, General, 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. Under the proposed rule Medicare IPPS payment rates would increase an estimated net 3.1 percent for hospitals that successfully … Continue reading

CMS Issues Second Round of Regulatory Waivers and Rule Changes

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 30, 2020 Posted in Coronavirus, General, Regulatory

Today, the Centers for Medicare & Medicaid Services (CMS) released an additional round of regulatory waivers and rule changes to support the healthcare system during the COVID-19 pandemic. The changes include new rules to expand COVID-19 diagnostic testing, increase care capacity and the healthcare workforce, and further promote telehealth services. Medicare no longer requires an … Continue reading

CMS Pauses Accelerated and Advanced Payments Programs

By Thomas Dowdell (US), Mark Faccenda (US), Rachel Park (US) and Jeff Wurzburg (US) on April 27, 2020 Posted in Coronavirus, General, Regulatory

CMS announced on Sunday, April 26, that it is suspending payments under the Advanced Payments Program to Part B suppliers immediately and reevaluating payment amounts under the Accelerated Payment Program. The Accelerated and Advanced Payments Programs enable Medicare providers and suppliers to receive advance Medicare payments and address cash flow issues during a disruption in … 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

COVID-19 Update: CMS Issues Recommendations for Re-Opening Facilities for Non-Emergent Care

By Yvonne Puig (US), Thomas Dowdell (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 20, 2020 Posted in Coronavirus, General, Regulatory

On Sunday April 19, 2020, CMS issued guidance for permitting non-emergent, non-COVID-19 healthcare in states that have passed the Gating Criteria provided in the Guidelines for Opening Up America Again. CMS reiterated support for telehealth, stating that “[m]aximum use of all telehealth modalities is strongly recommended.” Decisions should be” consistent with public health information and … 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: CMS releases additional guidance to states on how the FFCRA and CARES Act provisions apply to Medicaid and CHIP

By Thomas Dowdell (US), Jeff Wurzburg (US), Frances Morgan (US) and Hayley White (US) on April 14, 2020 Posted in Coronavirus, General, Regulatory

On Monday, April 13, 2020, CMS released an updated FAQ on the enhanced Federal Medical Assistance Program (FMAP) and the Families First Coronavirus Response Act (FFCRA) implementation, as well as new guidance on CMS’ Coronavirus Aid, Relief, and Economic Security (CARES) Act implementation. In these new resources, CMS explains the following changes, among others, to … Continue reading

COVID-19 Update: CMS Issues Additional Waivers to Assist Providers

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Rachel Park (US) on April 10, 2020 Posted in Coronavirus, General, Regulatory

The Centers for Medicare & Medicaid Services (CMS) temporarily suspended a number of rules to boost frontline medical staff at healthcare facilities during the COVID-19 pandemic. The new waivers expand on the workforce flexibilities announced by CMS on March 30, 2020 (previously covered by the HL Pulse here). The new waivers include: Physicians in Critical … Continue reading

COVID-19 Update: FEMA Issues Interim Final Rule Allocating Scarce or Threatened Materials

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

On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020. HL Pulse summary is available here. Specifically, the Executive Order … Continue reading

COVID-19 Update: CDC Issues Guidance on Decontamination of FFR and President Trump Issues Executive Orders for Medical Equipment

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on April 3, 2020 Posted in Coronavirus, General, News from DC, Regulatory

Earlier this week the U.S. Centers for Disease Control (CDC) provided recommendations for the decontamination and reuse of filtering facepiece respirators (FFR). The guidance states that a study found the coronavirus is able to survive for up to 72 hours on plastic, stainless steel, and cardboard. The CDC provides that “decontamination and subsequent reuse of … Continue reading

COVID-19 Update: CMS Issues Wide Ranging Blanket Waivers to Assist Providers

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US), Joseph Keillor (US) and Hayley White (US) on March 31, 2020 Posted in Coronavirus, General, Regulatory

On Monday, March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued wide ranging blanket waivers and published an interim final rule intended to “equip the American healthcare system with maximum flexibility” to respond to COVID-19. The waivers will remain in effect until the end of the emergency declaration. CMS issued a summary … 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

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

CMS Announces Relief on Quality Reporting Program Measures Due to COVID-19 (Coronavirus)

By Thomas Dowdell (US), Frances Morgan (US) and Jeff Wurzburg (US) on March 24, 2020 Posted in Coronavirus, General, Regulatory

On March 22, CMS announced that for providers participating in quality reporting programs the agency is granting extensions on reporting deadlines and allowing the omission of certain time periods for most program reporting. CMS released a programmatic chart explaining the relief granted considering the “extreme and uncontrollable circumstances” resulting from the COVID-19 pandemic. Of particular … Continue reading

COVID-19 (Coronavirus) Update: CMS Announces Targeted Plan for Facility Inspections – Infection Control and Immediate Jeopardy

By Thomas Dowdell (US) and Frances Morgan (US) on March 24, 2020 Posted in Coronavirus, General, Regulatory

On March 23rd, 2020, CMS announced a newly “enhanced, focused inspection process” to be implemented nationally in light of the COVID-19 (coronavirus) pandemic and released guidance to state survey agency directors. Standard and Revisit Inspections for nursing homes, hospitals, home health agencies, intermediate care facilities for individuals with intellectual disabilities, and hospices will not be … 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

Coronavirus | COVID-19 Update: CMS issues guidance to all PACE Organizations to implement policies and procedures to prevent the spread of COVID-19

By Yvonne Puig (US), Daphne Calderon (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on March 19, 2020 Posted in Coronavirus, General, Regulatory

On Tuesday, March 17, 2020, the Centers for Medicare & Medicaid Services (CMS) released guidance to all Programs of All-Inclusive Care for the Elderly (PACE) Organizations (POs) on policies and standard practices to follow in regards to the COVID-19 public health emergency.… 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