Topic: Regulatory

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

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

CMS releases proposed rule on extension and changes to the Comprehensive Care for Joint Replacement Model

By Jeff Wurzburg (US) on February 25, 2020 Posted in General, News from DC, Regulatory

On Thursday, February 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule (February 24 Federal Register publication) to extend the Comprehensive Care for Joint Replacement (CJR) Model for an additional three years in order to better evaluate the program. CMS states in the proposed rule that participating hospitals in the … Continue reading

FTC Advocates for Full Practice Authority for Advanced Practice Nurses in Kansas and Ohio

By Chandra Westergaard (US), Kajon Pompey (US) and Gerald Stein (US) on February 11, 2020 Posted in General, Regulatory

Last month, Federal Trade Commission (“FTC”) staff submitted comments in support of proposed legislation in Kansas and Ohio that would expand the scope of practice of advanced practice registered nurses (“APRNs”) in those states. In Kansas, H.B. 2412 would permit independent practice by APRNs who have completed a transition program consisting of 4,000 hours of … Continue reading

CMS Publishes Notice of Benefit and Payment Parameters for 2021 Proposed Rule

By Rachel Park (US) and Jeff Wurzburg (US) on February 4, 2020 Posted in General, Regulatory

On January 31, 2020, CMS issued the Notice of Benefit and Payment Parameters for 2021 proposed rule (“Payment Notice”). The proposed rule introduces updates to the “regulatory and financial standards applied to issuers and Exchanges” and also proposes parameters for the risk adjustment program. The proposed payment rule is available here. CMS also issued the … Continue reading

Texas Finalizes New Nursing Peer Review Committee Requirement for ASCs and Freestanding EDs

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on January 27, 2020 Posted in Regulatory

In final rules published in the January 24, 2020 Texas Register, the Texas Department of State Health Services established a new operational requirement for ambulatory surgical centers and freestanding emergency medical care facilities to establish a nursing peer review committee. The changes had been proposed on September 13, 2019. The Department did not receive any … Continue reading

Medicaid Update: South Carolina Becomes the First Non-Expansion State Approved to Implement Medicaid Work Requirements

By Jeff Wurzburg (US) on December 13, 2019 Posted in Regulatory

On Thursday, December 12, 2019, the Trump administration announced its approval of South Carolina’s request to condition Medicaid eligibility on work or community engagement activities. In a joint statement released on Thursday by CMS Administrator Seema Verma and South Carolina Governor Henry McMaster, Governor McMaster stated that “[i]n this economy, there is no excuse for … Continue reading

CMS Agrees to Pay for Clinic Visit Services Furnished in Excepted Off-Campus Provider-Based Departments at the Full OPPS Rate

By Thomas Dowdell (US) on December 12, 2019 Posted in Regulatory

CMS has announced that it will reimburse hospitals for clinic visit services furnished in excepted off-campus provider-based departments at the full OPPS rate without the payment reduction set forth in the agency’s CY 2019 OPPS final rule. CMS explains that it has installed a revised OPPS Pricer to update the payment rates applied to claim … Continue reading

CMS Publishes CY 2020 OPPS & ASC Price Transparency Requirements Final Rule and Transparency in Coverage Proposed Rule

By Mark Faccenda (US), Jeff Wurzburg (US) and Thomas Dowdell (US) on November 20, 2019 Posted in General, News from DC, Regulatory

On November 15, the Centers for Medicare & Medicaid Services (CMS) published the Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) & Ambulatory Surgical Center (ASC) Price Transparency Requirements for Hospitals to Make Standard Changes Public final rule and the Transparency in Coverage proposed rule. CMS intends through this rulemaking to increase price transparency … Continue reading

CMS Proposes Major Changes in Medicaid Fiscal Accountability Rule

By Jeff Wurzburg (US) and Thomas Dowdell (US) on November 20, 2019 Posted in General, News from DC, Regulatory

On November 12, 2019, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule for public inspection entitled Medicaid Fiscal Accountability Regulation. CMS states that the intent of the proposed rule is to ensure that state supplemental payments and financing arrangements under the Medicaid program are consistent with federal statutory requirements. In a … Continue reading

CMS Releases Final Rule on CY 2020 Physician Fee Schedule Updates and Implements Opioid Use Disorder Treatment Programs

By Jeff Wurzburg (US), Thomas Dowdell (US) and Mark Faccenda (US) on November 12, 2019 Posted in Enforcement, News from DC, Regulatory

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates the Medicare Physician Fee Schedule (PFS) rates and policies for calendar year (CY) 2020 and expands Medicare coverage to opioid treatment programs (OTPs) that treat beneficiaries with opioid use disorder (OUD). In a fact sheet accompanying the … Continue reading

CY 2020 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule

By Thomas Dowdell (US), Mark Faccenda (US) and Jeff Wurzburg (US) on November 11, 2019 Posted in FDA & Food Safety, News from DC, Regulatory

On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) published its CY 2020 Medicare Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule. The final rule implements a number of significant changes to payment policies and rates for services furnished to Medicare beneficiaries in hospital outpatient … Continue reading

CMS Issues Final Rule Implementing CY 2020 Home Health Prospective Payment System Updates, Other Policy Changes for Home Health Agencies, and Payment Policies for CY 2021 Home Health Infusion Therapy Services Benefit

By Thomas Dowdell (US) on November 4, 2019 Posted in Regulatory

On October 31, 2019, the Centers for Medicare & Medicaid Services (CMS) released its final rule with comment period that sets forth updates to the home health prospective payment system (HH PPS) for calendar year (CY) 2020 and includes other policy changes for home health agencies (HHA). This final rule also finalizes payment policies for … Continue reading

U.S. District Court Upholds Ruling that CMS Exceeded Its Statutory Authority in Reducing Medicare Payments for Clinic Visit Evaluation and Management Services Furnished in Hospital Excepted Off-Campus Provider-Based Departments

By Mark Faccenda (US) and Jeff Wurzburg (US) on October 25, 2019 Posted in Enforcement, News from DC, Regulatory

On October 21, 2019, U.S. District Judge Rosemary M. Collyer denied the government’s request to modify the Court’s previous ruling on September 17, 2019, that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory authority when it reduced Medicare payment rates for clinic visit evaluation and management (E&M) services provided to Medicare patients … Continue reading

CMS requests comments on the use of new technologies in the Medicare and Medicaid programs

By Jeff Wurzburg (US) on October 24, 2019 Posted in Regulatory

On Monday, October 21, 2019, the Centers for Medicare & Medicaid Services (CMS) posted a request for information (RFI) soliciting comments on the use of new technologies in the Medicare and Medicaid programs. In a blog post accompanying the release of the RFI, CMS Administrator Seema Verma referenced the Government Accountability Office’s designation of “Medicare … Continue reading

CMS and OIG release sweeping proposals to modernize Stark Law and AKS regulations

By Joseph Keillor (US) on October 16, 2019 Posted in General, News from DC, Regulatory

On Thursday, October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will publish in the Federal Register two proposals to implement major changes to Stark Law and Anti-Kickback Statute (AKS) regulations. We have summarized a portion of those proposed … Continue reading