Topic: Regulatory

COVID-19 Update: OSHA Issues Emergency Workplace Rules Applicable to Health Care

As we previously announced, on June 10, 2021 the U.S. Department of Labor issued long anticipated emergency workplace guidelines. The Emergency Temporary Standard is applicable to health care entities such as hospitals, nursing homes, and assisted living facilities. The full regulation text may be found here. The new rules do not apply to dispensing of … Continue reading

Biden Administration Withdraws Work Requirement Approvals in Arkansas and New Hampshire

By Jeff Wurzburg (US) and Mary Ytterberg (US) on March 19, 2021 Posted in General, Regulatory

Medicaid is the largest health coverage source in the United States, covering approximately 70 million individuals including children, pregnant women, people with disabilities, elderly adults, and in states that have expanded their Medicaid programs under the Affordable Care Act, low-income adults without children with household income up to 138%. One of the unique designs of … Continue reading

The Joint Commission’s First Special Edition Sentinel Event Alert

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on February 3, 2021 Posted in Coronavirus, General, Regulatory

Recognizing its unique position to understand and shed light on the collective experience of America’s health care organizations during the COVID-19 pandemic, on February 2, 2021, the Joint Commission published the first in its series of special edition Sentinel Event Alerts. The special edition publication addresses COVID-19-specific concerns and comments that the Joint Commission’s Office … Continue reading

COVID-19 Update: US President Joe Biden Releases COVID-19 Roadmap and Executive Orders

By Yvonne Puig (US), Daphne Calderon (US), Jeff Wurzburg (US) and Mary Ytterberg (US) on January 22, 2021 Posted in Coronavirus, News from DC, Regulatory

On January 20, 2021, Joseph R. Biden was sworn in as the 46th President of the United States. Within hours of taking the oath, President Biden signed an executive order entitled Executive Order on Protecting the Federal Workforce and Requiring Mask-Wearing that requires wearing masks and encouraging social distancing in Federal buildings and on Federal … 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 releases special alert on monitoring hospital compliance with price transparency requirements

By Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on December 21, 2020 Posted in General, News from DC, Regulatory

On Friday, December 18, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a special alert to remind hospitals that the Hospital Price Transparency final rule (“final rule”) requirements are effective starting January 1, 2021 and that CMS will monitor a “sample of hospitals” when the final rule goes into effect to determine compliance … Continue reading

CMS releases proposed interoperability rule to improve prior authorizations and the electronic exchange of healthcare data

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on December 14, 2020 Posted in General, News from DC, Regulatory

On December 10, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to revise the prior authorization process and to add new requirements for state Medicaid and Children’s Health Insurance Program (“CHIP”) fee-for-service programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan issuers on the Federally-facilitated Exchanges … 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

CMS Announces New Acute Hospital Care At Home Program and Additional Flexibility in the Hospitals Without Walls Program

By Thomas Dowdell (US) on November 25, 2020 Posted in General, News from DC, Regulatory

On Wednesday, November 25, the Centers for Medicare & Medicaid Services (CMS) announced its new Acute Hospital at Home program and additional regulatory flexibility in its Hospitals Without Walls program. The Acute Hospital Care at Home program is for beneficiaries who require acute inpatient admission to a hospital and who require at a minimum daily … 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: OSHA Updates and Reporting Requirements

By Yvonne Puig (US), Kevin Mayer (US), Daphne Calderon (US) and Jeff Wurzburg (US) on October 5, 2020 Posted in Coronavirus, News from DC, Regulatory

The Occupational Safety and Health Administration (“OSHA”), part of the U.S. Department of Labor, continues to update guidance for employers regarding protection of employees from exposure to COVID-19. Despite their best intentions, many employers have struggled to adapt to the constantly changing safety and reporting requirements during the COVID-19 pandemic. OSHA recently updated its COVID-19 … Continue reading

CMS launches website intended to assist hospitals in complying with the price transparency requirements effective January 1, 2021

By Thomas Dowdell (US) on October 1, 2020 Posted in General, Regulatory

The Centers for Medicare & Medicaid Services in its 2020 outpatient prospective payment system final rule requires hospitals to publicly post standard charge information beginning January 1, 2021. On September 30, CMS launched a website intended to assist hospitals in complying with the price transparency requirements. The website is available at link here. The website … Continue reading

CMS Withdraws Proposed Medicaid Fiscal Accountability Rule

By Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on September 15, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On Monday, September 14, 2020, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Seema Verma announced on Twitter that CMS was withdrawing the proposed Medicaid Fiscal Accountability Rule (“MFAR”) from its regulatory agenda. The MFAR, which was proposed in November of 2019, would have added new reporting requirements for state governments to receive state … Continue reading

President Trump Signs Most Favored National Executive Order

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

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

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on September 4, 2020 Posted in General, Regulatory

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would establish a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (“MCIT”), for medical devices that are designated by the Food and Drug Administration (“FDA”) as breakthrough devices. Under the proposed MCIT pathway, CMS would provide national … Continue reading

CMS Issues FY 2021 IPPS and LTCH PPS Final Rule

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on September 4, 2020 Posted in General, Regulatory

On Wednesday, September 2, the Centers for Medicare & Medicaid Services (CMS) issued the FY 2021 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) final rule. The final rule is scheduled to be published in the Federal Register on September 18 and most of its provisions will be effective … Continue reading

COVID-19 Update: CMS Updates Conditions of Participation for Hospitals and CAHs to Require COVID-19 Reporting

By Yvonne Puig (US), Mark Faccenda (US), Thomas Dowdell (US), Jeff Wurzburg (US) and Hayley White (US) on August 28, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Tuesday, August 25, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule that updates the Medicare Conditions of Participation to require all hospitals to which 42 CFR Part 482 applies, as well as critical access hospitals (“CAHs”), to electronically report information including the number of confirmed or suspected COVID-19 … 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

COVID-19 Update: CMS Announces Resumption of Survey Activities

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on August 19, 2020 Posted in Coronavirus, Enforcement, General, Regulatory

On August 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) announced it was resuming inspections of Medicare and Medicaid certified providers and suppliers, which had been suspended in late March in response to the COVID-19 public health emergency. More specifically, CMS will be resuming onsite revisit surveys for surveys with end dates on, … 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

CMS Publishes CY 2021 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Proposed Rule

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley White (US) on August 7, 2020 Posted in Coronavirus, General, Regulatory

On Tuesday, August 4, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published the calendar year (“CY”) 2021 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System proposed rule. The proposed rule would increase hospital Medicare OPPS payment rates by 2.6 percent and ASC payment rates by 2.6 percent … Continue reading

CMS Publishes CY 2021 Proposed Policy, Payment, and Quality Provision Changes to Medicare Physician Fee Schedule

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Rachel Park (US) on August 5, 2020 Posted in Coronavirus, Enforcement, Regulatory

On Monday, August 3, 2020, the Centers for Medicare & Medicaid Services (CMS) issued the CY 2021 Physician Fee Schedule (PFS) proposed rule. We describe certain material provisions from the proposed rule below. Telehealth CMS proposes to add services to the Medicare telehealth list on a Category 1 basis. The additional services include group psychotherapy, … Continue reading