Topic: Regulatory

CMS issues proposed rule repealing Medicare pending new “reasonable and necessary” definition and HHS issues proposed rule implementing provisions of the No Surprises Act

By Mark Faccenda (US), Thomas Dowdell (US) and Hayley White (US) on September 20, 2021 Posted in General, Regulatory

On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts A and B scheduled to go into effect on December 15, 2021. Proposing to repeal … Continue reading

COVID-19 Update: Biden Administration requires COVID-19 vaccine or proof of negative COVID-19 test for employees at large companies

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on September 10, 2021 Posted in Coronavirus, Regulatory

On September 9, 2021, President Biden announced a new, upcoming mandate that requires all employers with 100 or more employees “to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.” The Biden Administration projects this … Continue reading

COVID-19 update: United States military requires COVID-19 vaccine

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on August 28, 2021 Posted in Coronavirus, Regulatory

Secretary of Defense Lloyd J. Austin III issued a memorandum on August 25, 2021, mandating immediate and full COVID-19 vaccines for all members of the United States Armed Forces, including the Ready Reserve and National Guard. The memorandum began, “To defend this Nation, we need a healthy and ready force.” The Secretary of Defense noted … Continue reading

World Health Organization urges moratorium for COVID-19 booster shots

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on August 10, 2021 Posted in Coronavirus, General, Regulatory

On August 4, 2021, Director-General Tedros Adhanom Ghebreyesus of the World Health Organization (“WHO”) emphasized the import of delaying the administration of booster shots for the COVID-19 vaccine until at least September 2021. He believes this delay will allow at least 10% of the population of every country to be vaccinated against COVID-19. Director Ghebreyesus … Continue reading

Biden administration requires federal employees to receive COVID-19 vaccination with Delta variant on the rise

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on July 30, 2021 Posted in Coronavirus, Regulatory

On Thursday, July 29, 2021, the White House confirmed that the Biden Administration would articulate new goals related to COVID-19 and the Delta variant: Strengthening safety protocols for federal employees and federal contractors. Protecting those who serve our country. Expanding paid leave to get families and kids vaccinated. Calling on state and local governments to … Continue reading

COVID-19 update: CDC releases updated masking recommendations

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on July 27, 2021 Posted in Coronavirus, Regulatory

On July 27, 2021, Dr. Rochelle Walenksy updated the United States Centers for Disease Control and Prevention’s (“CDC”) recommendation regarding mask use for vaccinated individuals in a Media Telebriefing concerning COVID-19. At the time of this writing, the transcript is not yet available on the CDC’s media announcements. During the update, Dr. Walensky explained the … Continue reading

CMS issues 2022 OPPS proposed rule

By Mark Faccenda (US), Thomas Dowdell (US) and Hayley White (US) on July 22, 2021 Posted in General, Regulatory

On Monday, July 19, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released its Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgery Center (“ASC”) proposed rule for Calendar Year (“CY”) 2022. In the proposed rule, CMS proposes a net increase of 2.3 percent in Medicare OPPS rates from CY 2021 to 2022 for … Continue reading

The Joint Commission seeks to address disparities in the health care system

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on July 19, 2021 Posted in Coronavirus, Regulatory

The Joint Commission issued a new advisory to encourage health care providers to take tangible steps to better understand and meet the needs of the diverse populations of which they serve. The Joint Commission recognized that COVID-19 has “shed a light on the many gaps in health care that diverse populations have experienced for decades.” … Continue reading

COVID-19 update: CDC student guidelines and Delta variant

By Yvonne Puig (US), Daphne Calderon (US) and Hannah Putnam (US) on July 15, 2021 Posted in Coronavirus, Regulatory

On Friday, July 9, 2021, the Centers for Disease Control and Prevention (“CDC”) released new guidelines for students in kindergarten through twelfth grade. The CDC updated its guidelines to “provide safe and supportive learning environments for students.” It recognized that outbreaks of COVID-19 have occurred in schools; however, it indicated that multiple studies show that … Continue reading

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

By Yvonne Puig (US), Daphne Calderon (US) and Jeff Wurzburg (US) on June 11, 2021 Posted in Coronavirus, General, Regulatory

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