Topic: Regulatory

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President Biden declares monkeypox a public health emergency

The US is approaching 7,000 cases, the largest number of any country around the world. Of concern to the Administration is the nearly 80 percent increase in cases over the last 7 days. Of equal concern is the lack of more widespread availability of the vaccine and testing locations. Workplace safety is at the forefront … Continue reading

BA.5 transmissibility, new mask mandates, and the WHO declaration regarding monkeypox

Between 60 to 75 percent of new COVID-19 diagnoses are now said to be attributed the BA.5 variant.  Health officials have advised anyone who has not had a second booster to do so now, with fears that existing immunity could be waning.  Researchers have branded BA.5 the worst variation yet, one that has increased the … Continue reading

Australia – TGA updates the Therapeutic Goods Advertising Code

The TGA has issued an updated Therapeutic Goods Advertising Code (New Code). The New Code regulates advertising of therapeutic goods to consumers. Only certain therapeutic goods can be advertised to the public. The New Code seeks to ensure that permitted advertising provides consumers with accurate and balanced information concerning the quality, safety and efficacy of … Continue reading

FTC announces 2022 HSR thresholds

On January 24, 2022, the Federal Trade Commission (FTC) announced increased reporting thresholds under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Most importantly, the minimum “size-of-transaction” threshold will be increased from US $92 million to US $101 million; acquisitions below this threshold will not be reportable. The increases will apply to all transactions that close … Continue reading

COVID-19 Update: New CDC Guidance About the Omicron Variant

The Centers for Disease Control and Prevention (“CDC”) reported that the Omicron variant has been detected in all but sixteen of the United States. The Delta variant continues to be the main variant circulating in the United States, however. The World Health Organization (“WHO”) reported on December 14, 2021, that seventy-seven countries have reported cases … Continue reading

CMS Publishes Final Guidance for Hospital Co-location with Other Hospitals or Healthcare Facilities

On November 12, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued its final guidance for hospitals to clarify how CMS and state agency surveyors will evaluate space-sharing or contracted staff and service arrangements with other hospitals or healthcare providers for compliance with the Medicare Conditions of Participation (“CoPs”). According to CMS, “[c]o-location occurs … Continue reading

US OSHA issues COVID vaccine and testing Emergency Temporary Standard

On Friday, November 5, 2021, the federal Occupational Safety and Health Administration (“OSHA”) published an Emergency Temporary Standard (“ETS”) “to protect unvaccinated employees of large employers (100 or more employees) from the risk of contracting COVID-19 by strongly encouraging vaccination.” The ETS compels covered employers to develop and enforce a mandatory COVID-19 vaccination policy unless … Continue reading

CMS Issues COVID-19 Vaccine Mandate Interim Final Rule

On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring that Medicare-certified providers implement policies for vaccination of all health care workers against COVID-19.  Compliance with the requirement will be a Condition of Participation in the Medicare program, and providers may be subject to survey, requests for … Continue reading

CMS issues Calendar Year 2022 OPPS/ASC Payment System final rule

On November 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”)released its Calendar Year (“CY”) 2022 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment System final rule. This final rule is scheduled to be published in the Federal Register on November 16, 2021. In the final rule, CMS implements … Continue reading

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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