RISE summarizes the latest regulatory news that impacts Medicare and Medicare Advantage.

HHS delays effective date of Sunset Rule

The Department of Health and Human Services (HHS) has delayed the effective date of  the controversial 2021 “Sunset Rule" in response to a recent lawsuit filed by several health care groups that referred to the rule as a “ticking timebomb.” The rule, proposed by the Trump administration the day after the November election and finalized the day before President Biden’s inauguration, will add automatic expiration dates to more than 18,000 regulations issued by HHS and its sub-agencies, including the Centers for Medicare & Medicaid Services and the Food and Drug Administration starting in five years unless the agency conducts an intensive review of each regulation. The health care groups said in the lawsuit that the review would require the agency to take attention away from COVID-19.

RELATED: Health care groups sue HHS over Sunset Rule

In a filing scheduled to be published in the Federal Register on Tuesday, HHS noted that it believes the lawsuit to overturn the final rule has merit. A postponement of the effective date will allow the agency to review the Sunset final rule considering the claims raised in the litigation, the agency said.

The legal complaint was brought by a coalition made up of the County of Santa Clara, the California Tribal Families Coalition, the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, and the NRDC (Natural Resources Defense Council).

Although HHS does not concede to any of the claims of serious legal vulnerabilities of the rule, the department said it does need time to evaluate the final rule given the pending litigation. The complaint also raises whether the rule is consistent with the policies and goals of the current administration, in terms of the appropriate role of regulatory oversight of the health care industry and necessary engagement with the public, including tribal organizations.

The Sunset Rule was scheduled to take effect on March 22 but will be delayed for one year to March 22, 2022.

Issue brief examines the effectiveness of managing Medicare beneficiaries with chronic conditions during COVID-19

A new Commonwealth Fund issue brief examines the impact of COVID-19 on Medicare beneficiaries with chronic conditions, outlines the existing policy response, and offers options for future policies that may better protect this vulnerable population. Researchers reviewed the literature on the impact of COVID-19 on people with chronic conditions as well as reviewed policies from the Centers for Medicare & Medicaid Services (CMS). They found Medicare beneficiaries with chronic conditions are at high risk for having essential health services disrupted by the pandemic. Indeed, many of them have experienced substantial disruptions to disease management and reduced access to necessary care. However, the pandemic has also presented a series of secondary consequences, such as a decline in physical activity due to gym closures; a lack of access to groceries and fresh produce, which may lead to a less healthy diet; and isolation and heightened loneliness, which leads to deterioration in mental health.

To ensure policies mitigate the direct and indirect consequences of disrupted care during COVID-19, the analysts recommend equitable adoption of telemedicine; acceleration of the transition to outpatient and home-based care; and continued regulatory flexibility. “While the pandemic has had profound consequences, it also has created the opportunity to reimagine the U.S. health care system to refine value around investments in patient-centered care,” they concluded. “This includes moving away from the inpatient-dominant view of medical care and expanding acute care through telemedicine, ambulatory settings, and in-home settings.”

CDC director: US is at a critical point in pandemic, warns of avoidable surge in cases

Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., MPH, warned that the United States may face another avoidable surge in new COVID-19 cases due to states relaxing social distancing protocols.

During a White House press conference on Monday, Walensky said the most recent seven-day average is about 53,800 cases per day, a slight increase from the previous seven-day period. Over the past two weeks, cases have fluctuated between 50,000 and 60,000 daily cases. Hospital admissions have also been relatively stable, hovering between 4,500 to 5,000 admissions per day over the last two weeks. The most recent seven-day average of deaths is slightly under 1,000 per day.

Walensky said she is concerned about the leveling of cases and hospital admissions after consistent declines in early January through the end of February. She also noted that states in the Northeast and the Upper Midwest are beginning to see a significant rise in cases. Increasingly, she said, states are seeing a growing proportion of their COVID-19 cases attributed to variants. 

“Taken together, these statistics should serve as a warning sign for the American people. As I’ve stated before, the continued relaxation of prevention measures while cases are still high, and while concerning variants are spreading rapidly throughout the United States, is a serious threat to the progress we have made as a nation,” she said.

She understands the desire to return to normal life, but Walensky said Americans must continue to take precautions for a little longer. “We are at a critical point in this pandemic, a fork in the road, where we as a country must decide which path we are going to take. We must act now.  And I am worried that if we don’t take the right actions now, we will have another avoidable surge, just as we are seeing in Europe right now and just as we are so aggressively scaling up vaccination,” she said.

Currently more than 44 million people, or 13 percent of the population in the United States, have been fully vaccinated. Until much of the population is fully vaccinated, she urged Americans to remain vigilant to stop the spread of COVID-19 and continue to socially distant, wear a well-fitted mask, and avoid crowds and travel.