HHS Announces Interim Final Rule to Protect Patients From Surprise Medical Bills

With two-thirds of bankruptcies in the U.S. attributed to medical expenses – and one of every six emergency room visits and inpatient hospital stays involving care from at least one out-of-network provider – surprise medical billing can have devastating consequences for patients and their families.

To help protect patients from the "excessive" out-of-pocket costs due to surprise and balance building, the U.S. Department of Health and Human Services (HHS) has issued a new interim final rule that will extend similar protections that currently exist for balance billing in both Medicare and Medicaid to commercial and employer-sponsored health plans.

Key provisions of the interim final rule will now prohibit:

• Surprise billing for emergency services and requirements for prior authorization of emergency services, regardless of where services are provided
• High out-of-network cost-sharing for emergency and nonemergency services
• Patient cost sharing, such as coinsurance or a deductible, that is higher than if such services were provided by an in-network doctor (Note: any coinsurance or deductible must be based on in-network provider rates)
• Out-of-network charges for ancillary care, such as for an anesthesiologist or assistant surgeon, at an in-network facility
• Other out-of-network charges without advance notice.

Additionally, health care providers and facilities are required to provide patients with a "plain-language consumer notice" explaining that their consent is required should they wish to receive care on an out-of-network basis before the provider can bill at the higher out-of-network rate.

"Financial hardships associated with medical care can have devastating effects on our patients, including causing them to delay care or not take needed medications or even get important procedures," said ACC Health Affairs Committee Chair Samuel O. Jones IV, MD, MPH, FACC. "In medical emergencies, patients often do not have the ability to choose who provides their care. Attempting to navigate the maze of networks created by insurance companies, along with the confusing bureaucracy of hospital billing is frustrating and gets in the way of our trusted patient-physician relationship. The ACC is committed to protecting patients from unanticipated medical bills and will continue to work with regulators to craft policies that put patients first."

This rule, which will begin to take effect Jan. 1, 2022, implements the first of several requirements passed in the bipartisan No Surprises Act, which included several provisions informed by the ACC and others in the House of Medicine. These provisions include a process to determine cost-sharing amounts and setting out-of-network rates, along with an independent dispute resolution process. ACC Advocacy is currently analyzing the interim final rule and is planning to provide comments.

FDA Updates COVID-19 mRNA Vaccine Information For Providers

The U.S. Food and Drug Administration on June 25 announced revisions to the patient and provider fact sheets for the Moderna and Pfizer-BioNTech COVID-19 vaccines in light of new evidence suggesting increased risks of myocarditis and pericarditis following vaccination.

These revisions follow a discussion by the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practice on June 23 which thoroughly reviewed existing scientific evidence and determined a "likely association" between the two mRNA vaccines and cases of myocarditis and pericarditis. Over 150 million people have received either the Pfizer or Moderna vaccine, with the rare 1,200 plus cases predominantly occurring in males under 30 following the second dose of an mRNA vaccine. Of these cases, most involved symptoms appearing within a few days of vaccination and resolving on their own.

The updated fact sheets state that vaccine recipients should seek medical attention immediately if they experience "chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart after vaccination." The FDA stated that, alongside the CDC, it is continuing to monitor longer term outcomes and collecting data. No orders to stop vaccine administration due to the reports have been made.

"The ACC encourages all eligible people to get the COVID-19 vaccine as soon as possible and strongly agrees that the benefits of the vaccine, both for the individual and greater public good, far outweigh any risks," said ACC President Dipti Itchhaporia, MD, FACC, and Eric Stecker, MD, MPH, FACC, chair of ACC's Science and Quality Committee. "The FDA's new warning statement on the Moderna and Pfizer COVID-19 vaccines on potential risk for myocarditis should not overly alarm those being vaccinated and parents determining whether to vaccinate their children. Myocarditis is a very rare and treatable condition from which most patients fully recover with minimal treatment. While no one wants exposure to a potential complication, the risks from vaccination are much lower than remaining unvaccinated. Unvaccinated individuals, including adolescents, are at risk of not only myocarditis, but also more serious complications that can lead to hospitalization and death. As ever-more-infectious variants arise and pandemic fatigue sets in, the role of vaccination has become critical. We encourage everyone with concerns to consult with their health care clinicians, but we would provide maximum reassurance. After millions of adolescents and many tens of millions of adults have received COVID vaccination, the data are clear; the vaccine is safe and effective, will save lives, and can end the COVID-19 pandemic."

The College continues to provide information and analysis on the latest COVID-19 clinical and policy guidance on ACC's COVID-19 Hub at ACC.org/COVID19.

HHS Revises Provider Relief Fund Reporting

The U.S. Department of Health and Human Services (HHS) has issued revised reporting requirements for recipients of Provider Relief Fund (PRF) payments to reduce burdens on smaller providers. These revisions include deadline extensions for providers to report information and for expending PRF payments for recipients who received payments after June 30, 2020. Specifically, reporting must be completed by Sept. 30, 2021 for payments received prior to June 30, 2020.

The revised reporting requirements are only applicable to providers who received one or more payments exceeding an aggregate of $10,000 during a single Payment Received Period from the PRF General Distributions, Targeted Distributions, and/or Skilled Nursing Facility and Nursing Home Infection Control Distributions. Additionally, the reporting requirements do not apply to the Rural Health Clinic COVID-19 Testing Program, the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program, or the HRSA COVID-19 Coverage Assistance Fund.

"From the beginning of this pandemic, health care providers have gone above and beyond to care for their patients in extremely difficult circumstances that caused significant financial hardship," said HRSA Acting Administrator Diana Espinosa. "These updated requirements reflect our focus on giving providers equitable amounts of time for use of these funds, maintaining effective safeguards for taxpayer dollars, and incorporating feedback from providers requesting more flexibility and clarity about PRF reporting."

These funds were originally distributed based on measures included in the CARES Act that passed in 2020. HHS updated language to more seamlessly reflect verbiage included in the Coronavirus Response and Relief Supplemental Appropriations Act of 2021 this January.

Save the Date For HIMSS21

ACC Advocacy is excited to be an official Collaborator of HIMSS21 Global Health Conference and Exhibition, which is taking place Aug. 9 – 12 in person in Las Vegas, NV, and virtually.

HIMSS offers important opportunities to catch up on health policy topics like artificial intelligence and machine learning, health care informatics, data security, telehealth, digital transformation, patient safety, precision medicine, the transition from volume to value, and more.

ACC members can receive the HIMSS member rate to attend. When registering on the conference website, select ACC from the "Conference Collaborating Organizations" drop-down menu and enter the code COLLAB21.