Next Interim Final Rule for Surprise Billing Ban Released

Second interim final rule implements additional protections and addresses the independent dispute resolution process.

On Sept. 30, 2021, the Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury (the Departments), along with the Office of Personnel Management (OPM), released an interim final rule (IFR) with comment period, entitled “Requirements Related to Surprise Billing; Part II.” This is the second interim final rule related to the No Surprises Act (NSA) — legislation that regulates surprise (balance) billing in healthcare settings and mandates full transparency of coverage regulations for patients. The NSA was signed into law Dec. 27, 2020, as part of the federal Consolidated Appropriations Act, 2021, and is slated to take effect Jan. 1, 2022.

Part II implements additional protections against surprise medical bills under the NSA, including provisions related to the independent dispute resolution (IDR) process, good faith estimates for uninsured or self-pay individuals, the patient-provider dispute resolution process, and expanded rights to external review.

Independent Dispute Resolution

The Part II IFR establishes the federal IDR process that out-of-network (OON) providers, facilities, providers of air ambulances, plans, and issuers in the group and individual markets may use to determine the OON rate for applicable items or services after an unsuccessful open negotiation. Disputing parties must participate in a 30-day negation period initially to determine a payment rate. Then, if the negotiation fails, either party may initiate the IDR process. After a certified dispute resolution entity has been chosen to resolve the dispute, the parties will submit their offers for payment along with supporting documentation, and the entity will issue a binding determination on the chosen OON amount. See the full rule for the complete process.

The Departments and OPM have created a federal portal for organizations to apply to become certified IDR entities and for providers and payers to participate in the resolution process. More information on the IDR process, including how to initiate an IDR resolution process in the portal, and other provisions of the process will be posted over the next several months.

Good Faith Estimates

Requirements for providers and facilities concerning good faith estimates for uninsured or self-pay individuals is also addressed in the IFR Part II. When scheduling an item or service, providers and facilities must extend a good faith estimate to the patient that includes charges that are reasonably expected to be provided together for the primary item or service, including those that may be provided by other providers and facilities. A service such as a surgery, for example, might include the surgery itself, labs, tests, and anesthesia — all of these services must be included in a good faith estimate. HHS will use its enforcement discretion in the first year of the NSA regulations as providers and facilities develop their compliance processes.

Patient-Provider Dispute Resolution

When an uninsured or self-pay individual receives a good faith estimate and then is billed for a much higher amount, the Part II IFR has put a dispute resolution process in place to determine an actual payment amount. The patient must have received a good faith estimate which their bill exceeded by at least $400 to begin the dispute process. Select dispute resolution (SDR) entities will resolve disputes according to the rules set forth and following set timelines for submission and payment.

External Review

According to the Centers for Medicare & Medicaid Services (CMS), “The September 30, 2021, rule amends final rules issued by the Departments in 2015 related to external review. The September 30, 2021, rule expands the scope of adverse benefit determinations eligible for external review to include determinations that involve whether a plan or issuer is complying with the surprise billing and cost-sharing protections under the No Surprises Act and its implementing regulations. In addition, under these interim final rules, grandfathered plans that are not otherwise subject to external review requirements will be subject to external review requirements for coverage decisions that involve whether a plan or issuer is complying with the surprise billing and cost-sharing protections under the No Surprises Act.”

Further Protections

Part II of the IFR also builds on the Sept. 10 notice of proposed rulemaking (NPRM), entitled “Reporting Requirements Regarding Air Ambulance Services, Agent and Broker Disclosure Requirements and HHS Enforcement.” If finalized, this proposed rule would establish new disclosure and reporting requirements regarding air ambulance services, as well as new procedures for enforcement of Public Health Service Act (PHS Act) provisions against providers, healthcare facilities, and providers of air ambulance services.


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