Federal government delays and changes price transparency and surprise billing rules | Manatt, Phelps & Phillips, srl

The Biden administration this month significantly relaxed several compliance obligations related to price transparency and surprise billing that have raised serious concerns for the healthcare industry and have already sparked litigation. While these changes, which delay the implementation of legal requirements indefinitely or for a period of at least six months, give more flexibility to health plans, health care providers and pharmaceutical manufacturers, the news Federal laws on surprise billing and price transparency remain poised to reshape financial management. of the health care industry.

The Departments of Health and Human Services (HHS), Labor and the Treasury issued guidelines on August 20 that delay certain compliance deadlines in the No Surprises Act (which Congress enacted as part of the Consolidated Appropriations Act , 2021, in December 2020, and prohibits “surprise patient billing beyond plan cost sharing, in many emergency and non-emergency situations) and final coverage transparency rules (which departments released in November 2020 and require public disclosure of the prices health plans pay for all health care items and care services). In doing so, government departments have recognized the huge burdens imposed by the No Surprises Act and that they would not be able to publish essential guidance on compliance with legal requirements in time for plans and suppliers to comply by the January 1, 2022 deadline.

The most significant change could be the announcement that ministries would not enforce the requirement, which was due to go into effect on January 1, 2022, that commercial health plans publicly disclose the net prices they paid for health care. prescription drugs. This requirement was finalized at the end of the Trump administration in the coverage transparency rules. The prices that health plans pay for drugs, net of rebates and other discounts they receive from manufacturers, have long been closely watched by manufacturers and health plans. The United States Chamber of Commerce and the Pharmaceutical Care Management Association recently filed a separate action to prevent government departments from requiring disclosure of this information. Now departments say the requirement will not be enforced while they consider proposing new rules that could potentially eliminate the requirement. The Chamber of Commerce has already dropped its lawsuit.

Departments have delayed for six months, until July 1, 2022, the rules requirement for health plans to publicly disclose the contract prices they pay to their network health care providers and the amounts allowed that they will pay to off-grid providers. At least for now, the ministries have not repealed this requirement. While the delay gives health plans more time to prepare to implement the rules, it can also be an opportunity for stakeholders to push for further changes. Rules have the potential to be extremely cumbersome, generating gigantic data files that contain every price for every procedure code for every network provider and which could be very difficult to use in a practical way. Departments are likely to be under pressure to limit the disclosures required, as well as to provide more guidance on how other terms of reimbursement and contracting should be treated under the rules. (The American Hospital Association and others have challenged corresponding rules that require hospitals to publish a full list of their negotiated reimbursement rates with payers, but at the end of last year, the Court of Appeals for United States, for the DC Circuit, confirmed these rules.)

The guidelines also delay and change several other rules:

• Coverage transparency rules require health plans to have a self-service internet tool that allows patients to verify cost sharing for particular services, which was scheduled to come into effect on January 1, 2023. The law No Surprises has a similar requirement effective Jan. 1, 2022. The ministries say they will postpone the application of the No Surprises law requirement until 2023, so that the two overlapping requirements align better.
• The No Surprises Law requires health care providers and health facilities to provide a good faith estimate of expected charges for scheduled services. It was supposed to go into effect on January 1, 2022, but the Department of Health and Human Services (HHS) does not expect to issue implementing regulations by then, at least for patients with coverage. sickness. As such, the HHS says it will not enforce the requirement as it applies to insured patients until it promulgates regulations and they are enforceable. The HHS says it expects to issue regulations that will apply the rule to uninsured patients before the law comes into force.
• The No Surprises Act has a corresponding requirement on health plans to provide an “advanced explanation of benefits” (AEOB) that would provide patients with an estimate of their out-of-pocket costs for future services. The AEOB had to be triggered by and include the supplier’s good faith estimate. Ministries say they will not promulgate regulations until the Jan. 1, 2022 effective date, and will not enforce the requirement until the rules are in effect.

Even though these requirements are delayed, plans and vendors face significant operational hurdles over the next few months, including: implementing an independent dispute resolution process for off-grid payment disputes related to the plan. supplier in surprise billing situations. This is expected to come into effect in January 2022, but ministries have yet to issue regulations explaining this process.

Departments say other complex provisions will come into effect, although departments will not issue regulations by then. These include requirements for health plans to maintain up-to-date vendor directories and protect patients if the plan provides incorrect vendor information, and requirements for plans to treat off-grid vendors as vendors. network in certain situations to ensure patient continuity. of care. For provisions that go into effect before departments issue implementing regulations, departments said plans and suppliers should rely on their own “reasonable and good faith interpretation” of those laws.