Regulatory and Compliance Updates Payers Should Know

The Patient Access API has an upcoming enforcement date of July 1, 2021.

HealthEdge has all of the data required to enable compliance at the client site. However, we’re taking a deeper dive into the mapping to the Common Payer Consumer Data Set, the bridge to the FHIR Profiles required by member-facing applications. We are looking at what tools we can readily provide to our customers, in addition to the Data Warehouse Dictionaries, which are published routinely to see if there is room to improve upon the availability of that data for our customers.

We are also working on Bridge Mapping for the Patient Access API. We can expose the data required using HealthEdge API services. We are working to create an implementation guide and verify and document the data map from the system of record to the CPCDS (common payer consumer data set) format. Potentially this can be used to create flat files that will go over a bridge to the solution and easily map to the FHIR profile.

Recently sparking a bit of controversy, the CMS Interoperability and Prior Authorization Proposed Rule came out with a swift turnaround—less than two weeks.

This proposed rule builds on the policies finalized in the CMS Interoperability and Patient Access rule. It emphasizes the need to improve health information exchange, increase data sharing, and improve prior authorizations.

Achieving appropriate and necessary access to complete health records for patients, providers, and payers is driving this process. Some of the fallout from the pandemic has highlighted the need to be a more interoperable industry and have this information still protected but readily available.

We are monitoring the developments at the federal level and will keep everyone informed.

The first deadline for the Transparency in Coverage Final Rule is January 1, 2022, regarding machine-readable files.

Payers must post these files to their website, open to the public, and include all in-network negotiated provider rates, in-network drug pricing, and out-of-network rates.  We are looking at the file formats and will have more information to share in our next session.

We also received several questions regarding the only shopping tool, a tri-agency rule, effective January 1, 2023. The online shopping tool, or similar platform, includes out-of-pocket cost estimates and negotiated prices, specific to each patient, for 500 of the “most shoppable” services (it will expand to all customers in 2024). We have all of the data required available, as well as trial claim and additional tools that will help our customers accomplish this mandate.

As a reminder, the 2020 Medical Loss Ratio (MLR) reporting will allow plans to include in their numerator of the MLR any shared savings payments the issuer has made to an enrollee due to the enrollee choosing to obtain health care from a lower-cost, higher-value provider.

The 2021 Appropriations and COVID-19 Stimulus Package will impact health plans, including several Medicare reimbursement provisions.

One of the key things that came out of this package is a No Surprises Act at a Federal level, a bipartisan effort to address surprise medical billing. The COVID-19 pandemic highlighted situations where individuals seek emergency care and end up with surprise bills due to the physician being out of network or balances they were not anticipating.  Many states have Surprise Billing Statues, and we will need to look at how the federal rules impact those states.

The Tri-Agencies (departments of Health and Human Services, Treasury, and Labor) will issue regulations and guidance to implement a number of the provisions. That’s where we will get our compliance requirements. Most sections of the legislation will go into effect on January 1, 2022.

Another item that came out of recent legislation is the drug price transparency provisions that require drug manufacturers to report drug average sale prices to HHS for drugs covered under Medicare Part B beginning January 1 of 2022. This may impact Medicare Part D and CMS pricing in other settings.

President Biden announced a regulatory freeze of all items that were pending review in a Memorandum to the heads of the Executive Department and agencies.

Under the freeze, no rule shall be proposed or issued in any manner until Biden-appointed department heads review and approves. The memo also directs decision-makers to withdraw any rule sent to the Office of the Federal Register but not yet published, which applies to the recently finalized Prior Authorization and Interoperability Rules.

We will see some delay, but we will likely see a flurry of activity once all appointed department heads in place.

The freeze could also impact the proposed modifications to the HIPAA Privacy Rule to support and remove barriers to coordinated care and individual engagement.

The comment period ends March 22, 2021. Most of the changes center around the individual privacy rule, the right to inspect and obtain copies. And that, as you know, goes hand in hand with interoperability, payer-to-payer exchange, and the advent of being able to access your information using smart apps. Although these will likely see a delay,  I think we will see some of those modifications take hold.

Another Final Rule, likely to see a delay, requires health insurers operating on the federal exchanges participating in the Children’s Health Insurance Program and Medicaid to release faster decisions on prior authorization requests and use application programming interfaces to share prior authorization with data with patients and clinicians. Comments are due April 6, 2021.  We will continue to monitor and provide updates as they occur.