HHS Priorities for 2022

In December, the Office of Information and Regulatory Affairs released the 2022 unified agenda of the Biden administration. The report details the regulations and deregulatory actions for the government’s departments. Although not binding it can show the direction and priorities of the departments.

While HHS has over 130 rules in process, just over 50 belong to CMS, ONC, and HRSA and just 11 are om the final rule stage. Let’s look at some of what HHS is reporting for these agencies.

The ONC is looking to request information regarding Electronic Prior Authorization in the ONC Health IT Certification Program and proposing ONC Health IT Certification Program Updates, Health Information Network Attestation Process for the Trusted Exchange Framework and Common Agreement, and Enhancements to Support Information Sharing.

At CMS, Interoperability and Prior Authorization – This proposed rule would place new requirements on Medicare Advantage (MA) organizations, Medicaid managed care plans, Children’s Health Insurance Program (CHIP) managed care entities, state Medicaid and CHIP fee-for-service (FFS) programs, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of health care data and streamline processes related to prior authorization, while continuing CMS’ drive toward interoperability, and reducing burden in the health care market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together would play a key role in reducing overall payer and provider burden and improving patient access to health information.

Short-Term Limited Duration Insurance; Update – This rule would propose amendments to the definition of ‘short-term, limited-duration insurance’ under section 2791(b)(5) of the Public Health Service Act. The rule’s proposals would be designed to ensure this type of coverage does not undermine the Affordable Care Act, including its protections for people with pre-existing conditions, the Health Insurance Exchanges, or the individual, small group, or large group markets for health insurance in the United States.

Requirements for Rural Emergency Hospitals – This proposed rule would establish health and safety requirements for a new provider type, Rural Emergency Hospitals. It would aim to increase access to health care services, including emergency services, to rural communities. Many rural Americans face healthcare inequities resulting in worse outcomes overall in rural areas. Increasing access to key health care services in these communities will help address such healthcare inequities. Estimates of the cost and benefits of the developed provisions will be included in the proposed rule.

Transitional Coverage for Emerging Technologies – This proposed rule would establish the criteria for an expedited coverage pathway to provide Medicare beneficiaries with faster access to innovative and beneficial technologies.

Alternative Payment Model – This rule would propose a new mandatory Medicare payment model under section 1115A of the Social Security Act. This model would test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.

At HRSA, 340B Drug Pricing Program; Administrative Dispute Resolution – This proposed rule would replace the Administrative Dispute Resolution (ADR) final rule currently in effect and apply to all drug manufacturers and covered entities that participate in the 340B Drug Pricing Program (340B Program), It would establish new requirements and procedures for the 340B Program’s ADR process. This administrative process would allow covered entities and manufacturers to file claims for specific compliance areas outlined in the statute after good faith efforts have been exhausted by the parties.