The outcomes of the 2022 U.S. midterm elections—throughout which voters have been centered on the financial system, public security, and well being care and abortion points—may have longstanding penalties for the event of well being care coverage over the subsequent two years. With the U.S. Home of Representatives and U.S. Senate managed by completely different events, will probably be troublesome for Congress to return to bipartisan settlement and move important well being laws in the course of the 118th Congress. In consequence, the Biden Administration will concentrate on implementing laws for key legislative accomplishments and leveraging govt and regulatory authority to advance coverage priorities, together with implementing the Inflation Discount Act, decreasing well being care and prescription drug prices for sufferers, and addressing well being fairness gaps throughout inhabitants teams. Contemplating the impression of the COVID-19 pandemic and anticipated unwinding of the general public well being emergency (PHE), considerations relating to well being care financing and Medicare Belief Fund solvency, and the acceleration within the adoption of well being data know-how and digitization lately, implementation of those coverage priorities may have a considerable impression on all stakeholders inside well being programs.
In 2023, we anticipate to see well being care coverage developments within the following key domains: reproductive rights and gender discrimination, well being information privateness, telehealth, and worth transparency.
Reproductive Rights and Gender Discrimination
Following the Supreme Courtroom’s determination in Dobbs v. Jackson Girls’s Well being Group, federal businesses have taken a variety of actions to offer assets and steering on well being information privateness in accordance with President Joe Biden’s govt order to assist entry to reproductive well being care. In July, the Division of Well being and Human Companies (HHS) issued steering and despatched a letter to well being care suppliers reminding them of their duties, no matter conflicting state legal guidelines or mandates, to offer stabilizing medical therapy to pregnant sufferers below the Emergency Medical Therapy and Energetic Labor Act (EMTALA). HHS additionally issued steering reminding retail pharmacies of their nondiscrimination obligations below Part 1557 of the Reasonably priced Care Act and directing pharmacies to not discriminate in opposition to clients on the idea of intercourse and incapacity (e.g., these looking for medicine abortion). Whereas the EMTALA steering is presently being challenged in federal courtroom, we anticipate the Administration to deal with further points associated to reproductive well being care providers, together with state insurance policies affecting telehealth and journey restrictions for abortion. With out bipartisan settlement within the divided Congress, passage of wide-ranging abortion laws is unlikely.
Over the summer season, the HHS Workplace of Civil Rights (OCR) issued a discover of proposed rulemaking implementing Part 1557 of the Reasonably priced Care Act and establishing antidiscrimination necessities relevant to well being care entities. The proposed rule restores and strengthens sure civil proper protections below federally funded well being applications and HHS applications which have been restricted following the earlier variations of the rule, particularly relating to discrimination on the idea of intercourse, together with sexual orientation and gender identification. Notably, the proposed rule additionally addresses the appliance of federal conscience and non secular freedom legal guidelines and establishes a course of to overview whether or not an entity is entitled to an exemption or modification of the 1557 laws based mostly on such legal guidelines. Feedback on the proposed rule closed in October, and we anticipate associated developments on laws addressing gender discrimination in federal well being applications.
Well being Knowledge Privateness
Because of the Dobbs determination, the Biden Administration additionally continues to difficulty laws to guard sufferers’ well being information privateness, together with reproductive well being data. In August, the Federal Commerce Fee additionally issued a discover of proposed rulemaking on the prevalence of business surveillance and information safety practices, together with within the well being care sector. Most lately, the OCR issued a bulletin to stipulate the obligations of Well being Insurance coverage Portability and Accountability Act of 1996 (HIPAA) on regulated entities when utilizing on-line monitoring applied sciences and notably consists of a number of examples centered on defending reproductive well being data. Constructing on these actions, we anticipate federal businesses to difficulty further steering on the HIPAA privateness rule and defending reproductive well being care data.
Along with adjustments in steering to assist reproductive well being care providers, HHS has additionally centered on bettering entry to well being information, supporting care coordination, and bettering interoperability by issuing a discover of proposed rulemaking that proposes to make sweeping adjustments to laws at 42 C.F.R. half 2 (“Half 2”) governing the confidentiality of substance use dysfunction data. As we beforehand mentioned, these modifications are meant to align Half 2’s presently stringent guidelines extra intently with well being data privateness guidelines promulgated below HIPAA and to enhance the flexibility of entities topic to Half 2’s restrictions to make use of, disclose, and redisclose substance use disorder-related data. Regulatory motion on well being information privateness is being taken in opposition to the backdrop of stalled Congressional negotiations on the American Knowledge Privateness and Safety Act (H.R.8152), which proposes to ascertain a nationwide information safety and digital privateness framework, in addition to different information privateness payments. Bipartisan lawmakers agree that further safeguards are wanted to guard customers’ on-line information, which signifies that we might even see legislative motion within the new Congress.
Relying on whether or not telehealth extensions are included within the fiscal 12 months 2023 appropriations laws, Congress could act to bolster federal assist for telehealth and lengthen sure Medicare telehealth flexibilities past the COVID-19 PHE. HHS lately prolonged quite a few telehealth flexibilities within the 2023 Medicare Doctor Charge Schedule Ultimate Rule for 151 days after the tip of the COVID-19 PHE, in alignment with the Consolidated Appropriations Act, 2022. In July 2022, the Home of Representatives handed, 416-12, the Advancing Telehealth Past COVID-19 Act of 2021 (H.R.4040), which modifies the extension of sure Medicare telehealth flexibilities (i.e., waiving originating web site restrictions; permitting audio-only protection; and increasing the checklist of telehealth practitioners) via December 2024. HHS will possible present further assets and steering on telehealth, particularly relating to originating web site and supply modality flexibility. In the course of the COVID-19 pandemic, members of Congress and the Biden Administration have acknowledged the significance of telehealth for offering continued entry to care, particularly for sure susceptible populations, and have expressed curiosity in increasing federal assist for telehealth.
In 2023, Congress and the Administration will proceed to advance worth transparency efforts and urge hospitals to adjust to the Hospital Value Transparency Ultimate Rule, which required hospitals to reveal their normal expenses and make costs publicly accessible for customers. In September, the HHS Workplace of the Inspector Common (OIG) introduced that it might overview the controls in place on the Facilities for Medicare & Medicaid Companies (CMS) and statistically pattern hospitals to find out whether or not CMS’s controls are adequate to make sure that hospital pricing data is available to sufferers as required by legislation. The findings of OIG’s overview are anticipated to be launched subsequent 12 months. On the Congressional aspect, bipartisan leaders of the Home Power and Commerce Committee proceed to specific concern about hospital noncompliance with the ultimate rule. Committee leaders lately despatched a letter to the Authorities Accountability Workplace requesting that it look at hospital compliance with the provisions of the Hospital Value Transparency Ultimate Rule along with CMS’s efforts to watch and implement hospital compliance.
In regard to the Administration’s worth transparency efforts, we additionally anticipate to see rulemaking from HHS, together with three different federal businesses, on superior rationalization of advantages and good religion estimate (GFE) necessities of the No Surprises Act after that they had issued a request for data in September. Most lately, HHS introduced that it might lengthen past January 1, 2023 its enforcement discretion, pending future rulemaking, on the requirement that well being care suppliers make accessible GFEs to uninsured and self-pay people when there are co-providers or co-facilities below the No Surprises Act.
In collaboration with Crowell & Moring Authorities Affairs Group and Crowell & Moring Worldwide, Crowell Well being Options will look at the post-election panorama in well being care coverage on December 13 at 1:00 PM. We invite you to attend this webinar on what to anticipate in well being care in 2023 in Washington DC, throughout the U.S., and overseas and the way potential coverage adjustments could impression your group. Register for the webinar right here.
Crowell Well being Options is a strategic consulting agency centered on serving to shoppers to pursue and ship revolutionary options to the normal approaches of offering and paying for well being care, together with via digital well being, well being fairness, and value-based well being care.