The outcomes of the 2022 U.S. midterm elections—throughout which voters have been targeted on the economic system, public security, and well being care and abortion points—could 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, it will likely be troublesome for Congress to come back to bipartisan settlement and move important well being laws throughout the 118th Congress. Consequently, the Biden Administration will give attention to implementing laws for key legislative accomplishments and leveraging govt and regulatory authority to advance coverage priorities, together with implementing the Inflation Discount Act, reducing well being care and prescription drug prices for sufferers, and addressing well being fairness gaps throughout inhabitants teams. Contemplating the influence 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 info know-how and digitization in recent times, implementation of those coverage priorities could have a considerable influence on all stakeholders inside well being methods.
In 2023, we count on to see well being care coverage developments within the following key domains: reproductive rights and gender discrimination, well being knowledge privateness, telehealth, and worth transparency.
Reproductive Rights and Gender Discrimination
Following the Supreme Court docket’s choice in Dobbs v. Jackson Girls’s Well being Group, federal businesses have taken quite a few actions to supply assets and steering on well being knowledge 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 Providers (HHS) issued steering and despatched a letter to well being care suppliers reminding them of their duties, regardless of conflicting state legal guidelines or mandates, to supply stabilizing medical therapy to pregnant sufferers underneath the Emergency Medical Remedy and Lively Labor Act (EMTALA). HHS additionally issued steering reminding retail pharmacies of their nondiscrimination obligations underneath Part 1557 of the Inexpensive Care Act and directing pharmacies to not discriminate towards prospects on the premise of intercourse and incapacity (e.g., these in search of remedy abortion). Whereas the EMTALA steering is at the moment being challenged in federal courtroom, we count on the Administration to handle further points associated to reproductive well being care companies, 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 time, the HHS Workplace of Civil Rights (OCR) issued a discover of proposed rulemaking implementing Part 1557 of the Inexpensive Care Act and establishing antidiscrimination necessities relevant to well being care entities. The proposed rule restores and strengthens sure civil proper protections underneath federally funded well being packages and HHS packages which have been restricted following the earlier variations of the rule, particularly relating to discrimination on the premise of intercourse, together with sexual orientation and gender id. Notably, the proposed rule additionally addresses the applying of federal conscience and spiritual freedom legal guidelines and establishes a course of to assessment 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 count on associated developments on laws addressing gender discrimination in federal well being packages.
Well being Information Privateness
Because of the Dobbs choice, the Biden Administration additionally continues to challenge laws to guard sufferers’ well being knowledge privateness, together with reproductive well being info. In August, the Federal Commerce Fee additionally issued a discover of proposed rulemaking on the prevalence of economic surveillance and knowledge safety practices, together with within the well being care sector. Most just 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 contains a number of examples targeted on defending reproductive well being info. Constructing on these actions, we count on federal businesses to challenge further steering on the HIPAA privateness rule and defending reproductive well being care info.
Along with adjustments in steering to assist reproductive well being care companies, HHS has additionally targeted on bettering entry to well being knowledge, 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 supposed to align Half 2’s at the moment stringent guidelines extra carefully with well being info privateness guidelines promulgated underneath HIPAA and to enhance the power of entities topic to Half 2’s restrictions to make use of, disclose, and redisclose substance use disorder-related info. Regulatory motion on well being knowledge privateness is being taken towards the backdrop of stalled Congressional negotiations on the American Information Privateness and Safety Act (H.R.8152), which proposes to determine a nationwide knowledge safety and digital privateness framework, in addition to different knowledge privateness payments. Bipartisan lawmakers agree that further safeguards are wanted to guard customers’ on-line knowledge, which signifies that we may even see legislative motion within the new Congress.
Telehealth
Relying on whether or not telehealth extensions are included within the fiscal yr 2023 appropriations laws, Congress might act to bolster federal assist for telehealth and prolong sure Medicare telehealth flexibilities past the COVID-19 PHE. HHS just lately prolonged quite a few telehealth flexibilities within the 2023 Medicare Doctor Price Schedule Ultimate Rule for 151 days after the top 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 website restrictions; permitting audio-only protection; and increasing the listing of telehealth practitioners) via December 2024. HHS will probably present further assets and steering on telehealth, particularly relating to originating website and supply modality flexibility. Through 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.
Worth Transparency
In 2023, Congress and the Administration will proceed to advance worth transparency efforts and urge hospitals to adjust to the Hospital Worth Transparency Ultimate Rule, which required hospitals to reveal their customary expenses and make costs publicly accessible for customers. In September, the HHS Workplace of the Inspector Basic (OIG) introduced that it will assessment the controls in place on the Facilities for Medicare & Medicaid Providers (CMS) and statistically pattern hospitals to find out whether or not CMS’s controls are adequate to make sure that hospital pricing info is available to sufferers as required by legislation. The findings of OIG’s assessment are anticipated to be launched subsequent yr. On the Congressional aspect, bipartisan leaders of the Home Power and Commerce Committee proceed to precise concern about hospital noncompliance with the ultimate rule. Committee leaders just lately despatched a letter to the Authorities Accountability Workplace requesting that it study hospital compliance with the provisions of the Hospital Worth Transparency Ultimate Rule along with CMS’s efforts to observe and implement hospital compliance.
In regard to the Administration’s worth transparency efforts, we additionally count on to see rulemaking from HHS, together with three different federal businesses, on superior clarification of advantages and good religion estimate (GFE) necessities of the No Surprises Act after they’d issued a request for info in September. Most just lately, HHS introduced that it will prolong 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 underneath the No Surprises Act.
Subsequent Steps
In collaboration with Crowell & Moring Authorities Affairs Group and Crowell & Moring Worldwide, Crowell Well being Options will study 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 might influence your group. Register for the webinar right here.
Crowell Well being Options is a strategic consulting agency targeted on serving to purchasers to pursue and ship revolutionary alternate 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.
