/ en Tue, 29 Apr 2025 06:03:23 -0500 Tue, 15 Apr 25 14:47:55 -0500 /news/headline/2025-04-15-cms-update-spa-template-medication-assisted-treatment-benefit <p>The Centers for Medicare & Medicaid Services today released a <a href="https://www.federalregister.gov/public-inspection/2025-06400/agency-information-collection-activities-proposals-submissions-and-approvals-medicaid-and-childrens" title="CMS notice">notice</a> seeking public comment on the collection of information request regarding the State Plan Amendment template for medication-assisted treatment. SPA templates are provided by CMS to assist states with Medicaid application submissions as well as reducing administrative burden and increasing efficiency. States are required to cover MATs for opioid use disorder under their state Medicaid programs. CMS said it is planning to update the SPA template for MAT to align with statutory updates. The comment period will be open for 14 days following publication in the April 16 Federal Register.</p> Tue, 15 Apr 2025 14:47:55 -0500 Regulations and Regulatory Advocacy /news/headline/2025-04-10-trump-administration-issues-executive-orders-reducing-anti-competitive-barriers-repealing-unlawful <p>The Trump administration yesterday released executive orders on reducing anti-competitive regulatory <a href="https://www.whitehouse.gov/presidential-actions/2025/04/reducing-anti-competitive-regulatory-barriers/" title="EO on barriers">barriers</a> and repealing certain <a href="https://www.whitehouse.gov/presidential-actions/2025/04/directing-the-repeal-of-unlawful-regulations/" title="EC on regs">regulations</a> deemed unlawful.  </p><p>  </p><p>The order on reducing anti-competitive barriers directs federal agencies to review all regulations subject to their rulemaking authority and identify those that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market.   </p><p>  </p><p>The order on repealing unlawful regulations is linked to a Feb. 25 <a href="https://www.federalregister.gov/documents/2025/02/25/2025-03138/ensuring-lawful-governance-and-implementing-the-presidents-department-of-government-efficiency" title="Feb 5 EO">executive order</a> that directed agencies within 60 days to identify unlawful and potentially unlawful regulations to be repealed. The new order instructs agencies to take steps to immediately repeal regulations and provide justification within 30 days for any identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.</p> Thu, 10 Apr 2025 15:26:14 -0500 Regulations and Regulatory Advocacy <div class="container"><div class="row"><div class="col-md-8"><p>The Trump administration April 9 released a series of executive orders (EOs) and took other administrative actions aimed at reducing regulatory burden.</p><p>The Office of Management and Budget April 9 issued a <a href="https://www.federalregister.gov/public-inspection/2025-06316/request-for-information-deregulation" target="_blank" title="Federal Register: Request for Information: Deregulation">request for information (RFI)</a> seeking public comment on regulations that should be rescinded as unnecessary, unlawful, unduly burdensome or unsound. According to the RFI, recommendations should focus on regulations that are inconsistent with statutory text or the Constitution, entail costs that exceed benefits, are outdated or unnecessary, or are otherwise burdening businesses in unforeseen ways. Comments are due within 30 days of publication in the Federal Register.</p><p>Relatedly, the White House issued two EOs, <a href="https://www.whitehouse.gov/presidential-actions/2025/04/directing-the-repeal-of-unlawful-regulations/" target="_blank" title="The White House: Directing the Repeal of Unlawful Regulations">“Directing the Repeal of Unlawful Regulations”</a> and <a href="https://www.whitehouse.gov/presidential-actions/2025/04/reducing-anti-competitive-regulatory-barriers/" target="_blank" title="The White House: Reducing Anti-competitive Regulatory Barriers">“Reducing Anti-Competitive Regulatory Barriers.”</a></p><h2>Directing the Repeal of Unlawful Regulations</h2><p>This EO is linked to the Feb. 25 EO 14219, <a href="https://www.federalregister.gov/documents/2025/02/25/2025-03138/ensuring-lawful-governance-and-implementing-the-presidents-department-of-government-efficiency" target="_blank" title="Federal Register: Ensuring Lawful Governance and Implementing the President's " department of government deregulatory>“Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative.”</a> EO 14219 directed agencies to identify, within 60 days (approximately April 20), categories of unlawful and potentially unlawful regulations to be repealed. The related April 9 EO tasks agencies with immediately taking steps to repeal regulations after the 60-day period has ended, prioritizing those regulations that implicate several Supreme Court rulings. Additionally, it requires agencies to provide justification within 30 days for any regulations that were identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.</p><h2>Reducing Anti-Competitive Regulatory Barriers</h2><p>This EO directs federal agencies to review all regulations subject to their rulemaking authority and identify those regulations that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market. Agencies must submit recommendations to the Federal Trade Commission (FTC) and the Attorney General on whether anti-competitive regulations should be rescinded or modified within 70 days of the order (approximately June 18). Additionally, the EO directs the FTC to issue, within 10 days of the order, an RFI seeking public comment on anti-competitive regulations.</p><p>Additional information will be forthcoming as agencies provide supporting guidance or notices.</p><h2>Additional Information on Executive Actions</h2><p>The Trump administration has issued many executive orders and taken other administrative actions. The AHA has compiled a <a href="/system/files/media/file/2025/01/2025-New-Executive-Orders-20250127.pdf">tracker of the actions the administration has taken</a> that may be of interest to hospitals and health systems. The tracker will be updated regularly as new actions are taken.</p><h2>Further Questions</h2><p>If you have further questions, please contact the AHA at <a href="tel:1-800-424-4301">800-424-4301</a>.</p></div><div class="col-md-4"><p><a href="/system/files/media/file/2025/04/Member-Advisory-Trump-Administration-Issues-Additional-Deregulation-Orders-and-Notices.pdf" target="_blank" title="Click here to download the Member Advisory: Trump Administration Issues Additional Deregulation Orders and Notices PDF."><img src="/sites/default/files/inline-images/Page-1-Member-Advisory-Trump-Administration-Issues-Additional-Deregulation-Orders-and-Notices.png" data-entity-uuid="31a05d9f-f2f8-46cb-9473-74ff7873b661" data-entity-type="file" alt="Member Advisory: Trump Administration Issues Additional Deregulation Orders and Notices page 1." width="695" height="900"></a></p></div></div></div> Thu, 10 Apr 2025 14:32:06 -0500 Regulations and Regulatory Advocacy /news/headline/2025-04-09-omb-seeks-input-rules-potential-deregulation <p>The Office of Management and Budget April 9 released a <a href="https://www.federalregister.gov/public-inspection/2025-06316/request-for-information-deregulation" target="_blank">notice</a> seeking public input on rules to potentially be rescinded, requesting detailed reasons for their rescission. Comments must be received by OMB no later than 30 days after publication of the notice in the Federal Register. The notice will be published April 11. Comments can be submitted at <a href="http://www.regulations.gov">www.regulations.gov</a>.</p> Wed, 09 Apr 2025 15:30:01 -0500 Regulations and Regulatory Advocacy <div class="container"><div class="row"><div class="col-md-8"><p>The Department of Health and Human Services (HHS) Feb. 28 issued a notice in the <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZAg2wgva7m2GO2kNGb3Z_SaO9EW7IYPqYlaUscce4T87I0ccBt3kysnNnETNrJFMJkeYNllM%3D&data=05%7C02%7Cdsamuels%40aha.org%7C878c3e4687c74e688bd808dd5b645fc9%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638767208853979537%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ejtWcXCU%2B%2Fs06y2t9xkE9cffKJzyVx0%2Fg28PKBCSiho%3D&reserved=0" target="_blank">Federal Register</a> rescinding its 1971 policy known as the “Richardson Waiver.” The Administrative Procedure Act (APA) generally requires federal agencies to give interested parties an opportunity to participate in rulemaking through the submission of written comments. However, the APA exempts from these notice-and-comment requirements “matter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” Under the 1971 Richardson Waiver, HHS chose to require the APA’s notice-and-comment rulemaking procedures for these types of matters, even though they are not required to do so under law.</p><p><strong>The AHA has received several questions from its members about Friday’s rescission of the Richardson Waiver. To help hospitals and health systems understand the implications of this announcement, the AHA is sharing a </strong><a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZAg2wgpoGkU4z0h0FKPveTmvU-LfI0DxmkMT6q9WRG09REi37fZZTArgdVlSntGrKQjEzUxY%3D&data=05%7C02%7Cdsamuels%40aha.org%7C878c3e4687c74e688bd808dd5b645fc9%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638767208853992089%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZoyZBJIHVtGX%2FNECt5pRvshRCrCohbnXCYSKsWSpm94%3D&reserved=0" target="_blank"><strong>memo</strong></a><strong> that it commissioned from outside counsel.</strong></p><p><strong>QUESTIONS</strong></p><p>If you have further questions, please contact AHA General Counsel Chad Golder at <a href="https://nam11.safelinks.protection.outlook.com/?url=https%3A%2F%2Femail.advocacy.aha.org%2FNzEwLVpMTC02NTEAAAGZAg2wgoDChqOjakp2rvMgEmCEbIQbe2yPfQw2FN58hFw-B5ngId07TwLZH9XmPohDWBxYOzg%3D&data=05%7C02%7Cdsamuels%40aha.org%7C878c3e4687c74e688bd808dd5b645fc9%7Cb9119340beb74e5e84b23cc18f7b36a6%7C0%7C0%7C638767208854003810%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=IbhJ3ePkj%2BWl9U0z9B%2Bh%2F%2BDImNUShHY9h3npjHipACI%3D&reserved=0" target="_blank">cgolder@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2025/03/guidance-for-hospitals-hhs-rescission-of-richardson-waiver-affecting-public-comment-advisory-3-5-25.pdf"><img src="/sites/default/files/inline-images/cover-guidance-for-hospitals-hhs-rescission-of-richardson-waiver-affecting-public-comment-advisory-3-5-25.png" data-entity-uuid="dad1a0b6-c24f-4306-a737-40971f4a9770" data-entity-type="file" alt="Cover image Member Advisory" width="679" height="878"></a></div></div></div> Tue, 04 Mar 2025 11:14:04 -0600 Regulations and Regulatory Advocacy <div class="container"><div class="col-md-8"><p>In its first week, the Trump administration issued an unprecedented series of executive orders (EOs) and administrative actions that reinforce their administration priorities. EOs are directives issued by the president to federal agencies, guiding how the federal government should be managed. The federal agencies then set the rules moving forward. When a new administration takes office, it is common practice to review and overturn EOs and administrative actions from the previous administration to align with its own policies and priorities. <strong>The AHA has assembled a </strong><a href="/system/files/media/file/2025/01/2025-New-Executive-Orders-20250127.pdf"><strong>tracker</strong></a> (with information through Monday, Jan. 27 at 5 p.m. ET) of the actions that may be of interest to hospitals and health systems.</p><p>The AHA continues to review these administrative actions, as well as new actions that are being taken. We will provide additional updates to the field.</p><h2>Further Questions</h2><p>If you have further questions, please contact the AHA at 800-424-4301.</p></div><div class="col-md-4"><div><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/01/2025-New-Executive-Orders-20250127.pdf" target="_blank" title="Click here to download the table of 2025 Executive Orders PDF.">Download the 2025 Executive Orders PDF</a></div><p><a href="/system/files/media/file/2025/01/Member-Advisory-Trump-Administration-Issues-Executive-Orders.pdf" target="_blank" title="Click here to download the Member Advisory: Trump Administration Issues Executive Orders PDF."><img src="/sites/default/files/inline-images/Member-Advisory-Trump-Administration-Issues-Executive-Orders.png" data-entity-uuid="8a86becd-03cd-40f3-8401-452fca8ad249" data-entity-type="file" alt="Member Advisory: Trump Administration Issues Executive Orders." width="695" height="900"></a></p></div></div> Tue, 28 Jan 2025 16:09:18 -0600 Regulations and Regulatory Advocacy <div class="container"><div class="row"><div class="col-md-8"><p>The AHA today released its 2025 Advocacy Agenda, which contains the association’s key priorities for Congress, the Administration, regulatory agencies and courts. The agenda is focused on ensuring access to care, strengthening the health care workforce, advancing quality, equity and health care system resiliency, leading innovation in care delivery, and reducing health care system costs for patient care. <strong>View the </strong><a href="http://www.aha.org/advocacy-agenda" target="_blank"><strong>2025 AHA Advocacy Agenda</strong></a><strong> for the association’s detailed priorities and key highlights.</strong></p><p>In addition, if you haven’t registered yet, AHA members can sign up for a Feb. 5 virtual briefing to learn about important issues affecting hospitals and health systems. AHA leaders will provide updates on the current congressional landscape and outlook for 2025 and share tools and resources that hospital leaders can use to engage with lawmakers on key priorities. <strong>Please </strong><a href="https://aha-advocacy.ispresenting.live/register/"><strong>click here</strong></a><strong> to register for the Feb. 5 virtual advocacy update, which begins at 2 p.m. ET. </strong></p><h2>AHA ADVERTISING HIGHLIGHTS HOSPITALS’ PIVOTAL ROLE IN COMMUNITIES</h2><p>With the new Congress and Administration beginning their work, the AHA and the Coalition to Strengthen America’s Healthcare are running advertising campaigns highlighting how hospitals and health systems are always there ready to care for patients and communities.</p><p>The AHA’s multi-platform, multimedia advertising campaign includes a <a href="https://www.youtube.com/watch?v=n_JRVYmYS1o">commercial that is running on national and cable TV channels</a> as well as stations in Washington, D.C., along with digital and social advertising to reach Capitol Hill lawmakers and staff, policymakers and influencers. In addition, the <a href="https://strengthenhealthcare.org/">Coalition to Strengthen America’s Healthcare</a> is running <a href="https://docs.google.com/presentation/d/1TVL-ZWdlrJH4zdk-sAxwQzAU2X4khzvs/mobilepresent?slide=id.p2">new billboard advertising</a> at Ronald Reagan Washington National Airport. The ads will be visible during this important period to key stakeholders, including lawmakers, staff and influencers as they travel to and from Washington, D.C. The AHA is a founding member of the Coalition.</p><h2>FURTHER QUESTIONS</h2><p>Visit the <a href="/advocacy/action-center">AHA Action Center</a> for the latest advocacy messages and resources to assist you with conversations with your lawmakers. If you have further questions, please contact AHA at 800-424-4301.</p></div><div class="col-md-4"><a href="/system/files/media/file/2025/01/aha-releases-2025-advocacy-agenda-new-advertising-highlights-the-essential-role-hospitals-bulletin-1-15-2025-f.pdf"><img src="/sites/default/files/inline-images/aha-releases-2025-advocacy-agenda-new-advertising-highlights-the-essential-role-hospitals-bulletin-1-15-2025-f.png" data-entity-uuid="ffbac950-49f6-4470-8367-c0f44a3a4215" data-entity-type="file" alt="Special Bulletin Image" width="640" height="834"></a></div></div></div> Wed, 15 Jan 2025 14:20:39 -0600 Regulations and Regulatory Advocacy <div class="container"><div class="row"><div class="col-md-8"><p>The House of Representatives today filed the Further Continuing Appropriations and Disaster Relief Supplemental Appropriations Act, a <a href="https://docs.house.gov/billsthisweek/20241216/CR.pdf" target="_blank" title="Bill to fund the government through March 2025.">bil</a><a href="https://docs.house.gov/billsthisweek/20241216/CR.pdf">l</a> to fund the government through March 14, 2025, provide disaster relief and address a number of provisions that affect hospitals and health systems, including many the AHA strongly advocated for throughout the year. The year-end package is expected to be voted on in the House and then taken up by the Senate in the next few days. <br> </p><div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2><p>The bill contains provisions: </p><ul><li>Preventing cuts in Medicaid Disproportionate Share Hospital payments.</li><li>Extending critical rural Medicare programs.</li><li>Reducing the physician fee schedule cut.</li><li>Extending telehealth and hospital-at-home programs. </li></ul><p>The package <u>does not</u> include: </p><ul><li>Any site-neutral hospital cuts.</li><li>Price transparency provisions. </li></ul></div></div><h2>AHA TAKE</h2><p>The AHA greatly appreciates that Congress will provide continued support on many of our top advocacy priorities including preventing Medicaid disproportionate share hospital reductions, providing a boost to doctors caring for Medicare patients, extending key programs that support access to care in rural communities, and delivering critical extensions for telehealth and hospital-at-home programs, among other provisions. We regret the inclusion of the National Provider Identifier (NPI) policy, which will add unnecessary and duplicative regulatory burdens at a time the hospital field is striving to create more efficiencies. However, the health care package represents a big victory for the patients and communities hospitals serve. We thank Congress for their support and look forward to our continued work to ensure hospitals and health systems have the resources they need to advance health for patients and communities. </p><p><strong>Based on an initial review of the package, the following are highlights of provisions that affect hospitals and health systems.</strong></p><h2>MEDICAID AND MEDICARE </h2><p><strong>Medicaid Disproportionate Share Hospital (DSH) Relief. </strong>The bill eliminates the Medicaid DSH cuts for fiscal year (FY) 2025 and delays the start of the remaining two years of cuts until Jan. 1, 2027.<strong> </strong>The FY 2027 and FY 2028 reductions are $8 billion each year.<strong> </strong></p><p>The bill modifies the hospital-specific DSH limit methodology of Section 203 of the Consolidated Appropriations Act of 2021 by including the costs and payments for people who are covered by both Medicaid and Medicare. </p><p>The bill also allows Tennessee to make Medicaid DSH payments until Jan. 1, 2027.</p><p><strong>Medicare Rural Extenders. </strong>The bill will extend the enhanced low-volume adjustment and the Medicare-dependent hospital programs for one year through Dec. 31, 2025. They were set to expire Dec. 31, 2024<strong>.</strong></p><p><strong>Medicare Telehealth and Hospital-at-home Extensions. </strong>The bill will extend key telehealth waivers for two years and the hospital-at-home program for five years. They were set to expire Dec. 31, 2024<strong>.</strong></p><p><strong>Physician Payment. </strong>The bill will provide partial relief for Medicare physician reimbursement rates, which under current law and regulatory policy had a 2.8% reduction scheduled for 2025. Instead, this legislation will increase the statutory conversion factor adjustment by 2.5%, averting most of the scheduled cut. </p><p><strong>Extension of the Work Geographic Index Floor under the Medicare Program. </strong>The bill will extend a 1.0 floor on the work Geographic Practice Cost Index (GPCI) through Dec. 31, 2025. This was scheduled to expire at the end of this year. </p><p><strong>Incentive Payments for Alternative Payment Models. </strong>The bill will extend incentive payments for alternative payment models for an additional year. Specifically, the legislation includes a provision that will extend payments through the calendar year (CY) 2027 payment period, at 3.53%. For the 2026 payment period, incentive payments had been reduced to 1.88% from the historic 5% (for 2025 incentive payments had been reduced to 3.5%). </p><p><strong>Medicare Rural Ambulance</strong>. The bill will extend add-on payments for ambulance services through Dec. 31, 2026. These add-on payments support rural, “super-rural,” as well as urban, ambulance services. They were set to expire Dec. 31, 2024. </p><p><strong>Maternal Health Study.</strong> The bill requires states to conduct studies on the costs of providing maternity, labor, and delivery services in rural hospitals and hospitals that serve a high proportion of Medicaid beneficiaries, and payments for such services under private health insurance, Medicare, Medicaid and the Children’s Health Insurance Program (CHIP). States will submit a report every five years to the Department of Health and Human Services (HHS). </p><h2>OTHER ITEMS OF INTEREST </h2><p><strong>PAYGO Sequester. </strong>Under PAYGO requirements, Congress must pay for any legislative package, either by reducing entitlement spending or increasing revenue. The legislation would waive PAYGO reductions by “wiping the scorecard clean,” preventing a 4% Medicare sequester cut from taking effect in January. </p><p><strong>Pandemic and All-Hazards Preparedness Act Extension. </strong>The bill will extend the Pandemic and All-Hazards Preparedness Act (PAHPA), including the Hospital Preparedness Program, for two years. It was set to expire Dec. 31, 2024. </p><p><strong>SUPPORT Act Reauthorization.</strong> The bill will reauthorize for five years key programs in the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. These programs expired in October 2023. </p><p><strong>Dr. Lorna Breen Health Care Provider Protection.</strong> This bill reauthorizes grants through 2029 to help health care organizations offer behavioral health services to prevent burnout and suicide for health care workers. </p><p><strong>Workforce Extenders. </strong>The legislation will extend the Community Health Centers, National Health Service Corps, and Teaching Health Centers Graduate Medical Education (GME) programs for two years through Dec. 31, 2026. They were set to expire Dec. 31, 2024. </p><p><strong>Maternal Health Programs Reauthorized.</strong> The bill reauthorizes for five years the Preventing Maternal Deaths Act, which supports state-based maternal mortality review committees and directs HHS to disseminate best practices on maternal mortality prevention, as well as the Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative that directs the National Institutes of Health to carry out research focused on reducing maternal mortality and morbidity and improving health outcomes for pregnant and postpartum women. </p><h2>OFFSETS</h2><p>The health care portion of the bill includes the following offsets. </p><ul><li><strong>Medicare Improvement Fund. </strong>The bill reduces the amount of funding in the Medicare Improvement Fund from $3.197 billion to $1.8915 billion.</li><li><strong>National Provider Identifier (NPI) for HOPDs. </strong>The bill will require each offcampus hospital outpatient department (HOPD) to be assigned a separate unique health identifier from its provider as a condition of payment under Medicare. </li><li><strong>Medicare Sequester. </strong>The bill extends the current law mandatory 2% Medicare sequester for the last four months of FY 2032 and the first two months of FY 2033.</li><li><strong>PBM Reforms.</strong> The bill will enact a number of reforms and changes on pharmacy benefit managers (PBMs), including a ban on the use of “spread pricing” in the Medicaid program, and preventing PBMs from deriving remuneration for covered Part D drugs based on the price of a drug. <br><br>The bill also will require 340B covered entities to report to the HHS Secretary total annual payments that exceed acquisition costs for drugs purchased under the 340B program. The aggregated data would be published publicly by the HHS Secretary annually. </li></ul><h2>ITEMS NOT INCLUDED IN THE BILL </h2><p><strong>Site Neutral. </strong>The package does not include any site-neutral payment cuts to hospitals.</p><p><strong>Price Transparency. </strong>The bill does not include any changes to the current Hospital Price Transparency rule requirements, such as no longer allowing the use of price estimator tools in order to meet the shoppable services portion of the rule, which were part of the Lower Costs, More Transparency Act (H.R. 5378) that passed the House last December. </p><h2>FURTHER QUESTIONS</h2><p>If you have further questions, please contact AHA at 800-424-4301. </p></div><div class="col-md-4"><a href="/system/files/media/file/2024/12/critical-health-care-priorities-for-hospitals-and-health-systems-included-in-year-end-legislative-package-bulletin-12-17-2024.pdf" target="_blank"><img src="/sites/default/files/inline-images/cover-critical-health-care-priorities-for-hospitals-and-health-systems-included-in-year-end-legislative-package-bulletin-12-17-2024.png" data-entity-uuid="d72838dd-3e92-44f7-b230-b6ce6c2ee67b" data-entity-type="file" alt="Special Bulleting Cover" width="682" height="882"></a></div></div></div> Tue, 17 Dec 2024 21:00:00 -0600 Regulations and Regulatory Advocacy /news/perspective/2024-09-06-keeping-congress-focused-protecting-access-care <p>Congress returns to Washington, D.C., next week following the summer recess, and lawmakers can expect a busy fall as they face a full plate of issues that need action.</p><p>The first order of business will be passing a stopgap funding bill by Sept. 30 to keep the lights on and prevent a government shutdown. While inability to agree on a budget is not the picture that lawmakers want to paint for the public prior to November’s election, the fact remains that leaders have their work cut out for them amid deep divides on spending.</p><p>That divide also extends to health care, because when it comes to a vision for health care in America, lawmakers of both parties have different ideas.</p><p>That’s why it’s more important than ever right now to cut through the noise of politics and get policymakers to focus on several immediate issues which are “must do.”</p><p>Look for an Action Alert coming soon that highlights these pressing issues that may see action in the lame-duck session of Congress that will likely follow the election. They include:</p><ul><li>Extending key rural programs that expire at the end of the year like the Medicare dependent hospital program and the low-volume adjustment program.</li><li>Extending telehealth and hospital-at-home programs as these innovative efforts, which have expanded access for millions of Americans and allowed patients to receive high-quality care more conveniently, are set to sunset on Jan. 1.</li><li>Ensuring that payment cuts for hospital services like those so-called site-neutral adjustments — that appropriately provide a differential for hospital outpatient services — are rejected.</li><li>Continuing to prevent Medicaid disproportionate share hospital cuts from kicking in next year that threaten essential financial assistance to hospitals that care for our nation’s most vulnerable populations — children, impoverished, disabled and elderly individuals.</li><li>Addressing the proposed Medicare payment reductions for physician services.</li></ul><p>Right now, our field is balanced between two realities. On the one hand, the challenges — financial, regulatory, workforce, and other matters — continue to be significant. At the same time, we are undeniably at the dawn of an exciting new era of bold innovation, technological progress and expanded ways to advance health for a greater number of people than ever before.</p><p>That is why it is essential that federal lawmakers understand the immediate challenges hospitals and health systems face and make policy decisions that account for what’s at stake for access to care for the patients and communities they represent.</p><h2>What You Can Do</h2><ul><li><strong>Contact</strong> your lawmakers and arrange conversations about the challenges your organization is facing and why additional support is needed.</li><li><strong>Invite</strong> your elected lawmakers to visit your hospital and use this opportunity to showcase some of the amazing work your organization does to support patients and communities. See <a href="/action-alert/2024-06-05-plan-august-summer-advocacy-success-begins-site-visit">AHA’s Action Alert</a> highlighting tools and resources to assist in your advocacy.</li><li><strong>Share</strong> this message with your team members and community so we can create an echo chamber for our key priorities.</li></ul><p>Uncovering solutions and sparking change is the conversation we need to be having with our elected officials whose views on health care will shape our field for years to come.</p><p>Together, it's vital that we make our voices heard now as part of our continued efforts to advance health in America.</p> Fri, 06 Sep 2024 09:03:40 -0500 Regulations and Regulatory Advocacy <div class="container"><div class="row"><div class="col-md-8"><p>The Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) April 19 published the 340B Administrative Dispute Resolution (ADR) <a href="https://www.federalregister.gov/documents/2024/04/19/2024-08262/340b-drug-pricing-program-administrative-dispute-resolution-regulation" title="final rule">final rule </a>establishing a process that was required under the Affordable Care Act. The purpose of the ADR process is to safeguard program integrity by providing 340B covered entities and drug companies the opportunity to resolve certain disputed claims through an administrative process after “good faith” resolution efforts have failed. Claims eligible for ADR review are limited to those where drug companies may have overcharged 340B covered entities, and where covered entities may have violated the statutory prohibitions against duplicate discount and diversion of 340B drugs. <strong>The rule goes into effect 60 days after publication in the Federal Register on or about June 19.</strong></p><div class="panel module-typeC"><div class="panel-heading"><h2>KEY HIGHLIGHTS</h2><p>The 340B ADR final rule would:</p><ul><li>Establish an administrative process that is less formal, allowing all covered entities, regardless of size or capability, to bring claims for review when they may have been overcharged by a drug company for a 340B drug. </li><li>Consider as an overcharge any instance where the drug company limited the ability of a covered entity to purchase a 340B drug at or below the 340B ceiling price, which could include claims related to drug company restrictions on contract pharmacies. </li><li>Allow 340B covered entities to bring forth claims regardless of the dollar amount of the claim at issue as long as “good faith” efforts were made with drug companies to address the issue prior to seeking ADR review. </li><li>Create an ADR panel of three staff members from HRSA’s Office of Pharmacy Affairs (OPA) who have relevant 340B expertise and are free of any conflicts of interest. </li><li>Allow drug companies to bring forth claims related to potential duplicate discounts or diversion of drugs only after they have conducted an audit of the covered entity. </li><li>Ensure that all ADR panel decisions are made within one year of claim submission for review and are not precedential. </li><li>Establish a reconsideration process where 340B covered entities and drug companies could seek reconsideration by the HRSA Administrator of an ADR panel decision within 30 days of that decision being rendered.</li></ul></div></div><h2>AHA TAKE</h2><p>In a <a href="/press-releases/2024-04-18-aha-statement-final-340b-administrative-dispute-resolution-process-rule-hhs" target="_blank">statement shared with the media</a> following the rule’s release, AHA General Counsel and Secretary Chad Golder said, “The Administration’s final rule for the 340B drug pricing program administrative dispute resolution (ADR) process is an important step in ensuring the integrity of the 340B program. The final rule contains several important process improvements, including a clear timeline for when ADR decisions must be made and an opportunity for reconsideration when parties are dissatisfied with the initial ADR decision. The AHA is particularly pleased that the final rule makes clear that an overcharge claim includes instances where a drug company has limited a hospital’s ability to purchase 340B drugs at or below the 340B ceiling price. This rule will help hold drug companies accountable for their rampant abuses of the 340B program and the patients it serves. We look forward to working with the Department of Health and Human Services to make sure it continues to use all tools available to stop drug companies from preventing 340B hospitals from providing vital care to their patients.”</p><h2>340B ADR FINAL RULE DETAILS</h2><p>The 340B ADR final rule creates an administrative process whereby covered entities and drug companies can bring certain 340B claims for review outside of the judicial system. The ADR process finalized in this rule is a considerable improvement from what HHS and HRSA had advanced in prior iterations of this rule in 2020 and again in 2022. Below we detail these improvements and the process finalized by HHS and HRSA.</p><h3>Makeup and Duties of ADR Panel</h3><p>The Secretary of HHS will appoint a roster of at least 10 individuals employed at HRSA’s OPA with relevant 340B program experience and have “daily exposure to the complex issues facing both covered entities and manufacturers.” This is to ensure that those deciding ADR cases are steeped in 340B program policy and regulations and that they can apply those standards accordingly.</p><p>Each ADR panel will consist of three individuals from the roster selected by the OPA director. All members of the ADR panel will be screened for any potential conflicts of interest including any financial interests, current or former business relationships or other involvement with the parties involved in the case. The OPA director or the Secretary of HHS has the discretion to remove any ADR panel member at any time if a significant conflict is found. HHS will make public all policies and procedures related to screening potential ADR panel members within 120 days of the publication of this final rule.</p><p>The rule outlines the specific duties of the ADR panel, which include:</p><ol><li>Reviewing and evaluating claims, including consolidated and joint claims, and documents and information submitted by covered entities and drug companies. </li><li>Reviewing and possibly requesting additional documentation, information or clarification of an issue.</li><li>Evaluating claims based on information received, unless, at the 340B ADR panel’s discretion, the nature of the claim requires that a meeting with the parties be held. </li><li>Consulting with other federal agencies while reviewing the claim, at the 340B ADR panel’s discretion. </li><li>Making decisions on each claim.</li></ol><h3>Claims Eligible for ADR Review</h3><p>Only certain claims are eligible for review under the ADR process. They are:</p><p>1) Claims by a covered entity that it has been overcharged by a manufacturer for a covered outpatient drug.<br>2) Claims by a drug company, after it has conducted an audit of a covered entity, that the covered entity has violated the statutory prohibitions of duplicate discounts under both Medicaid fee-for-service and Medicaid managed care and/or the prohibition of the resale or transfer of covered outpatient drugs to a person who is not a patient of the covered entity, also known as diversion.</p><p>Importantly, the final rule states that HHS and HRSA consider it an instance of overcharge when a drug company has “limited the covered entity’s ability to purchase covered outpatient drugs at or below the 340B ceiling price or the manufacturer does not offer the 340B ceiling price.” Though the rule does not specifically call out the issue of drug companies restricting access to 340B pricing for drugs dispensed through contract pharmacies, it would appear based on the language in the rule that claims where the drug companies have not offered 340B pricing or have limited access to 340B pricing would be subject to ADR review. Whether such claims are included in the ADR process likely will be subject to litigation.</p><p>The rule also specifies that drug companies cannot seek review of claims related to disputes over the covered entities eligibility for the 340B program.</p><p>In addition, claims submitted in 2020 for consideration under the old ADR process will be given first priority once the new process is implemented. Parties also have the ability to withdraw any such claims from consideration if review is no longer needed or warranted.</p><p>Finally, it was initially proposed that claims dealing with issues that are involved in active litigation were not subject to ADR review. The final rule abandons this policy. HHS will now allow issues that are involved in active litigation to move forward for ADR panel review to ensure that litigation is not used to undermine or circumvent the 340B ADR process.</p><h3>Process for Submitting Claims</h3><p>Both covered entities and drug companies must engage in “good faith” efforts to resolve any claims at issue before invoking the ADR process. The rule specifies that this could include “at least one instance of written documentation demonstrating that the initiating party has made attempts to contact the opposing party regarding the specific issues cited in the ADR claim.” The initiating party must provide documentation to this effect if it is seeking ADR review. In certain situations where a covered entity cannot access 340B pricing, HRSA acknowledges that it will facilitate good faith efforts between the parties.</p><p>To file a claim for ADR review, a covered entity or drug company must do so in writing to OPA <u>within three years of the date of the alleged violation</u>. OPA may provide flexibilities on the three-year period for filing a claim on a case-by-case basis, accounting for certain extenuating circumstances such as an alleged violation that arose from a past change or revision in the drug’s average manufacturer price or best price. For covered entities filing a claim, they must provide any and all supporting documentation to OPA and any other documentation that may be requested by OPA.</p><p>For drug companies filing a claim, they must provide documentation showing that they audited the covered entity and the alleged violation arose from that audit, including any documentation to support that alleged violation.</p><p>It also is important to note that covered entities cannot file a claim against multiple drug companies, even if the basis for the claim is the same for all drug companies. It must file individual claims against each drug company. However, two or more covered entities may jointly file claims of overcharges against the same drug company for the same drug. The same is true for drug companies, which can join together to file a claim on an alleged violation against the same covered entity. It also is permissible for an association or organization to file a consolidated claim on behalf of one or more covered entities representing their interests against a single drug company as long as all covered entities attest to being a part of this joint claim. This is not permissible for drug companies, however, because each drug company needs to conduct an audit before bringing an ADR claim, and “it would be difficult to have each manufacturer of the association or organization conduct an audit of a covered entity before filing a claim.”</p><p>After a claim has been submitted in writing to OPA for ADR review, there are several important phases to the process:</p><p><em>Phase 1 – Initial Review: </em>OPA staff will conduct an initial review to ensure the claim meets the minimum requirements for ADR review. This initial review will not involve any factual or legal review of the claim, and the staff conducting the initial review may not be appointed to serve on the three-person panel reviewing that claim. The OPA also can request additional information from the initiating party during the initial review phase. The party would need to respond to OPA’s request within 20 business days. If the initiating party does not respond within that timeframe or receive an extension, the claim will be considered ineligible for ADR review.</p><p><em>Phase 2 – Opposing Party Notification & Response: </em>Once the Phase 1 review is complete, OPA will provide written notification to the initiating party that the claim is complete and will send written notification to the opposing party that the claim was submitted for ADR review, including a copy of the claim and additional instructions to submit a response. The opposing party has 30 business days to respond to the claim, and OPA may grant extensions on a case-by-case basis. Once OPA receives this response, it will notify both parties whether the claim will move forward for ADR panel review or if it was deemed ineligible. For any claim that was deemed ineligible, the initiating party retains the ability to revise the claim with new information and refile.</p><p><em>Phase 3 – Additional Documentation Requests:</em> A covered entity initiating a claim against a drug company can request additional information or documents to support its claim within 20 business days of the receipt from OPA that the claim was forwarded to the 340B ADR Panel for review. If the ADR panel deems that the request is relevant and reasonable, it will forward the request to the drug company, which must respond in writing to the request within 20 business days of receipt of the request. A drug company may be granted an extension to this timeframe if it can demonstrate the covered entity’s document request is not feasible or will take longer to comply. If a drug company does not respond to the request within that timeframe, the ADR panel will move forward with the review based on the facts and documents available. In such an event of nonresponse, “there is a possibility that the decision may not be in favor of the nonresponsive party.”</p><h3>ADR Panel Decisions</h3><p>The 340B ADR panel will use all available and relevant information and documentation to conduct its review of the claim and render its decision. <u>All decisions will be made in writing through a letter to both parties and the OPA director no later than one year after the panel receives a complete claim for review.</u> If situations beyond the panel’s control affect the ability to render a decision within that one-year timeframe, all parties will be notified. The letter also will inform the parties of their reconsideration rights outlined below.</p><p>If a reconsideration request is not submitted, the ADR panel decision will be considered a final agency decision that is binding upon both parties effective 30 business days from issuance of the letter, unless one of the following occurs: (1) it is invalidated by a federal court; (2) the Secretary of HHS decides that he/she will review the decision; or (3) the HRSA administrator decides to initiate a reconsideration of the panel’s decision. Once the decision is rendered and finalized, the OPA director will determine if any corrective action or enforcement action is necessary.</p><p>ADR panel decisions are not precedential, meaning that each case will be considered on its merits and the relevant 340B program policies and regulations and will not be based on prior ADR panel decisions.</p><h3>Reconsiderations</h3><p>Once a decision has been rendered by the ADR panel, either party may initiate a request for reconsideration of that decision by the HRSA administrator, which is the final step of the 340B ADR process. <u>This request must be made in writing to the HRSA Administrator within 30 business days of the date of the ADR panel’s decision letter. </u>This request must include a copy of the decision letter and documentation indicating why a reconsideration is warranted based on misapplication of existing 340B policies, procedures or regulations. If the claim at issue is a joint or consolidated claim, the reconsideration request also must include an attestation that all parties involved in the claim have agreed to part of the reconsideration process. Importantly, new facts or information cannot be submitted as part of the reconsideration process.</p><p>The HRSA Administrator, or his or her designee, will issue a reconsideration decision within 180 calendar days of the initiation of the reconsideration process. The HRSA Administrator or his or her designee also can review the reconsideration and ultimately decide not to issue a revised decision. A reconsideration decision is considered final agency action and binding upon all parties involved effective 30 business days after issuance of the reconsideration decision unless the Secretary decides to review the decision or is invalidated by a federal court order.</p><h2>FURTHER QUESTIONS</h2><p>If you have further questions, please contact AHA’s Director of Policy and Health Analytics, Bharath Krishnamurthy at <a href="mailto:bkrishnamurthy@aha.org">bkrishnamurthy@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2024/04/2024-04-29-Regulatory-Advisory-on-340B-ADR-f.pdf" target="_blank"><img src="/sites/default/files/2024-04/RA-HRSA-finalizes-340B-ADR.png" data-entity-uuid data-entity-type="file" alt=" Cover Regulatory Advisory: HRSA Finalizes 340B Administrative Dispute Resolution Process" width="NaN" height="NaN"> </a></div></div></div> Mon, 29 Apr 2024 13:08:21 -0500 Regulations and Regulatory Advocacy