Letter/Comment

Letter/Comment / en Sun, 04 May 2025 02:17:05 -0500 Thu, 01 May 25 15:36:00 -0500 AHA Comments on Medicare Transaction Facilitator Under Medicare Drug Price Negotiation Program /lettercomment/2025-05-01-aha-comments-medicare-transaction-facilitator-under-medicare-drug-price-negotiation-program May 1, 2025 Kim Brandt Chief Operation Officer and Deputy Administrator of the Center for Medicare&nbsp; Centers for Medicare &amp; Medicaid Services&nbsp; 7500 Security Boulevard&nbsp; Baltimore, MD 21244Re: Medicare Transaction Facilitator for 2026 and 2027 under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) Information Collection Request under the Paperwork Reduction Act (PRA) (CMS-10912)Dear Ms. Brandt:On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, the 黑料正能量 Association (AHA) appreciates the opportunity to comment on the Centers for Medicare &amp; Medicaid Services (CMS) information collection request regarding the Medicare Transaction Facilitator (MTF) under the Medicare drug negotiation program.&nbsp;The AHA strongly supports the goal of reining in the exorbitant costs of prescription drugs in the U.S. However, we remain concerned that the retrospective process established by the prior administration to effectuate the maximum fair price (MFP) for selected drugs undermines congressional intent and impedes the agency鈥檚 goals of lowering drug prices for patients and providers. We believe that a prospective approach requiring all parties to participate in one standardized process overseen by CMS is the most efficient and effective way to advance the goals of the Inflation Reduction Act (IRA) and the 340B program.&nbsp;The MTF is intended to support the exchange of data among dispensing entities, plan sponsors and drug companies to implement drug discounts. Under guidance adopted by the prior administration, the MTF also serves as an optional mechanism to facilitate payment between drug manufacturers and dispensing entities. Although dispensing entities are required to participate in the MTF payment module, drug manufacturers are not. &nbsp;The retrospective process is complex, overly burdensome and operationally unworkable, particularly with respect to the critical 340B Drug Pricing Program. By allowing drug manufacturers to deny upfront access to the MFP or the 340B price and forcing dispensing entities to participate in a retrospective process designed by the manufacturers themselves, this process unfairly disadvantages patients and the providers who serve them in favor of the drug manufacturers whose pricing practices necessitated legislative intervention in the first place. Requiring providers to pursue rebates and 340B discounts after the fact, rather than mandating that manufacturers offer the lower negotiated prices upfront, runs counter to the established structure and intent of the 340B program. This needlessly complicated framework has already triggered a wave of avoidable litigation by creating a direct and unnecessary conflict between the drug price negotiation and 340B programs 鈥� an outcome not required, nor contemplated, by the statute.&nbsp;Fortunately, CMS can now course correct the previous administration鈥檚 misguided approach and help ensure the Medicare drug discount program fully achieves its goals of delivering lower prices to the patients and providers who count on these critical drugs. We appreciate the Trump administration鈥檚 efforts to reduce unnecessary administrative burden and promote efficiency across the federal government and private sector. Building on that intent, CMS can simplify the complex retrospective process by requiring all parties to participate in a single, standardized payment system administered by the MTF. This approach would promote strong oversight while ensuring both efficiency and accountability. We strongly urge CMS to finalize a process that ensures efficient and prospective access to the MFP and 340B price for all dispensing entities furnishing selected drugs to eligible Medicare patients. In addition, we urge the agency to impose strict accountability measures to ensure drug manufacturer compliance with applicable laws.<h2>CONCERNS WITH THE IMPLEMENTATION OF THE DRUG PRICE NEGOTIATION PROGRAM</h2>The Inflation Reduction Act of 2022 (IRA) included several provisions authorizing the secretary of Health and Human Services (HHS) to establish a drug price negotiation program (the program) under which the secretary enters into agreements with manufacturers to negotiate lower prices for certain prescription drugs on behalf of individuals enrolled in the Medicare program. While the AHA supports CMS鈥� efforts to negotiate lower prices for certain high expenditure drugs on behalf of Medicare beneficiaries, we believe a prospective, standardized approach administered under the oversight of the MTF is the most effective way to meet the program鈥檚 goals and ensure timely patient access to needed medications. &nbsp;The IRA directs the HHS secretary to establish procedures to ensure the MFP of a drug is applied before 鈥� 鈥� any coverage or financial assistance under other health benefit plans or programs that provide coverage or other financial assistance for the purchase or provision of prescription drug coverage on behalf of maximum fair price eligible individuals 鈥� and any other discounts.鈥�1 &nbsp; These administrative requirements are best satisfied through a process that ensures prospective access to the MFP. Unfortunately, the guidance issued by CMS focused on two retrospective processes, with little mention of a prospective process. The retrospective process finalized by the agency to effectuate the MFP is counter to the intent and goals of the program and unfairly disadvantages providers and other entities that care for Medicare patients in favor of drug manufacturers, which are the entities responsible for setting high drug prices. In short, this approach amounts to a 鈥減ay and chase鈥� model in which providers serving the most vulnerable populations will be forces to pay excess amounts to multi-billion dollar drug companies only to have to attempt to recoup their statutorily-owed discount later.&nbsp;We appreciate the agency鈥檚 efforts to balance the interests of a diverse set of stakeholders by devising a mechanism that would enable dispensing entities to access the MFP. We also appreciate the agency addressing hospitals鈥� concerns about sharing data directly with drug companies by establishing a neutral third-party MTF to facilitate the exchange of data and payment between dispensing entities, plan sponsors and drug companies. We remain concerned, however, that this elaborate process will put providers in the position of chasing rebates from drug manufacturers instead of requiring manufacturers to make the lower negotiated prices available upfront.&nbsp;We are further concerned that CMS鈥� current approach will allow each drug company to establish a unique payment arrangement 鈥� and unilaterally change the scope of any such arrangement, so long as 90-day notice is given 鈥� creating excessive burden and uncertainty for hospitals and other dispensing entities. While the agency requires drug companies to participate in the MTF data module (DM), it does not require them to participate in the MTF payment module (PM). As a result, each drug company can set up its own unique payment process and then change the process on a whim, leaving hospitals and other dispensing entities with the administrative burden of managing each unique process to access discounts. This approach could prove especially untenable for hospitals and other dispensing entities that may have established annual or longer-term contracts with vendors and third-party administrators to assist with claims processing.&nbsp;In addition to massive operational costs and related burdens, having so many different processes and also frequently changing processes will complicate hospitals鈥� ability to track whether they were actually paid within the 14-day payment window and paid the full amount owed. Hospitals report that tracking this information across multiple different systems would be costly technologically and extremely burdensome on staff, as in many cases it would need to be done manually. If these barriers left hospitals unable to identify and act on delayed payments, they could face cash flow and budgetary constraints.To avoid these issues, we urge CMS to require drug companies to participate in the MTF PM to standardize the payment process across drug companies, and enable dispensing entities to track refund receipts using a less burdensome and more timely process. Alternatively, we urge the agency to disallow drug companies from unilaterally changing alternative payment arrangements once established and approved by CMS.In addition to the unnecessary complications created by the process finalized earlier by CMS, the agency鈥檚 retrospective approach increases the risk of noncompliance on the part of drug manufacturers and diminishes the value and impact of the drug negotiation process. By not requiring drug manufacturers to participate in the MTF PM, we are concerned there will not be sufficient oversight to ensure drug manufacturers are complying with the law. We urge CMS to establish a more robust oversight and enforcement mechanism that conforms with specific penalties for noncompliance.&nbsp;2<h2>RETROSPECTIVE MFP PROCESS ENABLES DRUG COMPANY MISUSE OF THE 340B PROGRAM</h2>The retrospective process fundamentally changes the 340B program, stripping vital resources from providers caring for the most vulnerable communities. The 340B program is a critical resource for participating hospitals and other covered entities to stretch their resources to maintain, improve and expand access to care for the patients and communities they serve. From the start of the 340B program, participating entities purchased covered outpatient drugs at an upfront discounted price, which enables the entity to generate price savings that are used to support a range of patient programs and services, such as behavioral health, medication-assisted treatment and diabetes education. However, any retrospective model to access 340B discounted pricing would jeopardize the ability of 340B covered entities to support access to these important patient programs. We remain deeply concerned that the prior administration鈥檚 final guidance on the Medicare drug negotiation program has allowed drug companies to wrongly justify fundamental changes to the 340B program, changing it from an upfront discount to a retrospective rebate.&nbsp;3The IRA requires that drug manufacturers allow dispensing entities that participate in the 340B program access to the lower of the 340B price or the MFP for selected drugs.4 &nbsp;However, the federal government has long interpreted 340B statute as a prospective discount program, authorizing the secretary to enter into pharmaceutical pricing agreements (PPA) with manufacturers where the amount paid by 340B covered entities to the manufacturer to acquire a covered outpatient drug does not exceed the 340B ceiling price.5 &nbsp;Long-standing federal guidance interpreting its responsibilities under the 340B statute sets up a process that allows 340B covered entities to purchase covered outpatient drugs at an upfront discounted price.6 &nbsp;In its final guidance, CMS acknowledged potential implications for access to 340B pricing given that drug companies can choose to make access to the MFP available prospectively or retrospectively; however, the agency does not address this issue any further. CMS鈥� silence on this issue appears to have been perceived by drug companies as a 鈥済reen light鈥� to pursue a 340B rebate model whereby drug companies will make the 340B price available in a retrospective manner similar to the agency鈥檚 process for making the negotiated MFP available through the MTF DM and PM. To date, we have seen five drug companies (Johnson &amp; Johnson, Novartis, Eli Lilly, Bristol Meyers Squibb and Sanofi) announce they will no longer provide the upfront 340B discounted price and instead will unilaterally implement a retrospective rebate model. We anticipate more drug companies will pursue a similar approach.7 &nbsp;The 340B statute authorizes only the secretary of HHS to approve any model that alters access to 340B pricing for covered entities. Though the secretary has not approved any of these rebate models and HRSA has notified these companies that their efforts violate the 340B statute, all five companies have sued the federal government to pursue their rebate model. In those lawsuits, all five companies cited the prior administration鈥檚 final guidance as a reason necessitating the establishment of a 340B rebate model.&nbsp;We do not see a viable path under the statutory requirements of both the IRA and 340B programs that allow for retrospective access to the MFP but prospective access to the 340B price. It appears that CMS does not either since it does not provide such a process in its guidance. We believe that implementing a prospective process is the only viable way to protect upfront access to the 340B price while also ensuring that 340B covered entities receive the lower of the 340B price or the MFP. We urge CMS to implement a process for prospective access to the MFP, aligning with the federal government鈥檚 historic interpretation of the 340B statutory requirements and balancing the interests of Medicare patients, dispensing entities and manufacturers under the program.<h2>IMPACT ON THE 340B PROGRAM</h2>We cannot underscore enough the damage a retrospective 340B rebate would have on 340B hospitals and the patients they serve, including undermining the purpose of the program and the benefits it affords to patients and communities across the country.&nbsp;The AHA conducted a survey in March 2025 to better understand the impact of a retrospective 340B rebate model on its members. The findings from this survey include:&nbsp;<ol><li>Ninety-nine percent of hospitals indicated that a retrospective rebate model would limit their ability to fund critical patient programs and services. The rebate models would create access issues for patients who are unable to access certain 340B drugs because the hospital would be unable to stock them. Many hospitals reported that the requirement to purchase drugs at a higher price could lead to an inability to purchase certain drugs in the quantities required to meet patient demand.&nbsp;</li><li>The rebate model would require 340B hospitals to subsidize millions of dollars to drug companies by purchasing certain outpatient drugs at a higher price (e.g. wholesale acquisition cost). Some hospitals have indicated this alone could result in more than $10 million in added costs. Shifting this kind of financial liability to organizations operating on thin or negative margins and on the front lines of serving our most vulnerable populations, including millions of Medicare beneficiaries, could directly impact their ability to meet patient needs. This could harm patient access to care while also directly undermining the purpose of the 340B program.&nbsp;</li><li>More than 200 hospitals reported that floating millions of dollars to drug companies would reduce their cash on hand enough to risk violating their bond covenants. 340B hospitals rely on bond financing to raise money for new projects that enhance patient care. Those bonds typically include covenants requiring hospitals to maintain a certain amount of days of cash on hand. Violating those covenants would have calamitous effects on 340B hospitals, including downgrades in credit ratings, increased borrowing costs, lack of access to state-of-the-art medical equipment, and more.</li><li>One hundred percent of hospitals reported increased costs due to operational impacts of the rebate model. The model would create an enormous administrative burden for 340B covered entities, which would bear the responsibility of providing claims-level data elements to drug companies or risk not getting paid. Some hospitals have indicated that establishing the infrastructure for sharing these data is not only costly to establish, but some of the data being required by drug companies may be impossible to provide in their required timeframes. It effectively floats millions of dollars to drug companies without any assurance of being paid the discounts that are owed under the law. In addition, the 340B rebate models proposed so far are each markedly different, requiring different data elements and creating different timelines for 340B covered entities. If implemented, this will create an additional layer of burden and uncertainty for 340B hospitals.</li></ol>An unapproved 340B retrospective rebate model wrests oversight of the program away from HHS and places it in the hands of self-interested drug companies in ways neither Congress nor the department intended. The model is also in direct opposition to the administration鈥檚 goals of reducing burdensome administrative requirements that prevent Americans from accessing the care they need to live their healthiest lives. We strongly urge CMS to revisit its guidance and make clear that drug companies cannot misuse their obligations under the IRA to create an unlawful rebate model in the 340B program. &nbsp;<h2>PROPOSED APPROACH TO ENSURING PROSPECTIVE ACCESS TO MFP AND 340B PRICING&nbsp;</h2>Given the concerns outlined above, we urge the agency to adopt an approach that ensures prospective access to the MFP for any dispensing entity furnishing drugs to an eligible Medicare patient. In the case of a dispensing entity that is eligible and participating in the 340B program, we ask the agency to ensure that the 340B entity retains its ability to access the upfront 340B discounted price. Below, we propose one such process that would achieve these goals, is operationally feasible, and adheres to the statutory requirements, including the need to protect against the 340B nonduplication provision in section 1193(d)(1) of the Act.&nbsp;Purchasing at the prospective MFP or 340B price. Under our proposed approach, any dispensing entity would have prospective access to the MFP price when purchasing a selected drug for any eligible Medicare patient. Any dispensing entity participating in the 340B program would retain its ability to purchase a selected drug at the 340B price for all eligible Medicare patients. This likely would likely require dispensing entities to maintain separate inventories for these selected drugs. Dispensing entities, particularly those that participate in 340B, already operate separate 340B and non-340B inventories for their drugs either through separate physical inventories or through a virtual replenishment model facilitated by a third-party administrator (TPA). Since the statute requires the HHS secretary to publish the list of selected drugs far in advance of the applicability period, it would be feasible for dispensing entities to establish a separate physical or virtual inventory for these drugs, which could be facilitated by their TPAs if necessary.MTF facilitates refund payments from manufacturers to dispensing entities. If the MFP is lower than the 340B price for the selected drug, the MTF should then transmit to the manufacturer only the data required to verify the pricing. It is important that the MTF limits the ability of the manufacturer to receive data that is beyond the scope of effectuating the MFP and could be used by the manufacturer for its own financial advantage. Upon receipt of the data elements from the MTF, the manufacturer would have a 14-day timeframe, as proposed in section 40.4 of the agency鈥檚 draft guidance, to verify the pricing data and direct the MTF to facilitate payment to the dispensing entity. For the MTF to facilitate timely payment, we propose that dispensing entities share banking information only with the MTF. At the same time, we propose the MTF require each drug manufacturer to submit funds necessary to process any required refunds for the difference between the 340B price and MFP in a non-interest-bearing escrow account to be held by the MTF. The concept of CMS facilitating an escrow account is not without precedent as the agency uses escrow accounts in managing refunds under the Medicare shared savings program. Upon manufacturer verification of pricing or the 14-day timeframe, whichever occurs sooner, the MTF should be automatically authorized to deduct the appropriate amount from the manufacturers escrow account and issue payment to the dispensing entity. We believe this both ensures timely payment and minimizes burden for dispensing entities by not requiring them to share banking information with multiple manufacturers. As a final step, the MTF would notify the dispensing entity that the MFP price of the drug has been verified by the manufacturer and a refund has been issued so that the covered entity and/or TPA can ensure proper inventory management under a physical or virtual replenishment model.In conclusion, we appreciate the opportunity to provide feedback on this critically important program. We urge this administration to reconsider the approach previously developed, and simplify the payment process to better align with current law and congressional intent. It is of the utmost importance that the program is implemented in a way that carefully balances the interests of patients, providers, the government and manufacturers. We believe that a prospective approach requiring all parties to participate in one standardized process overseen by CMS is the most efficient and effective way to ensure patients will benefit from access to lower cost drugs.&nbsp;We welcome the opportunity to discuss our comments or any other aspects of this program in greater detail. If you have any further questions, please feel free to contact Megha Parikh, AHA associate director of policy and analytics, at <a href="mailto:mparikh@aha.org" target="_blank" title="Megha Parikh">mparikh@aha.org</a>.Sincerely,Ashley Thompson AHA Senior Vice President, Public Policy Analysis and Development&nbsp; __________1 Section 1196(a)(1) of the Social Security Act (42 U.S.C. 1320f-5(a)(1)). 2 See section 1197 of the Social Security Act (42 U.S.C. 1320f-6). &nbsp;&nbsp; 3 <a href="https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf" target="_blank">https://www.cms.gov/files/document/medicare-drug-price-negotiation-final-guidance-ipay-2027-and-manufacturer-effectuation-mfp-2026-2027.pdf</a>&nbsp; 4 See section 1193(d) of the Social Security Act (42 U.S.C. 1320f-2(d)) &nbsp; 5 See section 340B(a)(1) of the Public Health Service Act (42 U.S.C. 256b(a)(1)). &nbsp; 6 Limitation on Prices of Drugs Purchased by Covered Entities, 58 Fed. Reg. 27289, 27291 (May 7, 1993); Final Notice Regarding Section 602 of the Veterans Health Care Act of 1992 Entity Guidelines, 59 Fed. Reg. 25110, 25113 (May 13, 1994). &nbsp; 7 For example, see Sanofi鈥檚 proposed model: <a href="https://www.statnews.com/wp-content/uploads/2024/11/Sanofi_Credit_Model_Policy_Letter_11.22.2024_.pdf" target="_blank">https://www.statnews.com/wp-content/uploads/2024/11/Sanofi_Credit_Model_Policy_Letter_11.22.2024_.pdf</a> &nbsp; Thu, 01 May 2025 15:36:00 -0500 Letter/Comment AHA Letter to Congressional Leadership on Potential Medicaid, EPTC Policy Changes /lettercomment/2025-04-29-aha-letter-congressional-leadership-potential-medicaid-eptc-policy-changes April 29, 2025<div class="row"><div class="col-md-6">The Honorable John Thune&nbsp; Majority Leader&nbsp; U.S. Senate&nbsp; Washington, DC 20510</div><div class="col-md-6">The Honorable Mike Johnson&nbsp; Speaker&nbsp; U.S. House of Representatives&nbsp; Washington, DC 20515</div></div><div class="row"><div class="col-md-6">The Honorable Charles E. Schumer&nbsp; Democratic Leader&nbsp; U.S. Senate&nbsp; Washington, DC 20510</div><div class="col-md-6">The Honorable Hakeem S. Jeffries&nbsp; Democratic Leader&nbsp; U.S. House of Representatives&nbsp; Washington, DC 20515</div></div>Dear Leader Thune, Speaker Johnson, Leader Schumer and Leader Jeffries:On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, and our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, the 黑料正能量 Association (AHA) writes to express support for the Medicaid program as the reconciliation package is developed. We urge Congress to refrain from considering disruptive policy changes to Medicaid and other health care coverage that could impact access to health care for tens of millions of Americans.The Medicaid program provides health care coverage to a variety of individuals, including children, pregnant women, the elderly and disabled, veterans and working families. Federal support for the Medicaid program ensures that patients and communities can continue to access critical health care from hospitals, physicians, behavioral health care providers, long-term care facilities and many other caregivers.For example:<ul><li>Medicaid pays for approximately 41% of births nationally and 47% in rural areas.1</li><li>Medicaid is especially critical for children; it covers nearly half of all children with special health care needs, and about 1 in 3 children diagnosed with cancer.2, 3</li><li>Medicaid also covers more than 1 in 3, or nearly 15 million, individuals with a disability.4</li><li>Most working age adults on Medicaid are employed but in lower-wage jobs that do not provide affordable health care benefits.5</li><li>Medicaid is the nation鈥檚 largest payer of mental health and substance use condition services, ensuring patients have access to necessary services.6</li><li>Medicaid covers five in eight nursing home residents.7</li><li>More than 16 million Medicaid enrollees live in rural areas.8</li></ul>As part of the reconciliation process, Senate and House committees of jurisdiction may be considering harmful reductions to federal Medicaid spending. These include changing the underlying finance structure to a per capita cap, reducing the federal medical assistance percentage (FMAP) for certain states and placing new limits on provider taxes. Any of these changes would negatively impact state financing for their Medicaid programs, which in turn would harm hospitals and Medicaid beneficiaries. Should states see reductions in federal support for their Medicaid programs, it could force them to further reduce provider payments to account for these losses. It is important to note that the Medicaid program consistently underpays hospitals for the care provided to its patients, even with additional expenditures made by states to adjust for low base payment rates. Nationally, the Medicaid shortfall 鈥� the difference between the hospital's cost of serving Medicaid patients and the payments it receives for services 鈥� was $27.5 billion in 2023.Additionally, other policies congressional committees may consider could include those that could result in the displacement of Medicaid coverage for millions of beneficiaries and could lead to additional uncompensated care for our facilities. The combination of reduced provider payments and increased uncompensated care could force hospitals to make difficult decisions about reducing staffing and service lines and whether they will be able to remain open and continue to serve Medicaid beneficiaries as well as the wider community. The AHA urges Congress to consider the full impact these Medicaid proposals would have on all Americans and communities, including the hospitals, health systems and other care providers that serve them, before moving forward with these significant policy changes.In addition to being aware of the potential for harmful changes to the Medicaid program, we ask Congress to address before the end of this year the expiration of the enhanced premium tax credits (EPTCs). If these provisions fully expired, the impact would be a reduction to hospitals of $28 billion over 10 years. Congress must consider the totality of the impact of the Medicaid changes and the EPTC expiration on the financial stability on hospitals and their ability to operate and provide essential services.We appreciate your leadership and look forward to working together to ensure that Americans continue to have access to quality health care.Sincerely, /s/ Richard J. Pollack President &amp; Chief Executive Officer__________1 AHA analysis of WONDER data published by the Centers for Disease Control and Prevention, available at <a href="http://wonder.cdc.gov/" target="_blank" title="Wonder Data Website">http://wonder.cdc.gov</a>. 2<a href="https://www.kff.org/medicaid/issue-brief/children-with-special-health-care-needs-coverage-affordability-and-hcbs-access/" target="_blank" title="KFF.org Medicaid Issue Brief - Children with special health care needs coverage affordability and HCBS Access"> https://www.kff.org/medicaid/issue-brief/children-with-special-health-care-needs-coverage-affordability-and-hcbs-access/</a> 3<a href="https://www.sciencedirect.com/science/article/abs/pii/S0006497123089929" target="_blank" title="Science Direct Website">https://www.sciencedirect.com/science/article/abs/pii/S0006497123089929</a>&nbsp; 4 <a href="https://www.kff.org/medicaid/issue-brief/5-key-facts-about-medicaid-coverage-for-people-with-disabilities/" target="_blank" title="KFF Medicaid Issue Brief - 5 Key facts about Medicaid Coverage for people with Disabilities">https://www.kff.org/medicaid/issue-brief/5-key-facts-about-medicaid-coverage-for-people-with-disabilities/</a> 5 <a href="https://www.kff.org/medicaid/issue-brief/understanding-the-intersection-of-medicaid-and-work-an-update/" target="_blank" title="KFF Medicaid Issues Brief- Understanding the intersection of Medicaid and work an updated">https://www.kff.org/medicaid/issue-brief/understanding-the-intersection-of-medicaid-and-work-an-update/</a> 6 <a href="https://www.medicaid.gov/medicaid/benefits/behavioral-health-services/index.html" target="_blank" title="Medicaid Benefits, Behavioral health services index">https://www.medicaid.gov/medicaid/benefits/behavioral-health-services/index.html</a> 7 <a href="https://www.kff.org/other/state-indicator/distribution-of-certified-nursing-facilities-by-primary-payer-source/" target="_blank" title="KFF Other state indicator distribution of certified nursing facilities by primary payer source">https://www.kff.org/other/state-indicator/distribution-of-certified-nursing-facilities-by-primary-payer-source/</a> 8 <a href="https://www.kff.org/other/state-indicator/medicaid-enrollees-by-urban-rural-status/?dataView=1&amp;currentTimeframe=0&amp;selectedDistributions=rural&amp;sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D" target="_blank" title="KFF Other state indicator Medicaid enrollees by urban rural status">https://www.kff.org/other/state-indicator/medicaid-enrollees-by-urban-rural-status/?dataView=1&amp;currentTimeframe=0&amp;selectedDistributions=rural&amp;sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D</a>&nbsp; Tue, 29 Apr 2025 12:24:42 -0500 Letter/Comment AHA Supports House Securing Access to Care for Seniors in Critical Condition Act /lettercomment/2025-04-15-aha-supports-house-securing-access-care-seniors-critical-condition-act April 15, 2025The Honorable Kevin Hern U.S. House of Representatives 171 Cannon House Office Building Washington, DC 20515The Honorable Brendan Boyle U.S. House of Representatives 1502 Longworth House Office Building Washington, DC 20515Dear Representatives Hern and Boyle:On behalf of our nearly 5,000 member hospitals and health systems and other health care organizations, our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and our 2,425 post-acute care members, the 黑料正能量 Association (AHA) is pleased to support the Securing Access to Care for Seniors in Critical Condition Act (H.R. 1924).Long-term care hospitals (LTCHs) play a unique role for Medicare and other beneficiaries by caring for the most severely ill and medically complex patients, who often require extended hospitalization and highly specialized care. LTCHs are critical partners for acute-care hospitals, alleviating capacity for overburdened intensive care units and other parts of the care continuum that would otherwise be further strained without access to LTCHs for these patients.Since implementing the dual-rate payment system in 2016, the volume of LTCH standard-rate cases has fallen by approximately 70% from its peak under the prior system, and the number of LTCH providers has decreased by 20%. At the same time, the average acuity of LTCH patients has risen by 20% or more in that same period, and these patients are increasingly consolidated into a limited number of Diagnosis-Related Groups (DRGs).1 The smaller yet sicker patient population and dwindling reimbursement have created many challenges for LTCHs, as evidenced by the closure of so many of these facilities. The remaining patient pool is notably more acute and costly to treat, resulting in cases increasingly qualifying for high-cost outlier (HCO) payments to compensate for the lack of precision in the DRGs, as so many cases are consolidated into a limited number of DRGs. However, the fixed-loss amount for HCO cases has risen by more than 300% since 2016, forcing LTCHs to take on significant financial losses when caring for these particularly ill patients.For these reasons, the AHA supports legislation that would provide more adequate reimbursement to LTCH providers caring for some of Medicare鈥檚 sickest beneficiaries. Thank you for your leadership on these important issues to ensure patients have continued access to this vital care.Sincerely,/s/Lisa Kidder Hrobsky Senior Vice President Advocacy and Political Affairs __________1<a href=/white-papers/2023-12-29-white-paper-medicares-ltch-outlier-policy-needs-reforms-protect-extremely-ill-beneficiaries" target="_blank"> /white-papers/2023-12-29-white-paper-medicares-ltch-outlier-policy-needs-reforms-protect-extremely-ill-beneficiaries</a> Tue, 15 Apr 2025 13:22:45 -0500 Letter/Comment AHA Comments on CMS Marketplace Integrity and Affordability Rule /lettercomment/2025-04-11-aha-comments-cms-marketplace-integrity-and-affordability-rule April 11, 2025Mehmet Oz, M.D. Administrator Centers for Medicare &amp; Medicaid Services Hubert H. Humphrey Building 200 Independence Avenue, S.W., Room 445-G Washington, DC 20201RE: Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability (CMS-9884-P)Dear Administrator Oz:On behalf of the 黑料正能量 Association鈥檚 (AHA) nearly 5,000 member hospitals, health systems and other health care organizations, including approximately 90 that offer health plans, and our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, we thank you for the opportunity to respond to the Centers for Medicare &amp; Medicaid Services (CMS) rule on marketplace integrity and affordability.We appreciate CMS鈥� attention to concerns regarding the inappropriate enrollment of large numbers of low-income individuals into Health Insurance Marketplace coverage by certain brokers.&nbsp;As detailed in the proposed rule, it appears that in several states, some brokers have enrolled cohorts of low-income individuals (including, at times, Medicaid enrollees) into marketplace plans without the individuals鈥� knowledge. This has led to patient confusion, barriers to care and financial pressure on hospitals.These impacts have been confirmed by AHA member hospitals. In these instances, hospitals scheduled services for patients when their coverage indicated Medicaid. In one example, the hospital only learned that the patient鈥檚 coverage had changed upon submitting the bills for care to the appropriate Medicaid agency, which then denied the claims due to the patient having marketplace coverage. The patients were completely unaware of this change in their coverage, and, unfortunately, in many instances, the hospital was not in-network with the marketplace plan, leaving the care uncovered. This change in coverage without the patients鈥� consent is&nbsp;interfering with&nbsp;patients' access to care,&nbsp;including&nbsp;services being postponed or canceled. One health system shared that they have found 2,500 unique patients with this issue, resulting in over $45 million in outstanding claims going unpaid as a result. A separate health care system estimates the financial impact on their hospitals is much greater.The agency has proposed several policy changes to address this issue. While we appreciate the agency taking action to stop these inappropriate enrollments, we are concerned that the proposed changes will create barriers for truly eligible marketplace consumers without sufficient focus on the agents and brokers instigating these enrollments. Taken with other policies in the rule, CMS estimates that between 750,000 to 2 million consumers could lose their coverage. We are deeply concerned by these estimates of coverage loss, particularly as we have seen no credible evidence to support that such a high number of individuals have been impacted by inappropriate broker enrollments.Coverage loss of this magnitude would have substantial consequences for patient access to care, as well as the financial stability of hospitals, health systems, and other providers. As CMS notes in the rule, 鈥渟ome enrollees, particularly those facing financial constraints, might need to adjust their household budgeting to maintain coverage or, if they are not able to, become uninsured. Depending on the circumstances, these enrollees, if they become uninsured, could face higher costs for care and medical debt if care is needed. These costs could in turn be incurred by hospitals and municipalities in the form of uncompensated care鈥� (emphasis added). These new costs to hospitals would come at a time when many hospitals and health systems, particularly critical access hospitals and those in rural areas, are operating with little to no margin. They cannot absorb further losses without consequences on access to care that will be felt by everyone in a community, not just those enrolled in marketplace coverage.1For these reasons, we encourage the agency to pause finalizing many of these policies to give it and stakeholders additional time to consider the impacts while simultaneously investigating and taking appropriate action to stop the specific agents and brokers responsible for these inappropriate enrollments. In addition, we urge the agency to address reimbursement for services rendered to those impacted patients.Thank you for your consideration, and we look forward to working with the administration to ensure efficient and affordable marketplaces.&nbsp;Please contact me if you have questions, or feel free to have a member of your team contact Ariel Levin, AHA鈥檚 director of coverage policy, at 202-626-2335 or&nbsp;<a href="mailto:alevin@aha.org">alevin@aha.org</a>.Sincerely,/s/Ashley Thompson Senior Vice President Public Policy Analysis and Development<div><hr><div id="ftn1">1 <a href="/costsofcaring">/costsofcaring</a></div></div> Fri, 11 Apr 2025 12:10:58 -0500 Letter/Comment AHA Comments on MedPAC Physician Fee Schedule Payment Recommendations /lettercomment/2025-04-04-aha-comments-medpac-physician-fee-schedule-payment-recommendations April 4, 2025Michael Chernew, Ph.D. Chairman Medicare Payment Advisory Commission 425 I Street, NW, Suite 701 Washington, D.C. 20001Dear Chairman Chernew:On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations; our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, the 黑料正能量 Association (AHA) appreciates the opportunity to share our comments regarding the Medicare Payment Advisory Commission鈥檚 (MedPAC鈥檚) March meeting recommendations on physician fee schedule payments.We appreciate the thoughtful discussions the Commission has had over the past three years regarding physician payments. This is a challenging issue, but one that is critical to address to ensure beneficiary access to quality primary care and specialty providers. Thus, given recent discussions at the March meeting, we urge MedPAC to:<ul><li>Recommend a full inflationary update to physician payment instead of an update based on a portion of the Medicare Economic Index (MEI).</li><li>Remove recommendations to update relative value unit (RVU) calculations.</li><li>Reiterate its concerns about expiring alternative payment model (APM) incentive payments.</li></ul>Detailed feedback on these recommendations is below.<h2>PHYSICIAN FEE SCHEDULE AND MEI RECOMMENDATION</h2>In the March meeting, commissioners reviewed a recommendation for Congress to replace the current law updates to the physician fee schedule with an annual update based on a portion of the growth in the MEI (e.g., MEI minus 1%). We value the commission鈥檚 continued focus on addressing the woeful inadequacy of physician payment. However, we are concerned that such an annual update is not sufficient to make up for the existing shortcomings in physician reimbursement. Addressing this issue is of utmost importance to ensure the continued provision of vital care to Medicare beneficiaries. As we have commented previously, updates to the physician fee schedule conversion factor have not kept pace with inflation.1,2 Medicare鈥檚 conversion factor, which determines physician payment, declined by over 13% in real dollars from 2001 to 2024. The actual reduction when accounting for inflation is a staggering 29%. Continued decrements are unsustainable, particularly in light of the physician shortages the country is facing. Therefore, we continue to urge MedPAC to recommend a higher update to physician reimbursement that more fully accounts for inflation.<h2>ACCURACY OF RELATIVE PAYMENT RATES RECOMMENDATION</h2>MedPAC also reviewed a recommendation for Congress to direct the secretary to improve the accuracy of relative payment rates by 1) updating cost data regularly and 2) ensuring that the methodology used to determine payment rates for different services reflects the settings in which clinicians practice medicine. We are encouraged that MedPAC is evaluating strategies to improve the accuracy of RVU calculations. However, we are concerned that the policy recommendations presented do not address the underlying issues with payment and may inappropriately penalize facility-based providers.For example, the recommendation to update cost data regularly (which would yield a rebased and revised MEI) does not address the overall issue of inadequate payment per RVU. Additionally, any updates to RVUs would cause a redistribution of payments based on physicians鈥� geography and specialty. As such, we urge MedPAC to further evaluate the potential redistributive effects of cost data updates, especially in light of physician shortages and pervasive underpayments.Moreover, the recommendation to revise the RVU methodology based on clinician setting could inappropriately penalize facility-based providers and potentially exacerbate the consolidation of physician practices by non-traditional providers. Unsustainable reimbursement has driven many physicians to pursue employment models that provide stable payment through salaries and enable physicians to focus on direct patient care. Cutting payment to facility-based providers would not solve these issues in physician reimbursement; rather, it would lead to decreases in access since hospitals may no longer be able to absorb additional reductions in reimbursement without cutting services. Indeed, hospitals already must subsidize inadequate payment to preserve access to care in communities, with recent data indicating that subsidies per physician have increased 5% in the last three years to over $306,000 (see figure 1 below).3Figure 1. Average Subsidy Per Physician<img src="/sites/default/files/inline-images/image_55.png" data-entity-uuid="81dc2055-dec5-4391-9da3-0ea1782d0467" data-entity-type="file" alt="Figure 1 Image - Average Investment / Subsidy Per Physician " width="459" height="393">Furthermore, decrements to facility-based providers will create a greater incentive for physicians to seek out employment from non-traditional providers. Of the physician acquisitions that occurred over the last 5 years, the majority have been acquired by private equity companies, other physician groups and health insurers. In fact, of the physician acquisition deals from 2019 to 2023, private equity-backed startups acquired 65% of physician practices, and insurers acquired 14% of practices in that same timeframe. This is compared to hospitals and health systems that only accounted for 6% of physician acquisition acquirers. Therefore, we oppose policy options to revise RVU methodology in ways that would decrease payment to facility-based providers.<h2>ALTERNATIVE PAYMENT MODEL INCENTIVES</h2>Finally, we urge MedPAC to reiterate its concerns about the pending expiration of advanced APM incentive payments. While it has previously discussed incentives to support transition to value-based care, the absence of formal policy recommendations related to this issue may be misconstrued to mean that incentives are no longer needed. These payments continue to support providers鈥� transitions to value-based payment models and support the provision of non-fee-for-service programs like meal delivery programs, transportation services and care coordinators that promote population health.We thank you for your consideration of our comments. Please contact me if you have questions or feel free to have a member of your team contact Shannon Wu, AHA鈥檚 director of payment policy, at <a href="mailto:swu@aha.org">swu@aha.org</a> or 202-626-2963.Sincerely,/s/Ashley B. Thompson Senior Vice President Public Policy Analysis and DevelopmentCc: Paul Masi, M.P.P. MedPAC Commissioners____________________1 <a href="/lettercomment/2024-12-09-aha-comments-medpac-re-physician-fee-schedule-payments-apm-incentives-and-medicare-advantage-network" target="_blank">/lettercomment/2024-12-09-aha-comments-medpac-re-physician-fee-schedule-payments-apm-incentives-and-medicare-advantage-network</a>2 <a href="/2025-01-10-aha-comments-advance-medpac-january-2025-meeting" target="_blank">/2025-01-10-aha-comments-advance-medpac-january-2025-meeting</a>3 <a href="https://www.kaufmanhall.com/insights/research-report/physician-flash-report-q4-2024-metrics" target="_blank" id="https://www.kaufmanhall.com/insights/research-report/physician-flash-report-q4-2024-metrics">https://www.kaufmanhall.com/insights/research-report/physician-flash-report-q4-2024-metrics</a>4 <a href="/system/files/media/file/2023/06/Private-Equity-and-Health-Insurers-Acquire-More-Physicians-than-Hospitals-Infographic.pdf" target="_blank" id="/system/files/media/file/2023/06/Private-Equity-and-Health-Insurers-Acquire-More-Physicians-than-Hospitals-Infographic.pdf">/system/files/media/file/2023/06/Private-Equity-and-Health-Insurers-Acquire-More-Physicians-than-Hospitals-Infographic.pdf</a> Fri, 04 Apr 2025 15:09:55 -0500 Letter/Comment AHA Comments on PTAC Total Cost of Care Model Proposal /lettercomment/2025-03-27-aha-comments-ptac-total-cost-care-model-proposal March 27, 2025Terry Mills Jr., M.D., M.M.M, Co-chair Soujanya Pulluru, M.D., Co-chair ATTN: Physician-Focused Payment Model Technical Advisory Committee&nbsp; Assistant Secretary for Planning and Evaluation, Room 415F U.S. Department of Health and Human Services 200 Independence Avenue, SW Washington, D.C. 20201RE: Request for Input Reducing Barriers to Participation in Population-Based Total Cost of Care Models and Supporting Primary and Specialty Care TransformationDear Co-chairs Mills and Pulluru,&nbsp;On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, the 黑料正能量 Association (AHA) appreciates the opportunity to share our comments regarding the Physician鈥怓ocused Payment Model Technical Advisory Committee鈥檚 (PTAC) request for input on barriers to transitioning to population-based total cost-of-care (PB-TCOC) and primary and specialty care models.In particular, we urge the PTAC to:<ul><li>Adopt common principles that will support the implementation of PB-TCOC, primary and specialty care models.</li><li>Recommend removal of high/low revenue thresholds, which inappropriately prevent certain providers from entering primary and specialty care models.</li><li>Recommend extension of the advanced alternative payment model (APM) incentive payments.</li><li>Recommend more sustainable reimbursement to support the transition to value better.</li></ul>Our detailed comments on these issues follow.<h2>COMMON PRINCIPLES FOR PB-TCOC, PRIMARY CARE AND SPECIALTY MODELS</h2>Our members support the U.S. health care system moving toward the provision of more outcomes-based, coordinated care, and we continue to redesign delivery systems to increase value and better serve patients. Over the last 15 years, our hospital and health system members participated in a variety of APMs, including primary care and specialty care models as well as total cost-of-care models.While the movement to value holds tremendous promise, the transition has been slower than anticipated and more needs to be done to drive long-term system transformation.There are principles that we believe should guide the design of such APMs to make participation more attractive for potential participants, including hospitals, health systems and independent providers. These include:<ul><li>Appropriate On-ramp and Glidepath to Risk. Model participants should have an adequate on-ramp and glidepath to transition to risk. They must have adequate time to implement care delivery changes (e.g., integrating new staff, changing clinical workflows, implementing new analytics tools) and review data prior to initiating the program.</li><li>Adequate Risk Adjustment. Models should include adequate risk adjustment methodologies to account for chronic risk factors and clinical complexity. This will ensure models do not inappropriately penalize participants for treating the sickest, most complicated and underserved patients.</li><li>Voluntary Participation and Flexible Design. Model designs should be flexible, incorporating features such as voluntary participation and options for participants to leave models.</li><li>Balanced Risk Versus Reward. Models should balance risk versus reward in a way that encourages providers to take on additional risk but does not penalize those who need additional time and experience before they are able to do so. A glidepath approach should be implemented, gradually migrating from upside-only to downside risk.</li><li>Guardrails to Ensure Hospitals Do Not Compete Against Their Own Best Performance. Models should provide guardrails to ensure that participants are not penalized over time when they achieve optimal cost savings and outcomes performance. Participants must have incentives to remain in models for the long term.</li><li>Resources to Support Initial Investment. Upfront investment incentives should be provided to support organizations in the transition to value-based payment. To be successful in such models, hospitals, health systems and provider groups must, for example, invest in additional staffing and infrastructure to support care delivery redesign and outcomes tracking.</li><li>Transparency. Models鈥� methodologies, data and design elements should be transparently shared with all potential participants. Proposed changes should be vetted with stakeholders.</li><li>Adequate Model Duration. Models should be long enough in duration to truly support care delivery transformation and assess the impact on outcomes. Historically, models have been too short and/or have had multiple, significant design changes even within the designated duration, making it difficult for participants to self-evaluate and change course when necessary.</li><li>Timely Availability of Data.&nbsp;Model participants should have readily available, timely access to data about their patient populations. Ideally, the Centers for Medicare &amp; Medicaid Services (CMS) would dedicate staff and technology to helping provide program participants with more complete data as close to real-time as possible.</li><li>Waivers to Address Barriers to Clinical Integration and Care Coordination. Models must include waivers to Medicare program regulations that inhibit care coordination and work against participants鈥� efforts to ensure that care is provided in the right place at the right time.</li></ul>We urge the PTAC to adopt these core principles for future APM model design.<h2>REMOVING PROBLEMATIC LOW-REVENUE THRESHOLDS AS CRITERIA FOR APM PARTICIPATION AND INVESTMENT PAYMENTS</h2>As mentioned above, hospitals and health systems are critical stakeholders in the journey to value. However, certain policies have hampered their ability to participate in certain models. For example, CMS has leveraged captured revenue to distinguish Accountable Care Organizations (ACOs) as 鈥渓ow-revenue鈥� or 鈥渉igh-revenue,鈥� and by proxy, to identify ACOs as either physician-led (low-revenue) or hospital-led (high-revenue). The agency has then limited participation in certain APMs or qualification for advanced investment payments (AIPs) to only physician-led or low-revenue ACOs. It has based this policy on the faulty assumption that low-revenue ACOs perform better than high-revenue ACOs. However, research shows there is no significant difference in performance between high- and low-revenue ACOs.1Furthermore, high-revenue ACOs often have more clinically complex, higher-cost patients attributed to their model. In addition, limiting eligibility for AIPs to only low-revenue ACOs inappropriately penalizes high-revenue ACOs, many of which are actually small organizations that critically need these resources for infrastructure investment to transition to APMs. For example, analysis suggests that critical access hospitals, federally qualified health centers and rural health centers are predominantly classified as high-revenue and therefore ineligible for AIPs. This partially explains the disparity in APM adoption in rural and underserved areas, which the PTAC has previously highlighted. We, therefore, urge PTAC to recommend the removal of these problematic high- and low-revenue thresholds that inappropriately preclude certain ACOs from obtaining necessary resources for infrastructure investment.<h2>EXTENSION OF ADVANCED APM INCENTIVE PAYMENTS</h2>The bipartisan Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) provided incentive payments of 5% for providers participating in advanced APMs. These payments were designed to assist with the provision of non-fee-for-service programs like meal delivery programs, transportation services, digital tools and care coordinators that promote population health. However, MACRA statute only provided the advanced APM bonuses through the calendar year (CY) 2024 payment period. Congress has passed single-year extensions (although at lower rates) through the CY 2026 payment period. These incentive payments provide crucial resources for providers considering the transition to PB-TCOC, primary and specialty care APMs. As such, we urge PTAC to work with CMS to urge Congress to extend these incentive payments, which will better support providers transitioning to primary, specialty and total cost of care models.<h2>PHYSICIAN ACQUISITION AND PB-TCOC, PRIMARY AND SPECIALTY CARE MODELS</h2>Some presenters in the March PTAC meeting cited the acquisition of physician practices as a barrier to APM competitiveness. However, this discussion did not fully address the situation. Specifically, much like hospitals and health systems, physicians across the country face increased costs, inadequate reimbursements and administrative burdens from public and private insurer practices. These factors create major barriers to operating an independent practice. Furthermore, the transition to value-based programs often requires infrastructure investment for electronic health records, quality reporting, analytics and support staff, which many practices may not have the economies of scale to support. As a result, physicians are increasingly looking for alternative practice settings that will provide financial security so they can focus more on clinical care and less on managing their own practice.&nbsp;While a disproportionate amount of attention has been placed on hospitals鈥� acquisition of physician practices, the reality is that large commercial insurers have collectively invested billions in physician practice acquisitions. Based on an AHA analysis of Levin Associates data, private equity, physician groups and health insurers have acquired the vast majority of physician practices during the last five years.2 Comparatively, hospitals rank relatively low in the acquisition of physician practices. In fact, private equity-backed startups have acquired 65% of physician practices from 2019 to 2023, and insurers have acquired 14% of practices in that same timeframe. This is compared to hospitals and health systems that have only acquired 6% of physician practices.&nbsp;Therefore, we urge PTAC to recommend policies, such as more sustainable reimbursement aligned with inflation. Doing so will better support all providers鈥� abilities to transition to value-based care.&nbsp;We thank you for your consideration of our comments. Please contact me if you have questions, or feel free to have a member of your team contact Jennifer Holloman, AHA鈥檚 senior associate director of payment policy, at <a href="mailto:jholloman@aha.org" target="_blank">jholloman@aha.org</a>.&nbsp;Sincerely,&nbsp;/s/&nbsp;Ashley B. Thompson&nbsp; Senior Vice President&nbsp; Public Policy Analysis and Development__________1 <a class="ck-anchor" href="https://premierinc.com/newsroom/blog/pinc-ai-analysis-hospital-led-acos-perform-as-well-as-physician-led-models" target="_blank" id="https://premierinc.com/newsroom/blog/pinc-ai-analysis-hospital-led-acos-perform-as-well-as-physician-led-models">https://premierinc.com/newsroom/blog/pinc-ai-analysis-hospital-led-acos-perform-as-well-as-physician-led-models</a>2 <a href="/system/files/media/file/2023/06/Private-Equity-and-Health-Insurers-Acquire-More-Physicians-than-Hospitals-Infographic.pdf" target="_blank">/system/files/media/file/2023/06/Private-Equity-and-Health-Insurers-Acquire-More-Physicians-than-Hospitals-Infographic.pdf</a> Thu, 27 Mar 2025 13:46:53 -0500 Letter/Comment Senate Letter from AHA, Other Organizations in Support of Conrad State 30 and Physician Access Reauthorization Act S.709 /lettercomment/2025-03-27-senate-letter-aha-other-organizations-support-conrad-state-30-and-physician-access-reauthorization-act <div class="container"><div class="row"><div class="col-md-8">March 26, 2025<div class="row"><div class="col-md-6">The Honorable David Valadao US House of Representatives 2465 Rayburn House Office Building Washington D.C., 20515</div><div class="col-md-6">The Honorable Brad Schneider US House of Representatives 300 Cannon House Office Building Washington D.C., 20515</div></div><div class="row"><div class="col-md-6">The Honorable Don Bacon US House of Representatives 2104 Rayburn House Office Building Washington D.C., 20515</div><div class="col-md-6">The Honorable Sylvia Garcia US House of Representatives 2419 Rayburn House Office Building Washington D.C., 20515</div></div></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/03/senate-letter-from-aha-other-organizations-in-support-of-conrad-state-30-and-physician-access-reauthorization-act-s709-3-26-2025.pdf" target="_blank">Download the Senate Letter PDF</a></div><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/lettercomment/2025-03-27-house-letter-aha-other-organizations-support-conrad-state-30-and-physician-access-reauthorization-act" target="_blank">Read the House Letter</a></div></div></div><div class="row"><div class="col-md-8">Dear Senators Klobuchar, Collins, Rosen, and Tillis:On behalf of the 45 undersigned organizations, we are writing to strongly support the introduction of the Conrad State 30 and Physician Access Reauthorization Act (S. 709).The healthcare workforce is under increasing strain. The aging U.S. population is increasing demand for healthcare services while also contributing to physician attrition. At the same time, reimbursement challenges in Medicare, along with insufficient investment in graduate medical education, have made the practice of medicine more difficult and constrained the pipeline of new doctors. These challenges are particularly acute in rural and underserved communities, where workforce shortages have led to severe access issues. Today, more than 80 million Americans lack adequate access to primary care, exacerbating health disparities across the country.Confronting this challenge will require a comprehensive approach from Congress. A key part of the solution is leveraging international medical graduates (IMGs). One in five physicians in the U.S. is foreign-born, and these doctors play an essential role in filling workforce shortages in areas and specialties that struggle to recruit and retain physicians. These include geriatric medicine, interventional cardiology, nephrology, neurology, and critical care medicine, where IMGs are disproportionately represented. The Conrad 30 program is an effective tool for incentivizing U.S.-trained international physicians to work in these high-need areas.Over the last 30 years, the program has facilitated placement of approximately 20,000 physicians in communities that otherwise might not have had access to health care. The program has also demonstrated success at retaining physicians beyond the three-year commitment. However, misaligned incentives and outdated policies are jeopardizing the future success of the program.The Conrad State 30 and Physician Access Reauthorization Act would make necessary updates to strengthen the program. In addition to gradually increasing the number of available waivers per state if certain thresholds are met, it also clarifies and improves the waiver process for both physicians and employers by making clear the transition period between receiving a waiver and beginning work. These commonsense changes will improve program efficiency and help ensure that more IMGs can pursue opportunities in underserved areas.One of the strengths of the Conrad 30 program is its flexible design, which allows each state to tailor the program to meet its specific healthcare needs. This reauthorization will reinforce that flexibility while providing needed clarity and incentives to attract and retain more highly qualified physicians. As workforce shortages worsen, Congress must act with urgency to advance this legislation and strengthen one of the most successful programs for addressing healthcare workforce shortages.Thank you again for your leadership on this important issue. We look forward to working with you to advance this bill and ensure that the Conrad 30 program continues to serve as a healthcare and economic lifeline for communities in need.Sincerely,Alliance for Headache Disorders Advocacy Ambulatory Surgery Center Association American Academy of Family Physicians American Academy of Neurology American Academy of Physical Medicine and Rehabilitation American Association of Child and Adolescent Psychiatry American Association of Neuromuscular &amp; Electrodiagnostic Medicine American Brain Coalition American College of Obstetricians and Gynecologists American College of Physicians American College of Radiology American College of Rheumatology American College of Surgeons American Gastroenterological Association American Geriatrics Society 黑料正能量 Association American Medical Association American Psychiatric Association American Society of Anesthesiologists American Society of Neuroradiology Anxiety and Depression Association of America Association for Advancing Physician and Provider Recruitment (AAPPR) Association of Clinicians for the Underserved (ACU) Association of American Medical Colleges Association of University Professors of Neurology College of American Pathologists Bobby Jones Chiari &amp; Syringomyelia Foundation Dystonia Medical Research Foundation Federation of 黑料正能量s (FAH) Hope for HIE Hydrocephalus Association Infectious Diseases Society of America International Bipolar Foundation M-CM Network Miles for Migraine MLD Foundation NANOS (North American Neuro- opthalmology Society) National Ataxia Foundation The Niskanen Center Phelan-McDermid Syndrome Foundation Physicians for American Healthcare Access (PAHA) Premier Inc. Society of Hospital Medicine The Society of Thoracic Surgeons SynGAP Research Fund dba CURE SYNGAP1 &nbsp;</div></div></div> Thu, 27 Mar 2025 13:13:34 -0500 Letter/Comment House Letter from AHA, Other Organizations in Support of Conrad State 30 and Physician Access Reauthorization Act (H.R.1585) /lettercomment/2025-03-27-house-letter-aha-other-organizations-support-conrad-state-30-and-physician-access-reauthorization-act <div class="container"><div class="row"><div class="col-md-8">March 26, 2025<div class="row"><div class="col-md-6">The Honorable David Valadao US House of Representatives 2465 Rayburn House Office Building Washington D.C., 20515</div><div class="col-md-6">The Honorable Brad Schneider US House of Representatives 300 Cannon House Office Building Washington D.C., 20515</div></div><div class="row"><div class="col-md-6">The Honorable Don Bacon US House of Representatives 2104 Rayburn House Office Building Washington D.C., 20515</div><div class="col-md-6">The Honorable Sylvia Garcia US House of Representatives 2419 Rayburn House Office Building Washington D.C., 20515</div></div></div><div class="col-md-4"><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2025/03/house-letter-from-aha-other-organizations-in-support-of-conrad-state-30-and-physician-access-reauthorization-act-h-r585-letter-3-26-2025.pdf" target="_blank">Download the House Letter PDF</a></div><div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/lettercomment/2025-03-27-senate-letter-aha-other-organizations-support-conrad-state-30-and-physician-access-reauthorization-act" target="_blank">Read the Senate Letter</a></div></div></div><div class="row"><div class="col-md-8">Dear Representatives Valadao, Schneider, Bacon, and Garcia:On behalf of the 45 undersigned organizations, we are writing to strongly support the introduction of the Conrad State 30 and Physician Access Reauthorization Act (H.R. 1585).The healthcare workforce is under increasing strain. The aging U.S. population is increasing demand for healthcare services while also contributing to physician attrition. At the same time, reimbursement challenges in Medicare, along with insufficient investment in graduate medical education, have made the practice of medicine more difficult and constrained the pipeline of new doctors. These challenges are particularly acute in rural and underserved communities, where workforce shortages have led to severe access issues. Today, more than 80 million Americans lack adequate access to primary care, exacerbating health disparities across the country.Confronting this challenge will require a comprehensive approach from Congress. A key part of the solution is leveraging international medical graduates (IMGs). One in five physicians in the U.S. is foreign-born, and these doctors play an essential role in filling workforce shortages in areas and specialties that struggle to recruit and retain physicians. These include geriatric medicine, interventional cardiology, nephrology, neurology, and critical care medicine, where IMGs are disproportionately represented. The Conrad 30 program is an effective tool for incentivizing U.S.-trained international physicians to work in these high-need areas.Over the last 30 years, the program has facilitated placement of approximately 20,000 physicians in communities that otherwise might not have had access to health care. The program has also demonstrated success at retaining physicians beyond the three-year commitment. However, misaligned incentives and outdated policies are jeopardizing the future success of the program.The Conrad State 30 and Physician Access Reauthorization Act would make necessary updates to strengthen the program. In addition to gradually increasing the number of available waivers per state if certain thresholds are met, it also clarifies and improves the waiver process for both physicians and employers by making clear the transition period between receiving a waiver and beginning work. These commonsense changes will improve program efficiency and help ensure that more IMGs can pursue opportunities in underserved areas.One of the strengths of the Conrad 30 program is its flexible design, which allows each state to tailor the program to meet its specific healthcare needs. This reauthorization will reinforce that flexibility while providing needed clarity and incentives to attract and retain more highly qualified physicians. As workforce shortages worsen, Congress must act with urgency to advance this legislation and strengthen one of the most successful programs for addressing healthcare workforce shortages.Thank you again for your leadership on this important issue. We look forward to working with you to advance this bill and ensure that the Conrad 30 program continues to serve as a healthcare and economic lifeline for communities in need.Sincerely,Alliance for Headache Disorders Advocacy Ambulatory Surgery Center Association American Academy of Family Physicians American Academy of Neurology American Academy of Physical Medicine and Rehabilitation American Association of Child and Adolescent Psychiatry American Association of Neuromuscular &amp; Electrodiagnostic Medicine American Brain Coalition American College of Obstetricians and Gynecologists American College of Physicians American College of Radiology American College of Rheumatology American College of Surgeons American Gastroenterological Association American Geriatrics Society 黑料正能量 Association American Medical Association American Psychiatric Association American Society of Anesthesiologists American Society of Neuroradiology Anxiety and Depression Association of America Association for Advancing Physician and Provider Recruitment (AAPPR) Association of Clinicians for the Underserved (ACU) Association of American Medical Colleges Association of University Professors of Neurology College of American Pathologists Bobby Jones Chiari &amp; Syringomyelia Foundation Dystonia Medical Research Foundation Federation of 黑料正能量s (FAH) Hope for HIE Hydrocephalus Association Infectious Diseases Society of America International Bipolar Foundation M-CM Network Miles for Migraine MLD Foundation NANOS (North American Neuro- opthalmology Society) National Ataxia Foundation The Niskanen Center Phelan-McDermid Syndrome Foundation Physicians for American Healthcare Access (PAHA) Premier Inc. Society of Hospital Medicine The Society of Thoracic Surgeons SynGAP Research Fund dba CURE SYNGAP1</div></div></div> Thu, 27 Mar 2025 12:45:25 -0500 Letter/Comment AHA Letter Opposing the Physician Led and Rural Access to Quality Care Act (H.R.2191) /lettercomment/2025-03-27-aha-letter-opposing-physician-led-and-rural-access-quality-care-act-hr2191 March 25, 2025The Honorable Morgan Griffith U.S. House of Representatives 2110 Rayburn House Office Building Washington, DC 20515Dear Representative Griffith:On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, the 黑料正能量 Association (AHA) writes to express our opposition to H.R. 2191, the Physician Led and Rural Access to Quality Care Act.Rural hospitals are essential access points for care, economic anchors for their communities, and the backbone of our nation鈥檚 rural communities. These hospitals have maintained their commitment to ensuring local access to high-quality, affordable care despite continued financial and workforce challenges. The AHA strongly supports legislation that would enable rural hospitals across the nation to better care for their communities. However, we believe that H.R. 2191 is misguided legislation that would skew the health care marketplace in favor of physicians who self-refer patients to hospitals they own and would destabilize rural health care while failing to improve access to quality care.H.R. 2191 would result in additional gaming of the Medicare program, jeopardize patient access to emergency care, potentially harm sicker and lower-income patients, and severely damage the ability of 24/7 full-service community hospitals to provide care in rural areas.Physician self-referral 鈥� whether in rural, suburban or urban communities 鈥� is the antithesis of fair competition. The problematic practice allows physicians to steer their most profitable cases to facilities they own 鈥� facilities that often call 9-1-1 to handle their emergencies and are often located in the most affluent areas. By performing the highest-paying procedures for the best-insured patients, physician-owners inflate health care costs and drain essential resources from community hospitals, which depend on a balance of services and patients to provide indispensable treatment, such as behavioral health and trauma care. By increasing the presence of these self-referral arrangements, H.R. 2191 would only further destabilize community care.Since the Medicare Modernization Act of 2003, Congress has supported ending the egregious and costly practice of physician self-referral to hospitals they own. Current law represents a 15-year compromise that (1) allows existing physician-owned hospitals (POHs) to continue to treat Medicare patients, (2) permits the expansion of those physician-owned hospitals that meet communities鈥� needs for additional hospital capacity and treat low-income patients, and (3) prohibits Medicare from covering services in any new physician-owned hospitals established after Dec. 31, 2010. Congress established these guardrails to protect the Medicare program from overutilization, patient steering and the harmful patient selection practices that POHs employ.Data have shown time and time again that POHs select only the healthiest and most profitable patients, serving lower proportions of Medicaid, dual eligible and uncompensated care than full-service acute care hospitals. The <a href="https://www.cbo.gov/sites/default/files/111th-congress-2009-2010/costestimate/amendreconprop.pdf" target="_blank" title="Congressional Budget Office Website">Congressional Budget Office</a>, the <a href="https://www.medpac.gov/wp-content/uploads/import_data/scrape_files/docs/default-source/reports/Mar05_SpecHospitals.pdf" target="_blank" title="Medicare Payment Advisory Commission">Medicare Payment Advisory Commission</a> and the <a href="https://public-inspection.federalregister.gov/2023-16252.pdf" target="_blank" title="Center for Medicare &amp; Medicaid Services">Centers for Medicare &amp; Medicaid Services</a> all have concluded that physician self-referral leads to greater per capita utilization of services and higher costs for the Medicare program, among other negative impacts.For these reasons, the AHA strongly opposes the expansion of POHs 鈥� by either creating new categories of exceptions or allowing existing POHs to expand 鈥� and cannot support H.R. 2191. Congress should maintain current law, preserve the ban on physician self-referrals to new physician-owned hospitals, and retain restrictions on the growth of existing physician-owned hospitals, regardless of location.Sincerely,/s/Lisa Kidder Hrobsky Senior Vice President, Advocacy and Political Affairs Thu, 27 Mar 2025 10:36:14 -0500 Letter/Comment AHA Comments on DEA Proposed Rule on Special Registrations for Telemedicine Prescribing /lettercomment/2025-03-18-aha-comments-dea-proposed-rule-special-registrations-telemedicine-prescribing March 18, 2025Acting Administrator Derek Maltz Drug Enforcement Administration ATTN: DEA Federal Register Representative 8701 Morrissette Dr. Springfield, VA 22152Re: Docket No. DEA-407 Special Registrations for Telemedicine and Limited State Telemedicine RegistrationsDear Acting Administrator Maltz:&nbsp;On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations; our clinician partners 鈥� including more than 270,000 affiliated physicians, 2 million nurses and other caregivers 鈥� and the 43,000 health care leaders who belong to our professional membership groups, the 黑料正能量 Association (AHA) appreciates the opportunity to share our comments regarding the Drug Enforcement Administration鈥檚 (DEA鈥檚) proposed rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations.The AHA continues to support the concept of a special registration process to waive in-person evaluations prior to the prescribing of controlled substances. However, we are concerned that the proposed process would be inefficient and unnecessarily burdensome. We recommend the agency adopt a more streamlined process that would enable prescribers to register as part of the existing licensure framework. This approach would&nbsp;achieve the agency鈥檚 crucial goal of mitigating diversion while minimizing excessive burdens on our already overtaxed clinical workforce. Specifically, we urge the agency to:<ul><li>Expand the existing DEA registration forms to collect the information sought instead of creating separate registration forms and fees.</li><li>Expand the list of providers eligible for advanced telemedicine prescribing.</li><li>Remove the requirement for Prescription Drug Monitoring Program (PDMP) reviews for every state and territory.</li><li>Remove the requirement for Schedule II prescribers to be physically located in the same state as the patient.</li><li>Remove the requirement for Schedule II prescribers to have less than 50% of Schedule II prescriptions issued as special registration prescriptions.</li><li>Remove certain recordkeeping and reporting requirements, including the requirement to maintain a photographic record of patient identity verification.</li></ul>Given the scope of the proposed changes, we also encourage the DEA to extend the timeline for implementation, which we recognize would also&nbsp;require extension of the relevant waiver flexibilities until the final rule is published and in effect.&nbsp;Patients, practitioners, platforms, pharmacies and other stakeholders must have adequate pre-implementation periods to prepare for changes in process.Below are our detailed comments.BackgroundThe Ryan Haight Act of 2008 established specific requirements for in-person evaluations prior to the prescribing of controlled substances. This law also outlined seven&nbsp;categories of instances in which telemedicine, rather than in-person evaluations, could be utilized. One of these categories was a special registration process, and the law specified that the Attorney General&nbsp;shall&nbsp;promulgate regulations specifying circumstances in which a special registration for telemedicine prescribing may be issued as well as the procedures for obtaining such a special registration. The SUPPORT Act of 2018 again mandated that the DEA, in coordination with the Department of Health and Human Services (HHS), promulgate special registration regulations. The law specified: (1) the circumstances in which a special registration for telemedicine may be issued that authorizes prescribing of controlled substances without an in-person evaluation; and (2) the procedures for obtaining a special registration.The AHA has continuously supported a special registration process to waive in-person visit requirements for those prescribers who register. Indeed, a streamlined special registration process that ensures appropriate tracking of virtual prescribers would help safely ensure access to critical services. As such, we have recommended that the DEA establish such a process based on the existing registration process.1 Over the last five years, waivers of in-person visits and broad utilization of virtual prescribing have demonstrated significant benefits to patients in accessing lifesaving medication. Meanwhile, data have indicated no increased risk for diversion. As such, we support the agency鈥檚 pursuit of a permanent pathway for practitioners to waive in-person visit requirements. However, we have both concerns with and recommendations to improve the agency鈥檚 proposed special registration process.<h2>TYPES OF SPECIAL REGISTRATION</h2>The DEA proposes three types of special registration:<ul><li>Telemedicine prescribing registration, which would authorize qualified clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine.</li><li>Advanced telemedicine prescribing registration, which would authorize certain practitioners to prescribe select Schedule II-V controlled substances via telemedicine.</li><li>Telemedicine platform registration, which would authorize online telemedicine platforms to dispense Schedule II-V controlled substances.</li></ul>Under the proposed framework, clinician practitioners would be considered clinician special registrants, and platform practitioners would be considered platform special registrants.In general, we urge the agency to issue clarifying guidance on how post-graduate hospital trainees (also known as residents) would register under this scheme. Residents typically utilize a hospital DEA registration number when prescribing controlled substances in accordance with their residency program. The proposed rules did not address applications in training settings, and therefore we request clarifying.Additional feedback on the proposed registration types follows.Advanced Telemedicine Prescribing Registration. In addition to demonstrating a legitimate need for this type of special registration, the DEA proposes that only certain clinician practitioners would be eligible. These include:<ul><li>Psychiatrists.</li><li>Hospice care physicians.</li><li>Palliative care physicians.</li><li>Physicians rendering treatment at long-term care facilities.</li><li>Pediatricians.</li><li>Neurologists.</li><li>Mid-level practitioners and physicians from other specialties who are board-certified in the treatment of psychiatric or psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to the treatment and management of pain.</li></ul>The list does not include other specialties or clinical applications that serve patients who would benefit from virtual prescribing flexibilities. For example, a geographically remote patient with cancer receiving pain medications from an oncologist and a home-bound patient with a sleep disorder receiving sleep medication from a pulmonologist could both benefit greatly from access to these services. In these instances, seeing a practitioner in person is simply not an available option. As such, virtual prescription pathways should also be available to these practitioners and patients. Therefore, we urge the agency to expand the list of eligible providers able to register for advanced telemedicine special registration to include all practitioners who can prescribe these medications in person.&nbsp;Doing so also would include, for example, oncologists or pulmonologists registered with the DEA.Telemedicine Platform Registration.&nbsp;The DEA proposes a separate process for telemedicine platform registration, which would authorize virtual practitioners practicing only on telemedicine platforms (as opposed to seeing some patients in person and some via telemedicine) to prescribe controlled substances. While we agree that it would be beneficial to track these practitioners separately, we urge the agency to issue clarification on this registration process.&nbsp;We agree that platform providers should maintain certain records of clinicians who enter into a platform relationship (including disciplinary actions and complaints). However, we disagree that the threshold for clinical need should be lower for this category. Specifically, in the proposed rule, platform providers under this designation would be able to prescribe Schedule II-V drugs, the same as advanced registration clinicians; however, the requirements to demonstrate need are aligned instead with the standard telemedicine registration clinicians who are able to prescribe only Schedule III-V drugs. It is unclear why platform special registrants would be held to a different, less rigorous standard than advanced special registrants. This essentially penalizes clinicians leveraging hybrid models of care (in-person and virtual appointments). If the intent was for platform practitioners to also register as either general or advanced telemedicine prescribers in addition to platform registrants, then we request that the DEA issue such a clarification. Otherwise, we encourage the agency to adopt parallel requirements based on the schedule of drug prescribed.&nbsp;<h2>STATE REGISTRATION</h2>In addition to the aforementioned special registration categories, the DEA proposes that practitioners would need to complete a state registration for every state in which they treat a patient. The agency proposes that the state registration would be a novel, separate and ancillary credential administered by the DEA (not the states). We are concerned that this additional layer of licensure is overly burdensome without providing clear benefit, particularly considering existing licensure standards.&nbsp;Specifically, to require practitioners to submit separate registration forms for each state in which a patient is located is redundant, since the same information is already provided on other forms. That is, the existing general DEA registration process already asks for information on state medical licenses; the proposed process would duplicate efforts without providing additional safeguards.It is unclear what purpose registering for each individual state would serve given the existing DEA registration process, the proposed special registration questions and state medical licensure processes. If the purpose is to track the states that a telemedicine practitioner is not only licensed in but also wishes to prescribe certain controlled substances to, then a question about this could be added to the general registration form. For example, the DEA could add a question to the existing general registration form such as, 鈥淚n which states do you have patients that you will virtually prescribe special-registration controlled substances? (check all that apply).鈥� To avoid unnecessary and duplicative administrative burden, we urge the DEA to remove the requirements for practitioners to complete state-specific registration forms and adopt this approach instead.If the agency does move forward with this proposal, we request it provide guidance on state responsibility for enforcement as the proposed rule also does not address the notification and enforcement process for state registrations. Specifically, it does not address enforcement responsibilities in states where practitioners are licensed and in good standing through state medical boards, are registered and in good standing with the DEA, and have completed the general special registration process but are not registered for an individual state. Enforcement activities are often complex, involving the DEA, state medical boards and state law enforcement. If this policy is adopted, we request further guidance on both agency and state responsibilities for enforcement.&nbsp;<h2>SPECIAL REGISTRATION AND STATE REGISTRATION APPLICATIONS</h2>The DEA proposes two new forms (224S and 224S-M for modifications) that practitioners completing special registration and state registration would need to submit. However, as we previously noted, the establishment of a separate form would be redundant, creating undue administrative burden for both practitioners and the DEA, which would need to develop separate systems for processing and tracking the new forms. Specifically, practitioners, hospitals, clinics, pharmacies and others are already required to complete applications for registration and renewal of registrations for prescribing controlled substances through forms 224 and 224a. This process has established guardrails that build upon state medical licensure processes and Medicare reporting. State medical boards screen applicants for education and training as part of licensure processes and are responsible for investigating complaints, monitoring compliance and disciplining providers when necessary. Given the DEA鈥檚 unique role in mitigating risk of diversion for controlled substances, the registration process complements existing state-based processes. The DEA collects supporting information from physicians about state licensure, locations and adverse actions on the existing applications. Therefore, rather than creating a novel and separate process or form, we urge the DEA to add any additional information it needs on special registration to the forms 224 and 224a that are already in use. This way, the special registration process would include both key elements that providers already report 鈥� such as practitioner contact information, employer, practice address, state medical licenses, liability history, etc. 鈥�&nbsp;and providers&nbsp;could add unique attestations.&nbsp;Indeed, the proposed rule highlighted that the special registration would be contingent on good standing of other DEA registrations and that the special registration location would need to already be registered with the DEA. As such, it would make sense to link special registration questions to the existing form.<h2>SPECIAL REGISTRATION PRESCRIPTIONS</h2>In addition to abiding by state laws where the provider is located, the patient is located and the practitioner is registered with the DEA, under the agency鈥檚 proposal, providers also would need to follow several provisions related to the prescriptions administered under special registration.Nationwide PDMP Review.&nbsp;The DEA proposes that for the first three years after the rule is finalized, providers would need to complete PDMP checks for the states where the patient is located, the clinician is located and for any state with a reciprocity agreement to the patient/clinician locations. After three years, the DEA proposes that providers would need to review the PDMPs of all 50 states and territories when prescribing a controlled substance via telemedicine for each patient.While PDMPs can provide useful information on patients鈥� prescription histories, the proposal to perform PDMP reviews for all 50 states and territories is simply operationally infeasible and is unlikely to offer additional protection against diversion.&nbsp;Performing a PDMP check for all 50 states is not as easy as visiting one website, entering a patient鈥檚 name and receiving a list of results.&nbsp;First, interoperability infrastructure does not currently exist to support providers reviewing information across all 50 states and territories from a single platform. Interstate data-sharing partnerships vary, with some states limiting data sharing to noncontiguous states. Additionally, 鈥渙wnership鈥� of the PDMP within state health departments or other agencies (like law enforcement) can also hinder accessibility and data transfer across state lines. According to the Assistant Secretary for Technology Policy, only 31 states reported sharing data with more than 30 states through data-sharing systems like RxCheck or PMP InterConnect.2 This lack of data sharing means that physicians would have to maintain separate logins for different state PDMP portals, which is incredibly burdensome. In addition, 10 territories do not have PDMPs. There also are large gaps in integration with electronic health records (EHRs). Interfaces between state PDMP databases and EHRs minimize resource requirements, since physicians can seamlessly access prescription histories while reviewing the patient鈥檚 medical record. However, building PDMP/EHR interfaces can be resource intensive and requires providers to leverage an EHR of sufficient size and scope to support multi-state PDMP interfaces or interfaces with data-sharing systems (like the ones mentioned above). This lack of interoperability means that most physicians would need to manually check individual state PDMP portals, which would, in effect, negate their ability to use this waiver.Second, PDMP reviews themselves are often time consuming and administratively burdensome. Research (which typically involved just one state) shows that these reviews vary based on specialty. Using psychiatrists as an example, the estimated amount of time used to retrieve PDMP reports is around 22 hours annually.3 Extrapolating to all 50 states and 14 territories means that the physician would need over 1,400 hours annually just to perform PDMP reviews. That equates to 1,400 fewer patient hours and a cost of over $174,000 per year per prescriber to retrieve this information (using the Bureau of Labor Statistics鈥� average hourly rate for psychiatrists of $124).4 It is unlikely any provider could absorb this level of burden, especially given the already high degree of burnout among physicians.&nbsp;Finally, barriers to accessing and interpreting PDMP data are not limited to data interoperability and time challenges. Indeed, the specific data elements, standards and formats also vary from state to state. For example, while there are some common reporting elements, specific data elements are dictated by state-level statute and regulation. This variation hampers the ability of physicians to have a holistic view across all PDMP reports. Also, some states have the ability to create aggregate and custom reports to summarize data longitudinally, whereas others do not and the onus is on the physician to manually aggregate the data. Again, this highlights the cumbersome nature of PDMP review in the current environment.To be clear, PDMPs are helpful state-level interventions that can improve surveillance on inappropriate prescriptions; however, as we noted in our response to the Assistant Secretary for Planning and Evaluation鈥檚 <a href="/system/files/media/file/2019/08/hhs-rfi%20ensuring-patient-access-and-effective-drug-enforcement-8-23-2019.pdf" target="_blank">Request for Information</a> on Ensuring Patient Access and Effective Drug Enforcement, there is significant room for improvement in each state鈥檚 PDMP and serious limitations on interoperability across state programs. As such, we once again urge DEA to coordinate with HHS and other agencies to develop strategies to enhance the data interoperability of PDMPs. This will maximize the utility of PDMP data in the long term and better support physicians in mitigating risk of diversion. In the meantime, we urge the DEA to remove the requirements for additional PDMP reviews beyond current standards for in-person prescribing of controlled substances and limit the requirement to the state where the provider and patient are located.&nbsp;Special Registration Audio-Video.&nbsp;In the proposed rule, the DEA would mandate that a clinician special registrant utilize both audio and video components of an audio-video telecommunications system to prescribe under the special registration framework. This unnecessarily restricts patients鈥� access to virtual prescribing when video technology may not be available. CMS has identified the services that are eligible for audio-only encounters. Similarly, we encourage the DEA to provide parameters or exceptions where audio-only prescribing may be appropriate.Schedule II Special Registration Prescriptions.&nbsp;The agency proposes two additional requirements for special registration prescriptions of Schedule II drugs. First, the agency proposes that clinician special registrants prescribing Schedule II drugs be physically located in the same state as the patient. However, this arbitrary requirement defeats the purpose of virtual prescribing flexibilities and limits patient choice. Physician shortages are impacting some states and specialties more acutely than others. For example, Texas has over 13 million people living in mental health care provider shortage areas and would need 614 additional practitioners to remove that designation.5 Restricting special registration practitioners to prescribing these drugs only to patients in their state would not help with existing shortages such as these. Often practitioners are simply not available in some communities, and telemedicine provides options for patients to access geographically dispersed practitioners located in other states. So long as practitioners are abiding by federal and state statute and conforming to standards issued by state licensing boards, we urge the DEA to not arbitrarily limit access to services. As such, we ask that the DEA remove the requirement for providers and patients to be located in the same state for prescribing of Schedule II drugs.Additionally, the agency proposes to require that the number of special registration Schedule II drugs constitute less than 50% of the total number of Schedule II drugs issued by the clinician in their telemedicine and non-telemedicine practice in a calendar month. We are unclear from the discussion in the rule why the agency proposed this standard, and without further rationale, we recommend removing it. There is no evidence to suggest that requiring practitioners to prescribe less than 50% of drugs virtually would mitigate risk of diversion. Rather, the agency relies on a general assumption that because controlled substances can be misused, an increase in access results in increased risk.<h2>RECORDKEEPING AND REPORTING</h2>The DEA also proposes additional recordkeeping and reporting requirements. For example, it proposes that clinician special registrants be required to capture a photographic record of the patient presenting federal- or state-issued identification cards. If the patient does not feel comfortable with the clinician taking a picture, the patient could provide a copy of their ID. We are concerned that this requirement could raise fair concerns by patients about their privacy, while at the same time not adding additional protection against diversion.&nbsp;Telehealth providers generally document in the medical record an attestation that patient identification was verified. There are also standards at the state level on types of data fields required for identity verification, some of which may not be on a state or federal ID card. Therefore, having photographic evidence of identity presentation is unnecessary and adds administrative burden to take and preserve a photo in the medical record. This detracts from the clinical time that the practitioner is engaging with the patient, is costly to maintain and poses unnecessary risk (i.e., capture and maintenance of additional sensitive data). Just as a practitioner would not be expected to take a picture of a patient in an exam room to verify identity, the same standard applies to virtual appointments. Finally, there is no evidence to suggest that this added requirement would minimize risk of diversion. As such, we urge the DEA to defer to state requirements for identity verification and not impose additional requirements.&nbsp;We also are concerned that additional reporting requirements, like the requirement for pharmacies to generate monthly reports of special registration prescriptions filled and the requirement for practitioners to generate annual special registrant reports, are overly burdensome and will not lead to reduced risk of diversion. According to the proposed rule, the DEA would require pharmacies to report aggregate data within the first seven days of every month on the special registration prescriptions filled during the preceding month for each Schedule II controlled substance and certain Schedule III-V controlled substances. These requirements could result in further limiting access since providers may simply elect to no longer virtually prescribe medications or fill telemedicine prescriptions since it is too burdensome to keep up with the recordkeeping and reporting requirements. This has already been an issue with 鈥渞ed flags鈥� for prescriptions issued in remote geographies, where pharmacists have declined filling prescriptions for controlled substances from outside states. There are many reasons a virtual prescription may be filled in a remote state or geography: a patient is on vacation, a student is in college, a patient is maintaining the same provider after moving out of state, a patient is seeing a specialist in a different state when they cannot find a doctor locally, etc. Nonetheless, distance from the prescriber and patient has been identified as a 鈥渞ed flag鈥� and has hampered access as many pharmacies are simply opting to not fill virtual prescriptions. The potential risk to access in these cases may outweigh potential risk of diversion. In addition to removing the requirements for additional annual and monthly reports, we urge the agency to also remove reference to geography as a red flag for risk of diversion.Given the scope of a new special registration process and breadth of potential changes, we also urge the agency to delay implementation to allow adequate time for stakeholders to prepare. Specifically, we request that the DEA provide at least a one-year pre-implementation period after rules are finalized to ensure that practitioners can appropriately prepare for changes. Simultaneously, we urge the agency to extend the current in-person visit waivers to avoid gaps in access until rules are finalized.We thank you for considering our comments on this proposed rule. If you have any questions concerning our comments, please feel free to contact me or have a member of your team contact Jennifer Holloman, AHA鈥檚 senior associate director of policy, at jholloman@aha.org or Caitlin Gillooley, AHA鈥檚 director of behavioral health and quality policy, at cgillooley@aha.org.Sincerely,/s/Ashley Thompson Senior Vice President Public Policy Analysis and Development<div><hr><div id="ftn1">1<a href="/system/files/media/file/2023/03/aha-comment-letter-to-dea-on-telemedicine-prescribing-of-controlled-substances-proposed-rule-3-29-23.pdf" target="_blank">/system/files/media/file/2023/03/aha-comment-letter-to-dea-on-telemedicine-prescribing-of-controlled-substances-proposed-rule-3-29-23.pdf</a>.</div><div id="ftn2">2<a href="https://www.healthit.gov/buzz-blog/health-it/physicians-have-widespread-access-to-state-pdmp-data-but-data-sharing-varies-across-states" target="_blank">https://www.healthit.gov/buzz-blog/health-it/physicians-have-widespread-access-to-state-pdmp-data-but-data-sharing-varies-across-states</a>.</div><div id="ftn3">3<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC6176751/" target="_blank">https://pmc.ncbi.nlm.nih.gov/articles/PMC6176751/</a>.</div><div id="ftn4">4<a href="https://www.bls.gov/oes/2023/may/oes291223.htm" target="_blank">https://www.bls.gov/oes/2023/may/oes291223.htm</a>.</div><div id="ftn5">5<a href="https://www.kff.org/other/state-indicator/mental-health-care-health-professional-shortage-areas-hpsas/" target="_blank">https://www.kff.org/other/state-indicator/mental-health-care-health-professional-shortage-areas-hpsas/?currentTimeframe=0&amp;sortModel=%7B%22colId%22:%22Practitioners%20Needed%20to%20Remove%20HPSA%20Designation%22,%22sort%22:%22desc%22%7D</a>.</div></div> Tue, 18 Mar 2025 15:41:23 -0500 Letter/Comment