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	<title>State Policy &#8211; Policy &amp; Medicine</title>
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	<description>Legal, Regulatory, and Compliance Issues</description>
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	<title>State Policy &#8211; Policy &amp; Medicine</title>
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	<item>
		<title>PBM Prime Therapeutics to Pay $10 Million Antitrust Case Over Price-Fixing Scheme with Express Scripts, Inc.</title>
		<link>https://www.policymed.com/2025/01/pbm-prime-therapeutics-to-pay-10-million-antitrust-case-over-price-fixing-scheme-with-express-scripts-inc.html</link>
					<comments>https://www.policymed.com/2025/01/pbm-prime-therapeutics-to-pay-10-million-antitrust-case-over-price-fixing-scheme-with-express-scripts-inc.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 29 Jan 2025 09:01:36 +0000</pubDate>
				<category><![CDATA[FTC]]></category>
		<category><![CDATA[PBM]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[AIDS Healthcare Foundation]]></category>
		<category><![CDATA[antitrust litigation]]></category>
		<category><![CDATA[Express Scripts]]></category>
		<category><![CDATA[Healthcare Competition]]></category>
		<category><![CDATA[horizontal price restraint]]></category>
		<category><![CDATA[Minnesota antitrust law]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[pharmacy benefit management]]></category>
		<category><![CDATA[price fixing]]></category>
		<category><![CDATA[Prime Therapeutics]]></category>
		<category><![CDATA[Sherman Act violation]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17631</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="852" height="480" src="https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs.jpg 852w, https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs-300x169.jpg 300w, https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs-768x433.jpg 768w" sizes="(max-width: 852px) 100vw, 852px" /></div>In a recent antitrust arbitration ruling, Prime Therapeutics, a pharmacy benefit manager (PBM) owned by 19 Blue Cross and Blue Shield Plans, was found guilty of engaging in horizontal price-fixing in collaboration with Express Scripts, Inc. (ESI), a competitor owned by Cigna. The arbitration, led by Arbitrator Stuart M. Widman, concluded that this so-called &#8220;collaboration&#8221; [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="852" height="480" src="https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs.jpg 852w, https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs-300x169.jpg 300w, https://www.policymed.com/wp-content/uploads/2025/01/Business-hugs-768x433.jpg 768w" sizes="(max-width: 852px) 100vw, 852px" /></div><p>In a recent <a href="https://www.policymed.com/wp-content/uploads/2025/01/PrimeAHFInterimAward01-22-0000-2756.pdf">antitrust arbitration ruling</a>, Prime Therapeutics, a pharmacy benefit manager (PBM) owned by 19 Blue Cross and Blue Shield Plans, was found guilty of engaging in horizontal price-fixing in collaboration with Express Scripts, Inc. (ESI), a competitor owned by Cigna. The arbitration, led by Arbitrator Stuart M. Widman, concluded that this so-called &#8220;collaboration&#8221; violated federal and Minnesota antitrust laws and caused significant harm to competition and market fairness. The AIDS Healthcare Foundation (AHF), the claimant in the case, was awarded over $10 million in damages.</p>
<p><strong>Key Findings</strong></p>
<p style="padding-left: 40px;"><strong>Horizontal Price-Fixing</strong>: The ruling determined that Prime and ESI implemented a price-fixing scheme under the cover of a “collaboration” that began in December 2019 and was extended through 2025. This arrangement included strict pricing “guardrails,” such as minimums, maximums, and targets, which Prime was required to follow. ESI monitored compliance through regular reports and even issued financial adjustments to ensure adherence.</p>
<p style="padding-left: 40px;"><strong>Anticompetitive Practices</strong>: The collaboration effectively eliminated competition between Prime and ESI by aligning reimbursement rates for pharmacies across their networks. This arrangement placed Prime’s pricing decisions under ESI’s control, creating a non-competitive environment that harmed pharmacy providers like AHF.</p>
<p style="padding-left: 40px;"><strong>Market Harm</strong>: The ruling highlighted how these practices prioritized corporate self-interest over fostering a competitive marketplace. AHF demonstrated that this scheme caused millions in damages by reducing reimbursement rates for pharmacies, undermining both AHF’s revenues and broader market competition.</p>
<p style="padding-left: 40px;"><strong>Failure to Justify Procompetitive Benefits</strong>: Prime argued that the collaboration offered procompetitive benefits, such as reduced costs for consumers. However, Arbitrator Widman found these claims unsubstantiated, emphasizing that any economic benefits accrued primarily to Prime and its owners rather than benefiting consumers or improving market competition.</p>
<p><strong>Legal Implications</strong></p>
<p>The arbitration applied the <strong>per se rule</strong>, which automatically deems certain antitrust violations illegal without requiring detailed market analysis. Arbitrator Widman rejected arguments to evaluate the case under the more lenient &#8220;rule of reason&#8221; standard, concluding that the price-fixing agreement had no redeeming procompetitive features. The decision also emphasized that antitrust laws aim to protect competition itself—not individual competitors—underscoring the severity of Prime’s actions as “the cardinal sin of antitrust law.”</p>
<p><strong>Broader Industry Concerns</strong></p>
<p>This case sheds light on troubling practices within vertically integrated healthcare systems. By consolidating power among PBMs, insurers, and pharmacy networks, companies like Prime and ESI can manipulate pricing structures under the cover of cost-saving collaborations.  Look for an Express Scripts ruling to come out soon as well.</p>
<p>Such arrangements often escape regulatory scrutiny but can have devastating consequences for independent providers and market competition.</p>
<p><strong>Outcome</strong></p>
<p>AHF was awarded $10.3 million in trebled damages under federal antitrust law. The arbitrator also granted injunctive relief to prevent further harm from the ongoing collaboration between Prime and ESI. Additional proceedings will determine whether AHF is entitled to recover attorneys’ fees, costs, and interest.</p>
<p>Over the past few years, major PBMs like CVS Caremark, Express Scripts, Optum Rx, and Prime Therapeutics have faced numerous federal or multidistrict cases over allegations of various misconduct.   There are also several similar cases against PBM price fixing filed across jurisdictions around the US.</p>
<p>This ruling opens the door to private entities enforcing state antitrust laws to maintain fair competition and a new tool against PBM monopolization.</p>
<p><a href="https://www.policymed.com/wp-content/uploads/2025/01/PrimeAHFInterimAward01-22-0000-2756.pdf">Prime Antitrust Ruling 1-22-2025</a></p>
<p>&nbsp;</p>
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		<title>The Limits of Prescription Drug Affordability Review Boards</title>
		<link>https://www.policymed.com/2025/01/the-limits-of-pdabs.html</link>
					<comments>https://www.policymed.com/2025/01/the-limits-of-pdabs.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 20 Jan 2025 09:44:23 +0000</pubDate>
				<category><![CDATA[Drug Prices]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[340B Covered Entities]]></category>
		<category><![CDATA[affordability challenges]]></category>
		<category><![CDATA[Drug Affordability Reviews]]></category>
		<category><![CDATA[Drug Cost Reduction]]></category>
		<category><![CDATA[Drug Cost Review]]></category>
		<category><![CDATA[drug price negotiation]]></category>
		<category><![CDATA[Drug Pricing]]></category>
		<category><![CDATA[Drug Supply Chain]]></category>
		<category><![CDATA[Healthcare Cost Savings]]></category>
		<category><![CDATA[healthcare policy]]></category>
		<category><![CDATA[Healthcare Regulations]]></category>
		<category><![CDATA[Healthcare Stakeholders]]></category>
		<category><![CDATA[Maryland PDAB]]></category>
		<category><![CDATA[Medicaid Supplemental Rebates]]></category>
		<category><![CDATA[Oregon PDAB]]></category>
		<category><![CDATA[Patient Access to Care]]></category>
		<category><![CDATA[Patient Advocacy Groups]]></category>
		<category><![CDATA[PDAB]]></category>
		<category><![CDATA[Pharmaceutical Manufacturers]]></category>
		<category><![CDATA[Pharmaceutical Pricing Regulation]]></category>
		<category><![CDATA[pharmacy benefit managers]]></category>
		<category><![CDATA[Prescription Drug Affordability]]></category>
		<category><![CDATA[retail pharmacies]]></category>
		<category><![CDATA[State Prescription Drug Affordability Review Boards]]></category>
		<category><![CDATA[UPLs]]></category>
		<category><![CDATA[upper payment limits]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17398</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="(max-width: 1200px) 100vw, 1200px" /></div>We’ve previously written about state prescription drug affordability review boards (PDABs) that have been instituted around the country, often with the intent to review higher-cost prescription drugs and determine whether the state should take action to reduce those drug prices. While PDAB boards vary throughout the country in what they are permitted to do, PDABs [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>We’ve previously written about state prescription drug affordability review boards (PDABs) that have been instituted around the country, often with the intent to review higher-cost prescription drugs and determine whether the state should take action to reduce those drug prices. While PDAB boards vary throughout the country in what they are permitted to do, PDABs may attempt to reduce drug prices by performing affordability reviews, making recommendations to each state’s respective legislature on ways to reduce spending, negotiating prices and Medicaid supplemental rebates with manufacturers, and setting upper payment limits (UPLs) or caps on what a state will spend on a particular medication.</p>
<p>However, as PDABs continue to grow in popularity, it turns out their goals may not be reached as planned. Oregon, for one, found that drug pricing and complexities in the supply chain may limit implementation of its proposed upper payment limits. The State of Oregon Department of Consumer and Business Services, Division of Financial Regulation published a <a href="https://dfr.oregon.gov/pdab/Documents/OR-PDAB-UPL-Report-Draft-20240821.pdf">Constituent Group Engagement Report</a> based on the perspectives of seven constituent groups, (1) 340B Covered Entities, (2) carriers, (3) hospitals, (4) patient advocacy groups, (5) pharmaceutical manufacturers, (6) pharmacy benefit managers (PBMs), and (7) retail pharmacies.</p>
<p>The report found that while constituents were generally concerned about drug affordability, perceptions regarding using UPL to lower prices were mixed. More than half of respondents felt that UPLs woul dnot result in cost savings, and 47% were concerned that a UPL would have a negative financial impact on their organization. Additionally, 54% of respondents expressed their belief that a UPL would actually create challenges to patient access to care, with 47% of respondents expressing the belief that a UPL would have a neutral impact on patients’ ability to afford their medications and 26% expressing the belief a UPL would have a negative impact on patients’ ability to afford their medications.</p>
<p>The Oregon PDAB also conducted focus groups with constituent groups, with similar results to the report findings. Of note, the focus group participants were not in agreement as to the definition of affordability (or how it should be determined) and were uncertain about how to assess the impact of a possible UPL.</p>
<p>Despite concerns coming out of Oregon, Maryland recently moved forward with approving an <a href="https://pdab.maryland.gov/Documents/UPL%20Action%20Plan.2024.08.30.1745.pdf">Action Plan</a> for the state’s PDAB to use to reduce costs of medications in the state that pose an “affordability challenge,” including approval of the implementation of a UPL. The Maryland Action Plan also allows the state’s PDAB to begin the policy review process once it has been found that use of a drug has led – or will lead – to an affordability challenge. The policy review process is done in three phases: (1) information gathering, (2) preliminary policy recommendations, and (3) policy approval.</p>
<p>Maryland’s PDAB started with eight drugs to conduct a “cost review” to understand whether use of the drug has led – or will lead – to affordability challenges. If found to meet the requisite criteria, those drugs may be some of the first drugs subject to a UPL.</p>
<p>Over the course of time, we will see more data as to whether PDABs are achieving the goals they were set to achieve.</p>
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		<item>
		<title>Maryland PDAB Releases Draft Action Plan for Establishing UPLs</title>
		<link>https://www.policymed.com/2024/11/maryland-pdab-releases-draft-action-plan-for-establishing-upls.html</link>
					<comments>https://www.policymed.com/2024/11/maryland-pdab-releases-draft-action-plan-for-establishing-upls.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 20 Nov 2024 09:16:47 +0000</pubDate>
				<category><![CDATA[State Policy]]></category>
		<category><![CDATA[administrative costs]]></category>
		<category><![CDATA[affordability challenges]]></category>
		<category><![CDATA[draft action plan]]></category>
		<category><![CDATA[drug affordability]]></category>
		<category><![CDATA[drug availability monitoring]]></category>
		<category><![CDATA[eligibility criteria]]></category>
		<category><![CDATA[FDA drug shortage list]]></category>
		<category><![CDATA[government pricing]]></category>
		<category><![CDATA[legislative authority]]></category>
		<category><![CDATA[Maryland PDAB]]></category>
		<category><![CDATA[Medicaid best price]]></category>
		<category><![CDATA[Medicare Maximum Fair Price]]></category>
		<category><![CDATA[minimize adverse outcomes]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[policy recommendations]]></category>
		<category><![CDATA[policy review process]]></category>
		<category><![CDATA[prescription drugs]]></category>
		<category><![CDATA[stakeholder council]]></category>
		<category><![CDATA[supply chain experts]]></category>
		<category><![CDATA[Unintended Consequences]]></category>
		<category><![CDATA[UPL criteria]]></category>
		<category><![CDATA[upper payment limits]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17227</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Maryland’s Prescription Drug Affordability Board (PDAB) released its draft action plan for establishing upper payment limits (UPLs) for drugs identified as causing (or likely to cause) affordability shortages. In the draft action plan, the state outlines the process for whether a UPL should be set, and if so, the amount. The Maryland PDAB is a [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Maryland’s Prescription Drug Affordability Board (PDAB) <a href="https://pdab.maryland.gov/Documents/comments/Draft%20Outline%20UPL%20Action%20Plan.2024.08.09.1700.pdf">released its draft action plan</a> for establishing upper payment limits (UPLs) for drugs identified as causing (or likely to cause) affordability shortages. In the draft action plan, the state outlines the process for whether a UPL should be set, and if so, the amount.</p>
<p>The Maryland PDAB is a five-member board, and it confers with a 26-member appointed advisory Stakeholder Council that includes experts across the supply chain and stakeholder representatives. Under Maryland law, if the PDAB finds that a prescription drug product has led to – or will lead to – affordability challenges, it may consider, recommend, and implement policies to address those challenges, including establishing a UPL. However, a UPL may not be warranted in all situations, and in those circumstances, the Board may recommend another policy action, including seeking additional legislative authority to implement a policy solution and providing policy recommendations to the legislature, state and local government partners, and others to address the affordability challenges identified.</p>
<p>The Plan states that the Board shall apply the following criteria when determining whether to set an upper payment limit and when setting an upper payment limit amount:</p>
<ul>
<li>The Board shall consider the cost of administering the drug and delivering the drug to consumers, as well as other relevant administrative costs</li>
<li>The Board shall determine that an upper payment limit is an appropriate tool to address the driver(s) of the affordability challenge identified for the prescription drug product</li>
<li>The Board shall not set an upper payment limit for the prescription drug product if utilization of the product by Eligible Governmental Entities is minimal</li>
<li>The Board shall set an upper payment limit in a way to minimize adverse outcomes and minimize the risk of unintended consequences</li>
<li>The Board shall prioritize drugs that have a high proportion of out-of-pocket costs compared to the net cost of the drug</li>
<li>The Board shall not set an upper payment limit for generic prescription drug products that have nine (9) or more marketed therapeutic equivalents</li>
</ul>
<p>Additionally, the guidance notes that UPLs should work to minimize adverse outcomes and risk of unintended consequences. UPLs should also consider government prices, and UPLs should not be lower than the Medicare Maximum Fair Price (if present) and should not impact statutory or regulatory amounts, such as Medicaid best price. UPLs may not be set for a prescription drug product that is on the federal Food and Drug Administration (FDA) prescription drug shortage list and the Board is responsible for monitoring the availability of drugs for which it sets a UPL and if “there becomes a shortage of the prescription drug product in the State, reconsider or suspend the  upper payment limit.”</p>
<p>Importantly, it is the preliminary determination that a certain drug has led &#8211; or will lead &#8211; to affordability challenges that is the predicate for the Board to start the policy review process to study and assess what, if any, policy tools are best suited to redress the identified affordability challenges, including whether a UPL is an appropriate solution for the situation. Within the policy review process, the Board will gather information from various sources (including experts, government entities, and through informational hearings), make preliminary policy recommendations, and potentially achieve ultimate policy approval.</p>
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		<title>The Unintended Consequences of State Prescription Drug Affordability Boards</title>
		<link>https://www.policymed.com/2024/07/the-unintended-consequences-of-state-prescription-drug-affordability-boards.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 19 Jul 2024 08:24:49 +0000</pubDate>
				<category><![CDATA[Prescription Drug Prices]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16940</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Recently, Health Affairs published a review of State Prescription Drug Affordability Boards (PDABs), covering unanswered questions and unintended consequences. The intent behind PDABs is to lower spending on prescription drugs and improve affordability for patients. In the article, authors looked at key components of PDAB legislation in four states – Colorado, Minnesota, Maryland, and Washington [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Recently, Health Affairs <a href="https://www.healthaffairs.org/content/forefront/unanswered-questions-and-unintended-consequences-state-prescription-drug-affordability">published a review</a> of State Prescription Drug Affordability Boards (PDABs), covering unanswered questions and unintended consequences. The intent behind PDABs is to lower spending on prescription drugs and improve affordability for patients. In the article, authors looked at key components of PDAB legislation in four states – <a href="https://doi.colorado.gov/insurance-products/health-insurance/prescription-drug-affordability-review-board">Colorado</a>, <a href="https://mn.gov/commerce/insurance/health/pharmacy-drug-affordability-board/">Minnesota</a>, <a href="https://pdab.maryland.gov/Pages/default.aspx">Maryland</a>, and <a href="https://www.hca.wa.gov/about-hca/programs-and-initiatives/clinical-collaboration-and-initiatives/prescription-drug-affordability-board">Washington</a> – because those states passed legislation allowing PDABs the authority to set upper payment limits for prescription drugs that are deemed “unaffordable.”</p>
<p><strong>PDAB Composition</strong></p>
<p>In the states reviewed for the article, PDABs are statutorily composed of between five and seven voting members who have knowledge and expertise in health care economics and/or clinical medicine. By way of example, the entire Colorado board is clinicians while Maryland’s board has three members with doctoral training in health policy, health services research, or economics, and one clinician. The budget of the boards vary from $500,000 in Minnesota to roughly $1.5 million in Washington state.</p>
<p>PDABs may receive outside guidance and assistance, often required to be from a qualified independent third party, for specific board duties. Some states set aside hundreds of thousands of dollars annually for such activities.</p>
<p><strong>Identifying Drugs</strong></p>
<p>Each PDAB has criteria established by law to identify certain drugs that are eligible for affordability review, ranging from list prices and list price inflation for brand and generic drugs. For example, brand name drugs are often identified as eligible for affordability review if their wholesale acquisition cost (WAC) exceeds a defined amount per year or course of treatment, or if the WAC increases beyond a certain percentage or amount. Generic drugs, on the other hand, must meet both a price threshold and an inflation threshold to be eligible for a review in all four selected states. Biosimilar drugs are eligible for affordability review if their launch prices are less than a 15-20% discount from the referenced brand drug’s WAC.</p>
<p>Maryland also allows for a drug to be considered for review if it “may create affordability challenges” while Minnesota allows review for drugs that “may impose costs that create significant affordability challenges for the state health care system or for patients.”</p>
<p><strong>Selecting Drugs</strong></p>
<p>The process of selecting drugs for an affordability review varies widely among states and states tend to be less transparent about the selection process than they are about the identification process. Under Colorado law, the PDAB must consider the availability of therapeutically equivalent drugs, input from an advisory council, the average patient’s out of pocket costs, and additional “aggregate data.” Washington law requires similar review, though it omits “aggregate data.”</p>
<p>Minnesota is the least transparent of the reviewed states and the legislation only requires that the PDAB shall consider requests from board members and the public.</p>
<p><strong>Conducting the Reviews</strong></p>
<p>PDABs perform an affordability review for each selected drug to determine whether it is “unaffordable,” with each state having different statutorily-mandated considerations. Each state has different requirements when it comes to price/cost-related factors, access-related factors, and value-related factors. Similar to the requirements under selecting drugs for an affordability review, Minnesota has the least specific considerations, with many factors listed as “not specified” or just broadly “considered in review,” according to the article.</p>
<p>The article further notes that while all four states legislate that PDABs should consider drug prices in their affordability reviews, only two states (Colorado and Maryland) direct PDABs to look beyond drug costs and consider impacts on comprehensive costs of care (including health, medical, and social services costs) for reviewed drugs and their therapeutic alternatives.</p>
<p><strong>Unintended Consequences</strong></p>
<p>The authors of the article note that the long-term impacts of PDAB-established upper payment limits on benefit design, patient access, and innovation are still to be determined. Authors also raise concern that patient access may be impacted if upstream transactions that occur entirely outside of PDAB-states are subject to the provisions of state PDAB regulations. One example of concern is wholesalers, with authors positing that they may be “unable or unwilling to buy a drug if their contracted acquisition cost…is above a state UPL, given that doing so would mean incurring a loss on the transaction.”</p>
<p>As of the writing of this article, eleven states have established PDABs: the four mentioned in the Health Affairs article plus Maine, Massachusetts, New Hampshire, New Jersey, New York, Ohio, and Oregon. The National Academy for State Health Policy created a chart that highlights similarities and differences between nine of the eleven states <a href="https://nashp.org/comparison-of-state-prescription-drug-affordability-review-initiatives/">here</a>.</p>
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		<title>PhRMA Granted Summary Judgment in Challenge to Oregon Prescription Drug Price Transparency</title>
		<link>https://www.policymed.com/2024/06/phrma-granted-summary-judgment-in-challenge-to-oregon-prescription-drug-price-transparency.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 26 Jun 2024 08:21:11 +0000</pubDate>
				<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16893</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>In March, the U.S. District Court for the District of Oregon issued a ruling in Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi, granting in part PhRMA’s motion for summary judgment in its challenge to the Prescription Drug Price Transparency Act. The court held that the Act’s annual price increase reporting requirements violated the [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-76-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>In March, the U.S. District Court for the District of Oregon <a href="https://casetext.com/case/pharm-research-manufacturers-of-am-v-stolfi">issued a ruling</a> in <em>Pharmaceutical Research and Manufacturers of America (PhRMA) v. Stolfi</em>, granting in part PhRMA’s motion for summary judgment in its challenge to the Prescription Drug Price Transparency Act. The court held that the Act’s annual price increase reporting requirements violated the Free Speech Clause of the First Amendment. The court also held that the Act’s public-interest exception to the reporting of trade secret information violated the Takings Clause of the Fifth Amendment.</p>
<p><strong>More on Ruling</strong></p>
<p>On February 16, 2024, the district court granted a declaratory judgment to PhRMA, and its full opinion followed on March 19, 2024. The court concluded that the Act’s public-interest exception results in a regulatory taking without just compensation in violation of the Fifth Amendment’s Takings Clause. The court concluded that all factors supported the finding of a regulatory taking. Among other things, the court noted that Oregon Department of Consumer and Business Services (DCBS) had not explained how it determines when the public interest requires publication, which, in practice, places “an extremely low burden on [Oregon]” and results in an “irrevocable loss” for affected manufacturers. The court also explained that because the state is legally compelling the involuntary disclosure of trade secret information, manufacturers have a reasonable investment-backed expectation that the state will maintain the secrecy of such information.</p>
<p>The court also concluded the Act&#8217;s annual price increase reporting requirements violated the Free Speech Clause of the First Amendment. In reaching this conclusion, the court first evaluated whether the reporting requirements constituted compelled private speech or commercial speech and sided with Oregon’s stance that the Act regulates commercial speech. In support of this conclusion, the court observed that manufacturers are acting out of an “economic motivation” to provide information about prescription pricing in order to participate in the market, which the court found to provide strong support that the speech in question is commercial. The court concluded that Oregon had not satisfied its burden, which was to advance a substantial government interest in the regulation and to choose means not more extensive than necessary. Oregon had asserted various governmental interests, including providing accountability for prescription drug pricing to permit purchasers and pharmacy benefit managers to negotiate discounts and rebates and providing buyers of prescription drugs with better information about drug pricing. But even assuming these constituted substantial governmental interests, the court found that Oregon had failed to show how the Act would actually directly advance such interests.</p>
<p>The <em>PhRMA v. Stolfi</em> ruling is a significant development in the realm of state drug price transparency laws. Not only has it resulted in Oregon’s annual price increase reporting requirements being suspended, but — if followed by other courts — the district court’s reasoning could have far broader implications. Numerous other states have enacted similar laws that require reporting of significant pricing information from manufacturers or other health care entities that could potentially be subject to similar challenges. That said, the district court’s opinion will likely not be the final word.</p>
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		<title>Connecticut Pharmaceutical Reporting Deadline Approaches: New FAQ Document Released</title>
		<link>https://www.policymed.com/2024/06/connecticut-pharmaceutical-reporting-deadline-approaches-new-faq-document-released.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 19 Jun 2024 08:24:07 +0000</pubDate>
				<category><![CDATA[State Policy]]></category>
		<category><![CDATA[Transparency]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16906</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="323" height="156" src="https://www.policymed.com/wp-content/uploads/2024/06/connecticut-consumer.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/06/connecticut-consumer.png 323w, https://www.policymed.com/wp-content/uploads/2024/06/connecticut-consumer-300x145.png 300w" sizes="auto, (max-width: 323px) 100vw, 323px" /></div>With less than two weeks before the Connecticut reporting deadline for pharmaceutical companies to report representative interactions and payments to nurse practitioners, the Connecticut Department of Consumer Protection (DCP) released a comprehensive FAQ Document to aid compliance. Here are the key points from the FAQ document: Definition of a &#8220;Gift&#8221; A gift is anything of [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="323" height="156" src="https://www.policymed.com/wp-content/uploads/2024/06/connecticut-consumer.png" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/06/connecticut-consumer.png 323w, https://www.policymed.com/wp-content/uploads/2024/06/connecticut-consumer-300x145.png 300w" sizes="auto, (max-width: 323px) 100vw, 323px" /></div><p>With less than two weeks before the <a href="https://portal.ct.gov/dcp/drug-control-division/drug-control/expenditure-disclosure-form">Connecticut reporting deadline</a> for pharmaceutical companies to report representative interactions and payments to nurse practitioners, the Connecticut Department of Consumer Protection (DCP) released a comprehensive <a href="https://portal.ct.gov/-/media/dcp/drug_control/faq-pmf-final.pdf">FAQ Document</a> to aid compliance. Here are the key points from the FAQ document:</p>
<p><strong>Definition of a &#8220;Gift&#8221;</strong></p>
<p>A gift is anything of monetary value obtained for less than market value, including tangible items (pens, t-shirts, meals) and services (transportation, travel, lodging). If unsure, assume it qualifies as a gift or seek legal advice.</p>
<p><strong>Reporting Gift Values</strong></p>
<p>The &#8220;Gift Value ($) (No samples drugs)&#8221; field represents the total value of gifts provided by the sales representative over the reporting period.</p>
<p><strong>Reporting Requirements</strong></p>
<p>Only drug samples need to be reported in the &#8220;Fill Drug Sample Info&#8221; worksheet. Non-sample items like gifts are reported in the &#8220;Name of all Sales Reps&#8221; worksheet.</p>
<p><strong>Annual Registration for Pharmaceutical Manufacturers</strong></p>
<p>All pharmaceutical manufacturers, whether operating within Connecticut or not, must register if they use representatives to market legend drugs to prescribing practitioners.</p>
<p><strong>Marketing Firm Registration</strong></p>
<p>Manufacturers who outsource their sales force must still obtain a Pharmaceutical Marketing Firm Registration. This includes both contracted and outsourced sales forces.</p>
<p><strong>Virtual Manufacturer Registration</strong></p>
<p>Non-resident virtual manufacturers must obtain registration if they market or provide information about legend drugs to practitioners in Connecticut.</p>
<p><strong>Scope of the Regulation</strong></p>
<p>The regulation applies only to legend drugs and does not include over-the-counter (OTC) drugs or devices. It includes virtual manufacturers and those with sales representatives working in Connecticut.</p>
<p><strong>Fees and Record Keeping</strong></p>
<p>There is a $150 fee for both the application and renewal of pharmaceutical manufacturer registration. Updating contact information incurs no fee. Manufacturers must comply with state and federal record-keeping laws.</p>
<p><strong>Application Process and Contact Information</strong></p>
<p>The approval time for registration applications varies. To expedite, submit complete applications with all required information and fees. For questions, email <a href="mailto:DCP.DrugManufacturers@ct.gov">DCP.DrugManufacturers@ct.gov</a>.</p>
<p>The full text of the Public Act 23-171 can be found <a href="https://www.cga.ct.gov/2023/ACT/PA/PDF/2023PA-00171-R00HB-06669-PA.PDF">here</a>. For more information, visit the Connecticut General Assembly website.</p>
<p>For further details, including specific requirements and instructions for updating information, consult the <a href="https://www.cga.ct.gov/current/pub/chap_417.htm#sec_21a-70e">Connecticut General Statutes</a> and the <a href="https://portal.ct.gov/dcp/license-services-division/all-license-applications/change-of-address">eLicense online system</a>.</p>
<p>Though lately distributed pharmaceutical companies and their representatives should review the FAQ’s to ensure compliance with the new reporting and registration requirements. As the deadline approaches, companies should review these guidelines carefully to avoid potential penalties.</p>
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		<title>California Approves First-in-the Nation Cap on Health Industry Spending Increases</title>
		<link>https://www.policymed.com/2024/06/california-approves-first-in-the-nation-cap-on-health-industry-spending-increases.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 10 Jun 2024 08:27:25 +0000</pubDate>
				<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16865</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>The California Office of Health Care Affordability recently approved the country’s first state cap on health industry spending increases, with a growth limit of 3% by 2029. This means that the health care industry – including doctors, hospitals, and health insurance plans – will need to find ways to cut their costs to prevent the [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/05/stencil.default-2024-05-31T142329.878-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>The <a href="https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202120220SB184">California Office of Health Care Affordability</a> recently approved the country’s first state cap on health industry spending increases, with a growth limit of 3% by 2029. This means that the health care industry – including doctors, hospitals, and health insurance plans – will need to find ways to cut their costs to prevent the annual per capita spending from exceeding the limit. For reference, per capita health spending in California grew by more than 5% from 2015 to 2020.</p>
<p>The 3% cap will be phased in over 5 years, with a 3.5% increase in 2025, a 3.2% increase in 2027-2028, and the full 3% cap in 2029. The Office of Health Care Affordability will be responsible for enforcing the cap and has the ability to levy fines on non-compliant providers, though the Health Care Affordability Board has noted that the cap likely won’t be enforced until the end of the decade, <a href="https://apnews.com/article/california-health-care-costs-target-cap-0aefad8c177ed3e0447dc4e17258be08">according to the Associated Press</a>.</p>
<p>Currently, the process is just at the beginning phases and regulators still need to determine how the cost target will be applied across various health care sectors. “We want to be aggressive,” <a href="https://apnews.com/article/california-health-care-costs-target-cap-0aefad8c177ed3e0447dc4e17258be08">Board Chair Dr. Mark Ghaly said</a>, while acknowledging that the cap “really translates into a major challenge” for the health care industry.</p>
<p>While the health care industry has been relatively supportive of the cost target concept, stakeholders believe the 3% target is too low and will be difficult, if not impossible, to meet. The difficulty will only be increased by the fact that the Center for Medicare and Medicaid Services (CMS) said late last year that the cost to practice medicine in the United States would increase by 4.6% in 2024 alone.</p>
<p>The 3% figure was calculated based on the average annual change in median household income in the State of California from 2002 to 2022. Dr. Tanya W. Spirtos, president of the California Medical Association, notes in a letter to the board that particular number is “artificially low” because it includes the years of the Great Recession, when income dropped dramatically. She felt a better gauge would be looking at just the past 10 years, when median household income increased by an average of 4.1% per year.</p>
<p>Additionally, thought must go into the fact that some of what is charged is outside of the control of the medical providers, including salaries for health care workers, which are often set through collective bargaining agreements with labor unions and are subject to <a href="https://apnews.com/article/california-health-care-workers-minimum-wage-274c712eec29573731a479bc7ef9b452">state minimum wage laws</a>.</p>
<p>Carmela Coyle, president and CEO of the California Hospital Association, said when it comes to hospital finances, “the fat is already gone” and that “we’re fooling ourselves if we think [performing life-saving procedures is] cheap or can be done less expensively.”</p>
<p>It will be interesting to see if other states follow suit with similar caps and whether California is ultimately successful in lowering health care spending in the state with the implementation of the 3% cap.</p>
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		<title>Amgen Sues Colorado Prescription Drug Affordability Board</title>
		<link>https://www.policymed.com/2024/05/amgen-sues-colorado-prescription-drug-affordability-board.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 28 May 2024 08:42:55 +0000</pubDate>
				<category><![CDATA[Medical Legal]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16805</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Amgen Inc. recently filed a lawsuit in the United States District Court District of Colorado against the State of Colorado’s Prescription Drug Affordability Board over the Board’s efforts to potentially cap the price of its drug Enbrel. Amgen argues in its complaint that the moves by the Board are unconstitutional for at least four reasons. [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/11/stencil.default-68-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Amgen Inc. recently <a href="https://litigationtracker.law.georgetown.edu/wp-content/uploads/2024/03/Amgen_2024.03.22_COMPLAINT.pdf">filed a lawsuit</a> in the United States District Court District of Colorado against the State of Colorado’s Prescription Drug Affordability Board over the Board’s efforts to potentially cap the price of its drug Enbrel. Amgen argues in its complaint that the moves by the Board are unconstitutional for at least four reasons.</p>
<p>The Prescription Drug Affordability Board (PDAB) was created in 2021 and charged with lowering prescription costs for Coloradans. As part of its reach, the Board can review prescription drugs and set upper payment limits (essentially price caps) on drugs it considers unaffordable. In February 2024, the <a href="https://www.denverpost.com/2024/02/16/enbrel-unaffordable-colorado-prescription-drug-affordability-board/">Board voted unanimously</a> to declare Enbrel an unaffordable drug. That vote started a six-month process that may allow Colorado to place a price cap on the prescription drug. After those six months, an upper limit will be set and six months later, the price regulation would take effect.</p>
<p>In response to the Board’s vote, Amgen filed a lawsuit in Colorado to stop Enbrel from being declared unaffordable and a price cap being implemented. Amgen argues that the law and the Board violates the United States Constitution and potentially even Medicare laws and that the decision by the Board “puts in jeopardy access to Enbrel and other innovative drugs, endangering the lives and well-being of thousands of Coloradans with serious medical conditions.”</p>
<p>Amgen alleges that the law that created the Board is in violation of the Supremacy Clause because it conflicts with federal patent laws, including the Hatch-Waxman Act. Amgen further alleges violations of the Supremacy Clause as the Colorado law applies the “upper payment limit” to encompass federal payors, such as Medicare, interfering with the federal government’s ability to control its own payment and coverage decisions.</p>
<p>Amgen also alleges a violation of the Due Process clause because of a lack of procedural protections to guide the Board’s decision-making and to avoid the imposition of arbitrary, confiscatory, or other constitutionally-appropriate prices.</p>
<p>Amgen notes that while the law allows the Board to declare certain prescription drugs “unaffordable for Colorado consumers” and then place an “upper payment limit” on the drug, it does not provide any standards, definitions, or guidance to constrain the Board’s decisions about what it means for a drug to be “unaffordable” and what the “upper payment limit” for a drug should be.</p>
<p>Finally, Amgen argues that the law is in violation of the Commerce Clause as it regulates commercial transactions that take place outside of the state of Colorado. The complaint notes that the Colorado law applies even to “upstream” transactions, which are transactions that take place entirely outside of Colorado but where the drug is later dispensed or administered in Colorado.</p>
<p>“To incentivize the immense risk-taking and investment necessary to discover and develop new medical treatments, Congress has established a carefully calibrated intellectual property regime that rewards pharmaceutical innovation with a period of market exclusivity and the ability to charge prices that allow for further investment and innovation during that period,” the lawsuit states.</p>
<p>In its complaint, Amgen is seeking not just to overturn the decisions of the Board relating to Enbrel but also strike down parts of the law that created the Board.</p>
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		<title>Colorado Working to Be Second State to Import Drugs from Canada</title>
		<link>https://www.policymed.com/2024/05/colorado-working-to-be-second-state-to-import-drugs-from-canada.html</link>
					<comments>https://www.policymed.com/2024/05/colorado-working-to-be-second-state-to-import-drugs-from-canada.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 21 May 2024 08:35:21 +0000</pubDate>
				<category><![CDATA[Drug Prices]]></category>
		<category><![CDATA[Drug Shortages]]></category>
		<category><![CDATA[State Policy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16822</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Colorado’s General Assembly passed a law in 2019 that allowed the Colorado Department of Health Care Policy and Financing (HCPF) to develop a Canadian prescription drug importation program. In March 2020, Colorado submitted a program proposal and detailed comments in response to the December 2019 federal Health and Human Services (HHS) Notice of Proposed Rulemaking [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869.jpg 1200w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/01/stencil.default-2024-01-31T161034.869-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p class="MsoNormal">Colorado’s General Assembly <a href="https://leg.colorado.gov/bills/sb19-005">passed a law in 2019</a> that allowed the Colorado Department of Health Care Policy and Financing (HCPF) to develop a Canadian prescription drug importation program. In March 2020, Colorado submitted a program proposal and detailed comments in response to the December 2019 federal Health and Human Services (HHS) Notice of Proposed Rulemaking (NPRM)/draft rule.</p>
<p class="MsoNormal">The HHS final rule went into effect in November 2020, implementing a federal regulatory framework that directs how to develop and operate an Importation Program. In January 2021, HCPF sought vendors for the program and issued an Invitation to Negotiate, seeking vendors for the program. The ITN closed in April 2021 and HCPF started negotiations with supply chain partners and identified program consultants and certifiers to ensure compliant program development. Program partners were announced in August 2022 and on December 5, 2022, HCPF submitted the <a href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/hcpf.colorado.gov/sites/hcpf/files/Colorado%27s%20Drug%20Importation%20Program%202022%20Formal%20SIP.pdf">Section 804 Importation Program (SIP) application</a> to the Food and Drug Administration (FDA) for review and approval. In response to an FDA Request for Information, HCPF <a href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/hcpf.colorado.gov/sites/hcpf/files/Colorado%20Section%20804%20SIP%20Application%20Amended%202.27.24.pdf">amended the SIP application on February 27, 2024</a>, and <a href="https://hcpf.colorado.gov/drug-importation">currently estimates</a> that the Colorado Importation Program will be approved in 2024.<span style="mso-spacerun: yes;"> </span></p>
<p class="MsoNormal">According to a <a href="https://hcpf.colorado.gov/sites/hcpf/files/HCPF%20Drug%20Importation%20Annual%20Report%202023.pdf">report issued by Colorado in 2023</a>, the state said it was having difficulty with “securing drug supply for the program, drug manufacturer resistance, and regulatory ambiguity.” Additionally, the report states that of twenty-three drug companies, nine companies refused participation in Colorado’s drug importation program and four agreed to meet but said they would not participate in the program. The other ten companies did not respond to requests to meet, despite multiple attempts.</p>
<p class="MsoNormal">In that report, it was also noted that “[b]ecause drug manufacturers in Canada have contract terms with wholesalers, including any FDA-required foreign seller, that prohibit the exportation of drugs to the U.S., Colorado is unable to secure drug supply absent direct negotiation, and ultimately a contractual agreement, with manufacturers.”</p>
<p class="MsoNormal">Colorado turned to the FDA for help with the number of refusals, and the FDA said it is not mandatory that the agency help compel manufacturers to sell drugs that are intended for the Canadian market to the United States. Kim Bimestefer, executive director of the Colorado Department of Health Care Policy &amp; Financing, <a href="https://kffhealthnews.org/news/article/health-202-colorado-drug-importation/">said</a> that the state still hopes for the FDA’s help, “While we continue to reach out to manufacturers to ask them to do the right thing for consumers, employers and taxpayers, we are also working with the FDA for additional guidance on how to best navigate sourcing drugs.”</p>
<p class="MsoNormal">The FDA also reinforced its willingness to “continue to work with states and Indian tribes” to develop their individual importation programs <a href="https://kffhealthnews.org/news/article/health-202-colorado-drug-importation/">through a statement</a> by FDA spokesperson Jeremy Kahn.</p>
<p class="MsoNormal"><b>Florida Still Seemingly at a Standstill</b></p>
<p class="MsoNormal">For what it’s worth, Florida is still having difficulty in importing drugs from Canada, with Brock Juarez, a spokesperson for the Florida Agency for Health Care Administration, <a href="https://kffhealthnews.org/news/article/health-202-colorado-drug-importation/">saying</a>, “Our vendor is establishing relationships with drug manufacturers and working on negotiating agreements.”</p>
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		<title>New York City Health Care Transparency Law Now in Effect</title>
		<link>https://www.policymed.com/2024/05/new-york-city-health-care-transparency-law-now-in-effect.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 08 May 2024 08:37:21 +0000</pubDate>
				<category><![CDATA[State Policy]]></category>
		<category><![CDATA[Transparency]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16797</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Earlier this year, New York Local Law 844-A took effect, directing New York City Mayor Eric Adams to establish an Office of Healthcare Accountability to increase health care price transparency in New York City. The Local Law requires the Director of the new Office to be responsible for myriad tasks, including: providing recommendations regarding health [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/10/stencil.default-2023-10-23T201605.558-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Earlier this year, <a href="https://legistar.council.nyc.gov/LegislationDetail.aspx?ID=5958278&amp;GUID=91F10F2F-285C-4152-A9B8-C8B743F64C70&amp;Options=ID%7cText%7c&amp;Search=transparency">New York Local Law 844-A</a> took effect, directing New York City Mayor Eric Adams to establish an Office of Healthcare Accountability to increase health care price transparency in New York City.</p>
<p>The Local Law requires the Director of the new Office to be responsible for myriad tasks, including: providing recommendations regarding health care and hospital costs to the mayor, council, comptroller, or trustees of the city pension systems; analyzing the city’s spending on health care costs for city employees, city retirees, and their dependents; keeping detailed information on where the public can find the publicly available price of common hospital procedures; bringing together key stakeholders (including hospital representatives, health care providers, health plan stakeholders, and self-insured entities) to review health care costs in the city; and making each hospital’s IRS Form 900, Schedule H, audited financial statements, and annual cost reports available to the public upon request.</p>
<p>The law defines “hospital” to mean a “general hospital” as defined in New York law, a hospital that provides medical and surgical services primarily to inpatient individuals or under a physician’s supervision on a 24-hour basis. It does not include residential health care facilities, public health centers, treatment centers, dispensaries, laboratories, or central service facilities that serve more than one institution.</p>
<p>The Local Law also institutes reporting requirements, starting February 18, 2025, and annually by January 1 thereafter. The Director of the Office must submit an annual report outlining the hospital systems’ pricing practices in New York City to the mayor, the Speaker of the New York City Council, and the New York State Attorney General. The report will also be published on the Office of Healthcare Accountability’s website and will include a summary of publicly available data, including – but not limited to – prices charged for common hospital procedures disaggregated by hospital and utilizing a baseline price; prices charged for common hospital procedures disaggregated by hospital, type of procedure, average rate of reimbursement received by the hospital from each major insurance provider, and the average rate of denial by major insurance providers or payors of “medically necessary care;” a breakdown of each major insurance provider and other payor’s profit margins, employee headcounts, overhead costs, and executive salaries and bonuses; and the impact of pharmaceutical pricing, insurance premiums, and the cost of medical devices on the city’s health care costs and individual patient out-of-pocket spending. A major insurance provider is a health insurance company whose business accounts for a significant portion of hospital payments in the city, as possibly further defined by the Office.</p>
<p>The Office may be established as a standalone office or within any Office of the Mayor or any department. The Director shall be appointed by the mayor, unless the Office is established within an agency other than the Office of the Mayor, in which case, it will be appointed by the head of the appropriate agency.</p>
<p>“Health care is a human right, not a privilege, and this includes ensuring that there is cost transparency in our health care system,” <a href="https://www.nyc.gov/office-of-the-mayor/news/451-23/mayor-adams-signs-legislation-increasing-health-care-pricing-transparency">said Mayor Adams</a>. “New Yorkers shouldn’t have to break the bank to get the health care they need, and Intro. 844-A will help ensure that New Yorkers have all the information they need to stay healthy and get the care they deserve.”</p>
<p>&nbsp;</p>
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