/ en Mon, 28 Apr 2025 04:54:52 -0500 Wed, 10 Jul 24 13:33:43 -0500 /node/694280 <p>How should organizations harness AI’s transformative potential without creating unintended, adverse consequences? We offer steps to help establish guardrails, collaborations, and strategies for use.</p> Wed, 10 Jul 2024 13:33:43 -0500 White Papers /node/694279 <p>Cultivating equity in an organization’s workforce is essential for improving health equity for the community. These key questions can help boards promote equity and inclusion for the workforce.</p> Wed, 10 Jul 2024 13:29:34 -0500 White Papers <h2>Professional Membership Groups</h2><p>Your organization’s membership in the ���������� Association connects you to the nation’s most powerful advocacy organization for hospitals. But did you know that the AHA has a number of professional membership societies designed to support specific areas of hospital operations? These individual membership organizations offer tremendous opportunities for education, collaboration, and access to valuable tools and resources all designed to advance operational excellence within your organization.</p><p>Membership in these groups can help your teams with issues such as:</p><ul><li>Navigating supply chain challenges</li><li>Maintaining a safe and healing health care delivery environment</li><li>Keeping up with new standards for infection prevention</li><li>Navigating risk at a time of increasing uncertainty</li><li>Building your organization’s brand and market share</li><li>Convincing hesitant populations to get the COVID-19 vaccine</li></ul><p>Read on to learn more about these groups. We’ve also designed a form to make it easy for you to get more information for yourself or for others within your organization. Complete the form to the right with the names and contact information of the individuals you believe could benefit from access to these valuable professional membership societies.</p> Thu, 18 Apr 2024 20:26:26 -0500 White Papers /white-papers/2023-12-29-white-paper-medicares-ltch-outlier-policy-needs-reforms-protect-extremely-ill-beneficiaries <div class="container"><div class="row"><div class="col-md-8"><h2><span>Executive Summary</span></h2><p>Long-term care hospitals (LTCHs) play an important role for Medicare beneficiaries by caring for complex patients who require extended hospitalization. Traditional Medicare reimburses for this care through the LTCH prospective payment system (PPS). This PPS includes a high-cost outlier (HCO) policy that, as with similar policies in other payment systems, is intended to ensure that LTCHs are adequately reimbursed for extremely costly care provided to the most severely ill beneficiaries. It specifically does this by helping ameliorate some of the extraordinary costs LTCHs experience when caring for these beneficiaries.</p><p>Congress, beginning in 2016, put in place a dual-rate payment system under the LTCH PPS. This fundamental change in the payment system and other coinciding market factors dramatically reshaped the landscape of both LTCHs and the beneficiaries they serve. The HCO policy and underlying methodologies, however, remained largely unchanged. The result is an HCO policy that is now failing to achieve its stated purpose. Specifically, as the fixed-loss amount for HCO cases continues to rise, LTCHs are incurring greater and greater losses. Absent swift action from policymakers, financial pressures on LTCHs will likely result in loss of essential access for some of Medicare’s most severely ill beneficiaries. This will have ripple effects across the care continuum, placing additional burdens on short-term acute care hospitals and their intensive care units (ICUs), which may no longer be able to partner with LTCHs for the care of this unique population due to financial challenges or closures.</p><p>AHA recommends that policymakers take a number of actions to ensure that LTCHs can continue caring for their beneficiaries and communities. Specifically, AHA suggests several reforms that CMS should make in its annual regulatory cycle to relieve the extreme pressures on LTCHs caused by the HCO policy, including:</p><ul><li> Indexing the fixed-loss amount to market basket growth, which would help ensure the fixed-loss amount grows consistent with payment;</li><li>Including all LTCH cases in its methodology when calculating annual updates to the fixed-loss amount, which would provide more stability from year to year as well as provide only one fixed-loss amount for the entire LTCH PPS, allowing providers to better predict both HCO losses and the partial relief provided under the system; and</li><li>Initiating an analysis of LTCH cases’ cost variation within payment groups to determine whether refinements to improve overall payment accuracy are needed.</li></ul><p>AHA also recommends that Congress make fundamental reforms to the LTCH payment system, including:</p><ul><li>Increasing funding for HCO cases;</li><li>Indexing future changes to the fixed-loss amount to inflation; and</li><li>Adopting a stop-gap policy, pending a further restructuring of the LTCH PPS. Background</li></ul><p>View the detailed white paper below.</p></div><div class="col-md-4"><a href="/system/files/media/file/2023/12/white-paper-medicares-ltch-outlier-policy-needs-reforms-to-protect-extremely-ill-beneficiaries.pdf" target="_blank" title="Click here to download the White Paper: Medicare’s LTCH Outlier Policy Needs Reforms to Protect Extremely Ill Beneficiaries"><img src="/sites/default/files/2023-12/cover-white-paper-medicares-ltch-outlier-policy-needs-reforms-to-protect-extremely-ill-beneficiaries.png" data-entity-uuid data-entity-type="file" alt="White Paper: Medicare’s LTCH Outlier Policy Needs Reforms to Protect Extremely Ill Beneficiaries"></a><p> </p></div></div></div> Fri, 29 Dec 2023 11:44:18 -0600 White Papers <div class="container"> <div class="row"> <div class="col-md-8"> <p>In early February 2023, a senior U.S. Department of Justice Antitrust Division (DOJ) official abruptly announced that DOJ had withdrawn three longstanding statements of antitrust enforcement policy in health care (Policy Statements). The Policy Statements, familiar to many hospital executives and lawyers, cover the DOJ’s and the Federal Trade Commission’s (FTC) enforcement intentions with respect to a range of subjects important to health care providers, including mergers and acquisitions; joint ventures (JVs); clinical and technical collaboration; information sharing related to clinical outcomes, best practices, costs and fees; joint buying and group purchasing organizations (GPOs); clinically-integrated networks (CINs); and accountable care organizations (ACOs). The Policy Statements have enjoyed broad support across Democratic and Republican Administrations, have been cited positively by both agencies many times since they were introduced, and were not considered controversial.</p> <p>The DOJ and FTC (Antitrust Agencies) issued the Policy Statements in 1993 to respond to concerns from Congress and the health care field that “cooperative cost-cutting arrangements [were being delayed] because of uncertainty about antitrust restrictions.”1 The goal was to “alleviate uncertainty within the health care industry,” making it easier for providers to engage in innovative arrangements that would ultimately benefit patients.</p> <p><em>It is the general consensus among health care providers that the Policy Statements worked as intended. </em>With the 1993 and 19962 Policy Statements as a guide, providers have spent the last three decades structuring numerous provider collaborations, GPOs, benchmarking programs and other arrangements in accordance with the Antitrust Agencies’ expectations. Upon passage of the 2010 Patient Protection and Affordable Care Act (ACA), the Antitrust Agencies recognized again that guidance was necessary to encourage formation of procompetitive ACOs without running afoul of the antitrust laws. The resulting guidance led, in turn, to the creation of numerous ACOs aimed at furthering the policy goals of the ACA, such as better quality and coordinated care.</p> <p>Since release of the Policy Statements, the challenges facing the health care field have only proliferated. In addition to recovering from historic COVID-related clinical and financial challenges, hospitals and health systems face declining government reimbursement, recordbreaking inflation, rising expenses for supplies, drugs and equipment, and skyrocketing labor costs.3 These realities mean providers must find new ways to reduce costs, expand access and deliver high-quality care. So, it is particularly unfortunate that DOJ chose to add to this challenging environment by precipitously withdrawing all of the Policy Statements without notice to or consultation with the health care field. Moreover, the FTC, has not followed DOJ in withdrawing the Policy Statements, which adds to the confusion.</p> <p>To the extent the Policy Statements warranted updates, DOJ should have done what it has in other instances: Hold public workshops and listen to those with real-world experience to improve upon the Policy Statements. At a minimum, the DOJ owes the health care field a plausible explanation for withdrawing the Policy Statements. While DOJ’s withdrawal does not change the law itself, to the extent it signals DOJ’s enforcement intentions, those new<br> intentions should be clearly shared with providers.</p> <p>View the entire white paper below. </p> </div> <div class="col-md-4"> <div class="external-link spacer"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2023/04/doj-surprise-withdrawal-of-the-health-care-antitrust-policy-statements-white-paper.pdf" target="_blank" title="Click here to download the DOJ’s Surprise Withdrawal of the Health Care Antitrust Policy Statements PDF.">Download the PDF</a></div> <p><a href="/system/files/media/file/2023/04/doj-surprise-withdrawal-of-the-health-care-antitrust-policy-statements-white-paper.pdf" target="_blank"><img alt="Cover DOJ’s Surprise Withdrawal of the Health Care Antitrust Policy Statements." data-entity-type="file" data-entity-uuid src="/sites/default/files/2023-04/cover-doj-surprise-withdrawal-of-the-health-care-antitrust-policy-statements-white-paper-510px.png"></a></p> </div> </div> </div> Wed, 05 Apr 2023 08:45:49 -0500 White Papers /node/681829 <p>This white paper provides guidance on how health care organizations can reduce health disparities related to racial or ethnic group; religion; socioeconomic status; gender; age; mental health; cognitive, sensory, or physical disability; sexual orientation or gender identity; geographic location; or other characteristics historically linked to discrimination or exclusion.</p> Mon, 24 Jan 2022 15:28:58 -0600 White Papers /white-papers/2021-12-14-better-together-value-scale <div class="container"> <div class="row"> <div class="col-md-8"> <h2>Executive Summary</h2> <p>Spanning seven states, the Providence family of organizations delivers the same high standard of excellence in every area we serve, from rural communities to large cities. <span><strong>During more than 25 million patient visits each year, we are creating health for a better world and enabling our patients to find the care they need, closer to home.</strong></span> Together, we are using our scale to relentlessly pioneer new and better ways to bring health, hope and healing to more people in need.</p> <p>Our multi-state network shares medical innovations and best practices, administrative efficiencies and emergency support and advocates for patient-centered policies while giving back to the many diverse communities we serve. The full value of scale often is demonstrated over time, but many shorter-term benefits are already available to patients. Today, our size enables us to meaningfully invest in medical research, including more than <span><strong>1,400 active clinical studies;</strong></span> develop new ways to deliver care, such as our Maternal Early Warning Trigger System; partner with like-minded community-based organizations to invest $1.7 billion in community benefit in 2020; and protect rural health care access at our <span><strong>10 critical access rural hospitals.</strong></span></p> <p>The COVID-19 pandemic brought into sharp focus the strengths that the Providence system offers to the communities we serve. After treating the first confirmed COVID-19 patient in the U.S., we were able to use our scale and scope to quickly ramp up and deploy resources in response to this unprecedented public health emergency. Some highlights include:</p> <ul> <li>Updating our COVID-19 screening protocols in Epic, our electronic medical record, across the health system <span><strong>within 24 hours of admitting the first confirmed COVID-19 patient.</strong></span></li> <li>Dramatically expanding telehealth services from an average of 50 visits per day to a peak of more than 12,000 per day, totaling <span><strong>more than 1.7 million virtual visits in 2020.</strong></span> Patients continue to value this service, with <span><strong>530,000 telehealth visits</strong></span> during the first quarter of 2021.</li> <li>Operating some of the largest clinical trials in the country for drug therapies, including <span><strong>Remdesivir</strong></span> and antibody testing.</li> <li>Advocacy to secure regulatory flexibility, enabling us to serve where needs were greatest.</li> <li>Leveraging technology to support our patients and inform the public with a coronavirus consumer awareness hub, assessment and triage chatbot and urgent virtual visit platform.</li> <li>Providing <span><strong>behavioral health and child care support</strong></span> for our caregivers.</li> <li>Supporting mass and targeted local vaccination efforts across the Western U.S., <span><strong>administering more than 900,000 doses to date,</strong></span> with special emphasis on vulnerable groups.</li> </ul> <p>The pandemic has changed life as we know it, but the entire Providence family of organizations continues to invest in the future of health. <span><strong>We are transforming health care to help people live their healthiest lives, and make our services more convenient, accessible and affordable.</strong></span> Longer term benefits of scale are starting to emerge, for example from our investments in mental health, and from our population health approach to Medicare participation that is delivering consistent savings and quality scores. Our goal is a continuum of care with closely aligned partners that is focused on compassionate, value-based care for all.</p> <p><em><a href="/system/files/media/file/2021/12/Value-of-Scale-White-Paper-11521.pdf" target="_blank" title="Click here to download the Better Together: The Value of Scale PDF.">Click the Key Resources link below to download the Better Together: The Value of Scale PDF.</a></em></p> </div> <div class="col-md-4"> <p><a href="/system/files/media/file/2021/12/Value-of-Scale-White-Paper-11521.pdf" target="_blank" title="Click here to download the Better Together: The Value of Scale PDF."><img alt="Better Together: The Value of Scale cover." data-entity-type="file" data-entity-uuid="853c957c-b6ea-4cf5-8054-2153b4849506" src="/sites/default/files/inline-images/Page-1-Better-Together-The-Value-of-Scale-White-Paper-11521.png" width="1700" height="2200"></a></p> </div> </div> </div> Tue, 14 Dec 2021 09:19:23 -0600 White Papers /white-papers/2021-04-29-getting-ready-post-quantum-cryptography <p>William Barker<br /> Dakota Consulting<br /> Gaithersburg, MD</p> <p>William Polk<br /> Applied Cybersecurity Division<br /> Information Technology Laboratory</p> <p>Murugiah Souppaya<br /> Computer Security Division<br /> Information Technology Laboratory</p> <p>This publication is available free of charge from: <a href="https://doi.org/10.6028/NIST.CSWP.04282021" target="_blank">https://doi.org/10.6028/NIST.CSWP.04282021</a></p> <h2>Abstract</h2> <p>Cryptographic technologies are used throughout government and industry to authenticate the source and protect the confidentiality and integrity of information that we communicate and store. The paper describes the impact of quantum computing technology on classical cryptography, particularly on public-key cryptographic systems. This paper also introduces adoption challenges associated with post-quantum cryptography after the standardization process is completed. Planning requirements for migration to post-quantum cryptography are discussed. The paper concludes with NIST’s next steps for helping with the migration to post-quantum cryptography.</p> <h2>Keywords</h2> <p>crypto agility; cryptography; crypto transition; digital signatures; key establishment mechanism (KEM); post-quantum cryptography; public-key encryption; quantum resistant; quantum safe.</p> <h2>Disclaimer</h2> <p>Any mention of commercial products or reference to commercial organizations is for information only; it does not imply recommendation or endorsement by NIST, nor does it imply that the products mentioned are necessarily the best available for the purpose.</p> <h2>Acknowledgement</h2> <p>The authors wish to thank all of the individuals and organizations who provided comments, in particular Dusty Moody and Lily Chen from NIST and Brian LaMacchia from Microsoft.</p> <h2>Additional Information</h2> <p>For additional information on NIST’s Cybersecurity programs, projects, and publications, visit the Computer Security Resource Center, <a href="https://csrc.nist.gov/publications" target="_blank">csrc.nist.gov</a>. Information on other efforts at NIST and in the Information Technology Laboratory (ITL) is available at <a href="https://www.nist.gov/" target="_blank">nist.gov</a> and <a href="https://nist.gov/itl" target="_blank">nist.gov/itl</a>.</p> <p>Comments on this publication may be submitted to:</p> <p>National Institute of Standards and Technology<br /> Attn: Applied Cybersecurity Division, Information Technology Laboratory<br /> 100 Bureau Drive (Mail Stop 2000) Gaithersburg, MD 20899-2000<br /> Email: <a href="mailto:applied-crypto-pqc@nist.gov?subject=Comment on Getting Ready for Post-Quantum Cryptography: Exploring Challenges Associated with Adopting and Using Post-Quantum Cryptographic Algorithms">applied-crypto-pqc@nist.gov</a></p> <p>All comments are subject to release under the Freedom of Information Act (FOIA).</p> <hr /> <h2>Table of Contents</h2> <ol> <li><a href="/system/files/media/file/2021/04/NIST-POST-QUANTUM-ENCRYTION-ALGORITHMS-CSWP-04282021.pdf#page=4">Cryptographic Technologies</a></li> <li><a href="/system/files/media/file/2021/04/NIST-POST-QUANTUM-ENCRYTION-ALGORITHMS-CSWP-04282021.pdf#page=4">Impact of Quantum Computing Technology on Classical Cryptography</a></li> <li><a href="/system/files/media/file/2021/04/NIST-POST-QUANTUM-ENCRYTION-ALGORITHMS-CSWP-04282021.pdf#page=5">Post-Quantum Cryptography</a></li> <li><a href="/system/files/media/file/2021/04/NIST-POST-QUANTUM-ENCRYTION-ALGORITHMS-CSWP-04282021.pdf#page=6">Challenges Associated with Post-Quantum Cryptography</a></li> <li><a href="/system/files/media/file/2021/04/NIST-POST-QUANTUM-ENCRYTION-ALGORITHMS-CSWP-04282021.pdf#page=7">Planning for Migration to Post-Quantum Cryptography</a></li> <li><a href="/system/files/media/file/2021/04/NIST-POST-QUANTUM-ENCRYTION-ALGORITHMS-CSWP-04282021.pdf#page=9">Next Steps</a></li> </ol> Thu, 29 Apr 2021 09:53:55 -0500 White Papers /2021-03-31-ihfs-violence-against-people-hospitals-white-paper <p>In November 2017, the IHF General Assembly gathered in Taipei, Taiwan, and adopted the “Fighting violence in health services” Resolution. The purpose of this Resolution is to alert the international community of the growing violence in healthcare facilities and emphasize the need to implement measures to prevent and stop such phenomenon.</p><p>According to this Resolution, the IHF Secretariat prepared a survey on “Violence against people in hospitals” with the objective of having IHF Members explore violence risk levels of hospitals and what is in place to limit/face acts of violence.</p><p>The purpose of this document is to present the outcomes of the survey and to understand what measures exist to prevent and face acts of violence within healthcare organizations. View the entire white paper under Key Resources.</p><p><a href="/system/files/media/file/2021/03/ihfs-violence-against-people-in-hospitals-white-paper.pdf"><img src="/sites/default/files/2021-03/cover-ihfs-violence-against-people-in-hospitals-white-paper-518px.png" width="518" height="734" alt="International Hospital Federation (IHF) Violence Against People in Hospitals white paper cover."></a></p> Wed, 31 Mar 2021 10:08:36 -0500 White Papers /white-papers/2021-03-08-health-insurer-specialty-pharmacy-policies-threaten-patient-quality-care <p>Health insurers are driving significant change in the drug supply chain to the detriment of patient care. Under new policies being implemented by a number of large private insurance companies, providers are no longer permitted to acquire and store a variety of drugs needed to treat their patients. Instead, the health insurers are demanding that these providers accept drugs purchased and handled by their owned or affiliated pharmacies to use in patient care. In some cases, the providers are barred entirely from administering drug therapies to their critically ill patients and instead must direct their patients to seek care at unknown specialty pharmacies owned or affiliated by the health plan. These actions pose significant risks to quality of care as providers have inadequate control in ensuring patient access to high quality drugs, as well as the appropriate storage and handling of those drugs. These policies simply serve to drive more revenue to health insurers through their pharmacy benefit management and specialty pharmacy lines of business.</p> <p>Traditionally, the acquisition of and payment for drugs administered in a hospital setting was managed using the “buy and bill” model, which requires a provider to purchase, store and administer drugs, after which payers reimburse providers for both the cost of the drug and the administration of the drug. Health insurers are upending the traditional system, potentially sacrificing patient safety and quality care to benefit their profit margins. Specifically, the health insurers increasingly are implementing policies known as “white bagging” and “brown bagging” in their health plan products:</p> <ul> <li><strong>White Bagging.</strong> The practice of disallowing a provider from procuring and managing the handling of a drug used in patient care. Instead, a third party specialty pharmacy dispenses the drug and sends it to a hospital or physician office on a one-off basis.</li> <li><strong>Brown Bagging.</strong> Similar to white bagging, the provider is not permitted to procure and manage the handling of the drug used in patient care. However, in this instance, the third party specialty pharmacy dispenses the drug directly to a patient who then brings the drug to the hospital or a physician’s office for administration.</li> </ul> <p>White and brown bagging policies present a number of challenges for patients and providers that warrant closer scrutiny by regulators.</p> <ul> <li><strong>Patient Care.</strong> White bagging has implications for the safe care of patients requiring certain drug therapy treatments. The difficulties that white bagging policies place on cancer patients are a prime example of the potential harm. Specifically, many cancer patients are seen the same day as their scheduled infusion. Depending on a patient’s lab results and clinical presentation, initial treatment plans may be amended or cancelled altogether. Similarly, when oncologists use CT scans, infusion regimens may need same-day adjustments depending on the progression of the disease shown in the CT scan results. When either of these situations occur, not having the new infusion regimen immediately available at the hospital can cause delays in treatment, ultimately increasing risk for the patient and potentially adversely impacting cancer patients’ recovery.</li> <li> <p><strong>Patient Access to Medication.</strong> White and brown bagging policies have the potential to directly delay or disrupt the administration of a particular drug to a patient. For example, as the purchasers of pharmaceutical products under these policies, payers, not providers, are responsible for ensuring delivery of the product. However, this practice, especially in brown bagging situations, places significant reliance on the on-time delivery of product. Since these products are ordered on a patient-by-patient basis, as opposed to in bulk by hospitals, the potential for delay in care due to late or mistaken delivery of a product is a realistic outcome. In addition, brown bagging situations, in particular, could result in drug diversion.</p> <p>Moreover, changing the distribution of outpatient drugs has implications for the 340B Drug Pricing Program. This program allows providers that care for a large number of low-income and uninsured patients to stretch their scarce federal resources to provide better access to care, including, but not limited to, improved access to outpatient prescribed pharmaceuticals. Contract or community pharmacy arrangements under the 340B program have allowed hospitals to improve access to prescription drugs for their communities. White or brown bagging drugs allows the insurer to control the distribution of the drug and would eliminate the role of 340B community pharmacy arrangements as well as undermine the intent of the 340B program to allow hospitals to use savings from discounted drugs to improve access to care for the vulnerable communities they serve.</p> </li> <li><strong>Planning and Preparedness.</strong> To ensure the highest quality of care and patient safety, providers must have a clear line of sight into the acquisition, storage and administration of medications. White bagging and brown bagging remove providers from this process, creating significant, avoidable challenges that directly impact patient safety protections. For example, under the “buy and bill” model, hospitals are the purchasers and owners of medications necessary for patient care. This purchaser/ownership role allows providers to manage inventory; monitor dispensing, compounding, and dosing; and ensure proper preparation and storage of drugs from purchase through administration. White and brown bagging policies interrupt that process and require hospitals to receive and store product that is not their own with little-to-no notice. As a result, these policies have the potential to overwhelm hospital storage capacity or surprise hospital supply chain and pharmacy personnel as product is delivered, which has the potential to violate individual hospital supply acquisition guidelines. Further, because these drugs are ordered for specific patients, tracking and keeping record of each patient-specific product presents an unreasonable and resource-intensive challenge.</li> <li><strong>Quality of Handling.</strong> More complex medications require increased care and attention to ensure product quality control. When hospitals control and own medications, they can guarantee the point of origin of the drug and are responsible for and can demonstrate a clear chain of custody to ensure the highest quality product. White bagging and brown bagging, however, interrupt that process, disrupting a hospital’s ability to guarantee the safety of such drugs firsthand. For example, when a payer implements a white bagging policy for a specific drug, the hospital is unable to dictate where the product is manufactured or if it met storage requirements, like refrigeration, prior to delivery to the facility. In addition, certain drugs have very limited windows for use once mixed or compounded, further complicating matters and adding to concerns around excessive product waste.</li> <li><strong>Information on Drug Shortages.</strong> Prior to the utilization of white and brown bagging policies, hospitals were armed with more information to manage, address, and navigate drug shortages because they had clear line of sight into the medications their patients required. With the implementation of these new policies, hospitals are no longer responsible for the purchasing of pharmaceutical products, but still are left with the real consequences that drug shortages present, like alternative medication options and potential delay of receiving a specific drug. Further, removing hospitals from this juncture in the acquisition process limits provider access to critical data and information necessary to adapt to unanticipated challenges that may arise.</li> <li><strong>Inappropriate Shift in Liability.</strong> Providers have primary responsibility for the safety of their patients. As white and brown bagging policies continue to expand, the primary onus for patient safety remains with providers despite health plans stripping those providers of their control over the quality and handling of drug therapies. This shift represents an inappropriate distribution of responsibility to be shouldered by providers, who no longer own or manage the acquisition of certain pharmaceutical products. For example, as drug therapies become more complex, they require significant resources and focus when it comes to storage, dispensing, compounding and administration. Given the significant liability attached to any error in preparation or administration, and without appropriate provider opportunity to oversee the acquisition process due to white and brown bagging, hospitals are more likely to feel compelled to refuse to administer products under these conditions because they cannot guarantee their safety or efficacy.</li> </ul> <h2>Policy Recommendations</h2> <p>We urge policymakers to take action to ensure that access to quality care and drug therapies is not compromised through white or brown bagging policies. <strong>Specifically, regulators should ensure that health insurers comply with the following policies:</strong></p> <ul> <li><strong>No Brown Bagging.</strong> Brown bagging should be prohibited. Shipping pharmaceutical products that require provider administration directly to patients presents significant and serious patient safety issues. Specifically, there is no method to guarantee proper storage of these drugs and the risk of drug diversion increases.</li> <li><strong>Prohibitions on Certain White Bagging.</strong> There are some situations where white bagging poses significant risks to patient care. For example, drug doses for certain patients are dependent upon the results of lab tests and, therefore, dosing levels could change over the course of a treatment based on those test results. White bagging policies severely hinder a provider’s ability to adapt and change dosing as necessary, at best, delaying needed patient care. In order to eliminate this potential harm, policies should be implemented that prohibit white bagging when the dosage or compounding of a pharmaceutical product is dependent upon the results of a patient’s lab tests.</li> <li><strong>Safety Criteria for When White Bagging Can Apply.</strong> In instances where white bagging is not prohibited, it should be restricted, allowing the practice only when certain criteria are met. Specifically, the practice should be restricted to the following situations. First, the practice only should be permissible in instances where the provider and health plan agree through their standard negotiations that such arrangements are in the clinical best interests of the patient. For example, certain providers, such as smaller or more rural facilities, may prefer to partner on some pharmacy operations in which case white bagging may present a reasonable solution. However, providers must be a joint partner in setting the terms of the agreement, including the quality and safety criteria, and have shared oversight of the specialty pharmacy arrangement. Second, there may be instances where white bagging policies are necessary to ensure patient access to a medication. In those cases, specific safety criteria should be satisfied before any white bagging policy is permissible. Finally, at no point should providers be required to accept these arrangements when they are unilaterally forced upon them by payers. Providers should be permitted to decline any such arrangements based on quality of care concerns.</li> <li><strong>Provider Notice.</strong> Oftentimes, providers learn about the payer implementation of these policies with little-to-no notice. When permitted to use white bagging, payers should be required to give sufficient and advance notice to providers to mitigate any gaps in critical information and secure the type of agreement referenced above.</li> </ul> Mon, 08 Mar 2021 14:33:35 -0600 White Papers