340B Insight

This week we are joined by Maureen Testoni, 340B Health’s president and CEO. Maureen provides her expert analysis on the top 340B developments from the first quarter of 2021. The conversation includes the latest on drug manufacturers denying 340B discounts on drugs dispensed at community pharmacies, attempts to turn 340B into a rebate program, and payers and pharmacy benefit managers making mandatory changes to their claims processes. Maureen also shares positive recent developments on advocating for 340B.  

Updates on the Community Pharmacy Issue

The Department of Health and Human Services (HHS) has indicated that drug manufacturers are violating the law when they refuse to provide 340B discounts on drugs dispensed at community pharmacies. Maureen explains that she is encouraged by new HHS Secretary Xavier Becerra’s statements in support of 340B but that advocacy needs to continue on this issue to ensure the secretary and the department move forward with enforcing the 340B statute. One factor is the 340B administrative dispute resolution (ADR) process. The ADR process was created to resolve individual disputes between covered entities and manufacturers. However, because HHS has made it clear through an advisory opinion and in other court filings that drug manufacturers are violating the law, Maureen believes that the community pharmacy issue is not appropriate for the ADR process. ADR panels have not yet been appointed, and they will take longer to resolve the issue. Meanwhile, hospitals will continue losing 340B discounts every day. Maureen recommends that hospitals file overcharge notices with the Health Resources & Services Administration (HRSA) to demonstrate the harm caused by these restrictions and continue documenting all losses when refused 340B discounts. Hospitals also should continue contacting their members of Congress to ask them to reach out to the new administration on this issue.

Attempts to Turn 340B Into A Rebate Model

Maureen explains that while no concrete action has taken place, Kalderos, a drug manufacturer consultant, is marketing a new rebate system where 340B discounts are not provided when the drug is purchased but are later given as a rebate. This would result in higher upfront costs and would put covered entities at risk for a loss of access to 340B savings should the manufacturer not grant the rebate. 340B always has operated as an upfront discount per the direction of HHS, so 340B Health is advocating that HHS prevent this proposal from moving forward, Maureen explains. 

Payers and PBMs Making Mandatory Changes to Claims Processes 

Express Scripts recently notified 340B hospitals that they want providers to identify which claims are 340B. The company says this can be done either by placing a modifier on the claim when dispensing the drug or retroactively by using a transaction known as N1. While Express Scripts has said they are not planning to reduce reimbursements, Maureen explains that it is concerning that the company gives no clear reason why 340B drug claims must be identified and treated differently than non-340B drugs. 340B Health and the 340B Coalition, representing 340B providers at different types of covered entities, have written to Express Scripts about the concerns with this issue. 340B Health also has been communicating concerns about the policy to members of Congress.  

Separately, Humana has notified 340B hospitals about plans to reimburse hospitals less for 340B drugs than non-340B drugs, which undermines the intent for safety-net hospitals to provide more care to low-income and rural populations through 340B savings.

Positive Developments on Advocacy

Maureen discusses 340B Health’s recent Virtual Hill Day, which included more than 300 individuals from 340B Health member hospitals meeting with more than 250 congressional offices. 340B Health members focused on all the issues Maureen analyzed earlier in the episode, including Medicare Part B cuts to 340B hospitals and DSH hospitals losing 340B eligibility due to the pandemic. 340B Health members shared Impact Profiles about their 340B savings and how they use them. Maureen also gives a preview of what to expect at the 340B Coalition Summer Conference in July.

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, please email us at [email protected].

Resources 

1. New York Delays Medicaid Pharmacy Benefit Transfer for at Least Two Years
2. Stop 340B Cuts – Drug Manufacturers Are Refusing to Provide Required 340B   Discounts
3. Express Scripts Granting Extensions on 340B Claims ID Mandate 
4. 340B Health Virtual Hill Day Video 
5. 340B Coalition 2021 Summer Conference 

April is National Cancer Control Month, and this week we are joined by Dr. Gerold Bepler, president and CEO at the Barbara Ann Karmanos Cancer Institute in Detroit. Dr. Bepler discusses the unique role cancer centers play in preventing and treating cancer, the importance of 340B to Karmanos and its patients, how Karmanos is addressing racial and ethnic disparities in cancer treatment, and the partnership it has formed to expand access to cancer research and treatment in rural communities. Before the interview, we recap 340B Health’s recent virtual Hill Day. 

The Karmanos Comprehensive Approach to Cancer Research and Treatment

The Karmanos Cancer Institute is one of 51 National Cancer Institute (NCI)-Designated Comprehensive Cancer Centers. Karmanos has a comprehensive integrated organization that conducts research to evaluate how cancer grows and progresses, develops new targets, provides access to new drugs, and leverages early detection and prevention programs. Karmanos also has developed a genetic counseling program and a clinical trial program. Dr. Bepler shares that 15-20% of Karmanos patients are uninsured or underinsured and another third rely on Medicare.  

340B Is Improving Access to Cancer Treatment

Karmanos’s main Detroit location is a disproportionate share hospital (DSH). 340B helps it to purchase highly effective cancer drugs that often can be $10,000-$15,000 per month. Dr. Bepler explains that Karmanos has established a specialty pharmacy that uses 340B savings to provide direct financial assistance to help patients in need cover the gap between what their insurer pays and the cost of the medication to the patient. In 2020, Karmanos provided $1.7 million in patient assistance through this specialty pharmacy. 340B also helps fund follow-up support that Karmanos pharmacists provide patients on the medications they need for their cancer treatment. 

Ongoing 340B Issues Affect Cancer Treatment 

Drug manufacturers’ refusals to provide 340B discounts on drugs dispensed at community pharmacies have had a detrimental effect on cancer patients. Karmanos has had to help some rural patients find alternative medications to replace the ones they have lost access to, and this risks a reduction in medication adherence. Dr. Bepler also discusses how cancer and rural hospitals are unable to access 340B discounts on orphan drugs when they are used for off-label purposes or to treat common conditions. 

How Cancer Centers Advocate for 340B

Karmanos collaborates with several associations to advocate for 340B, including the Association of American Cancer Institutes (AACI). Dr. Bepler discusses that it is critical to be part of a larger organization that has power to affect and understand legislative action regarding 340B compliance. 

Addressing Disparities in Cancer Prevention and Treatment 

Dr. Bepler explains that different racial and ethnic groups have unique risks in developing cancer and that cancer may behave in different ways biologically. Karmanos conducts research to understand these biological differences and investigate if they require new drug development. Karmanos also has established an Office of Cancer Health Equity and Community Engagement to communicate directly with community leaders and understand the priorities of the communities it serves. They then match these needs to the development of screening, treatment, and early detection programs to reduce cancer risk and improve outcomes for diagnosed patients.

Bringing World-Class Cancer Research and Treatment to Rural Communities 

Because NCI-Designated Comprehensive Cancer Centers are usually in metropolitan areas, more effort is required to reach rural patients with the latest treatments. Karmanos partnered with McLaren Health, a community-based health network. They work together to improve the quality of cancer care in rural communities and provide expedited access to newer treatments. Dr. Bepler shares that quality of care has improved and enrollment in clinical trials has increased five-fold in recent years in the rural communities they serve together. 

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources

1. 340B Health Virtual Hill Day Video 
2. 340B Health’s Staffing 340B Webinar 

This week we are joined by Amanda Sellers Smith, the assistant counsel for 340B Health. While 340B is a federal program, it is intertwined with Medicaid and states’ oversight of the health care marketplace. Amanda discusses how states are protecting 340B covered entities from discriminatory reimbursement, why changes to state Medicaid policy can affect 340B in multiple ways, and how listeners can advocate for 340B at the state level. Before the interview with Amanda, we recap the results of the newly released 340B Health annual survey of 340B hospitals. 

How States Can Protect 340B Hospitals

Some pharmacy benefit managers (PBMs) have attempted to cut reimbursement for covered entities on 340B drugs. This ignores the intent of 340B drug pricing to enable covered entities to buy drugs at a discounted price and be reimbursed at the regular reimbursement rate. However, the 340B statute does not protect against PBMs making discriminatory reimbursements. Some states, including Utah, Ohio, Montana, and West Virginia, have passed anti-discriminatory laws. Regarding the ongoing issue of drug manufacturers’ refusals to provide 340B discounts on drugs dispensed at community pharmacies, Amanda explained that state officials can serve as key, high-profile advocates to the federal government.

The Intersection of 340B and Medicaid 

The intersection of Medicaid and 340B policy has become the most significant 340B policymaking area in states. Congress decided that when a drug is purchased at the 340B price, the drug is not subject to the Medicaid rebate. This leads to debate on whether covered entities or states should receive the benefit. 

States want the financial benefit of Medicaid drug rebates, and some states transfer the pharmacy benefit from Medicaid managed care into Medicaid fee-for-service. This transfer ties reimbursement to actual acquisition costs, and 340B covered entities no longer can negotiate the higher Medicaid reimbursement rate. This is happening in states such as California and New York. Other states are choosing a single PBM to administer the Medicaid managed care program. These policies are not focused on 340B, but covered entities in Ohio and other states have shared concerns with state policymakers that a single PBM for Medicaid managed care means the PBM has the power to set reimbursement at a rate that results in cuts to 340B savings. Another major trend is the use of mandatory carve-outs, where the state declares certain or all 340B drugs to be ineligible for Medicaid patients. Examples of states pursuing these policies include South Dakota, Massachusetts, and Louisiana. 

How to Advocate at the State Level

Amanda recommends providers demonstrate to state lawmakers why the 340B drug pricing should remain with covered entities. Every state’s legislature operates differently, but advocacy work can be done through sharing how 340B savings are aligned with program intent and are used to benefit the community. It also is important to engage with local media, state Medicaid agencies, and anyone in charge of state-level advocacy within a covered entity. 

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources 

1. 2020 340B Health Annual Survey Report 

This week we are joined by Dr. John Carlo, CEO of Prism Health North Texas. Prism Health is a Ryan White Clinic, which are grantees of the Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS program. They provide care to patients at risk of or living with HIV/AIDS and are one of 16 types of 340B covered entities. John discusses 340B’s role in Prism Health’s ability to care for patients, how Ryan White Clinics work together with 340B hospitals, how they are serving patients during the pandemic, and the latest innovations in HIV care. Before the interview, we share important updates related to drug company denials of 340B discounts to covered entities that partner with community pharmacies.

How 340B Savings Help Ryan White Clinics Serve Patients 

Prism Health’s primary focus is on providing care and effective treatment for uninsured or underinsured patients at risk of or living with HIV/AIDS. As a Ryan White Clinic, Prism Health receives federal funding through the HRSA Ryan White HIV/AIDS program. John shares that this funding is not sufficient to cover the increasing number of people who need access to services. HIV medications are expensive, and the 340B program enables clinics to purchase more medications for uninsured and underinsured patients. The 340B savings also enable Prism Health to provide wraparound services including transportation access, case management, and behavioral health services. 

Ryan White Clinics and 340B Hospitals Working Together 

John describes Ryan White Clinics as part of a “medical neighborhood” for underserved patients along with 340B hospitals and other covered entities. Ryan White Clinics partner with 340B hospitals to ensure their patients have access to tertiary care, specialty care, diagnostics, and imaging, which are resources Ryan White Clinics do not have. In turn, 340B hospitals will refer patients who come to the hospital with HIV-related medical complications to Ryan White Clinics to maintain primary care services after they are discharged. 

Drug Manufacturers’ Denial Of 340B Discounts and the Impact on HIV/AIDS Patients

John shares that drug manufacturer denials of 340B discounts to covered entities when drugs are dispensed at community pharmacies have a detrimental effect on care delivery for patients. The manufacturers have threatened to stop providing the discounts to Prism Health, which relies on community pharmacy partnerships because many of its patients are not local and live in rural areas. John explains how this decision from drug manufacturers risks access to prescription drugs for uninsured and underinsured patients and harms patient care. 

The Effects of the COVID-19 Pandemic on HIV Care 

Due to the pandemic, fewer patients are going to Prism Health to receive care and access needed medications. This can lead to a higher risk of patients contracting HIV and patients living with HIV experiencing disease progression or transmitting the disease to others. John discusses how Prism Health’s case management team takes several steps to provide outreach to patients who are missing appointments and prescription pickups, including having mobile teams go into neighborhoods and working with partners in housing and homelessness. The additional time and resources spent to accomplish this is another example of why 340B savings are needed to augment government grant funding. 

Preventing HIV And the Future OF HIV/AIDS Care 

Prism Health also works with patients who are at risk of HIV through pre-exposure prophylaxis (PrEP). Under the Ryan White Act, grant funds only can be used to provide care for someone living with HIV, so 340B is critical for supporting access to PrEP. John shares that Prism Health has used 340B savings to launch a program that provides PrEP to patients with sexually transmitted diseases, because these patients are at higher risk for HIV. John says ending the HIV/AIDS epidemic this decade is possible but will take substantial commitment, resources, and funding to support HIV/AIDS prevention and continued care for patients living with the disease.

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources 

1. HHS Response to Eli Lilly Motion for Preliminary Injunction Regarding Administrative Dispute Resolution  
2. Statement on Court Dismissal of 340B Community Pharmacy Lawsuit 
3. Majority of U.S. House Backs Efforts to Protect 340B from Unlawful Drug Company Actions 
4. Prism Health North Texas 
5. 340B Coalition Winter Conference 

This week we continue our two-part series focused on how 340B hospitals are pursuing health equity. In our recently released Health Equity Report, 340B Health profiled nine hospitals working to eliminate health disparities in their communities. Today, we continue sharing the stories of three hospitals from that report. For this episode, we are broadcasting from our virtual booth in the exhibit hall at the 340B Coalition Winter Conference that started Feb. 16 and will run through Feb. 24. 

After we recorded this episode, a federal judge granted the government’s motion to dismiss a joint lawsuit that 340B Health and other plaintiffs had filed over drug company refusals to offer 340B pricing on drugs dispensed at community pharmacies. Read our statement about the decision, and we will provide additional analysis of the decision in upcoming episodes. 

We sit down this week with health equity leaders from each of the three hospitals: Rukiya Curvey Johnson, director of community health and engagement at Rush University System for Health in Chicago; Dr. Cheryl Clark, director of health equity, research and intervention at Brigham and Women’s Hospital’s Center for Community Health and Health Equity in Boston; and Greta Todd, executive director of diversity inclusion and community affairs at St. Louis Children’s Hospital.   

How Data Collection Identifies Disparities

Rush implemented a data-driven approach to identify health disparities within Chicago communities. Curvey Johnson explains how Rush uses assessments and metrics to determine priorities and progression of strategies. Dr. Clark shares how data were critical for Brigham and Women's Hospital in addressing disparities in the COVID-19 pandemic. Data informed the hospital more about the diversity within their community. To ensure culturally appropriate conversations, they purchased technology that enabled providers to communicate with patients in their preferred languages. 

Setting Measurable Goals Supported with Data 

With the use of timely data, 340B hospitals are setting goals relevant to their communities. Rush uses their data to help reduce the life expectancy gap in specific Chicago neighborhoods by focusing on education, access to care, and resources for managing chronic disease. Todd explains how St. Louis Children’s Hospital used data from employee engagement surveys to create a safe, inclusive environment for Black nurses in the hospital workforce. 

Learning Cultural Competency

One way St. Louis Children’s Hospital pursues health equity is with cultural competency training for the hospital workforce, including senior leadership. Todd believes that cultural competency can help providers better understand and communicate with patients of diverse backgrounds. Todd shares stories of how unconscious bias can affect care for patients of color and the important role the hospital supply chain has in addressing disparities.  

Collaboration and Courage Is Necessary to Overcome Health Equity Challenges 

Curvey Johnson explains that pursuing health equity is hard work and must involve senior leadership. Collaboration with local and national organizations also is crucial for eliminating racial and ethnic disparities in health care. 

Dr. Clark says providers need to collect more data to better understand the needs of people with disabilities as well as individuals with different sexual orientations and gender identities.”

Todd recommends that those working to pursue health equity ground themselves in the data that support this mission to demonstrate to stakeholders why it is critical to eliminate disparities. 

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources

1. 340B Insight Episode 20: Pursuing Health Equity 
2. 340B Health Equity Report 
3. 340B Health Equity Report Infographic 
4. 340B Health Webinar: The ADR Final Rule & Its Implications for Hospitals 
5. 2021 340B Coalition Winter Conference 

This week, we begin a two-part series focused on how 340B hospitals are pursuing health equity. The COVID-19 pandemic has spotlighted the significant racial and ethnic disparities in health care and patient health outcomes. Today, we focus on three hospitals featured in 340B Health’s recently released health equity report and hear more about how they’re working to eliminate health disparities in their communities. Before we launch into the episode, we answer a member question about the many lawsuits that have been filed related to disputes over 340B contract pharmacies.  

We sit down with representatives from three hospitals: Dr. Cheryl Clark, director of health equity, research and intervention at Brigham and Women’s Hospital; Rukiya Curvey Johnson, director of community health and engagement at Rush University System for Health in Chicago; Julia Bassett, manager of health and community benefit at Rush; and Greta Todd, executive director of diversity inclusion and community affairs at St. Louis Children’s Hospital. 

Why Health Equity Matters 

340B hospitals are integral elements in the movement to reduce health disparities in the U.S. Dr. Clark explains why health equity is essential and defines the concept as the ability for all people to reach their optimal health without barriers such as reduced access to care and lack of affordability. Curvey Johnson discusses that 340B hospitals serve vulnerable, underinsured, and uninsured populations and should be part of a multi-sector collaboration to address health equity. Todd references health care’s core mission to “do no harm” and affirms that all hospitals should be working to prevent the harm of health disparities. 

COVID-19’s Disproportionate Effect on People of Color

African Americans and Hispanic people experience higher infection rates and deaths from COVID-19. Brigham and Women’s Hospital acted on this by creating the COVID-19 Equity, Diversity and Community Health Response team. The team’s efforts included ensuring equity in participation for the hospital’s remdesivir research trial. Dr. Clark believes recruiting clinicians and staff from diverse backgrounds to create trustworthy, culturally sensitive environments was critical to ensuring that trial participants represented the same patient demographics as the community Brigham and Women’s serves. 

The Connection Between Health Equity and Social Determinants

Identifying and addressing social determinants are critical to the pursuit of health equity. Brigham and Women’s Hospital participates in the Massachusetts Accountable Care Organization, serving patients with public insurance. As part of its participation, the hospital places a strong focus on the need to screen patients for social determinants and then connect them to needed services. Brigham and Women’s implemented best practices during the pandemic that it learned prior to COVID-19, including by screening for social determinants at COVID testing sites. Rush University System for Health screens patients for food insecurity and uses some of their 340B savings to deliver healthy meals to community members. St. Louis Children’s is using mobile pediatric units to remove barriers to transportation that make it difficult for families to travel to clinics for services that include hearing and vision screenings, immunizations, asthma treatment, diabetes services, and dental care.

Stay tuned for our next episode as we explore other key trends in 340B Health’s new equity report.

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources 

1. 340B Health Equity Report 
2. 340B Health Equity Report Infographic 
3. 340B Health Manufacturer Updates Page 
4. Stop 340B Cuts 
5. 2021 340B Coalition Winter Conference 

This week we are joined by Scott Milner, senior director of pharmacy, business development, purchasing, 340B, and infusion services at St. Luke’s Health System in Idaho. Scott shares his personal experiences on how the health system has been finding ways to overcome COVID-19 vaccine distribution challenges and describes how the effort has become a personal mission for him. Prior to the interview, we discuss in our news update segment how drug companies are suing HHS in response to the department’s advisory opinion on 340B contract pharmacies. When we recorded the episode, three companies had filed such lawsuits. Since then, a fourth company also has gone to court over the issue. 

Preparing for the COVID-19 Vaccine 

Scott shares his and his colleagues’ reactions to the exciting moment when they received the news that the vaccine had arrived at the hospital. To be prepared for the first delivery, decisions were made quickly without knowing full details about the vaccines. St. Luke’s acquired extra needles and syringes in case they were not provided with the doses. After learning what temperatures were needed to store vaccines, they purchased ultra-low freezers and ensured they had enough generator power. Preparation occurred while the hospital continued making pharmacy decisions to support the treatment of COVID-19 patients. 

Overcoming Distribution Challenges 

St. Luke's must track who is first eligible to receive the vaccine and ensure all eligible patients who request a dose receive it. They monitor this by using appointments. The initial vaccine deliveries were delayed in arriving due to the holiday season, so when St. Luke’s received the first shipment, they immediately enlisted their medevac helicopters to deliver the vaccines to their other locations throughout the state. Scott also noted the extra hours hospital staff and volunteers have worked as being key to smooth operation of the vaccine clinics. 

Ensuring No Community is Overlooked 

St. Luke’s has critical access facilities, a sole community hospital, and disproportionate share hospitals in Idaho. Scott explains that they treat many uninsured and underinsured patients, many of whom work several part-time jobs. The 340B assist program allows the system to provide 1,800 patients with access to medication cost assistance. St. Luke’s also has been working with remote rural communities with smaller numbers of patients and staff and limited access to equipment and storage space to grant them access to the optimal amount of COVID-19 treatments and vaccines. 

One COVID-19 Vaccine Side Effect is Hope

Scott shares a personal story of why working on vaccine distribution is so meaningful to him and why he is eager to educate and support people who are uncertain about receiving the vaccine. He believes the most important “side effect” of COVID-19 vaccines is hope. 

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources

1. 340B Health Analysis of Drug Manufacturers’ Lawsuits Against HHS 
2. 340B Insight Episode 14: The Biden Administration, New Congress, and 340B 
3. Scott Milner’s Video of the Phone Call Announcing the Arrival of the COVID-19 Vaccine 
4. Faces of 340B: St. Luke’s Health Patient Kathleen Cavanagh 
5. 340B Health Advocacy Webinar: A New Congress and Administration. What Does This Mean for 340B?
6. 340B Coalition 2021 Winter Conference  

 This week we are joined by Steven Miller, vice president of pharmacy services at 340B Health. Steve discusses Health Resources & Services Administration (HRSA) audits of 340B hospitals and shares practical advice for how hospitals can best prepare, including the resources that are available to them. Prior to the interview, we provide a major news update you might have missed during the holiday season on the ongoing 340B contract pharmacy issue.  

HRSA Audits 101

In 2015, HRSA started auditing 200 covered entities each fiscal year, with 155 of those covered entities being 340B hospitals. HRSA uses an algorithm to determine 90% of the covered entities to audit. The more 340B purchases, child sites, and contract pharmacies an entity has, the more likely they are to be audited. The other 10% of audits focus on complaints from 340B stakeholders or on covered entities that had previous audit findings. Steve explains that auditors are usually pharmacists and have an in-depth knowledge of the 340B program. 

Data Are Important 

Steve explains that hospitals must have a clear understanding of their data and how they connect between departments and relate to 340B eligibility. Software resources, third-party vendors, and split-billing tools can help hospitals monitor these data. It is important for the data to be clean and well-organized. 

Following Policies and Procedures 

HRSA also will assess if covered entities are following their institutional policies and procedures. This is because the policies and procedures are considered the standard for any aspect of compliance that is not explicitly addressed in the 340B statute. The policies and procedures should be aligned with HRSA enforcement. 

Internal Auditing vs. External Auditing

340B hospital staff conduct internal audits to ensure their data systems’ logic and filters are working as they should. HRSA expects hospitals to review their own systems and data routinely. Internal auditing can be biased, because the staff works in 340B operations and thus can accidentally miss how the system is working. That is why external auditing allows the hospital to obtain a more objective report. Steve explains that this can reassure the hospital, especially in addressing problems that might not be found in the internal review. Steve suggests hospitals conduct internal reviews weekly or monthly and external audits once a year.  

Resources for Preparing for Audits

340B Health has policy guides, compliance resources, and audit trends for hospitals to use in preparation for an audit. Steve encourages 340B Health members to contact 340B Health when they learn of an upcoming audit for a technical assistance call. 340B hospitals also should reference the website of the HRSA Office of Pharmacy Affairs (OPA). The HRSA Prime Vendor also provides additional resources. 

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources

1. Office of the HHS General Counsel’s Advisory Opinion on Contract Pharmacies Under the 340B Program
2. 340B Health and National Hospital and Pharmacists’ Organizations Lawsuit against HHS 
3. www.stop340bcuts.org   
4. 340B Health Compliance Resources 
5. 340B Coalition 2021 Winter Conference  

In our final episode of 2020, we are joined by Maureen Testoni, the president and CEO of 340B Health. Our episode follows up last week’s bonus episode on 340B Health’s recent joint lawsuit against the Department of Health and Human Services regarding drug manufacturers’ refusals to provide 340B discounts when drugs are dispensed at community-based contract pharmacies. Maureen provides additional analysis on the issue and discusses her concerns with how some drug companies are attempting to change 340B into a rebate program. She also discusses the role 340B has played in helping hospitals respond to the COVID-19 pandemic this year. 

340B Savings Help Hospitals Fight COVID-19

340B hospitals are using 340B savings during the pandemic to expand care to patients through telehealth and enhanced medication therapy management services. Maureen shares stories of hospitals throughout the country that have expanded services to reach more chronically ill patients in need or to secure the additional beds they need to care for COVID-19 patients. HRSA’s extended flexibilities to 340B are key in helping hospitals provide more services and avoid drug shortages.

Steps Hospitals Should Take When Drug Companies Refuse to Provide 340B Pricing

If drug manufacturers overcharge or refuse to provide 340B discounts to covered entities on drugs dispensed to contract pharmacies, Maureen strongly recommends the affected hospitals file notices of overcharge with HRSA to start the process of enforcement. Advocacy outreach to the new administration and new Congress also will be necessary for educating policymakers about 340B and the threats to the program posed by drug manufacturers not following the statute. 

Manufacturers Attempt to Convert 340B Into Rebate Program

Maureen shares her concerns about drug companies working to convert 340B into a rebate program. She says a rebate process would make it very expensive for covered entities to access 340B savings, as they would have to pay for the drugs at the higher wholesale acquisition cost. With this model, manufacturers also potentially could deny the rebate, and there would be no clear process for hospitals to appeal. 340B Health has communicated its concerns about drug manufacturers converting 340B into a rebate program to HHS and has urged the agency to block such a move. Nearly half the members of the House of Representatives sent a letter to HHS expressing its concerns about the issue. Maureen also recommends 340B hospitals review with their counsel the terms and conditions presented by any drug manufacturers asking them to participate in a rebate program.

Check out all our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you’d like us to cover in this podcast, email us at [email protected].

Resources: 

1. BONUS 340B INSIGHT EPISODE: TAKING THE 340B CASE TO COURT
2. Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals Of 340B Discounts
3. State Attorneys General Letter to HHS Regarding Drug Manufacturer Denials of 340B Discounts 
4. Nearly Half of U.S. House of Representative Oppose Move to Convert 340B Into a Rebate Program  
5. 340B Health Webinar: 340B & the Courts: How Lawsuits Shape 340B Enforcement  

This week we have a breaking news bonus episode of 340B Insight. 340B Health President and CEO Maureen Testoni joins us to discuss the filing of a lawsuit against the Department of Health & Human Services with four other national hospital organizations, a national pharmacist’s organization, and three individual 340B hospitals, seeking to halt drug companies’ refusals to provide 340B discounts to hospitals on covered drugs dispensed at community-based contract pharmacies. 

Manufacturers’ Actions are Unlawful A group of major drug companies have taken unilateral actions to refuse to provide 340B pricing, and the federal government has failed to act to enforce the law. As a result, 340B Health, four other national hospital organizations, a pharmacist organization, and three individual 340B hospitals have filed a lawsuit in the U.S. District Court for the Northern District of California. 

What the Lawsuit Asks the Court to Do 340B Health and the other joint plaintiffs will demonstrate to the court that HHS has the authority and the responsibility to enforce the 340B statute to protect safety-net hospitals and patients. The lawsuit asks the court to order HHS to require drug manufacturers to provide 340B pricing on covered drugs dispensed to community-based contract pharmacies and refund to 340B hospitals the money that they lost because of the manufacturers’ actions. The complaint also asked for an order requiring HHS to refer the matter to the Office of the Inspector General for potential civil penalties. 

Could a New Administration Affect the Case? Maureen says 340B Health will be educating the incoming Biden administration about the matter of drug manufacturers not complying with the 340B statute. The issue could be resolved quickly if the next HHS Secretary enforces the 340B statute, which would result in drug manufacturers having to provide 340B discounts again when drugs are dispensed at community-based contract pharmacies. 

Tune in Next Week for More Analysis Maureen will join us again next week for our final podcast episode of 2020 to provide additional analysis of what comes next in responding to drug companies continued attacks on 340B as well as other issues that have affected 340B hospitals in 2020. 

Check out all of our episodes on the 340B Insight podcast website. You also can stay updated on all 340B Health news and information by visiting our homepage. If you have any questions you would like us to cover in this podcast, email us at [email protected].

Resources 

1. Hospitals and Pharmacists File Lawsuit Over Drug Companies’ Refusals Of 340B Discounts