The Federal 340B Program: A Call to Order

By: Jeffrey R. Lewis & Willam E. Arnold, Co-Chairs, Community Access National Network 340B Commission

The 340B Drug Pricing Program was created by Congress to allow nonprofit healthcare providers to maximize their use of limited dollars to ensure access to medicines for uninsured patients with acute and chronic health conditions and disorders.

Since its inception, the program has grown dramatically, and with it so have the challenges, opportunities and the questions of whether what was created 26 years ago should be re-cast? While advocates argue that the status quo is good enough, others are asking questions that get to the heart of the future of the program. Is this program benefiting nonprofit healthcare providers or patients who do not have prescription drug coverage? Are nonprofit hospitals and other 340B providers treated equally or are there different levels of transparency rules? Are all 340B providers required to reinvest their 340B revenue in patient care and staffing, or is the program so opaque that the rules are disproportionately benefiting one certain kind of 340B providers?

At the inception of the 340B program, the number of uninsured individuals in the U.S. was greater than it is currently; many state Medicaid programs limited eligibility; and access to free or subsidized medication programs was not as robust as it is today.

Unlike all other federal health programs, the costs of the 340B program are born by the pharmaceutical industry. The 340B program requires pharmaceutical manufacturers that participate in Medicaid and Medicare (Part B) programs to provide discounts on covered outpatient medicines to nonprofit healthcare providers (Covered Entities) licensed to provide care under the 340B program.  When the 340B program was created, many uninsured patients used hospital emergency rooms for primary care; nonprofit hospitals were often paying for the needed medications to keep the patient from showing up again; and, the cost impact on the hospitals was rising. Congress wanted to ensure that nonprofit healthcare providers could stretch limited dollars. So, the 340B program was designed to aid that effort.

Today, the 340B program has grown considerably – both in the number of people being served and, in the type, and number, of providers allowed to participate in the program. The program provides uninsured patients access to medications at considerable savings, lowering the cost of pharmaceuticals by 20-50 percent, and has benefited many at-risk clinics and the patients they serve. But, how are patients who have insurance, particularly high deductible health plans, benefiting from the 340B program?

As the program has evolved, questions have grown: Should the status quo be maintained? Should Congress take a fresh look at who qualifies for the program, as well as whether the number and types of providers have grown too much? Is the program transparent? Should transparency be enhanced/modified? Why are hospitals participating in the 340B program treated differently than other Covered Entities in how they can spend 340B program revenue? Why should drug stores be allowed to dictate their “pay to play” price to Covered Entities and take a portion of the 340B savings? Why aren’t all pharmacies paid a consistent, flat fee? What role do Pharmacy Benefits Managers play in the 340B program? Is there a true value proposition? How can technology and innovation play a larger role in ensuring that Covered Entities are not double billing Medicaid and 340B for the same medication?

The Community Access National Network (CANN) is a national, nonprofit organization that has been involved in 340B policy issues for many years. It recognized the need to provide Congress, the White House, other elected officials and regulators with a frank assessment of the program. Recently, CANN gathered a diverse group of healthcare professionals for this purpose and the National 340B  Commission was created.

The Commission found that, generally, the 340B program has made and continues to make an invaluable impact on the lives of the institutions it was initially targeted to help. But, with an increasing number of uninsured covered through employer plans and expanded Medicaid programs, it’s important to ensure that those patients truly in need are being helped. It also appears that the program needs technological updates to how it is administered, to maximize the value of every 340B dollar spent.

While the 340B program has been invaluable to many Covered Entities, no federal program is perfect.  We believe that there are areas in which private sector technology and skills can help close some of the holes in the 340B program, and, where common sense needs to rule.

1. Transparency

Transparency should be woven into the fabric of the 340B program. Congress, governors, state legislatures, Covered Entities, and pharmaceutical manufacturers should understand how the 340B program is helping to serve more people. Specifically, it must be made clear how Covered Entities are generating 340B revenue, which types of patients are served and which kinds of medicines are covered. It is important to explain how this revenue is reinvested in the program to provide greater patient care and access to providers and help Covered Entities strengthen their medical staffs.

Why is it important?  Federally Qualified Health Centers (FQHCs) and Hemophilia Treatment Centers are required to reinvest every 340B dollar earned into patient care or into the operation of the Centers to maximize patient access and care. For example, when a patient with private insurance receives healthcare services from a 340B provider (known as a Covered Entity), they pay their traditional copay for any needed medication.All 340B providers retain the difference between the 340B discounted price and the higher reimbursement paid by insurers.

The one exception is how the “pocketed” money must be spent. FQHCs and other participating medical providers are required to pass along the discounts to patients and to provide annual reports about their service to vulnerable populations to the Health Resources and Services Administration (HRSA), which oversees the 340B program. However, 340B hospitals are not required to do this.  Consequently, these providers can generate 340B profits by pocketing the difference between the discounted price that they paid for the drugs and the higher reimbursement paid by insurers and patients.

Consequently, we do not know how the 340B dollars are reinvested. We have no way of knowing how much is utilized for direct and indirect patient care, hiring medical professionals, or other needs.  Also, given the growth of high deductible health insurance plans, it is important to fully understand whether and how hospitals are using the 340B revenue to help reduce out-of-pocket costs,  particularly for patients who do not qualify for Medicaid and whose incomes are less than 300 percent of the federal poverty level.

2. Duplicate Discounts

Duplicate discounts are the direct result of a conflict between two federal programs - Medicaid rebates intended to benefit state Medicaid programs, and 340B discounts intended to benefit eligible safety-net health care providers (340B-Covered Entities). There is a substantial overlap in prescription eligibility between the two programs, making it possible for both states and Covered Entities to claim a discount for the same purchase. The federal government has failed to address this problem.

The Commission proposes five recommendations:

• Claims Level Standards

There is a need to collect claims level data standards for Medicaid rebates being made by the states to manufacturers. Currently, there are no standards for the kind of data the states must supply. As a result, pharmaceutical manufacturers are playing catch up using limited data. This makes recovering or preventing duplicate discounts almost impossible.

• Data Fields Used to Prevent Duplicate Discounts

Medicaid uses a combination of Medicaid Exclusion File (MEF) and claims modifiers to prevent duplicate discounts, but the system is rife with confusion. First, states are not required to use any set format or form; entities utilize a variety of methods. Second, the MEF doesn't apply to managed Medicaid or contract pharmacies, limiting its utility. Third, the claims modifiers used by states require 340B awareness at the time of dispensing, which is not how 340B programs generally work. Finally, states have effectively punted managed Medicaid and 340B to plans which are the least likely to understand or have experience managing 340B participation.  This means the entire system is stacked against the manufacturers. At a time when we are asking for greater clarity in the 340B program, this is an important place to start.

• Creating a Claims Clearing House

To proactively prevent duplicate discounts, the Secretary of Health and Human Services should seek the development of a private sector claims clearinghouse platform for the Covered Entities and manufacturers (and plans and states), so they can share data in an antitrust safe harbor. This clearinghouse would collate data from participating parties and pass it back to them in a manner that prevents duplication

• Pharmacy Adjudication Chaos

To overcome the chaos surrounding contract pharmacy adjudication, we recommend establishing a HIPAA-compliant HUB for Covered Entities. Entities would send verified 340B drug usage files to this HUB. Registered drug manufacturers could access and use the files to match against rebate requests. We also recommend mandating that Covered Entities submit 340B-eligible dispensing data files to the HUB within 30 calendar days after the date of service.
 
(340B data aggregators exist and can meet this requirement. A 30-day turnaround should accommodate any return-to- stock,  and other similar processes).

• Learn from Hemophilia Treatment Centers How  to Avoid Duplicate Billing

Hemophilia Treatment Centers in California, in collaboration with the state, created a coding system that distinguishes 340B products from non-340B products, making it possible to track product eligibility for pharmaceutical rebates to the state. We recommend that Congress, HHS, and the GAO review and comment on the California HTC system to determine whether a similar system could address or solve Medicaid and pharmaceutical industry concerns regarding duplicate billing.

3. Contract Pharmacy, TPA or PBM: Transparency

The Commission proposes three recommendations:

• 340B Revenue

With respect to 340B revenue, any entity is serving as a contract pharmacy, TPA or PBM should be required to report its fees to a Covered Entity and submit the data (by state) to the  HUB, HRSA, state Medicaid agencies and the Office of the Inspector General at the Department of Health and Human Services. Also, each company’s website should list, by state, its 340B revenue.  It is important for elected officials to understand where the 340B revenue is going, and for what purpose it is being spent.

• Charity Policy

We recommend requiring that all Covered Entities develop enterprise charity care policies for contract pharmacy services, similar to what FQHCs are currently required to do. For example, they could utilize sliding scale fees and report the number of individuals that realized savings as compared to the total number of people eligible to receive benefits. This could be accomplished using a centralized processor.

• Dispensing Fees

We recommend requiring the disclosure of contract dispensing fees and all other fees to HRSA/OPA. Covered Entities would be required to explain whether the contract pharmacies are simply dispensing medications or providing additional services which warrant their fees. We also recommend establishing safe harbor guidelines for the flat fair market value of contract pharmacy dispensing fees, which take into consideration a contract pharmacy’s margin loss, increased the cost of the pharmacy services, and the projected entity cost associated with developing its distribution capabilities.

4. Create a National Database with the Expertise of 340B Software Experts

We recommend that HRSA/OPA and the HHS Office of the Inspector General work with the top five 340B software vendors (Sentry Data Systems, Rx Strategies, PharMedQuest, McKesson, and Cardinal Health) to create a national database to provide for compliance with HRSA/OPA 340B oversight. Such a database would ensure that the Office of the Inspector General at HHS has complete access to all 340B claims by Covered Entities.

• Data Clearinghouse

We recommend establishing a nationwide clearinghouse or retrospective claims identification process to identify and remove 340B claims from Medicaid managed care drug rebate claims. The clearinghouse, which could be developed by the private sector,  could be funded with a user fee on Covered Entities and administered without the involvement of manufacturers.

5. Patient Definition

Advocates of the 340B program have consistently argued that the 1996 definition of who qualifies as a 340B patient should not be changed.  Others argue it is ambiguous, and even the federal agency in charge of the program, Health Resource Services Administration put forth an effort in the Obama Administration recommending a revised definition. But, nothing changed.

Today, many of the uninsured patients who were being cared for by nonprofit hospitals have coverage through Medicaid or ObamaCare. The targeted 340B population has changed over time, but the program has not. While more providers are eligible to participate in the 340B program, with fewer uninsured, many providers are targeting insured patients particularly hospitals that have purchased oncology practices.

While there is little discussion regarding why it is well known that these hospitals are chasing the 340B spread on oncology and infusion medications (the difference between the 340B acquisition price and the price reimbursed by the health plan PBM).

Who qualifies as a 340B patient should be at the root of future discussions to help ensure that those in need have access to care and the lowest possible price on medications. In examining this, it is important to remember the growing income disparities that are impacting working class Americans and the value they receive when receiving care from a Federally Qualified Health Care Center, a Ryan White Clinic or a Hemophilia Treatment Center. Often their incomes may be above the 200 percent of poverty threshold which eliminates them from eligibility for a sliding fee scale for their healthcare services. We believe, when it comes to 340B medications, it is long overdue for Congress to recognize these disparities and increase patient eligibility to 300 percent of the federal poverty level.

While controversial, the stark income realities of our time dictate this.

Over the years, one of the most contentious issues is which patients are eligible for 340B? No single issue has caused greater angst among the advocates and opponents of the 340B program. To date, despite efforts by the Obama Administration to change the “patient definition,” the only definitive definition was issued by HRSA in an October 1996 regulatory final notice.

While organizations are benefitting from the current 340B program advocate for the patient definition to remain the same, others argue that the definition is overly broad and tough to interpret and that it has led to the unsustainable growth of the 340B program.

First, the CANN 340B Commission recommends that the existing HRSA patient definition is left in place with the following modifications: For those patients being discharged from the hospital, the prescriptions given to them as they leave will continue to be considered outpatient prescriptions. This is important in reducing avoidable readmissions by ensuring patients who are discharged have the medicines they need to become healthier. Most importantly, if they cannot afford the medicines, the hospital will use its 340B revenue to cover those expenses.

An alternative would be to use 340B savings to help patients by creating a community-based risk pool in which a portion of net income or “savings” would be placed and managed by a third party to address patient needs. This program could be managed by entities such as a nonprofit PBM, a community-based charity care program, or a patient-based organization, with proper credentials that are approved by pharmaceutical manufacturers and HRSA.

Second, patients referred for infusion therapy must be ongoing patients of the referring Covered Entity. This means that when an FQHC, for example, refers a patient to a hospital-based infusion center or other 340B qualified infusion entity, the link between the patient and the Covered Entity cannot be broken so that the patient retains his or her patient status with the referring Covered Entity.
Further, we recommend the elimination of two Covered Entities both benefiting from 340B for the same patient. In other words, when a patient is referred to another Covered Entity for infusion therapy, the referring Covered Entity will ship the medication with the patient or replenish it using its 340B program. As a result, the second Covered Entity will be paid for their services, but not benefit from the 340B program.

The exception for all of this would be when a patient is referred from an FQHC or other Covered Entity to a 340B eligible hospital, and it is discovered that the patient has an illness that the FQHC had not discovered. For any new outpatient medical treatment provided by the hospital, any medication required for that specific illness would be prescribed by a hospital-based medical provider, and the 340B savings would remain with the hospital. However, if the patient is referred to his or her FQHC or another grantee for disease management, that entity assumes primary responsibility. Furthermore, if meds are provided, the prescribing entity would realize those savings. The savings go to the entity prescribing and delivering the service if the patients’ medical record is housed there.

Third, it is critical in rural America that we create 340B flexibility, recognizing that access to infusion therapy and other 340B-covered services may not be as readily available as it is in other service areas. To address this issue, we encourage Covered Entities in rural areas to explore partnering with Home Health Agencies, Visiting Nurses and other professionals to provide the infusion service without the need for hospital partners. However, should medication be recommended for the patient, only the 340B Covered Entity that holds the patient’s medical record could prescribe.

Conclusion

The 340B program offers eligible nonprofit healthcare providers an opportunity to serve more people.  Closing loopholes using technology to create systemic change is critical. It is also incumbent upon Congress and HHS to challenge the status quo to ensure that the intent of the program is being met.  In doing so, the opportunity exists to redefine whom this program should focus on -- patients or providers? Should the program only serve uninsured patients, those who are under-insured, or all patients?

Hospitals live on a unique 340B island. But why do they live under different rules than other Covered Entities? FQHCs, Ryan White Clinics, ADAPs, and Hemophilia Treatment Centers are required to reinvest 100% of their 340B savings into direct or indirect patient care. Why not require hospitals to do the same?

For the CANN 340B Commission, the status quo is simply not good enough! We look at the 340B program as an integral part of the healthcare safety net. But, the gaping holes in the safety net caused by inconsistent regulations and oversight have stymied the programs ability to serve more people in need. Both the challenge and the opportunity for Congress, the White House and Regulators are to change the status quo or continue to sit on their hands and fingers.

The CANN 340B Commission's final report can be downloaded online.

Jeffrey R. Lewis and William E. Arnold co-chaired the 340B Commission. The views expressed are their own.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

Where the Rubbers Meet the Road on "Ending the HIV Epidemic: A Plan for America"

By: Marcus J. Hopkins, Policy Consultant

In his 2019 State of the Union Address, Donald Trump asked for a bipartisan committee to end the HIV epidemic in the United States within 10 years. Those of us who work in HIV activism and advocacy were (and still are) incredulous, given the Trump Administration’s penchant for undermining virtually every public health initiative.

Photo Source: Business Insider

A mere five months prior to his announcement, the Trump Administration (TA) put the kibosh on HIV cure research because it used fetal tissue donated by women who have legal abortion in an effort to appease faux religious liberty activists (Wadman, 2018).

Also, in 2018, the TA released plans to take $3.8 million from HIV/AIDS programs and $5.8 million from the Ryan White HIV/AIDS Program (Kopan, 2018).

Before that, Trump “fired” the reaming members of the Presidential HIV/AIDS Council (formed in 1995 by President Bill Clinton) after six members quit the council in June 2017 in response to TA’s removal of the Office of National AIDS Policy website and Trump’s failure to appoint anyone to lead the White House Office of National AIDS Policy (Thomsen, 2017).

The announcement by Trump that his administration suddenly cares about ending HIV/AIDS came as a surprise to virtually everyone amid continually piling evidence to the contrary. There has been little evidence to support the idea that the TA is concerned with much of anything other than furthering initiatives that, in virtually every other administration, would have resulted in immediate reprisal from Congress.

So, what, really, is the TA’s grand plan to elimination HIV/AIDS by 2030? Health and Human Services (HHS) Secretary, Alex Azar, revealed their proposal, “Ending the HIV Epidemic: A Plan for America,” on February 7th, 2019 (HHS, 2019):

The plan has two primary goals: 1.) Reduce new HIV infections by 75% within five years; 2.) Reduce new HIV infections by 90% within ten years.

These goals will purportedly be reached using three major areas of action: 1.) Increasing investments in geographic hotspots through our existing, effective programs, such as the Ryan White HIV/AIDS Program, as well as a new program through community health centers that will provide medicine to protect persons at highest risk from getting HIV; 2.) Using data to identify where HIV is spreading most rapidly and guide decision-making to address prevention, care and treatment needs at the local level; 3.) Providing funds for the creation of a local HIV HealthForce in these targeted areas to expand HIV prevention and treatment (HHS).

They plan to focus these efforts on 48 high-burden counties, Washington, DC, San Juan, Puerto Rico, and 7 states with a substantial rural burden. How, you may ask? Well, they have four key strategies: Diagnose, Treat, Protect, and Respond – diagnose early, treat rapidly and effectively, protect uninfected populations, and respond rapidly to detect and respond to emerging HIV clusters to prevent new infections.

If this plan seems overly ambitious, it’s because it is.

Realistically speaking, adequately attacking the HIV/AIDS epidemic in the U.S. with the goal of ending it within 10 years is entirely possible…if we’re willing to pony up the resources required to realize that goal. Facts are facts: ending any epidemic is going to be costly, and the Feeral Fiscal Year (FY) 2019 budget for HIV of $34.8 billion dollars isn’t going to come anywhere near close to achieving this goal.

Why? Two words: “Rural America.”

At the beginning of the AIDS epidemic in the 1980s, people who lived in rural parts of the country felt “safe” from HIV/AIDS, because it “…only affected those big city queers.” This thinking dwelled in a peculiar place in the American psyche that believed that Americans largely remained in one place for their entire lives. And then, the 1950s happened…and the 60s, and 70s. As automobiles because more affordable, more Americans left their hometowns and relocated around the country to seek better opportunities and lives. Younger generations were moving out of the hills and hallows of their youths and into…why, they could just go anywhere! With this freedom of movement came certain costs – namely, the spread of infectious diseases.

Travel has always been the enemy of contagion containment, from the earliest days of commerce and conquest when trader ships brought to Europe the deadliest plagues Earth had to offer. So, too, was the case with HIV/AIDS. The idea that a sexually transmitted disease could be contained to metropolitan areas was a quaint notion. People travel to cities; people often have sex in cities (hell, there’s a whole cable series dedicated to the topic); people come back home and bring with them any STDs/STIs they might have picked up and spread them within their local communities.

What has not consistently been the case is that easy access to travel will mean that services will reach the same rural and/or remote places as those diseases. With America’s for-profit healthcare model, healthcare providers must generate a profit in order to remain open; statistically speaking, it is highly unlikely that those providers are going to opt to open locations in the very small towns where services are most needed, because the demand either doesn’t exist, or the residents can’t afford it.

Photo Source: Gina Ferazzi / Los Angeles Times via Getty Images file

Geographic barriers to care are an immense problem for a variety of reasons:

1. Remote parts of the country are not always easily accessible throughout the year – snowfall, flooding, and even seasonal road conditions severely limit both patients’ and providers’ abilities to access and/or provide care;
2. Telemedicine services are extremely limited in many of these rural areas, because high-speed Internet services and cell phone services are either severely limited or nonexistent – it takes a lot of money to fund expanding high-speed Internet access to rural areas;
3. Distances to and from healthcare service provision can prove insurmountable for many rural Americans – it’s too costly to travel by vehicle due to gas prices and vehicle maintenance; little to no public transportation exists to take people to and from appointments; a trip to the doctor can consume literally an entire day, which means lost hours at work that cannot easily be recovered.

I know these things because I have personally experienced them. I’ve moved 43 times in my 37 years on this earth and have had HIV services in four different states – Florida, Tennessee, California, and West Virginia. Only in Ft. Lauderdale, FL was it easy for me to get to and from doctor’s appointments without spending entire days. In Tennessee, it took me literally weeks to even find out basic information about the state’s Ryan White program (which did not, in 2008, have a website). In California, though I lived in Long Beach, the nearest location where I could be treated was in Torrance, CA – a mere 15.1 miles on a map, but an hour or longer drive, each way, to get to and from appointments that would last entire days.

This brings me to my current state – West Virginia. In West Virginia, I luckily live close to one of the two Ryan White HIV/AIDS Program Medical Provider clinics. That’s right – there are only two Ryan White clinics in the state of West Virginia – one in Charleston, and one in Morgantown. By Interstate travel, these two cities are 156 miles apart, meaning that everyone in the middle and on the outskirts of the state – where Interstate travel is not always available or easy to access – may end up spending hours driving to and from appointments.

Another client at the WVU Positive Health Clinic in Morgantown, WV drives two hours each way to get to his doctor’s appointments, each of which can last up to three or four hours. For him, this means up to an eight-hour day solely dedicated to accessing HIV care and treatment, traveling along poorly maintained state routes and country roads. Luckily, he has progress well enough in his treatment to be on six-month visits, but realistically, each of these trips is a hassle. If he is sick, injured, or otherwise unable to travel, that means a missed appointment with a long waiting period before he can be seen, again.

These anecdotal evidences aren’t just true for West Virginia, but for the majority of the country. All around the U.S., patients living with HIV in rural areas spend entire days just going to their HIV doctor. And this is the crux of the problem for not only the Trump Administration, but any future administration: in order to truly eliminate HIV/AIDS in the U.S. by 2030, it’s going to require a massive increase in financial and human resources to tackle reaching rural America.

Part of the TA’s proposal focuses on states that already have high rates of HIV transmission in rural areas – Alabama, Arkansas, Kentucky, Mississippi, Missouri, Oklahoma, and South Carolina. These states do have high burdens of rural transmission, with 10% or more of new infections occurring in rural areas. What the current plan fails to take into account, in my opinion, is the growing risk of infection via Injection Drug Use (IDU).

IDU is already contributing to high rates of Hepatitis C (HCV) infections in places like West Virginia. In 2015, the rate of new HCV infections was 3.4 (per 100,000); in 2016, that rate increased to 5.1; in 2017, the rate increased, again, to 9.1 (WV Department of Health and Human Resources, 2018). A majority of the Hepatitis B (HBV) and HCV cases in WV reported IDU or street drug use as the primary risk of infection.

It’s not a big leap to assume that, as was the case in Scott County, Indiana, IDU will lead to increased transmission of HIV in state with a high incidence of IDU. This means that there will need to be significant increases in intervention funding in rural states, not just in the small metropolitan cities like Charleston and West Virginia, but in areas that are less easily accessible. Those interventions come neither cheaply, nor without significant public opposition.

Frankly, I don’t believe that the current administration is either willing or able to pony up the kind of cash that will be required to fund the types of interventions needed to achieve their goal. We’re not just talking about reaching rural areas, although that’s the largest roadblock; we’re talking about hiring and training thousands of new personnel, paying for treatment for lower- and middle-income individuals who cannot afford the high price of HIV Anti-Retroviral (ARV) medications, covering transportation costs for both patients and medical personnel, purchasing testing supplies, paying for confirmatory testing and blood work (the latter of which can run into the thousands-of-dollars per patient), hiring, training, and deployment case workers to ensure medication/treatment/physician adherence. The list of things that are going to be required in order to accomplish this goal is so long and so costly, that I doubt it can feasibly be accomplished.

I’m going to be pegged as a naysayer; as a cynic. In realistic terms, what we’ve seen over the past thirty years is that, on average, they type of funding that is necessary to successfully deploy this kind of ambitious plan hasn’t been put on the table for decades. Within the HIV activist/advocacy community, we have been all but terrified to reopen the Ryan White program to reauthorization, out of fear that a Republican legislature will gut the funding down to the bare bones. And honestly, that’s not a fear that is without precedent. Outside of Defense spending, Republicans, on the whole, have been loath to increase funding for anything else without drastic spending cuts elsewhere – a strategy that is both shortsighted and destructive to public health initiatives.

I’ve attended numerous conferences where statements like the following have been made:

“The primary job of big HIV organizations is to ensure that we don’t lose any of the $35 billion dollars in funding that we have.”

This quote (which is a direct quote from an Atlanta area activist/advocate) is terrifying, because it not only indicates that there is fear amongst organizations that those funds will be cut, but that we cannot – and should not – be vocal about our needs. If we make too many waves or too much noise, we risk losing funding. As a result, we cannot be ambitious or innovative in tackling the rural HIV crises we face, because to do so will risk the funds we’re already using to address the underserved needs of people in urban areas.

So, yes – when it comes to the Trump Administration’s grand plans for HIV prevention, I am skeptical that they will succeed. They haven’t even tried to produce enough staff members to work on their own initiatives; what would lead us to think that they would do so to address a problem as widespread as HIV?

References:

• Health and Human Services. (2019, February 07). What is ‘Ending the HIV Epidemic: A Plan for America’?. Washington, DC: United States Department of Health and Human Services: HIV.gov: Office of HIV/AIDS and Infectious Disease Policy: Federal Response. Retrieved from: https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview
• Kopan, T. (2018, September 20). Trump admin moves $260M from cancer research, HIV/AIDS and other programs to cover custody of immigrant children costs. Atlanta, GA: CNN: Politics. Retrieved from: https://www.cnn.com/2018/09/20/politics/hhs-shifting-money-cancer-aids-immigrant-children/index.html
• Thomsen, J. (2017, June 17). Six resign from presidential HIV/AIDS council because Trump 'doesn't care'. Washginton DC: The Hill: Healthcare. Retrieved from: https://thehill.com/news-by-subject/healthcare/338296-six-resign-from-presidential-hiv-aids-council-because-trump-doesnt
• Wadman, M. (2019, December 13). Updated: NIH says cancer study also hit by fetal tissue ban. Science. Washington, DC: American Association for the Advancement of Science: Science: News. Retrieved from: https://www.sciencemag.org/news/2018/12/trump-administration-has-quietly-barred-nih-scientists-acquiring-fetal-tissue
• West Virginia Department of Health and Human Resources. (2018, July 01). Acute Hepatitis C Incidence Rate, 2007-2017. Charleston, WV: West Virginia Department of Health and Human Resources: Bureau for Public Health. Retrieved from: https://oeps.wv.gov/HCV/documents/data/acute_hcv_chart.pdf

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.

How Americans could unknowingly end up taking black market drugs

By: Brandon M. Macsata, CEO, ADAP Advocacy Association

Senators Chuck Grassley (R-IA) and Amy Klobuchar (D-MN) recently introduced a bill that would permit Americans to import pharmaceuticals from Canada. The two lawmakers believe their bill will reduce drug costs.[1] But their effort begs the question: at what cost?

The bill would instead expose patients to potentially dangerous counterfeit drugs. Lawmakers would be wise to vote against it.

Photo Source: impactlab.net

Americans currently have the safest pharmaceutical supply chain in the world. In large part, that's thanks to the Food and Drug Administration, which strictly supervises the manufacturing and transport of medicines. About 60 percent of our drugs are manufactured at high-tech, ultra-safe facilities right here in the United States.[2] The remainder are made in foreign factories but shipped into the United States through trusted vendors, who never allow the medicines to leave their control.

Sens. Grassley and Klobuchar's bill would allow people to purchase drugs that didn't go through this tightly controlled supply chain. That's worrying. No matter its rigorous safety precautions at home, the FDA can't vouch for the safety and efficacy of foreign-made and supervised drugs. That’s a pretty high price to pay for cheaper drugs.

This is particularly concerning when it comes to drugs coming in from Canadian pharmacies, which often resell drugs imported from India, Turkey, and other countries with subpar safety standards.[3][4]  In fact, one FDA investigation found that 85 percent of packages imported to the United States from online Canadian pharmacies contained potentially counterfeit drugs.[5] One in 10 drugs from low and middle-income countries is fake or substandard, according to the World Health Organization.[6] Some are laced with deadly ingredients, like boric acid and fentanyl.[7]

I've experienced firsthand the dangers of foreign drug imports. I was diagnosed with HIV just shy of my 30th birthday.[8] That day, I found out I was destined to undergo antiretroviral therapy for the rest of my life.[9]

But when my out-of-pocket costs hit $1,300 in just my second month of treatment, I started looking for a cheaper option. I began ordering my medicine from an online pharmacy in Canada.[10]

It never crossed my mind that I might have been taking counterfeit medicine, or that the medicines meant to control my HIV could be compromising my immune system. So when my doctor found out, she told me to stop immediately. She warned me that online pharmacies often sell counterfeit drugs.

Government officials have long opposed importation policies for the same reason.

Photo Source: The Partnership for Safe Medicines

Former FBI Director Louis J. Freeh warns that "importation proposals would do nothing but shift the costs and burden to law enforcement and open up the U.S. drug supply to adulterated and counterfeit drugs."[11]

Former FDA associate commissioner Peter Pitts, meanwhile, opposes the Grassley-Klobuchar proposal for the same reason. He adds that the bill "could endanger American lives by opening the floodgates to harmful counterfeit drugs."[12]

Four other past FDA commissioners penned a letter to Congress explaining that importation would "harm patients" and "compromise" the United States' "carefully constructed system."[13]

And former HHS Secretary Mike Leavitt echoed similar concerns, writing that, while in office, it was "impossible… to certify that importation of medicines from unregulated sellers is safe."[14]

They're all right.

For nearly two decades, liberal and conservative officials have warned against the dangers of drug importation. Not a single FDA commissioner or HHS secretary has been able to verify that it's safe.  Let's listen to the experts -- importation is not a risk worth taking.

This opinion piece was also published in the March 6th edition of the Times of Northwest Indiana.

__________
[1] https://www.grassley.senate.gov/news/news-releases/grassley-klobuchar-introduce-legislation-permit-personal-importation-rx-drugs 
[2] https://www.consumerreports.org/cro/news/2014/04/are-generic-drugs-made-in-india-safe/index.htm:  "About 40 percent of the medications Americans use everyday are made outside the U.S."
[3] https://www.safemedicines.org/2015/10/5-secrets-canadian-pharmacies-dont-want-you-to-know.html 
[4] http://www.safemedicines.org/wp-content/uploads/FDA-Operation-Reveals-Many-Drugs-Promoted-as-_Canadian_-Products-Really-Originate-From-Other-Countries-captured-January-2017.pdf 
[5] https://www.hivplusmag.com/treatment/2016/7/01/how-avoid-black-market-hiv-drugs 
[6] https://www.reuters.com/article/us-pharmaceuticals-fakes/tens-of-thousands-dying-from-30-billion-fake-drugs-trade-who-says-idUSKBN1DS1XJ 
[7] https://www.safemedicines.org/2015/11/poisons.html 
[8] https://www.washingtonblade.com/2017/08/11/opinion-buying-medicines-online/ 
[9] https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/21/51/hiv-treatment--the-basics 
[10] https://www.washingtonblade.com/2017/08/11/opinion-buying-medicines-online/ 

[11] https://storage.googleapis.com/m1738/20170605_Report%20on%20Counterfeit%20Drugs.pdf (page 5)

[12] https://www.safemedicines.org/2019/01/importation-is-too-risky-warns-former-fda-associate-commissioner.html and https://thehill.com/opinion/healthcare/426615-proposed-drug-importation-bill-would-expose-americans-to-counterfeit-meds

[13] https://www.washingtonpost.com/news/to-your-health/wp/2017/03/17/four-former-fda-commissioners-denounce-drug-importation-citing-dangers-to-consumers/?utm_term=.c21f7b053dab 

[14] https://morningconsult.com/opinions/drug-importation-flawed-policy/ 

[15] https://www.safemedicines.org/2018/07/who-opposes-drug-importation-every-head-of-the-fda-and-hhs-since-2000.html 

Reflections from an HIV Advocate's Journey: LaWanda N. Wilkerson

By: LaWanda N. Wilkerson, Advocate

My journey as an HIV advocate started in April 2015, when I received a telephone message from my doctor’s office asking me to call them back. Thinking nothing about the message because I had been to the doctor earlier that week, I believed that they had call in a prescription for another sinus infection (I could not have been so wrong in my life). I called the doctor's office and the nurse put me on hold to get the doctor. No big deal, right?

The doctor gets on the phone and says, “Miss Wilkerson, your test came back and you are HIV positive." In that moment, it felt like the air in my lungs was released from me. As the doctor continued to talk in a very cold voice without any compassion, letting me know that they had referred me to a clinic that specialized in infectious diseases and then hung up the phone. Still sitting in my rocking chair in my classroom for what seemed like hours but in reality only had been fifteen minutes (yes, you guest it I was still at work), I went through several emotions. Anger! Guilt! Pain!

The biggest thing for me was not knowing if I would live or die. How would this diagnosis impact my life? No compassion or comfort was given to me on the phone call with the doctor, so I was left to merely speculate.

So many questions raced through my head. How do I tell my family? How do I tell my daughter that her mom is HIV-positive? How could I have let this happen?

My appointment at Warren Vance Community went better than I expected, mostly because I received the compassion and the reassurance that everything would be okay. I still had my whole life ahead of me! Not only did I receive excellent care, but I was gifted a second family from fellow advocates.

Later that year, my case manager at the clinic helped me get a scholarship to go to AIDS WATCH.  Little did I know that this conference would connect me with fellow compassionate advocates right here in North Carolina, and it would jumpstart my advocacy journey. It connected me with Wanda Brendle Moss (my guardian angel and mentor). Wanda was the hand that touched my back and said, "You are safe here and it's okay to share your story about finding out my status over the telephone instead of begin called into the doctor’s office."

Lee Storrow with the North Carolina AIDS Action Network (NCAAN) also encouraged me to share my story during our legislative visits. As I sat in Senator Richard Burr’s office, I shared my story with complete strangers and I once again felt that anger, guilt, and pain. Yet by sharing my story it melted away those negative feelings and it empowered me not to be a victim. It was my first step to use my voice, affecting change on how people...especially women living with HIV...are viewed in the community.

After AIDS WATCH, Wanda took me under her wings as my advocacy mentor and she helped me to stop being a victim. My first mission as a new advocate was to write a blog about my experience at AIDS WATCH for NCAAN.

Next, Wanda connected me with the The Well Project as a blogger for their “A Girl Like Me” and as an independent contractor for their Building With Hope project. The Well Project has helped me to help others like me by sharing my story, including how I was told about my status, as well as my day-to-day struggles.

In 2016, I was introduced to the ADAP Advocacy Association's Annual AIDS Drug Assistance Program Conference, which I attended on a scholarship. I was honored to have attended this amazing advocacy event in Washington, DC each of the following two years in 2017 and 2018. And now, I've been asked by the organization to serve as a co-vice-chair of their ADAP Consumer Advisory Council.

Now, I am a long way from begin a victim because I use my voice to represent others who cannot speak publicly about their HIV-positive status. I serve on the board at the health center where I receive care as a way to give back to the people who have helped me. I have learned that my imperfections are what makes me an advocate. While I was a very quiet and shy person, I have learned how to open up to others and share my story and my experiences. It reassures others like me to know that they are not alone.

In my advocacy work, I have become a more confident woman. I found my voice to help make change happen in my community. I've learned to educate people about HIV/AIDS, but also about stigma, criminalization, healthcare, and our life-saving medication. I still consider myself a newbie, but my passion for learning is still helping me to advocate for others like me.

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.