Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

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

In May 2018, drug pricing took center stage as the U.S. Department of Health & Human Services released its proposed Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. It what has been characterized as "a way forward in fight against mushrooming costs,"[1] HHS has set the stage for an extremely important debate...and likely the most contentious battle on health policy since passage of the Affordable Care Act.

Photo Source: NBC WPSD-6

According to the Notice published in the Federal Register, HHS' blueprint covers multiple areas including, but not limited to:[2]

• Improving competition and ending the gaming of the regulatory process,
• supporting better negotiation of drug discounts in government-funded insurance programs,
• creating incentives for pharmaceutical companies to lower list prices, and,
• reducing out-of-pocket spending for patients at the pharmacy and other sites of care.

Comments on the blueprint were due on or before July 16, 2018.

The ADAP Advocacy Association endorsed two coalition letters submitted to HHS.

One letter, spearheaded by the Patient Access Network Foundation (PAN), "cautions against HHS undertaking policy changes without evidence-based research. HHS must be confident that any changes it makes will have the intended positive impact on individuals and families, with no unintended consequences that could harm patients and make prescription drugs less affordable and accessible."[3] PAN's letter was signed by 52 patient advocacy organizations, representing millions of patients with serious, life-threatening, chronic, complex and disabling conditions.

The other letter was a collaborative effort led by the HIV Health Care Access Working Group (HHCAWG), which represents over 100 national and community-based HIV service organizations representing HIV medical providers, public health professionals, advocates, and people living with HIV who are all committed to ensuring access to critical HIV- and Hepatitis C-related health care and support services.

We have compiled a listing of the comments submitted by some other organizations, which are available to download here:

• AIDS United
• American Academy of HIV Medicine (AAHIVM)
• Biotechnology Innovation Organization (BIO)
• HIV Health Care Access Working Group (HHCAWG)
• National Alliance of State & Territorial AIDS Directors (NASTAD)
• Patient Access Network Foundation (PAN)
• Pharmaceutical Care Management Association (PCMA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Southern AIDS Coalition (SAC) 
• Southern HIV/AIDS Strategy Initiative (SASI)
• The 340B Coalition
• Treatment Action Group (TAG)
• 340B Health

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[1] Aronson, Lauren (2018, July 13). Blueprint to Lower Drug Prices could offer a way forward in fight against mushrooming costs. The Hill. Retrieved online at http://thehill.com/blogs/congress-blog/healthcare/396883-blueprint-to-lower-drug-prices-could-offer-a-way-forward-in.
[2] A Notice by the Health and Human Services Department (2018, May 16). HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Retrieved online at https://www.federalregister.gov/documents/2018/05/16/2018-10435/hhs-blueprint-to-lower-drug-prices-and-reduce-out-of-pocket-costs.
[3] Naples, Maggie (2018, July 17). National Patient Advocacy Organizations Come Together to Respond to the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket (OOP) Costs. Patient Access Network Foundation. Retrieved online at https://panfoundation.org/index.php/en/about-us/media-room/national-patient-advocacy-organizations-come-together-to-respond-to-the-hhs-blueprint-to-lower-drug-prices-and-reduce-out-of-pocket-oop-costs.

UPDATE: Hey Trump! Hands Off Our Ryan White HIV/AIDS Program!

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

The ADAP Blog last week addressed troubling news that the U.S. Department of Health & Human Services ("HHS") planned to divert funds from existing programs to pay for the rising cost associated with the Trump Administration's controversial "zero-tolerance" immigration policy. This statement was indeed true (as fact checked by Snopes),[1] though fortunately the impact is debatable since none of the diverted funding came from the current year's program. What it did accomplish was to ignite a firestorm among many in the HIV grassroots community.

The good news, especially for the HIV grassroots community, is none of the transferred funding will impact Ryan White-funded supports or services to people living with HIV/AIDS for the current program year. The transfer included expired Ryan White funds from FY 2016, which hadn't been spent and was due to be returned to the U.S. Treasury. Basically the news is still bad, but not nearly as bad as initially thought.

Though news about HHS transferring funds only broke last week by Slate, it has subsequently been determined that the transfer request was made in January 2017. As reported by POLITICO, nearly $200 million in funds were moved to address the refugee crisis, including "at least $17 million in unspent funds on the Ryan White HIV/AIDS program."[1]

Emily Holubowich, executive director of the Coalition for Health Funding, raised an excellent point in the POLITICO article when she argued, "If there’s leftover money from Ryan White, it should go to support programs for poor people with HIV and AIDS, not this outrageous separation policy."[3]

This point is exactly why the flames are still burning among many grassroots activists at the state and local levels. It begs the question, couldn't those Ryan White dollars have been used to expand drug formularies under the AIDS Drug Assistance Programs ("ADAP") to pay for anti-diarrhea medications, or Hepatitis C ("HCV") therapies for people co-infected with HCV, or lipodystrophy treatments? These concerns were spelled out in a blog earlier this year.

Photo Source: NY Magazine

Furthermore, at what point does the HIV community draw a red line with the Trump Administration and its Family-Research Council ("FRC") cronies known for their anti-immigrant, racist, homophobic, and misogynistic views? This Administration has been attacking people living with HIV/AIDS for the last eighteen months by proposing harsh federal budgets; demonstrating a flagrant disregard for the public health system; ignoring key leadership posts; sanctioning discrimination by healthcare workers; undermining the Patient Protection and Affordable Care Act, and most recently deleting 20 years of critical medical guidelines. Make no mistake...Trump and the FRC have brought the fight to people living with HIV/AIDS.

Overall the Ryan White program, in general, and ADAPs, specifically, are extremely well-run programs. This is a message that the community should embrace, and not run away from out of fear. The best defense is a good offense!

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[1] Garcia, Arturo (2018, July 13). Are Federal HIV Treatment Funds Being Used for Immigrant Internment? Snopes. Retrieved from: https://www.snopes.com/fact-check/hiv-treatment-funds-immigrants/.
[2] Diamond, Dan (2018, July 18). Trump’s migrant fiasco diverts millions from health programs. POLITICO. Retrieved from: https://www.politico.com/story/2018/07/18/trump-migrants-health-programs-692955.
[3] Diamond, Dan (2018, July 18). Trump’s migrant fiasco diverts millions from health programs. POLITICO. Retrieved from: https://www.politico.com/story/2018/07/18/trump-migrants-health-programs-692955.

Hey Trump! Hands Off Our Ryan White HIV/AIDS Program!

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

Earlier this week, Slate reported that the U.S. Department of Health & Human Services ("HHS") planned to divert funds from existing programs to pay for the rising cost associated with the Trump Administration's controversial "zero-tolerance" immigration policy. The policy, which separates children from their families on the southern border, is overseen by the HHS Office of Refugee Resettlement, and it is burning through so much cash that it needs more. In the crossfire is millions of dollars in funding designated for HIV/AIDS services under the Ryan White CARE Act.[1]

According to the reporting by Slate, HHS is planning for a surge in immigrant minors over the next three months:[2]

"The internal documents estimate that if 25,400 beds are needed, ORR would face a budget shortfall of $585 million for ORR in fiscal year 2018, which ends on Sept. 30. Under this scenario, that shortfall would increase to $1.3 billion in the first quarter of fiscal year 2019, adding up to a total shortfall of $1.9 billion for the period between Oct. 1, 2017, and Dec. 31, 2018. The documents stress that these budget estimates represent maximum possible expenditures and that actual expenses may be lower. The Department of Health and Human Services did not respond to multiple requests for comment about these figures or anything else relating to the documents."

In order to offset the budgetary shortfall, HHS will seek supplemental appropriations from Congress, as well as reallocate existing funds from within the department — including Ryan White funding. Slate's reporting also indicates the process of transferring those HIV/AIDS funds is underway.

The ADAP Advocacy Association has strongly condemned this decision. In an era when people living with HIV/AIDS are already facing enough uncertainty over the current government's commitment to fighting the epidemic, it was the latest setback to achieving an AIDS-free generation.

The pushback from a leading national patient advocacy group was swift when news broke that the Trump Administration would use Ryan White HIV/AIDS program dollars to fund its widely unpopular family separation policy at the southern border. AIDS United CEO Jesse Milan, Jr. issued a strongly-worded statement on the funding reallocation:[2]

"As a payer of last resort, the Ryan White Program covers services for people that have no other means to pay for them. Any shortages in funding to the program would result in essential services not provided to potentially thousands of Americans. This could mean people not receiving life-saving medications or losing insurance coverage because funding was not available to cover their premiums. For an administration that just recently proclaimed its commitment to ending the HIV epidemic in this country, stripping funding from the largest HIV-specific federal program defies all logic."

The fact that the money being diverted is "unspent" money makes no difference to people living with HIV/AIDS who rely on Ryan White-related supports and services. There are always creative ways to spend or transfer federal money within an agency's budget,[4] because it happens all of the time. And considering there are ongoing challenges facing ADAP consumers limiting their access to care, such as restrictive drug formularies, that money should be spent on people living with HIV/AIDS. (Editor's Note: Read our previous blog on open drug formularies, "ADAP Open Drug Formulary Programs Improve Access to Care & Treatment; So why are there so few?")

Numerous national LGBTQ groups also condemned the news, including Lambda Legal and Human Rights Campaign. It appears that this development is fluid, and we will continue to closely monitor it.

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[1] Stern, Mark Joseph. (2018, July 10). Trump’s Office of Refugee Resettlement Is Budgeting for a Surge in Child Separations. Slate. Retrieved from: https://slate.com/news-and-politics/2018/07/trumps-office-of-refugee-resettlement-is-budgeting-for-a-surge-in-child-separations.html
[2] Stern, Mark Joseph. (2018, July 10). Trump’s Office of Refugee Resettlement Is Budgeting for a Surge in Child Separations. Slate. Retrieved from: https://slate.com/news-and-politics/2018/07/trumps-office-of-refugee-resettlement-is-budgeting-for-a-surge-in-child-separations.html
[3] Milan, Jr., Jesse. (2018, July 10). AIDS UNITED STATEMENT ON TRUMP ADMINISTRATION PLANS TO REALLOCATE RYAN WHITE FUNDING FOR CHILD SEPARATION TIED TO ZERO TOLERANCE BORDER POLICY. AIDS United. Retrieved from: https://www.aidsunited.org/News/Default.aspx?id=1197
[4] EveryCRSReport.com (2013, June 6). Transfer and Reprogramming of Appropriations: An Overview of Authorities, Limitations, and Procedures. R43098. Retrieved from https://www.everycrsreport.com/reports/R43098.html.

Linkages to Care During Post-Incarceration

By: Jonathan J. Pena, intern, ADAP Advocacy Association, and rising junior in social work, North Carolina State University

The ADAP Advocacy Association late last year announced its Correctional Health Project, which aims to raise awareness about issues confronting formerly incarcerated populations living with HIV/AIDS (and/or Hepatitis C) who also access care and treatment (or whom could benefit from such care and treatment) under the AIDS Drug Assistance Program ("ADAP"), as well as provide useful resources and tools to the communities serving them. A subsequent blog also focused on the issue. While this approach is an effort to sharpen the scope and need for access to care and treatment for HIV-infection (and/or HCV) among formally incarcerated populations, it is equally important to widen to the lens just for a minute in order to see where we stand globally on the issue of incarceration.

Incarceration rates are highest in the United States out of any country, which translates to 910 per 100,000 adults.[1] When you factor in the 1.2 million people living with HIV in the U.S, a sixth of this population are entering prisons and jails and also transitioning back into their communities.[2] This sets the stage for an enormous request to address the needs of these populations so that the public health system may begin to seal the cracks that they fall through by utilizing accurate assessments and combining it with proactive case management in order to link them to care.

Programs do exist, such as State ADAPs, which are designed to assist these individuals. But the most recent National ADAP Monitoring Project demonstrates that ADAPs are assisting some of these individuals, it is also clear more can be done to assist them. The National AIDS Strategy also provides some guidance to help formerly incarcerated populations achieve viral suppression.

Viral suppression is crucial for HIV-positive ex-offenders during post-incarceration but the challenges that they face can seem monstrous and when faced with so many immediate competing needs like housing, food and transportation, continuity of viral suppression may fall by the waste side. Very often the linkage to care is lost for these populations due to poor discharge planning and thus limited access to quality based community programs. As a result the natural onset of vulnerability that is placed on an HIV-positive ex-offender is amplified when re-entering their communities that the possibility for them to engage in risky behavior like drug use, and transactional unprotect sex to maintain goods increases. These negative affects of poor discharge planning not only hurts the ex-offender but also hurts those within their community with other possible new cases of infection if they are not adherent to their medication.

Photo Source: SERO

Download SERO's "Staying Strong Inside"

Jails and prison systems are such dynamic institutions that they face additional compounding challenges to providing heath services other than HIV. With such a revolving door, these institutions have to tackle issues like addiction and mental illness. However, what seems to be alarming is the rate of HCV infections. A team of researchers at the National Drug and Alcohol Research Centre at the University of New South Wales in Sydney pooled together a series of data from 196 countries spanning from 2005 through 2015 that aimed at determining the number of inmates with HIV, hepatitis B virus, hepatitis C virus, and TB. This data indicated that out of 10 million inmates, HCV ranked at the top with 15.1% of infections and with HIV estimated at 3.8% of infections.[3]

As the ADAP Advocacy Association's Correctional Health Project continues to take shape, it is important to convey some of the needs driving our interest behind it. Important community resources will be made available in a few months.

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[1]  The Lancet HIV. (2017, November 27). Predictors of linkage to HIV care and  suppression after release from jails and prison: a retrospective cohort study. Retrieved from: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(17)30209-6/fulltext?code=lancet-site
[2] The Lancet HIV. (2017, November 27). Predictors of linkage to HIV care and  suppression after release from jails and prison: a retrospective cohort study. Retrieved from: https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(17)30209-6/fulltext?code=lancet-site
[3] HIVandHepatitis. (2016, September 07). AIDS 2016: Neglect of Infectious Disease in Prisons Highlighted at Conference. Retrieved from: http://www.hivandhepatitis.com/hiv-epidemiology/5845-aids-2016-neglect-of-infectious-disease-in-prisons-highlighted-at-conference

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.