Thursday, June 22, 2017

Summer is Hot, but the Debate Over Drug Pricing could be even Hotter

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

Temperatures across the United States are sizzling with the arrival of summer, but they could pale in comparison to the emerging debate over the rising cost of prescription drugs. A state ballot initiative, coupled with a rumored presidential executive order and pending federal legislation in Congress are setting the stage for a heated battle over drug pricing.

In Ohio, voters are already being inundated with 30-second political attack ads from both sides of the debate. One advocate in the state has said, "Every commercial break is flooded with them... and it is only summer." The "Ohio Drug Price Relief Act" will take center stage before the voters in November 2017, with spending on political ads expected to break all previous records for any statewide ballot initiative.

The ballot initiative would "require the state of Ohio to pay no more for prescription drugs than the U.S. Department of Veterans Affairs (VA), which has negotiated a discount of up to 40 percent."[1] It is supported by the Ohio Taxpayers for Lower Drug Prices, and it is opposed by the Ohioans Against the Deceptive Rx Ballot Issue. Veterans groups have also lined up against the ballot initiative.

According to Ballotpedia, a "yes" vote supports the measure to require state agencies and programs to purchase prescription drugs at prices no higher than what the VA pays for them, and a "no" vote opposes the measure to require state agencies and programs to purchase prescription drugs at prices no higher than what the VA pays for them.[2]

"I would assume that the happiest people in Ohio today are the people who are selling television commercials. The pharmaceutical industry will spend whatever they believe they need to spend to try to confuse and mislead the public," summarized Rick Taylor, a consultant for the Ohio Taxpayers for Lower Drug Prices.[3] Here is a political ad airing in support of the ballot initiative:

TV commercial linked to https://youtu.be/HlubsZisoVQ
Source: Ohio Taxpayers for Lower Drug Prices

Curt Steiner, campaign manager for the Ohioans Against the Deceptive Rx Ballot Issue, argued, “Experts who have studied the proposal — including three former Ohio Medicaid Directors and a former state Budget Director — say it’s not only unworkable, but could actually increase prescription drug costs for the majority of Ohioans and reduce patient access to needed medications.”[4] Here is a political ad running against the ballot initiative:


Source: Ohioans Against the Deceptive Rx Ballot Issue

With the ballot initiative over four months away, voters in Ohio might simply turn off their televisions rather than contend with the forthcoming onslaught of these negative ads. There has been no public polling released on the issue in Ohio (...yet), but a similar ballot initiative failed last November in California.

In the meantime, news reports are floating that President Donald J. Trump plans to issue an executive order on drug pricing, though the timeline remains unclear. A draft version of the executive order, which was obtained by The New York Times, appears to give into demands by the pharmaceutical industry and rolls back numerous regulations.[5]



Some had hoped for rebates in Medicare Part D that would be similar to Medicaid,[6] but they appear absent from the draft obtained by The New York Times. Such a move would have greatly benefited consumers. It hard to see how the draft executive order would assist consumers, or public payors — such as State AIDS Drug Assistance Programs.

The measure is already being met with skepticism, especially because it appears to roll-back discounts authorized under the 340B Drug Discount Program. Dr. Joshua M. Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health, summarized this concern by saying, “That’s one that sticks out as a bit of a head scratcher. This is the executive order to lower drug prices — why would you put in a provision that would raise drug prices?[7]

Speaking for many in the patient advocacy community, Eddie Hamilton with the ADAP Educational Initiative questioned, "We don’t have any further information on this proposed draft, but it does raise some concerns. It appears to target 340B and the hospitals are, of course, screaming but we can’t verify that our community will be spared."

Congress isn't absent from the debate over drug pricing. In fact, a recent article in Roll Call spelled out the enormous pressure faced by lawmakers to do something on lowering the cost of prescription drugs. Presently, 802 bills addressing drug pricing have been introduced in Congress since the beginning of the year. Among them are the following:
  • S.1369 - A bill to amend the Internal Revenue Code of 1986 to establish an excise tax on certain prescription drugs which have been subject to a price spike, and for other purposes. (Note: H.R.2974 is the companion legislation before the House of Representatives)
  • S.1131 - Fair Accountability and Innovative Research Drug Pricing Act, which is a bill to require reporting regarding certain drug price increases, and for other purposes. (Note: H.R.2439 is the companion legislation before the House of Representatives)
  • H.R.1316 - Prescription Drug Price Transparency Act, which is a bill to amend title XVIII of the Social Security Act to provide for pharmacy benefits manager standards under the Medicare prescription drug program and Medicare Advantage program to further transparency of payment methodologies to pharmacies, and for other purposes.
  • H.R.242 - Medicare Prescription Drug Price Negotiation Act, which is a bill to amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries.
Ballot initiatives, executive orders, and legislation are all stoking the flames over the drug pricing debate, but they don't even include ongoing litigation filed by 20 state attorney generals. It is clear that the issue has reached a climactic point and something needs to be done about it. The ADAP Blog will continue to monitor each of these developments.


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[1] Pelzer, Jeremy (2017, May 3). Fight over Ohio Drug Price Relief Act ballot issue could set spending record. Cleveland.com. Retrieved from http://www.cleveland.com/politics/index.ssf/2017/05/fight_over_ohio_drug_price_rel.html.
[2] Ballotpedia. Ohio Drug Price Standards Initiative (2017). Retrieved from https://ballotpedia.org/Ohio_Drug_Price_Standards_Initiative_(2017). 
[3] Pelzer, Jeremy (2017, May 3). Fight over Ohio Drug Price Relief Act ballot issue could set spending record. Cleveland.com. Retrieved from http://www.cleveland.com/politics/index.ssf/2017/05/fight_over_ohio_drug_price_rel.html.
[4] Troy, Tom (2017, May 23). Opponents launch TV ad against Ohio Drug Price Relief Act. The Toledo Blade. Retrieved from http://www.toledoblade.com/State/2017/05/23/Opponents-launch-TV-ad-against-Ohio-Drug-Price-Relief-Act.html.
[5] Kaplan, Shelia, and Katie Thomas (2017, June 20). Draft Order on Drug Prices Proposes Easing Regulations. The New York Times. Retrieved from https://www.nytimes.com/2017/06/20/health/draft-order-on-drug-prices-proposes-easing-regulations.html.
[6] Nather, David (2017, May 12). Mulvaney says Trump wants executive action on drug prices. Axios. Retrieved from https://www.axios.com/vitals-2403219901.html.
[7] Kaplan, Shelia, and Katie Thomas (2017, June 20). Draft Order on Drug Prices Proposes Easing Regulations. The New York Times. Retrieved from https://www.nytimes.com/2017/06/20/health/draft-order-on-drug-prices-proposes-easing-regulations.html.

Thursday, June 15, 2017

2017 National ADAP Monitoring Project Annual Report

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

National ADAP Monitoring Project - 2017 Annual ReportOn May 18th, an analysis of the AIDS Drug Assistance Program (ADAP) was released by the National Alliance of State & Territorial AIDS Directors (NASTAD). The 2017 National ADAP Monitoring Project Annual Report tracked state-by-state programmatic changes, emerging trends, and latest available data on the number of clients served, expenditures on prescription drugs, among other things.

The report, which is published annually by NASTAD, provides stakeholders an important snapshot into ADAP-related data, information, and trends. This year's report focuses on several areas, including:
  • The importance of the Ryan White Program and ADAP (p. 6)
  • What does it take to achieve viral suppression (p. 20)
  • Comprehensive care for people living with HIV/AIDS (p. 42)
  • Who benefits from services (p. 58) 
Upon releasing the 2017 National ADAP Monitoring Project Annual Report, Murray C. Penner, NASTAD's executive director, stated the following:[1]
"Over the course of time, there have been significant shifts in funding and client needs; ADAPs have worked to meet those needs, however, have sometimes found themselves unable to serve all those in need of services. Lessons have been learned from these circumstances and ADAPs continue to look to identify how they can meet client need and ensure program sustainability. At a time now when ADAPs are documenting program stability, it is imperative that ADAPs look back on how challenges were resolved and look to the future of client needs and determine ways to prepare for the future. ADAPs are at an unprecedented juncture of being able to look to target resources to populations that need them most, to partner with the RWPB to ensure that the whole client’s needs are met, and to identify ways to bolster treatment for individuals’ health."
The 2017 National ADAP Monitoring Project Annual Report overall yielded some very compelling data on the success of the AIDS Drug Assistance Program nationwide in 2016. Some key points are:
  • ADAPs provided medications to 225,517 clients in calendar year (CY) 2015, a 235% increase in utilization over the last 10 years;[2]
  • The majority (77%) of all clients served by ADAPs in CY2015 were reported as virally suppressed, de ned as having a viral load that is less than or equal to 200 copies/mL;[3]
  • Twenty-eight (28) states contribute funding to their ADAP budget.[4]
  • Thirty-eight (38) states receive drug rebates to their ADAP budget.[5]
  • Overall, nearly 98% of Part B and ADAP budgets are allocated to program services; only 2.2% of Part B and ADAP funding is used to administer the program;[6]
  • The majority of ADAPs pay premiums (84%), deductibles (84%) and prescription co-payments/co-insurance (94%) on behalf of eligible clients.[7]
  • Forty-three (43) ADAPs reported using funds for insurance purchasing/continuation, representing $161.8 million in estimated expenditures (10% of the ADAP budget at that time) for 30,621 ADAP clients, with an average cost per client of $5,284.[7]
Accompany this year's report are two infographics. NASTAD used one infographic to provide an analysis on ADAPs with the highest rates of viral suppression. Download the infographic, Key Characteristics of Ten ADAPs With Highest Rates of Viral Suppression. The other infographic gives an analysis on the Ryan White Part B and ADAP partnership. Download the infographic, Ryan White Part B and ADAP Partnership to Bolster Health Outcomes.

Total ADAP budgets range from $2.5 million (New Hampshire) to $348.9 million (New York)
Photo Source: NASTAD

Several advocates commented on the 2017 National ADAP Monitoring Project Annual Report, providing some important state perspectives. They include:

Ken Bargar, co-chair of the Florida HIV/AIDS Advocacy Network in Florida stated, "FHAAN has made access to our state's ADAP for Floridians a number one priority for many years. As Co Chair, I can tell you that we experience a great relationship with the Florida Department of Health, and we have provided many solutions for improving the program that they have implemented over the years. As a Medicaid non-expansion state, ADAP is crucial for people living with HIV in Florida. The increasing amount of clients receiving premium support for ACA plans has made this program robust and diverse in the ways they get access to HIV medication to our state’s most vulnerable clients. Recently, we were thrilled to see “pharmacy choice” finally became a reality for a section of the programs enrollees."

Eddie Hamilton, executive director of the ADAP Educational Initiative in Ohio, "In terms of transparency and the responsiveness to client’s concerns, Ohio's ADAP has come a long way since the last waiting list era. The ease of access to the program has drastically improved as there are now multiple routes of access (via case management, or direct application)."

Marcus J. Hopkins, an ADAP recipient and HIV/AIDS advocate in West Virginia, summarized, "West Virginia's ADAP is one of only twelve states in which 89% of enrolled clients in 2015 have achieved HIV Viral Loads ≤200. Our state had 1,139 clients in 2015, and only 3 Ryan White-specific clinics, meaning that many clients must travel 60 miles or more in order to reach one of these facilities. Our state is broken up into seven Ryan White regions, with 1 primary case manager contact per region. The small number of clinics serving 55 clinics (not including private Infectious Disease specialists) sometimes creates confusion, as clients living in different regions may have to coordinate between two different case workers. West Virginia's program also offers insurance continuation assistance, providing premium and co-pay assistance for clients enrolled in employer-based or ACA Insurance Marketplace coverage."

Matt Pagnotti, Director of Policy and Advocacy for AIDS Alabama, noted, "Since Alabama has failed to expand Medicaid under the ACA, the state's ADAP has operated as a vital safety net for thousands of people living with HIV in Alabama. Over three fourths of the clients served by Alabama's ADAP earn 133% FPL ($16,040 a year for a single adult) or less, most of whom find themselves in the "Medicaid coverage gap." In addition, roughly 16% of those served by ADAP in Alabama qualify for subsidized health insurance under the ACA marketplace. To assist these clients in overcoming financial barriers to access and create greater coverage completion, Alabama also operates an innovative Insurance Assistance Program that pays for premiums and co-payments."

The ADAP Advocacy Association commends NASTAD for its ongoing efforts to keep stakeholders informed, and engaged on the issues enumerated in this year's National ADAP Monitoring Project. Download a copy of the 2017 National ADAP Monitoring Project Annual Report.

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[1] Penner, Murray (2017, May 18); NASTAD Release: 2017 National ADAP Monitoring Project Annual Report; National Alliance of State & Territorial AIDS Directors.
[2] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 60. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[3] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 22. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[4] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 9. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[5] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 9. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[6] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 22. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[7] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 44. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.
[8] National Alliance of State & Territorial AIDS Directors (2017, May 18); 2017 National ADAP Monitoring Project Annual Report; p. 43. Retrieved from http://www.nastad.org/sites/default/files/2017-national-adap-monitoring-project-annual-report.pdf.

Thursday, June 8, 2017

Linkages to Care - Housing is Healthcare: Linking Stable Housing & Medication Adherence

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

Find me a physician who treats patients living with HIV/AIDS, and I'm certain the physician stresses medication adherence to anyone who will listen (yes, probably even Dr. Ben Carson). Find me a patient living with HIV/AIDS, and I'm certain the patient notes an equally important message: I cannot worry about my medications unless I have a roof over my head (yes, someone needs to tell Dr. Ben Carson). Intertwined are these two important facts.

The important linkage between housing and healthcare was spelled out last year in a blog by Kathie Hiers, who serves as the President & CEO for AIDS Alabama. In her blog, Housing=Healthcare, Hiers stated the following key points:
According to the National Low Income Housing Coalition’s 2015 Out of Reach Report, not a single state in our nation offers a one-room apartment that a person working full time and making minimum wage can afford. In fact, federal minimum wage has not increased since 2009 while rents have risen in almost all metropolitan areas. For PLWH, the need for housing assistance is far too commonplace. According to the National AIDS Housing Coalition, at any given time about 50% of 1.2 million PLWH in our country experience homelessness or housing instability. Additionally, research indicates that people who are unstably housed or homeless have HIV rates up to 16 times as high as persons in stable housing. Unfortunately the need substantially outstrips the resources. But here’s the bottom line: housing for PLWH improves medical outcomes, reduces new transmissions through a reduction in risky behaviors, and provides cost savings. So much research exists to confirm these results that AIDS and Behavior in 2007 dedicated an entire issue to illustrate the findings.[1]
Unfortunately, there aren't enough affordable, stable housing units available to keep up with demand. The shortage undermines efforts to achieve positive health outcomes in many areas of the country, both in rural and urban areas. Efforts are underway to modernize the federal housing programs designed to help those in need, including the Housing Opportunities for Persons with AIDS (HOPWA). But not all of the "efforts" are necessarily good for the people the programs are designed to assist.

Dr. Ben Carson testifying before Congress
Photo Source: Slate.com

Testifying earlier this week before the U.S. Senate Committee on Appropriations Subcommittee on Transportation, Housing and Urban Development, Dr. Ben Carson, Secretary of the U.S. Department of Housing & Urban Development (HUD), summarized some of these changes to the federal government's housing policy:
"Last year’s changes to the formula for Housing Opportunities for Persons with AIDS (HOPWA) was a great step towards efficiency, shifting funding to areas with higher numbers of HIV/AIDS cases, rather than historical incidents. This is the kind of targeted efficiency that will help us do the most with limited Federal resources. We provide a phased-in approach to the new formula to provide communities time to adjust. The additional funding in 2017 also will help provide communities more time to adjust to the new formula. The 2018 Budget provides $330 million for HOPWA."[2]
Ironically, Secretary Carson failed to mention that the Trump Administration's proposed Fiscal Year 2018 budget calls for a $26 million funding cut from HOPWA and that "these cuts will certainly increase the number of people living with HIV who will not have stable housing."[3] The proposed reduction represents nearly a 7 percent cut in funding.

Concerns have been mounting over the potential impact of funding cuts to housing programs, as well as healthcare programs. David Reiss' Op-Ed earlier this year characterized the proposed budget as "bad news."[4]

Housing is Healthcare
Photo Source: Community Partnership of the Ozarks

In an effort to raise awareness about affordable, stable housing and how it improves medication adherence for people living with HIV/AIDS and/or viral hepatitis, we will host an educational training webinar on June 28, 2017. The webinar, "Housing is Healthcare: Linking Stable Housing & Medication Adherence," will discuss the research that supports housing as a structural intervention that improves health outcomes through improved adherence to treatment. Presenters will share successful housing models where residents have seen this success. It will provide webinar attendees with how to use research to show the direct causation between health outcomes and housing placement, and understand strategies to the connection between medication adherence and stable housing.

Registration is open to all stakeholders. Registration is complimentary for PASWHA members, and it is also complimentary for patients living with HIV/AIDS. Use this scholarship link if you are a patient living with HIV/AIDS applying for a webinar scholarship.

Additional information about the webinar is available online at https://www.123signup.com/event?id=nhjqn.

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[1] Hiers, Kathie (2016, May 6); ADA Blog; Housing=Healthcare; ADAP Advocacy Association. Retrieved from http://adapadvocacyassociation.blogspot.com/2016/05/by-kathie-hiers-president-ceo-aids.html.
[2] Carson, M.D., Ben (2017, June 7); Written Testimony on Review of the FY2018 Budget Request
for the U.S. Department of Housing & Urban Development; Committee on Appropriations Subcommittee on Transportation, Housing and Urban Development. Retrieved from https://www.appropriations.senate.gov/imo/media/doc/060717-Carson-Testimony.pdf.
[3] Schmid, Carl (2017, May 23); TRUMP BUDGET: A SETBACK TO HIV AND HEPATITIS ELIMINATION; The AIDS Institute. Retrieved from http://www.theaidsinstitute.org/sites/default/files/attachments/TAI%20FY18%20Budget%20Press%20Release%20FINAL.pdf. 
[4] Reiss, David (2017, March 16); Trump's budget proposal is bad news for housing across the nation; The Hill. Retrieved from http://thehill.com/blogs/pundits-blog/economy-budget/324211-how-trumps-budget-cuts-could-affect-housing-for-thousands.

Thursday, June 1, 2017

Finding Emotional & Physical Health in Sobriety

By: Jonathan J. Pena

Philosopher Kahlil Gibran once wrote, “Out of suffering have emerged the strongest souls; the most massive characters are seared with scars.”

I believe that we are all products of our environment. That the experiences we are exposed to greatly influences our behavior and process of thinking, which we carry with us throughout our entire lifetime. The products of my environment lead me down a path of immense suffering; it was one I desperately tried masking by altering myself with my great escape into drugs. My addiction, my sexuality, my HIV-positive diagnosis, and the loss of my mother to cancer were all struggles that have left there mark.

When I was five years old my parents got divorced because my dad was unfaithful to her. I was totally devastated. As I got older, I started to carry feelings of blame and started to believe that I had done something wrong to cause my father not be around my mom and his two first-born sons.  Around this same time, I was also feeling displaced from my peers because I just felt different from everybody else. I didn’t necessarily fit in with any of the kids or groups in school, and feelings of loneliness seeped in. I don’t believe that children are capable of processing the emotions of a divorce, nor the complexities of ones sexuality. All I knew for sure is that I was in a lot of pain and feeling very inadequate.

All of that emotional weight and pressure needed a place to go or a way to be released, and I found my escape in drugs. It started with pot and escalated into harder drugs. In the end, I became addicted to crystal meth and my life became completely unmanageable. My relationships with family and friends suffered or completely disappeared. I was losing countless jobs, tons of money, along with my dignity...and my life. My addiction to crystal meth led me into prostitution. I couldn’t hold down a steady job so in order to manage any sort of bills and my habit, I sold my body to any man who was willing to open up his wallet. Somewhere, in the middle of all that, I became HIV-positive. I was already struggling with the mere idea of my self worth, and testing HIV-positive completely shattered me because who was going to love me knowing that I was so tainted?

In 2015, I checked myself into a drug rehabilitation center in Philadelphia and during this time my mom’s battle with Leukemia was taking its toll. The cancer had spread to her brain and one month after I completed my program she passed away. I was holding her hand when she passed and the pain of her loss was unbearable. However, I was grateful that sobriety gave me the opportunity to be present for her death. I relapsed shortly afterwards because I was unable to process my emotions of pain and loss. But...I didn't give up on myself.

Photo of Jonathan J. Pena
Today, I am living a sober life and approaching my one-year anniversary. My outlook on being HIV-positive has changed, and I no longer view myself as being tainted or unlovable. I am completely adherent with my medication and as such, my viral load is undetectable. I have realized the importance of maintaining and respecting my emotional and physical health, which includes taking my medication every day. Being HIV-positive doesn’t define me, but rather it is a part of me. 

Through sobriety and therapy, I have also become employed and living in my own apartment. I was recently accepted into North Carolina State University, where I will begin classes in the Fall 2017. I am studying to be an Oncology social worker with the hopes of being a support system for those who have lost a loved one due to cancer. I have re-established my connections with the people that I love and that love me in return. I am grateful, humbled, and renewed in my purpose in life through my sobriety.

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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. 
            

Thursday, May 25, 2017

Trump's Proposed Federal Budget Puts Bullseye on People Living with HIV/AIDS (and many other chronic conditions)


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

The executive budget — which is mandated by federal law to be submitted by the President of the United States to Congress — is rarely taken seriously because the legislative branch typically adopts a federal budget that does not come close to resembling the budget proposed by the executive branch. That said, it does signal the President's priorities for the coming year. Sadly, President Donald J. Trump's proposed budget makes clear that people living with HIV/AIDS (among many other chronic health conditions) aren't among his priorities.

The ADAP Advocacy Association was quick to condemn Trump's proposed budget via Twitter @adapadvocacy.

Trump Administration's proposed budget is a complete nightmare, but fortunately Congress never adopts the prez budget. #HIV #NoFundingCuts
There is an emerging pattern with Trump, which started during the presidential primary and continued throughout the general election...and now into his presidency. He routinely makes statements that completely contradict one another, and his proposed budget continued that trend.

How?

Trump's budget for the U.S. Department of Health & Human Services ("HHS") included legislative language relevant to the reauthorization of the Ryan White CARE Act, which is technically due for an update. The language reads:
"The Administration looks forward to working with Congress to reauthorize the Ryan White program to ensure that Federal funds are allocated to address the changing landscape of HIV across the United States. Reauthorization of the Ryan White program should include changes to the funding methodologies for Parts A and B to ensure that funds may be allocated to target populations experiencing high or increasing levels of HIV infections/diagnoses, such as minority populations, while continuing to support Americans that are already living with HIV across the nation. African Americans, for example, account for a higher proportion of new HIV diagnoses, those living with HIV, and those ever diagnosed with AIDS as compared to other races/ethnicities. The new Ryan White authorization should allow for resources to be focused on populations with disproportionately high rates of new infections/diagnoses."
Yet, that same budget called for draconian funding cuts to numerous federal programs specifically designed to assist people living with HIV/AIDS (including some authorized under the very same Ryan White). Among them:
  • Eliminating $34 million for AIDS Education and Training Centers
  • Eliminating $25 million for Special Projects of National Significance
  • Reducing $13 million in funding for Rural Outreach Grants (19.05% decrease)
  • Eliminating $42 million for Rural Hospital Flexibility Grants 
  • Reducing $7 million in funding for Telehealth (41.18% decrease)
  • Reducing $9 million in funding for State Offices of Rural Health (90% decrease)
  • Reducing $186 million in funding for HIV/AIDS, Viral Hepatitis, STIs and TB Prevention (16.61% decrease)
  • Reducing $1.3 billion in funding for Social Services Block Grant (78.69% decrease)
The budget also calls for flat funding for many other HIV-specific programs, including the AIDS Drug Assistance Programs (ADAPs) at $899 million. That might be acceptable under "normal" conditions, but the President and the Republican-led Congress are simultaneously trying to rollback numerous protections provided under the Affordable Care Act ("ACA") — such as Medicaid expansion, and Essential Health Benefits. It includes significant cuts to programs authorized under the National Institutes of Health ("NIH"), as well as programs providing mental health services, housing assistance, and addiction treatment.

Trump's budget has been universally denounced by the HIV/AIDS and Viral Hepatitis communities, as noted herein:
  • Ken Bargar, Co-Chair, Florida HIV/AIDS Advocacy Network (FHAAN): "Somewhere the President's advisors failed him. These are budget cuts to peoples' lives, their medications, their care and their shelter. As advocates, we cannot allow this budget to get any traction or legitimize it in any way. Congress appropriates our country's spending and that's were we should put our efforts. Let's let every Member of Congress know we won't stand for an administration that is willing to kill it's own people."
  • Michael Ruppal, Executive Director of The AIDS Institute: "The country has made great progress in the fight against HIV/AIDS and STDs, but if these cuts are enacted, we will turn back the clock, resulting in more new infections, fewer patients receiving care, and ultimately, more suffering from diseases that are preventable and treatable."
  • William E. Arnold, President & CEO of the Community Access National Network: "The president’s budget fails to meet the rising tide of viral hepatitis at a time when we’re on the cusp of seeing a sharp rise in new Hepatitis C infections. Flat funding HCV programs, while also cutting key HIV-related programs will prove problematic as we attempt to address the growing number of individuals co-infected with both HIV, and HCV."
  • Jesse Milan, Jr., President & CEO of AIDS United: "We have seen historic decreases in the number of new HIV infections over the past six years because of sustained investments in prevention, and we have thousands of HIV positive Americans who have yet to achieve viral suppression through treatment programs. By cutting funding, the work we have done will be reversed, and all the work left to do will falter and put the health of our nation at risk."
  • Ryan Clary, Executive Director of the National Viral Hepatitis Roundtable (NVHR): "President Trump’s assault on the health care system through his unconscionable cuts to Medicaid and other vital safety net programs will cause severe harm to people living with and at risk for hepatitis B and C. If enacted, the result will be continued alarming increases in hepatitis B and C infections, high numbers of individuals unaware of their status, and needless death and suffering due to lack of access to care and treatment. NVHR calls on Congress to reject this budget immediately and work together to pass an appropriations bill that expands access to quality health care for all and increases badly needed funding for the Division of Viral Hepatitis at CDC."
  • Murray C. Penner, Executive Director of the National Alliance of State & Territorial AIDS Directors (NASTAD): "Together we will fight these cuts at every stage of the appropriations process. We need to protect these programs that provide life-saving treatment for those living with HIV and work to prevent the spread of HIV and STDs. We trust that Congress will agree and recognize that these cuts are harmful, short-sighted, and will damage our nation's public health infrastructure."
  • Edward Hamilton, Executive Director of the ADAP Educational Initiative: "The administration’s proposed budget cuts across multiple programs will set back the gains that have been made in domestic and worldwide HIV epidemics 20 years. With the proposed changes in Medicaid and the Affordable Care Act, ADAPs nationwide will collapse due to the unprecedented strains on their budgets from rising drug costs coupled with forecasted increased premiums."
People living with HIV/AIDS, as well as viral hepatitis and other chronic conditions, don't deserve to have a bullseye on them. Trump's proposed budget would fail our nation's most vulnerable and neediest people, and as such, Congress should ignore it.
Bullseye target with arrows in the center
Photo Source: GalleryHip.com
The President's budget can be viewed online at https://www.whitehouse.gov/omb/budget/.

Friday, May 19, 2017

PAN Foundation Opens HIV Prevention & Treatment Fund

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

The Patient Access Network (PAN) Foundation — a corporate partner of the ADAP Advocacy Association — announced that it opened its fund for HIV Prevention And Treatment. Presently, there are 56 HIV-related medications covered by this program.

Apply Online at https://panfoundation.org/index.php/en/patients/how-to-apply
The PAN Foundation is accepting applications for new and renewal patients. People needing financial reprieve from the cost of their HIV-related medications are eligible for assistance up to $3,400 per year (additional assistance may be available, subject to the availability of funding). In fact, nearly 60 disease-specific assistance programs to help patients pay for their out-of-pocket costs are made available by the organization.

The PAN Foundation is an independent, national 501 (c)(3) organization dedicated to helping underinsured patients with chronic and critical illnesses afford their out-of-pocket medical expenses. Over the last thirteen years, they have provided more than 700,000 underinsured patients with over $2.5 billion dollars in financial assistance.[1]

Patients and advocates can apply for PAN assistance by phone at (866-316-7263) or online (Click here to start the application online).

[1] Patient Access Network Foundation (2017).

Thursday, May 11, 2017

Communication is key in creating an environment for shared decision-making

By: Kathleen D. Gallagher, MPH, Patient Advocate Foundation, and Rebecca Kirch, JD, National Patient Advocate Foundation

Patients and families confronting chronic, debilitating or life-threatening conditions at any age and any disease stage require reliable and affordable access to high quality therapies and supportive services throughout the care continuum in the settings that are best for them to optimize their outcomes and experiences. Yet today’s disease-centric care is fragmented across multiple specialists, subspecialists and settings, creating pressures to navigate pathways-driven treatments that overlook quality of life, functional outcomes, other personal priorities or individual characteristics that matter a great deal to patients and their families.

We know that patients rarely experience their symptoms as one isolated problem and can benefit from care that is truly person-centered and involves shared decision making. To accomplish this person-centered health care transformation, knowing precisely what is important to patients and families is paramount. Progress also requires dedicated commitment to enhancing clinical communication that is person-centered and goal-directed – learned skills that are essential drivers for delivering value-based care.

Photo Source: paintalks.com

Better health care value begins with improved communication about goals of care and personal values. Patients and families consistently report that they want to be involved in understanding their disease prognosis and treatment options and making decisions about their care. We chose to address these concerns as part of a grant funded project through targeted online survey efforts. Our primary goal was to examine multiple thematic areas from a broad patient perspective designed to explore the dimensions of what matters to patients.

The following highlights the preliminary analysis of some of the data collected from our virology cohort (HIV+ patients), specifically around the theme of communication. Survey participants were asked a series of 5 questions to gather information on how they wanted to receive health information, how involved they wanted to be in making healthcare related decisions, discussing what matters to them when selecting a treatment option, and their comfort level in broaching the conversation about quality of life with their doctor.

When asked, “how do you like to approach making decisions about your treatment” over 65% of the respondents wanted to make decisions in partnership with their medical versus the 14% who wanted to make their decisions alone or the 5% wanted the physician to make the choice for them. An additional 14% wanted their doctor to explain all of the options to them in detail before working together to make a treatment choice. The message from this data point is clear and supports our hypothesis that patients want dialog and information from their medical team and they want to be partners in making treatment choices.

In regards to doctor initiated conversations about things that are important to the patient in their care (non-clinical outcomes) 60% of respondents stated that their doctor did ask them about “what is important to you as part of making plans for your treatment”. Although this data point is encouraging, what was most compelling was that over 95% of those who answered in the affirmative, followed this question with a positive response to the question “did you feel that your doctor took that information into account when making recommendations”. So not only were the able to have the conversation – but their input was valued and used to identify and select a treatment option that was of value to them.

While only a small selection of the 100+ questions asked in the Patient Value Survey, the preliminary data gathered around patient-provider conversation in regards to treatment and care is encouraging. Historically, the HIV population have been the groundbreakers and drivers of action and having a voice in the way their chronic condition is treated. As we continue to use the collected data to drive a better understanding of what matters to patients, and how best to equip them for conversations about their comprehensive care and planning treatments that provide them the quality of life that they are seeking, we will continue to reach out to our non-profit partners to ensure that all voices are being heard.

________
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. 

Thursday, May 4, 2017

AHCA Passed the House Today; Do Not Panic

By: Jen Laws, Board Member, ADAP Advocacy Association, and HIV/transgender health advocate

The American Health Care Act ("AHCA") is not the law of the land...but rather it still is the Affordable Care Act ("ACA") governing our nation's healthcare framework. Let’s preface this fact with the message advocates have been stumping for months: stay vigilant, stay active, and stay on top of your elected representatives. For policy “wonks” and advocates assessing how potential legislation affects the American public, policy impact matters just as much as the political environment.

The American Health Care Act passed the U.S. House of Representatives on the narrowest of margins at 217-213. Twenty Republicans voted “no” on deep concerns of both negative impact on access and quality of care, and due to their seats being vulnerable in the 2018 midterm election (Roll Call, 2017). This vote took three months, one failed vote earlier this year, and days of “arm twisting in the cloak room” to make it happen. For the culture of the House, it is somewhat extraordinary in modern times. Now the legislation rests in the hands of the U.S. Senate.

Vote totals on passage of the American Health Care Act
Photo Source: C-SPAN

The Senate, while subject to more of the weight of Presidential politics, is a different beast entirely (Washington Post, 2017). Presidential politics plays both in favor for those Senators aligned with the President and against those from contentious states due to vulnerability of the seats. With a narrow Republican majority in the Senate, the coming months will see the divisions of the House amplified and thus weakening the possibility of the AHCA in its current form (or any form for that matter) passing the Senate. Additionally, once a Congressional Budget Office “score” is available, the Senate parliamentarian must assess if the bill meets the requirements of the “Byrd rule” as the AHCA is a “reconciliation” measure. Amendments added to the bill as it moves through the Senate committees will further change the CBO score and may make passage even less likely.

Among topics of concern with the bill are popular ACA provisions like consumer protections regarding pre-existing conditions, annual and lifetime limits, and the ability for children to stay on their parents’ coverage until the age of twenty-six. Less popular, though still maintaining wide support is the Medicaid expansion. The AHCA weakens these provisions by giving states the option to “opt out” of Essential Health Benefits, attacking Community Health Ratings, and forming “risk pools” for people with pre-existing conditions. Of note, independent analysis has shown that to adequately fund state risk pools, the AHCA would need to provide for $25 billion of funding. Currently, the AHCA only offers $8 billion over the course of 5 years. The ACA provided for $5 billion and ran out of funds at the 3rd year. The AHCA also structures “punishments” for those who experience lapses in coverage and older Americans. Combining these facts with substituting current subsidies with tax credits, people will face greater likelihood of lapse in coverage and increases in rates due to being unable to afford coverage in the first place. All while cutting funding and adding caps to state Medicaid programs.

Medicaid funding cuts are of special note as Medicaid expansion has eased the burden of other assistance programs like state AIDS Drug Assistance Programs, shortening waiting lists for services, and providing direct and continuous care opportunities for the most vulnerable of the American public.

The aforementioned issues will continue to be the center of the debate on the AHCA and why the CBO has scored the AHCA to cause tens of millions to lose coverage over projected 10 years following implementation.

Differing views in the Senate that label the health care programming and policy as “entitlement” will compete strongly with the attitudes of moderate Republicans that the government should provide protections and an avenue of care for their constituents and consensus will be exceptionally difficult to find. What’s likely to bring moderates on board will alienate Libertarian-minded Republicans, and vice versa. Democrats are expected to behave as a “blue wall” and vote as a caucus against the AHCA. The two Democrat Senators to watch will be Joe Manchin (WV) and Heidi Heitkamp (ND), as the most likely to indicate if the AHCA may gain even a single blue vote and thus is altered enough to gain a moderate majority.

Photo of West Virginia Senator Joe Manchin III and North Dakota Senator Heidi Heitkamp
Photo Source: trofire.com

The best way for constituents and advocates to make their voices known is, and will always be, to call their elected representatives offices, both at home and in DC, show up to town hall meetings, and take action with advocacy organizations aligned with their values.

You can find your Representative’s contact information here: http://www.house.gov/representatives/find/.

You can find your Senator’s contact information here:
https://www.senate.gov/senators/contact/.

________
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. 

Thursday, April 27, 2017

Could New Research Pave Way for Official Guidelines for the Treatment of Lipohypertrophy

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

There purports to be an "obesity epidemic" in the United States,[1] though strong evidence suggests that people can be healthy at every size.[2] Data shows from 1960-2002, in the United States the average male weighed 25 pounds more and average female weighed 24 pounds more. Putting the debate over obesity aside, undesirable weight gain for many people living with HIV/AIDS is often grudgingly accepted as normal. This paradigm could soon be changing because new research could pave the way for better guidelines for treating HIV-related weight gain — namely, Lipohypertrophy.

Example of lipohypertrophy – Man
Photo Source: myclickfine.com

Research published in the Clinical Infectious Diseases by a panel of international authors (U.S., Canada, Europe) from 12 universities represents a consensus opinion on the diagnosis, clinical consequences and treatment of excess fat in adults with treated HIV infection. The groundbreaking study offers some hope to people living with HIV-infection concerned about facial wasting, belly fat, lipomas, or the dreaded "buffalo hump" on the back of the neck.

The publication, "Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection," concludes, "Both generalized obesity and lipohypertrophy are prevalent among HIV-infected persons on ART. Aggressive diagnosis and management are key to the prevention and treatment of end-organ disease in this population, and critical to the present and future health of HIV-infected persons."

Among the research findings, management of HIV-related weight gain includes lifestyle changes in diet and exercise, though there was "insufficient data to support any specific dietary or exercise strategy in patients with HIV and abdominal obesity."[3] Changes in anti-retroviral therapy is also suggested, since some of the new medications have less side-effects.[4] Medical interventions are also identified as viable options — including Growth Hormone (GH) Axis Therapy and Metformin.[5] Finally, surgical interventions are also included in the options identified by the authors.[6]

The research findings are already gaining attention in respected HIV news publications, too.

The ADAP Advocacy Association sees promise in the report findings for patients suffering from a condition for which treating physicians are paying little attention, and in many cases where payors — including many State ADAPs — are excluding coverage for treatment options approved by the U.S. Food & Drug Administration. In late 2016, we urged the Health Resources and Services Administration ("HRSA") to update to the Guide for HIV/AIDS Clinical Care. The national sign-on letter wasn't an endorsement of a specific product or treatment, but rather an attempt to afford patients suffering from HIV-associated lipodystrophy syndrome the opportunity to access the available treatment options (all of which were identified in the aforementioned research).

HRSA now has a template for updating its treatment guidelines. It is up to the federal agency to respond to the needs to the patients!



Read our related blogs on this topic:

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[1] Rauh, Sherry (2010); Is Fat the New Normal? A rise in average body weight may be changing how we see ourselves. WebMD. Retrieved from http://www.webmd.com/diet/obesity/features/is-fat-the-new-normal#1.
[2] Bacon, Linda (2010, May 4); Health At Every Size: The Surprising Truth About Your Weight; BenBella Books. Retrieved from https://lindabacon.org/health-at-every-size-book/.
[3] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[4] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[5] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[6] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.

Thursday, April 20, 2017

Linkages to Care - Plugging the Treatment Gap: Navigating Patient Assistance Programs

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

In the United States, everyone hates how insurance companies "stick" it to consumers. There is pretty much universal agreement that the cost of prescription drugs are too high. There is also near consensus that the marketplace plans under the Affordable Care Act ("ACA") have caused a lot of headaches for patients with chronic conditions  including HIV/AIDS  especially with respect to the high tier drug plans. It is no wonder that so many cracks exist within the current healthcare framework. Fortunately, there also exist patient assistance programs ("PAPs") designed to plug the treatment gaps for these patients. PAPs serve as key linkages to care...and treatment!

According to PatientAssistance.com, "Commonly referred to as PAPs, Patient Assistance Programs are services offered by pharmaceutical companies for those who cannot afford their medication. Patient assistance programs are available to low-income individuals or families who are under-insured or uninsured and are provided to those who meet the eligibility guidelines. Assistance may range from reduced cost of drugs to free medicine. Each drug that a company offers will have its own unique program and may even have a different eligibility requirement than the other drugs they offer. As there is no unified standard of designation for these programs, you may also see them referred to as medication assistance programs, indigent drug programs, and charitable drug programs."[1]

Pharmacist standing in front of the pharmacy with prescriptions.
Photo Source: MedicineCoupons.net
PAPs are vitally important to patients living with chronic conditions. They not only improve access to care and treatment, but they also save consumers money and reduce lost productivity. They also benefit the drug manufacturers because PAPs keep patients (would-be consumers) in treatment. The data shared by the Partnership for Prescription Assistance ("PPA") — which connects qualifying patients with the assistance program that’s right for them — is mind-blowing.

Celebrating its 12-year anniversary, PPA recently reported that its website is visited by over 75,000 consumers per month and makes available information on more than 475 patient assistance programs. It also offers a database of nearly 10,000 free or low-cost health care clinics across the country. Over 10 million consumers have been helped since the program's inception.[2]

Aside from the resources made available to consumers directly from the drug manufacturers, there also exists other patient-centric organizations designed to assist patients with prescriptions, discount drug cards, and other patient resources. Just to name a few, they include the Patient Access Network Foundation ("PAN"), Patient Advocate Foundation ("PAF"), and NeedyMeds. Each of these organizations serve as vital linkages to care for social workers, case managers, and allied health professionals assisting patients. These organizations also each partner with the ADAP Advocacy Association.

In an effort to raise awareness about patient assistance program and how they serve people living with HIV/AIDS and/or viral hepatitis, we will host an educational training webinar on May 31, 2017. The webinar, "Plugging the Treatment Gap: Navigating Patient Assistance Program," will showcase important information about these patient-centric PAPs. It will provide webinar attendees with a greater understanding about patient assistance programs, tools for how to navigate patient assistance programs to best assist patient needs, strategies for better seamless delivery of health-related care and treatment, and useful resources and tools to plug the treatment gap.

Registration is open to all stakeholders. Registration is complimentary for PASWHA members, and it is also complimentary for patients living with HIV/AIDS. Use this scholarship link if you are a patient living with HIV/AIDS applying for a webinar scholarship.

Additional information about the webinar is available online at https://www.123signup.com/event?id=nhjqn.


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[1] PatientAssistance.com (2014); The Catalyst; What are Patient Assistance Programs?; PatientAssistance.com, Inc. Retrieved from https://www.patientassistance.com/faq.html.
[2] Mooney, Hannah (2017, April 5); 12 years of the Partnership of Prescription Assistance; Pharmaceutical Research and Manufacturers of America®. Retrieved from http://catalyst.phrma.org/12-years-of-the-partnership-of-prescription-assistance.

Friday, April 7, 2017

Is it Time for a Reset to the Ryan White CARE Act?

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

It has been almost 27 years since the mother of a young boy dying of AIDS received a phone call from the late Senator Edward Kennedy (D-MA), asking if it would be okay to attach the boy's name on federal legislation.1 That young boy's name was Ryan White, and it has become synonymous with the Ryan White Comprehensive AIDS Resources Emergency Act (Ryan White CARE Act). Since 1990, it has saved countless lives of people living with HIV/AIDS in the United States. The law is due to be re-authorized by Congress, and some are asking if the time is right for a "re-set" so that the supports and services authorized under the law better reflect the state of the epidemic.

HIV surveillance data reveals some interesting trends about the epidemiology of the disease over time. Diagnosis of HIV infection demonstrates that some things have remained constant, such as men who sex with men (MSM) and intravenous drug use (IDU) represent two of the high-risk transmissions groups. But today, HIV infection disproportionately impacts communities of color, as well as people living in rural areas of the country. Heterosexual woman and adolescents are also greatly at risk for HIV infection.

The following charts published by the Centers for Disease Control & Prevention (CDC) help to explain the trends in HIV diagnoses in the United States between 2010 - 2014:2

Photo Source: CDC

Photo Source: CDC

Photo Source: CDC
According to the CDC, "The South now experiences the greatest burden of HIV infection, illness, and deaths of any U.S. region, and lags far behind in providing quality HIV prevention and care to its citizens." It begs the question, shouldn't the federal government adopt a "money follows the person" paradigm to reflect the changing epidemiology?

Some of the important questions surrounding Ryan White reauthorization include the following:
  • should funding stream formulas count cumulative AIDS cases or only living HIV-positive people?
  • should wrap-around services be expanded for clients who have Medicare Part D, Medicaid or Veterans Affairs healthcare?
  • should coverage include inpatient hospital care?
  • should coverage include Hepatitis C (HCV) drug therapies?
  • should commercial health insurance premium assistance programs be liberalized?
"At a time when we have the most effective and simple HIV treatments and a very volatile healthcare insurance landscape, WE NEED the Ryan White safety net program for continuity - less we forget without care and treatment HIV is a deadly and transmissible disease," summarized David Poole, Director of Legislative Affairs at AIDS Healthcare Foundation."

Next week this issue will be discussed at the ADAP Advocacy Association's AIDS Drug Assistance Program Regional Summit in Raleigh, North Carolina. "Ryan White & Service Delivery Systems in the Age of Budget Austerity" is one of the topics on the agenda with leading policy stakeholders concerned about the future of the program, and potential impact on patients living with HIV/AIDS and other underserved populations.

For complete information about the Ryan White CARES Act please visit http://hab.hrsa.gov/abouthab/legislation.html.


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[1] Groppe, Maureen (2014, July 30); Future of Ryan White program not clear; JConline. Retrieved from http://www.jconline.com/story/news/2014/07/30/future-ryan-white-program-clear/13376961/.
[2] National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (2017, March 24); HIV Surveillance—Epidemiology of HIV Infection (through 2015); Centers for Disease Control & Prevention, U.S. Department of Health & Human Services. Retrieved from https://www.cdc.gov/hiv/pdf/library/slidesets/cdc-hiv-surveillance-genepi.pdf.
[3] Centers for Disease Control & Prevention (2016); HIV in the Southern United States; TheBody.com. Retrieved from: http://www.thebody.com/content/76879/hiv-in-the-southern-united-states.html. 

Thursday, March 30, 2017

340B Program: Don't throw the baby out with the bathwater

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

The pharmaceutical industry and other interest groups have lobbied Congress to "reform" the 340B Drug Pricing Program, which they claim is riddled with waste, fraud, and abuse. Abound are damaging audits and reports that certainly back up the claim, except this over-generalization can be dangerous. Whereas hospitals are the program's primary participating vendors, there are many other smaller entities that also leverage the discounts on prescription drugs to assist their clients. No better example exists than the Ryan White covered entities, including Ryan White clinics, State AIDS Drug Assistance Programs (ADAPs), and other safety net providers.

The Health Resources and Services Administration (HRSA) summarizes the 340B Drug Pricing program as follows:
"The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers."[1]
It is understandable why the drug manufacturers — most of which are required by law to to provide significant discounts (20-50%) off drug pricing— would be concerned about the growth of the program. Total sales under the program increased from $1.1 billion in 1997 to more than $7 billion in 2013,[2] and quickly climbing toward $20 billion. There are plenty of shenanigans with hospitals boosting their profits rather than providing supports and services for low-income and uninsured patients.[3] A recent study concluded, “Our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics.”[4]

Some in Congress are also alarmed. Senator Charles E. Grassley (R-IA) is chief among them, arguing a few years back, "Congress needs to know the extent to which the agency believes it lacks the statutory authority to ensure that hospitals use the 340B program to help the uninsured receive affordable prescription drugs. Medicare and private insurance are paying much more for some drugs than the hospitals paid because of the program discount. Congress needs a full picture of how hospitals are using the program and how their uses affect other programs in the health care system.[5]

Photo Source: Brendan Smialowski/Getty Images
But there is an age-old saying, "Don't throw the baby out with the bathwater."

Earlier this year, Harish Thiagaraj authored a detailed report on how AIDS Service Organizations (ASOs) — some of which are Ryan White covered entities — have served as the poster child for the success of the 340B Drug Pricing Program. Thiagaraj accurately notes that proposed "reforms" to the program would leave such HIV entities largely untouched,[6] but there is no guarantee that harmful changes, or unintended consequences couldn't result from the programmatic reforms targeting large hospitals.

The study concludes:
"Those in the 340B industry realize that the 340B Drug Discount Program runs much more deeply than lower cost prescriptions. It provides treatment for those who are seriously ill. Its savings go towards valuable community services. Its creation was born out of necessity, and program growth directly correlates with better health and outcomes, which the Ryan White clinics’ achievements exemplify."[7]
Thiagaraj's assessment couldn't be more accurate, and we applaud him. Ryan White covered entities participating in the 340B Drug Discount Program have contributed to achieving viral suppression, and more needs to be done. The savings are re-invested back into the clinics, thereby allowing them to offer much needed supports and services to their clients.

ACHIEVING VIRAL SUPPRESSION: MORE PEOPLE WITH HIV NEED TO BE IN MEDICAL CARE
Source: Wellpartner
That said, it is important that the integrity of the program is protected.

"The 340B program has been challenged since its inception," summarized Jeffrey R. Lewis, President and Chief Executive Officer at Legacy Health Endowment. "The challenge today is to ensure that the program is operating the way Congress intended. To accomplish this, Legacy Health Endowment will be organizing a national commission to recommend specific ways to ensure the long term solvency of the 340B program, and to determine what changes may need to be made to ensure that the program does not exceed its Congressionally mandated purpose."

Next month this issue will be discussed at the ADAP Advocacy Association's AIDS Drug Assistance Program Regional Summit in Raleigh, North Carolina. "Ryan White & 340B Drug Access" is one of the topics on the agenda with leading policy stakeholders concerned about the future of the program, and potential impact on patients living with HIV/AIDS and other underserved populations.


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[1] Health Resources and Services Administration (2017). 340B Drug Pricing Program. U.S. Department of Health & Human Resources. Retrieved from: http://www.hrsa.gov/opa/index.html. 
[2] Vandervelde, Aaron (November 2014). GROWTH OF THE 340B PROGRAM: PAST TRENDS, FUTURE PROJECTIONS. Berkley Research Group. Retrieved from: http://www.thinkbrg.com/media/publication/524_Vandervelde_340B_GrowthDrivers_WhitePaper_20141202_FINAL.pdf.
[3] Adamopoulos, Helen (2014, October 7). Are hospitals abusing the 340B drug discount program? New study reignites controversy. Becker's Hospital CFO. Retrieved from: http://www.beckershospitalreview.com/finance/are-hospitals-abusing-the-340b-drug-discount-program-new-study-reignites-controversy.html.
[4] Myers, Nan (2016, May 31). Concerns Persist about the 340B Program. Pharmacy Times. Retrieved from: http://www.pharmacytimes.com/news/concerns-persist-about-the-340b-program.
[5] Sen. Charles Grassley (2013, October 13). Grassley: Questions Continue About 340B Discount Drug Program. United States Senate. Retrieved from: https://www.grassley.senate.gov/news/news-releases/grassley-questions-continue-about-340b-discount-drug-program.
[6] Thiagaraj, Harish (2017, January 18). The 340B Drug Pricing Program Success Story: Ryan White HIV Entities," 2017. Wellpartner. Retrieved from: http://wellpartner.com/wp-content/uploads/2017/01/WP_TPL_ThoughtLeadership_RyanWhite.pdf. 
[7] Thiagaraj, Harish (2017, January 18). The 340B Drug Pricing Program Success Story: Ryan White HIV Entities," 2017. Wellpartner. Retrieved from: http://wellpartner.com/wp-content/uploads/2017/01/WP_TPL_ThoughtLeadership_RyanWhite.pdf. 


Wednesday, March 22, 2017

Despite Trump's Troublesome Policies, HIV Advocacy Must Remain in Motion

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

Earlier this year, we highlighted a decade of accomplishment achieved by the ADAP Advocacy Association since the organization's inception in 2007. Unfortunately, there is little time to celebrate because so much uncertainty  and yes, fear  exists over some of the troubling policies being put forth by the Trump Administration, and how they could potentially impact people living with HIV/AIDS. For that very reason, HIV advocacy must remain in motion!

The ADAP Advocacy Association has long contended the Affordable Care Act (ACA) is far from perfect, but it would be a mistake to ignore how the law has expanded coverage for low income and disadvantaged Americans. In fact, according to FactCheck.org nearly 20 million Americans have gained access to health insurance thanks to the ACA. There is no fake news behind that number!

Umbrella showing who is covered by Medicaid expansion
Affordable Care Act Medicaid Expansion; KFF.org

Medicaid expansion — which was authorized by the ACA had a lot to do with the dramatic decrease in the number of people uninsured in the United States. Many people living with HIV/AIDS benefited from Medicaid expansion, and their ability to access timely, appropriate care and treatment actually saved the taxpayers money. That's not to suggest that other negative, unintended consequences haven't emerged since the ACA's passage — including insurance discriminatory design with extremely high co-payments for anti-retroviral medications, adverse selection limiting access to care, or rising premiums and cost-sharing. There is also no fake news behind these facts, either!

Repeal? Replace? Repair? It is hard to know the future of the current ACA, but the Republican plan...as it currently exists...is bad for people living with HIV/AIDS. There is little debate over that statement. In fact, four Republicans governors — Snyder of Michigan, Kaisch of Ohio, Hutchinson of Arkansas, and Sandoval of Nevada —who actually favor the ACA's repeal have come out against the GOP-sponsored American Health Care Act, as it is known. Why? Because they recognize the important role Medicaid expansion has played for the people living in their respective states.

Ohio Governor John Kaisch talking to the press outside the West Wing of the White House
Ohio Governor John Kasich has voiced concerns about
repealing the Affordable Care Act; The Atlantic 

People living with HIV/AIDS haven't been well-served by the hyper-partisanship that has swept over the nation's capitol in recent years, especially with respect to the ACA. One political party buried its collective head in the sand and ignored the law's flaws, while the other political party obsessed over repealing the law without a viable alternative to replace it. Blame can be placed at the feet of both the Democrats, and the Republicans.

But rather than trying to score political points or rehash political talking points, people living with HIV/AIDS are making their voices heard loud and clear. They are trying to be part of the solution by engaging in HIV advocacy in motion...whether is activism via social media, or the National HIV Call-In Day (which was held on March 21st), or the countless sign-on letters being sent to Congress. It is encouraging that it is happening at the national, state, and local levels.

The ADAP Advocacy Association, for its part, has a robust schedule of events and projects planned for the current year. They include:
Scholarships are available for people living with HIV/AIDS who wish to participate, so that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion. The webinar series will include the following topics:
  • Wednesday, May 31st – Plugging the Treatment Gap: Navigating Patient Assistance Programs
  • Wednesday, June 28th – Housing is Healthcare: Linking Stable Housing & Medication Adherence
  • Wednesday, July 26th – Transgender Healthcare: Removing Barriers to Healthy Cultural Expectations
  • Wednesday, September 27th – Body & Soul: Combatting the Dual Epidemic of HIV-Infection and Substance Abuse
More information about the ADAP Advocacy Association's sponsored events is available online at http://adapadvocacyassociation.org/events.html.

These activities are designed to raise awareness, offer patient educational programs, and foster greater community collaboration. Each one is enhanced by partnering with various other organizations, such as the AIDS Healthcare Foundation (AHF), Community Access National Network (CANN), North Carolina AIDS Action Network (NCAAN), and the Professional Association of Social Workers in HIV/AIDS (PASWHA). Several other projects are also in the works for the coming year.

If one good thing has come from the Trump Administration's proposed policies, then it is an increasingly energized front by the HIV community.

ADAP Advocacy Association 10th Annual Conference - "Unchartered Water: AIDS Drug Assistance Programs in the Age of Trump"