BIO's 2018 Patient & Health Advocacy Summit

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

The ADAP Advocacy Association has long prided itself on building advocacy partnerships, and thus it is fitting that our organization's leadership — including board members Wanda Brendle-Moss and Jen Laws, as well as myself — was invited to attend the Biotechnology Innovation Organization's (BIO) 2018 Patient & Health Advocacy Summit in Washington, DC. What makes the annual event useful is it assembles the advocacy community, industry partners, regulators, academia, students, and of course, patients.

Susan Stein, MPH, who serves as CEO of the E4 Health Group, shared a simple, yet powerful characterization: "Partnerships between patient advocacy organizations and industry are more important than ever."

Photo Source: FierceAdvocate

The BIO 2018 Patient & Health Advocacy Summit brought together over 200 key stakeholders for two days of programming to discuss current policy issues, share best practices, and exchange ideas. Nearly two-thirds of the attendees represented the patient advocacy community. The BIO Summit also provided an invaluable opportunity to advance partnership among stakeholders in the healthcare ecosystem. Whereas the ADAP Advocacy Association's participation represented HIV/AIDS, there were many other disease groups in attendance, such as Psoriasis, Arthritis, Muscular Dystrophy, Metachromatic Leukodystrophy, and many more.

The BIO Summit immediately addressed the 800 pound gorilla in the healthcare ecosystem with an important pre-summit workshop on best practices for engaging with industry. As the patient perspective plays a more central role in the drug development process, it is recognized that clearer conflict-of-interest policies and best practices would better serve all stakeholders. The patient voice has moved beyond simply participating in clinical trials, and as a result industry and regulators are engaging patients earlier in the process. The 21st Century Cures Act includes a commitment to patient-focused drug development ("PFDD"). It amends the Federal Food, Drug, and Cosmetic Act to require the Food & Drug Administration to establish processes under which patient experience data may be considered in the risk-benefit assessment of a new drug.

The timing of the BIO Summit couldn't have been planned any better with the Trump Administration's latest announcement under its blueprint for prescription drug reform. The latest proposal would set up an international pricing index in an effort to drive down prescription drug costs under Medicare Part B, which in turn, could also drive down patient out-of-pocket costs. The U.S. Department of Health & Human Services ("HHS") Secretary Alex Azar discussed the "pro patient access proposal" at the BIO Summit, only hours after it was announced.

HHS's decision to announce an Advance Notice of Proposed Rulemaking ("ANPRM") translates into the patient advocacy community having ample time to weigh-in on it. It could very well be the case that the public comment period represents one of the times where the patient advocacy community and industry view things differently, but that is a good thing.

For a policy brief on the ANPRM, please visit: https://www.hhs.gov/about/leadership/secretary/priorities/drug-prices/ipi-policy-brief/index.html.

For a fact sheet on the ANRPM, please visit: https://www.cms.gov/newsroom/fact-sheets/anprm-international-pricing-index-model-medicare-part-b-drugs.

Comments on the ANPRM will be accepted until December 31, 2018 and may be submitted electronically through the CMS e-Regulation website at: https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/eRulemaking/index.html?redirect=/eRulemaking.

The ANPRM can be downloaded at: https://www.cms.gov/sites/drupal/files/2018-10/10-25-2018%20CMS-5528-ANPRM.PDF.

Policy Recommendations & Action: Transgender Advocacy

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

As advocates, we are asked frequently about the concrete steps we would like to see from our industry partners. Effective advocacy requires actionable items, clear direction, and tangible benefits for affected communities. With this in mind, we have established a few recommendations for our industry partners to consider when seeking to do “the next right thing” for Transgender populations. We chose to highlight Transgender and Gender Non-Conforming populations due to disparate impacts in health this population faces.

While reviewing, industry partners may notice certain common principles: leverage of positions of power in advocating for governmental recognition of personal dignity, protections of individual right to access to care, “centering” affected populations and population needs in funding and proposals, “filling” gaps in necessary medical knowledge with regard to the specific needs of affected population, partnership with smaller entities, more closely connected to or run by affected populations, and an introspective evaluation of our own operations. After all, leading by example empowers and invites other partners to join us in best practices.

Effective advocacy may require precision in action; it also requires broad understanding outside of traditional scope of one’s organization. In understanding the variety of socio-economic determinates in health, to effectively close the gaps of disparities, we must also work to affect change in areas outside of health.

Policy Recommendations and Action: Transgender Advocacy

• Public comment on rulemaking:
• Religious Freedom/Conscience: “Religious freedom” is currently being used as a beacon call for restricting the rights and/or protections of LGBTQ persons. While not always specifically naming Transgender persons, the Trump Administration has preferred to use language regarding “medical sterilization”, a coded effort targeting transition related care such as cross-sex hormone replacement therapy and gender confirmation surgeries. Oppose these changes.
• Section 1557: The Trump Administration has chosen to not defend the reading of Section 1557 of the Affordable Care Act as interpreted by the Obama Administration. Government entities are enjoined from enforcing protections on the basis of gender identity and pregnancy history due to the Northern District of Texas ruling in December of 2016. The U.S. Department of Health & Human Services and U.S. Department of Justice has indicated the agencies will re-write the rule to exclude these protections. Oppose these changes.

• Amicus Briefs: 
• Employment and other rights as described under the Civil Rights Act ("CRA")of 1964: Case law has begun to recognize the inclusion of gender identity as covered by the prohibition of sex based discrimination in the CRA. The Obama Administration adopted an interpretation stemming from the Price Waterhouse decision on sex stereotyping: “but for” the sex assigned at birth/biological anatomy of a person, entities would respect the rights and protections of a person as their self-identified gender. The Trump Administration is seeking to codify into case law a strict reading of the “sex” provisions of the as “anatomical sex” as opposed to gender identity. Oppose these arguments where possible via amicus briefs and sign-on letters.

• Funding and Programing:
• Transgender specific organizations are often in competition for grant funding with larger LGBTQ organizations: Prioritize “by/for” Community Based Organizations ("CBOs") and projects when issuing Requests For Proposals for Transgender specific grants.
• Expand funding in RFPs for Transgender-specific grants: Often, Transgender-specific grants are ambiguous in nature and limited in funding. Ensure each Transgender-specific grant RFP is large enough for 1 FTE and deliverables has measurable impact on Transgender populations. Consider seeking a Transgender consultant to help draft these grant RFP.
• Ad Hoc Funding: Seek out Transgender-specific CBOs and ask what services they lack funding for.
• Fully fund full-time and part-time internships: Transgender persons often lack formal education requirements for employment, most typically due to fears of harassment and increased poverty experiences. As a result, it is common for Transgender persons to seek “underground economy” work. Funding internships exempt from formal education requirements and accounting for previous work experience and lived experiences would provide an opportunity to reduce poverty among Transgender persons, ensure health insurance coverage, and position Transgender persons to build formal and meaningful work experience while also assisting funded entities on a variety of projects.
• Fund Transgender-specific depression coping skills programming.

• Internal Competencies:
• Ensure local offices receive Transgender cultural competency training annually: Hire “by/for” organizations local to each office. This is especially important for community liaisons and sales staff.
• Hire Transgender persons: Estimates show Transgender persons are 1-3% of the population. Perform an internal audit and ensure internal employment statistics reflect this population.
• Ensure company sponsored health insurance covers gender affirming care: Many insurance carriers impose burdensome bureaucratic barriers to coverage approval for gender affirming care; ie. Gender marker changes on government identification or name changes as evidence of “living as the desired gender”. To fulfill either of these, requires a court order. Making gender affirming care the only type of standard medical care that requires a court order on a consistent basis. Ensure employee plan offerings do not impose such barriers.

• Lobbying:
• Lobby on behalf of Transgender rights protections legislation: Both on the state and federal level.
• Lobby state insurance regulators to standardize policies for gender affirming care: Few states have a codified avenue for complaint when an insurance company refuses to cover or imposes burdensome requirements to gender affirming care coverage.
• Lobby for Federal Qualified Health Center ("FQHC") infrastructure funding: Many Transgender persons rely on FQHC’s for their gender affirming care. Unfortunately, the federal government has not issued physical infrastructure support funding for FQHCs in 4 years. Work to ensure FQHCs are appropriately funded.
• Lobby for mental health funding in schools: Limited to no funding is provided to include development of coping skills in children. Transgender children or children exploring their gender identity are prone to depression due to social and peer stigma. Work with education lobbying efforts to ensure funding and programmatic develop of effective empathy building and coping skills building.

• Invest and research:
• Invest in and include transgender persons in research for product development; including but not limited to clinical study, marketing, and Transgender-specific research. Develop research ethics protocols for including Transgender persons in clinical research. Ensure studies include socio-economic adherence barriers among Transgender populations and meaningful strategies to overcome.
• Areas of interest may include hormonal impacts on mental health, efficacy of products among Transgender populations, hormone replacement therapy impacts on efficacy of products, and more.

• Build Partnerships:
• With Transgender-specific CBOs and Transgender serving CBOs.
• With lobbying entities working on behalf of Transgender persons
• With patient advocacy organizations working at the intersections of health disparities affecting Transgender persons; ie. HIV, STIs, addiction, etc.

Industry partners interested in learning more about implementing Transgender advocacy policy recommendations and action can contact us at info@adapadvocacyassociation.org. 

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.

NPR Examines Health Disparities Facing Former Inmates Living with HIV/AIDS

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

The inadequate approach to linking formerly incarcerated inmates living with HIV/AIDS in the United State to timely access to care and treatment gained an important spotlight. This week, National Public Radio's public health feature by Heather Boerner, "After Prison, Many People Living With HIV Go Without Treatment," draws attention to formerly incarcerated people struggling to get health care and treatment for HIV on re-entering society.

The ADAP Advocacy Association has elevated the issue among its public policy portfolio this year, highlighted by its Correctional Health Project — which has included numerous blog posts, an infographic, and forthcoming policy white paper on the role of the State AIDS Drug Assistance Programs ("ADAPs") serving these people. As noted on July 5th by our intern, Jonathan J. Pena, "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."[1]

Photo Source: Kenyon Ellsworth for NPR

Boerner's article examines a recent study about post-incarceration release and the disparities that exist in gaining access to healthcare (including anti-retrovirals medications). Unfortunately, nearly one-third of the inmates tracked had fallen out of care within one year after being released from prison or jail.[2]

It isn’t to say that incarcerated and formerly incarcerated HIV-positive populations aren’t being served by the ADAPs. According to the National Monitoring Project’s annual report, services provided to recently incarcerated individuals in 2016 shows that 42% were receiving federal funds for ADAP-related services; however, 64% of those who were currently incarcerated in county or city jails were not being provided any services because the reach of ADAP doesn’t include jail divisions.[3]

Our forthcoming policy white paper aims to shed further light on the issue, with recommendations. We commend NPR and Boerner for covering this important issue on health disparities for former inmates living with HIV/AIDS.

__________
[1] Pena, Jonathan J. (2018, July 5). Linkages to Care During Post-Incarceration. ADAP Blog. Retrieved from https://adapadvocacyassociation.blogspot.com/2018/07/linkages-to-care-during-post.html. 
[2] Boerner, Heather (2018, October 9). After Prison, Many People Living With HIV Go Without Treatment. National Public Radion. Retrieved from https://www.npr.org/sections/health-shots/2018/10/09/655890525/after-prison-many-people-living-with-hiv-go-without-treatment?utm_campaign=storyshare&utm_source=twitter.com&utm_medium=social.
[3] National Alliance of State & Territorial AIDS Directors (2018). National Ryan White HIV/AIDS Program Part B & ADAP Monitoring Project Annual Report. Retrieved from: https://www.nastad.org/sites/default/files/Uploads/2018/2018-national-rwhap-partb-adap-monitoring-project-annual-report.pdf

Did Trump Pull the Plug on ONAP & PACHA?

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

The ADAP Advocacy Association has learned from a highly credible source that the Trump Administration will not fill the vacant director position at the Office of National AIDS Policy (ONAP), nor will appointments be made for the Presidential Advisory Commission on HIV/AIDS (PACHA). These important leadership roles have remained unfilled since President Barack Obama left the White House, or soon thereafter.

Photo Source: crooksandliars.com

Earlier this year the ADAP Advocacy Association called for the appointment of an ONAP director after Amy Lansky, ONAP's last-serving director, stepped down. Subsequently, it has been an issue at the center of our advocacy efforts, including a previous ADAP Blog. It should really come as no surprise that the Trump Administration, which has proven itself to not be friendly to the HIV/AIDS community, would leave ONAP vacant. 

Equally troubling is how the Trump Administration solicited nominations for PACHA, only to file them in the trash. It begs the question: Is there no regard for our community’s input into this nation’s public health response to the ongoing epidemic here in the United States?