By Rescinding the Richardson Waiver, RFK, Jr Shuts Out Patient Advocates at HHS

By: Ranier Simons, ADAP Blog Guest Contributor

The federal government seeks input from the public to make “informed policy decisions” that affect many aspects of citizens' daily lives. A recent guidance letter from the Office of Management and Budget (OMB) concerning broadening public participation and community engagement states, “Hearing from the individuals and communities most or uniquely affected by a particular issue can help agencies better understand how to address that issue, leading to more responsive and efficient policies and programs…Federal agencies are committed to making it easier for the American people to share their knowledge, needs, ideas, and lived experiences1 to improve how government works for and with them” (OMB, 2025). Yet, a recent rule change issued by the U.S. Department of Health & Human Services (HHS) published in the Federal Register seems to be in opposition to this transparency and public discourse. The rule rescinds the current policy regarding public participation in rulemaking in many areas governed by HHS (HHS, 2025).

Photo Source: Respiratory Therapy | MEDQOR LLC

The new rule upends over 50 years of precedent. The American Procedures Act (APA) established regulations governing how agencies are to operationally issue rules and regulations, including giving the public ample opportunity to comment and provide feedback and data as rules are developed. The law carved out certain exemptions from the requirements: “matter(s) relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” (5 U.S.C. 553(a)(2)). Through the Richardson Waiver (36 FR 2532), in 1971, HHS waived the APA statutory exemptions requiring the Department to subject those matters to the APA’s notice and comment rulemaking guidelines. 

By rescinding the Richardson Waiver (McGrath, 2025), which is basically what is being done, newly minted HHS Secretary Robert F. Kennedy, Jr. effectively removes the legal mandate of meaningfully including the public in developing and implementing policies that significantly affect the lives of individuals and industries. Usually, agencies post rules in the Federal Register, open a set comment period of, on average, 60 days to receive public feedback, and then evaluate all the input before they enact finalized rules. Linda Malek, a partner at global law firm Crowell and Moring, points out, “The public comment period is an iterative and educational process that often results in changes of mutual benefit to the government and affected stakeholders (Pugh, 2025).

Numerous stakeholders are alarmed at the potential adverse consequences. Stella Dantas, MD, president of the American College of Obstetricians and Gynecologists (ACOG), said in a statement, “The practice, delivery, and regulation of medicine is incredibly complex. The experiences of patients, clinicians, administrators, and other stakeholders across medicine must be taken into account in order to avoid unintended outcomes.” She added, “Expert input from medical societies, researchers, and patient advocates is necessary "to inform regulatory bodies and ensure the soundness of final rules and other actions” (Clark, 2025).

Photo Source: Healthcare Brew | Chip Somodevilla/Getty Images

The broadness of the rule also concerns many stakeholders because it is unclear how many crucial areas of HHS policy will be affected. The rule rescinds the notice-and-comment practice for HHS “rules and regulations relating to public property, loans, grants, benefits, or contracts.” This does not apply to Medicare because Medicare falls under the provision of the Medicare Act. However, Medicaid, the Substance Abuse and Mental Health Services Administration (SAMHSA), the Administration for Children and Families (ACF), and other agencies under HHS are subject to the new rule (Clark, 2025). 

The ability to push through policies, regulations, and initiatives without partnering with the public means decisions with potentially harmful outcomes would only be public after they were finalized. At that point, the only recourse for remedy from bad policy is suing in court. Alice Bers, JD, litigation director for the Center for Medicare Advocacy, explained that the new rule attempts to avoid public comment on policies that HHS knows will be unpopular (Clark, 2025). 

Verbiage is key when it comes to legal proceedings and government regulations. The new rule states, “The extra-statutory obligations of the Richardson Waiver impose costs on the Department and the public, are contrary to the efficient operation of the Department, and impede the Department's flexibility to adapt quickly to legal and policy mandates” (HHS, 2025). This adds to the concern that the impetus for the rule is to swiftly enact policies, such as ones that would adversely affect Medicaid, that otherwise would not survive public scrutiny or would take longer to modify and implement. Samuel Bagenstos, JD, who served as general counsel to OMB and HHS during the Biden Administration, explains, "For example, if they wanted to allow work requirements under Medicaid, they could do that now ... without going through rule-changing policies" (Clark, 2025). 

Photo Source: Pinterest

HHS is a federal department that exercises policies that directly influence the health and well-being of all Americans. Transparency, communication, and public collaboration are key to ensure HHS policies are developed with the best interests of all affected stakeholders in mind. When the Richardson Waiver was first enacted, it was because there was a recognized need to include scholars, scientists, clinicians, economists, and even patients with lived experiences as part of the policy development process. HHS’s Office of the Assistant Secretary for Planning and Evaluation (Ramirez, 2023) even defines lived experience as “knowledge based on someone’s perspective, personal identities, and history, beyond their professional or educational experience” (Ramirez, 2023). 

Shutting the public out of a means of informing legislators with real-world data, expertise, and perspectives they otherwise would not have access to is a problematic way to produce public policy. Clinicians, legal experts, and patient advocates, among many others, will be watching to see how this new rule is enforced.

[1] Clark, C. (2025, March 3). New HHS Rule Wipes Out Some Public Comment on Rulemaking. Retrieved from https://www.msn.com/en-us/politics/government/new-hhs-rule-wipes-out-some-public-comment-on-rulemaking/ar-AA1AaWmQ?ocid=socialshare

[2] McGrath, C. (2025, March 4). HHS overturns 54-year-old public comment rule. Healthcare Brew. Retrieved from https://www.healthcare-brew.com/stories/2025/03/04/hhs-overturns-54-year-old-public-comment-rule

[3] Policy on Adhering to the Text of the Administrative Procedure Act, 90 FR 11029 (proposed March 3, 2025). Retrieved from https://www.federalregister.gov/documents/2025/03/03/2025-03300/policy-on-adhering-to-the-text-of-the-administrative-procedure-act

[4] Pugh, T. (2025, March 5). RFK Jr.'s Limits on Rule Comments Have Risk for Medicaid, Grants. Retrieved from https://news.bloomberglaw.com/health-law-and-business/rfk-jr-s-limits-on-rule-comments-have-risk-for-medicaid-grants

[5] Ramirez, G., et. al. (2023, January 25). What is Lived Experience?. Office of Human Services Policy, U.S. Department of Health & Human Services. Retrieved from https://aspe.hhs.gov/reports/what-lived-experience.

[6] Young, S. (2025, January 15). Memorandum for the Heads of Executive Departments and Agencies. Office of Management and Budget, Executive Office of the President. Retrieved from https://www.whitehouse.gov/wp-content/uploads/2025/01/M-25-07-Broadening-Participation-and-Engagement.pdf

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

Surge in STI Rates Cause Alarm

By: Ranier Simons, ADAP Blog Guest Contributor

Public health in the United States has been challenged heavily in recent years with the coronavirus, meningococcal disease, and monkeypox virus. Newly released data, from the U.S. Centers for Disease Control & Prevention (CDC), paints a grim picture evidenced by the rates of sexually transmitted infections (STIs) sharply increasing during this time.[1] Personal behavior choices, regarding sexual activity, are one of many factors contributing to unfavorable STI numbers. For example, research is indicating that MSM (men who have sex with men) who are taking PrEP are using condoms less.[2] The protection provided by PrEP against HIV is causing MSM to have a false sense of security even though it does not protect against other STI’s.[3] However, behavior modification is only part of the discourse towards solutions.[4] Issues with insufficient public health funding, persistent social stigma, demonizing politics, and inconsistent policy comprise the scaffolding that undergirds the increased STIs rates.

Photo Source: ACT for Youth

Recent CDC reporting of the preliminary data indicates 2.5 million reported cases of chlamydia, gonorrhea, and syphilis in 2021.[1] The numbers will increase as 2021 numbers continue to be reported in 2022. New cases of chlamydia, gonorrhea, and syphilis all increased. In 2021, syphilis infection rates reached the highest level since 1991 and the total number of cases was the highest since 1948.[5] There was a 26% increase in new syphilis infections from 2020 to 2021 in contrast to a 7% increase from 2019 to 2020.[6] The number of gonorrhea and chlamydia infections increased 4%. HIV cases also increased 16% in 2021 from 2020.[5] Increased numbers of congenital syphilis cases coincided with the increase in overall syphilis infections. Higher congenital syphilis numbers mean more child deaths, deformities, blindness, and stillbirths.[5]

Higher STI numbers indicates increases in sexual activity. Surges in sexual activity can partially be attributed to people becoming more active as covid lockdowns ended and people relaxed their social distancing practices. Data also indicates increased substance abuse during the pandemic has led to more unprotected sex and other less safe sexual practices.[5] 

Prevention and treatment are the best ways to combat STIs. However, existing barriers hamper  efforts. During the pandemic, many people lost their jobs which meant a loss of health insurance. Additionally, many free clinics paused in-person testing and some closed. Funding issues existed even before the pandemic. Elizabeth Finley, Director of Communications for the National Coalition of STI Directors states: “The programs and safety net clinics that provide essential services have long been operating on shoestring budgets and are at a breaking point – a trend accelerated by the devastating impact of COVID-19 and monkeypox…It’s long past time to increase program budgets so that they can respond to the exploding number of infections in their communities and to create a dedicated funding stream for STI clinical services.”

The federal Title X program is an example of a funding challenge. In its most recent spending bill, Congress kept the program funding flat at $286 million dollars instead of increasing it. Many state health departments and independent sexual health clinics are part of the Title X family planning program. Keeping funding flat means that the U.S. Department of Health and Human Services had to shift resources to try and reach the areas of the country with the most need. Thus, many providers in the program, in states with high STI rates, received large budget cuts.[7] Title X providers reach those who fear getting an STI test or treatment at a regular doctor’s office for fear of it showing up on insurance statements; especially youth still on parents’ insurance policies. 

Photo Source: Signature Care

Jen Laws, President and CEO of Community Access National Network, states: “Social stigma associated with sex is an extraordinary contributing factor in both the rise of STIs and the refusal of legislators to appropriately fund treatment and prevention programs. The current socio-political environment is toxic – rhetoric demonizing LGBTQ people and ignoring the educational needs of adolescents only fosters an environment where it's increasingly dangerous for patients to seek the care and advice they need to navigate a healthy sex life.”

The Biden Administration has proposed to increase Title X funding to $400 million for 2023, but that will not help the current situation. Other solutions involve the current infrastructure as well as private industry. Leandro Mena, the CDC’s director of STI prevention, suggests that drug addiction treatment facilities should add STI services, and the private sector needs to develop more effective STI tests, treatments, and vaccines.[7] Home test kits for STI’s would be a worthwhile private sector development effort. Kits will make it easier for people to find out if they have an STI as well as take steps to prevent spread in the same manner that home coronavirus test kits do.

A multi-pronged approach is required to battle surging STI rates. Proper funding is required, private sector interest and innovation is necessary, normalizing sexual health as a part of wholistic healthcare, and increasing education efforts. Even though money is a large part of the equation, a paradigm shift is also key to effective change.

[1] CDC. 2022. Preliminary 2021 STI Surveillance Data. Retrieved from https://www.cdc.gov/STI/statistics/2021/default.htm
[2] Hendrie, D. (2018, June 7). Rapid uptake of PrEP linked to declining condom use. Retrieved from https://www1.racgp.org.au/newsgp/clinical/rapid-uptake-of-prep-linked-to-declining-condom-us
[3] Nelson, R., Nagata, J. Condom Use for Anal Sex in the Era of Pre-exposure Prophylaxis (PrEP). Journal of Adolescent Health. 2022. 71(2). 245. DOI: https://doi.org/10.1016/j.jadohealth.2022.05.014
[4] Samuel, K. (2020, Nov 30). How PrEP users decide whether to use condoms. Retrieved from https://www.aidsmap.com/news/nov-2020/how-prep-users-decide-whether-use-condoms
[5] Stobbe, M. (2022, September 19). Out of control STI situation prompts call for changes. Retrieved from https://apnews.com/article/monkeypox-science-health-covid-epidemics-aaac64591251293f45c225d3fe963d0c?utm_campaign=KHN%3A%20First%20Edition&utm_medium=email&_hsmi=226604169&_hsenc=p2ANqtz-9DxmD1qskNMHydAQMYYJt6z-rEy9GkI1vckbWlm85Rf6g4BgWoG5YdpKYLf4iD7wLXHxxFxmWJ3bIHEHk5BX0HmKU0Ng&utm_content=226604169&utm_source=hs_email
6] Muller, M. (2022, September 19) Syphilis cases in the US Surged 26% last year, along with other STIs. Retrieved from https://www.bloomberg.com/news/articles/2022-09-19/us-sees-sharp-rise-in-some-sexually-transmitted-infections
7] Ollstein, A. (2022, April 12) STIs are surging. The funding to fight them is not. Retrieved from https://www.politico.com/news/2022/04/12/STIs-funding-00024678

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. 

Profiting From Misery Because They Can

By: Marcus J. Hopkins, Founder & Executive Director, Appalachian Learning Initiative

Since the passage of the Affordable Care Act (ACA) in 2010, millions of Americans have gained access to health insurance and other forms of healthcare coverage which they were previously unable to afford. According to the U.S. Department of Health and Human Services (HHS), a record 31 million Americans have access to healthcare coverage through the ACA’s Marketplace or Medicaid Expansion coverage (HHS, 2021). And yet, for a significant percentage of Americans, healthcare has not become, despite the name of the law, “affordable.”

When we talk about “affordability,” we often speak in terms of average numbers—the average costs of services and prescriptions; the average costs of insurance premiums and deductibles. By those measures, the ACA has failed:

• The cost of services has increased at an average annual rate of 3.5% per year over the past 20 years (Peter G. Peterson Foundation, 2022). Several factors contribute to this increase in costs, including the introduction of new and innovative technologies leading to more expensive procedures and products, the complexity of the U.S.’s overly complex multi-payor healthcare system that naturally leads to administrative waste, and the decrease of competition as hospital systems consolidate and take over smaller hospitals.
• The cost of prescription drugs has increased on an annual average of around 5% (Keown, 2022). Two HIV drugs, Biktarvy and Descovy (Gilead Sciences), saw price increases of 5.6% in 2021 which, according to a Gilead spokesperson, are offset by rebates and other discount programs (Keown).
• The cost of premiums has increased on an annual average of 11.6% (Antos & Capretta, 2020). Deductibles have risen dramatically, as well, increasing from an average of $2,425 in 2014 to $4,500 in 2020 for Silver Plans offered on Healthcare.gov (Antos & Capretta).

While these costs have increased at a consistent rate, the Real Median Personal Income in the U.S. has largely stagnated since the late-1990s, hovering between $30,000 and $37,000 (U.S. Census Bureau, 2022). This translates to the reality that, while the costs associated with healthcare services and treatments have increased, median incomes have not increased in conjunction to support those increased expenditures.

According to a recent report released by Peterson Center on Healthcare and the Kaiser Family Foundation, although 90% of Americans now have access to some form of health insurance coverage (private, employer-sponsored, or public), medical debt remains a persistent problem for 23 million people—nearly 1 in 10. This is especially true for Americans with lower incomes, Black Americans, and patients with significant medical needs. In terms of age, patients aged 35-64 were more likely than any other demographic to have significant medical debt. In terms of geographic location, people living in the South or in states that have not expanded Medicaid were more likely to have significant medical debt (Rae, et al, 2022). 

Other aspects of the ACA—such as the 80/20 rule, requiring insurers to spend at least 80% of the premiums they collected on medical claims—were designed to limit the profits made by insurance companies. If insurers fail to meet that percentage, they are required to rebate the difference to policyholders. In the early years of the ACA, this resulted in billions in rebates to consumers. However, insurers have successfully devised numerous schemes to ensure that consumers pay more, and insurance provider profit margins stay high.

One such mechanism involves a practice referred to as “Co-Pay Accumulator Programs.”

What Are Co-Pay Accumulators and How Do They Work?

Co-Pay Accumulator Programs are stipulations included in many private and employer-sponsored health insurance plans, often hidden in the “fine print.” Under these programs, money paid to pharmacies and healthcare providers via coupons, assistance cards, discounts, product vouchers, and other third-party sources does not count towards patients’ deductibles or out-of-pocket maximums (OPMs). Since reaching a deductible or OPM makes the insurance company responsible for any further cost of treatment and services covered under a plan, delaying these benchmarks makes patients liable for more costs, increasing the amount they end up paying for prescriptions and other services.

Co-Pay Accumulator Programs save money for insurers by passing along higher costs to patients. For instance, a patient with hepatitis C might be prescribed a direct-acting antiviral (DAA) costing $28,000 per month. Even if an industry co-pay assistance program (CAP) only covers up to 25% of the drug’s cost, meaning $7,000, then just by paying for the first $3,500 dose, the CAP will already meet the patient’s $3,000 deductible. The patient only pays a token amount out of pocket, perhaps $5, while the CAP pays the other $3,495, and all future doses are billed to the insurer.

However, if the plan includes a co-pay accumulator program, that CAP payment will not count towards meeting the patient’s deductible. Instead, the patient uses the CAP for the second dose as well, hitting the CAP maximum of $7,000 yet even then still not meeting their plan’s deductible. With no more help from the CAP, the patient then has to spend $3,000 out of pocket for the next dose before finally hitting their deductible. This saves the insurance company $10,000 by costing the patient $3,000 and the CAP $7,000 before the insurance company even begins helping to pay for the drug. (Hopkins, 2021)

It is our belief that regardless of the source of payment—be it manufacturer coupon, AIDS Drug Assistance Program, or other patient assistance organization, such as the Patient Access Network (PAN) Foundation—all payments should count toward both deductibles and OPMs.

How Many Patients Are Impacted?

According to a 2018 analysis by Zitter Health Insights, 12% of patients with commercial plans were subject to Co-Pay Accumulator Programs in 2018, with 44% of commercial plans including Co-Pay Accumulator Programs. They predicted that 40% of patients would be impacted in 2019 with that number expected to grow annually (Schweitz, 2019). Many patients who are impacted, however, are unaware that their plans contain Co-Pay Accumulators Programs in no small part due to companies using seemingly innocuous language such as “Out-of-Pocket Protection Program” (Express Scripts), “True Accumulation” (Caremark), or “Coupon Adjustment: Benefit Plan Protection Program” (UnitedHealthcare) (Hopkins, 2021).

Photo Source: The Matrix Consulting, LLC

How Can We Address Co-Pay Accumulators?

At the end of 2021, only state-level action had been successfully undertaken to prohibit the inclusion of Co-Pay Accumulator Programs, with twelve states and Puerto Rico having passed such legislation:

• Arizona (HB 166)
• Arkansas (HB 569)
• Connecticut (SB 003)
• Georgia (HB 946)
• Illinois (HB 0465)
• Kentucky (SB 45)
• Louisiana (SB 94)
• North Carolina (SB 257)
• Oklahoma (HB 2678)
• Tennessee (HB 0619)
• Virginia (HB 2515)
• West Virginia (HB 2770)

In 2022, eleven states have introduced legislation to address Co-Pay Accumulators (that the author was able to find):

• District of Columbia (B24-0557)
• Florida (SB 1480) – FAILED; (HB 1063) – FAILED
• Iowa (H 2384)
• Maine (SP 621)
• Minnesota (SF 2136)
• Mississippi (HB 880) – FAILED; (SB 2470) – FAILED
• Missouri (SB 1031)
• New York (A1741); (SB 5299) – FAILED
• South Carolina (H 4987)
• Utah (SB 139) – FAILED
• Washington state (HB 1713) – FAILED; (SB 5610) – PASSED

In addition to state-level actions, Congress recently introduced the Help Ensure Lower Patient (HELP) Copays Act (H.R 5801). The HELP Copays Act, sponsored by Rep. A. Donald McEachin (D-VA-04), would ban co-pay accumulator programs by:

• Updating the Affordable Care Act’s (ACA) definition of cost-sharing to require that all out-of-pocket payments made by or on behalf of a patient count toward the patient’s deductible and out-of-pocket limit. This would end co-pay accumulator programs in marketplace exchange insurance plans. 
• Stipulating that any item or service covered by an employer health plan is part of the essential health benefits (EHB) package and therefore the plan must count any cost sharing toward patients’ annual limits. This would end the ACA’s EHB loophole that allows plans to deem certain categories of drugs as non-essential.

This addition to the ACA would require insurers to count co-pay assistance paid by any third party on behalf of the patient toward their insurance deductible or out-of-pocket maximum (Immune Deficiency Foundation, 2021). The bill has bipartisan support with 20 co-sponsors and 116 state and national organizations sent a sign-on letter via the All Copays Count Coalition to Secretary of Health and Human Services, Xavier Becerra, in support of the HELP Copays Act.

Whom Should We Contact?

While federal legislators continue to work on the HELP Copays Act, people can (and should) reach out to their state legislators to pass legislation at the state level to prohibit insurers from implementing Co-Pay Accumulators by any name. They may find their state legislators online.

At the federal level, the HELP Copays Act continues to sit in the House Committee on Energy and Commerce. People should reach out to their Congressional Representatives, which they may find here.

In addition to contacting members of the House, we urge patients to contact their Senators to ask for a companion bill to be introduced in the Senate. They may find their contact information here.

The ADAP Advocacy Association, Patient Access Network Foundation, and The Matrix Consulting, LLC, invite you to direct your elected representatives to the PAN Foundation’s excellent campaign:

End harmful co-pay accumulator programs online at https://www.panfoundation.org/end-copay-accumulators/.

References:

• Anton, J. R. & Capretta, J. C. (2020, April 10). The ACA: Trillions? Yes. A Revolution? No. Washington, DC: Health Affairs Blog: Health Affairs Forefront. https://www.healthaffairs.org/do/10.1377/forefront.20200406.93812/full/
• Keown, A. (2022, January 04). Drug Price Increases for 460 Drugs in 2022. Urbandale, IA: BioSpace. https://www.biospace.com/article/a-new-year-means-price-increases-for-many-prescription-drugs/
• Peter G. Peterson Foundation. (2022, February 16). WHY ARE AMERICANS PAYING MORE FOR HEALTHCARE? New York, NY: Peter G. Peterson Foundation: Blog. https://www.pgpf.org/blog/2022/02/why-are-americans-paying-more-for-healthcare
• Hopkins, M. J. (2021, April 07). How “Co-Pay Accumulators” Stifle Healthcare Access and Empty Patients’ Wallets. Lost River, WV: Community Education Group: Rural Health Service Providers Network: Publications. https://secureservercdn.net/198.12.144.78/m60.322.myftpupload.com/wp-content/uploads/CoPay_Accumulators-FINAL.pdf
• Immune Deficiency Foundation. (2021, December 02). Support the HELP Copays Act and fight unfair copay accumulators. Towson, MD: Immune Deficiency Foundation: News. https://primaryimmune.org/news/support-help-copays-act-and-fight-unfair-copay-accumulators
• Rae, M., Claxton, G., Amin, K., Wager, E., Ortaliza, J., & Cox, C. (2022, March 10). The burden of medical debt in the United States. Peterson-KFF Health System Tracker. https://www.healthsystemtracker.org/brief/the-burden-of-medical-debt-in-the-united-states/?_hsmi=206419781&_hsenc=p2ANqtz--ts2CCK83uE9bi6lOcPJxnqqO0KQG5tOHocn9uAhHCAiYGFqKj4-5sQwvC4s15sMUuMqmLSQsg_QORW4rajQjwpITJZg&utm_campaign=KFF-2022-Health-Costs&utm_medium=email&utm_content=206419781&utm_source=hs_email
• Schweitz, M. C. (2019, January 22). The Cost-Shift Conundrum of Copay Accumulator Programs. Thorofare, NJ: Healio: News: Rheumatology: Practice Management. https://www.healio.com/news/rheumatology/20190114/the-costshift-conundrum-of-copay-accumulator-programs
• United States Census Bureau. (2022, March 11). Real Median Personal Income in the United States [MEPAINUSA672N]. Retrieved from FRED, Federal Reserve Bank of St. Louis. https://fred.stlouisfed.org/series/MEPAINUSA672N
• United States Department of Health and Human Services. (2021, June 05). New HHS Data Show More Americans than Ever Have Health Coverage through the Affordable Care Act. Washington, DC: U.S. Department of Health and Human Services: About HHS: News. https://www.hhs.gov/about/news/2021/06/05/new-hhs-data-show-more-americans-than-ever-have-health-coverage-through-affordable-care-act.html

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.

HIV & Diabetes

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

Diabetes is a disease all too familiar in the United States. Those who are of older age, have family history of the disease, and are overweight are at high risk of developing either Type 1 or Type 2 diabetes at some point in their lifetime. One risk factor that is not spoken on is the risk HIV positive persons being more likely to have Type 2 diabetes. 

Statistics released by the U.S Department of Health and Human Services ("HHS") recommend those living with HIV should have blood glucose levels checked before starting treatment with HIV medications, as some may need to avoid certain medications if they have higher blood glucose levels.

Photo Source: extremetech.com

While people living with HIV/AIDS are at a higher risk of developing Type 2 diabetes, it can be prevented and managed properly. HHS recommends maintaining a healthy weight, eating healthy and adding physical activity to one’s daily routine. However, for HIV-positive patients who already have diabetes, finding proper medications for HIV that work alongside diabetes medication can be difficult. 

“As antiretroviral therapy is now recommended for all patients regardless of CD4 T lymphocyte (CD4) cell count, and because therapy must be continued indefinitely, the focus of patient management has evolved from identifying and managing early antiretroviral-related toxicities to individualizing therapy to avoid long-term adverse effects, including diabetes and other metabolic complications, atherosclerotic cardiovascular disease, kidney dysfunction, bone loss, and weight gain,” HSS said on its website. 

Predisposed conditions also put individuals at risk of adverse effects of ARV medications for HIV: these include underlying liver disease, viral hepatitis, psychiatric disorders and genetic factors. Finding an effective regimen for HIV that works alongside other medications is a tricky business, according to the HHS.

“Switching a patient from an effective ARV agent or regimen to a new agent or regimen must be done carefully and only when the potential benefits of the change outweigh the potential risks of altering treatment. The fundamental principle of regimen switching is to maintain viral suppression,” HHS said. (HHS, 2019)

In 2018, a cross sectional study looking at people living with HIV/AIDS in London was held to determine prevalence and risk factors for type two diabetes. Alastair Duncan and his colleagues discovered that the prevalence of Type 2 diabetes was alarmingly high. One in three patients had pre-diabetes or Type 2 diabetes. (Duncan, A., Goff, L., & Peters, B.)

“The duration of HIV infection, ARV treatment and particularly the use of metabolically toxic ARVs, weight gain following initiation of ARVs, and the presence of lipodystrophy are all significantly associated with an increased risk of dysglycaemia,” Duncan said.

This high prevalence of Type 2 diabetes in HIV-positive patients requires improved screening targeted to older patients, according to Duncan’s study. Antiretrovirals cause weight gain, which can in turn greatly increase the chance of developing Type 2 diabetes. (NIH, 2019).

People living with HIV/AIDS who are concerned about the chance of developing diabetes should speak to their primary care provider about solutions and new medications to look at. 

References:

• Duncan, A., Goff, L., & Peters, B. (2018, March 12). Type 2 diabetes prevalence and its risk factors in HIV: A cross-sectional study. Retrieved July 29, 2020, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5847234/
• Adverse Effects of ARV Limitations to Treatment Safety and Efficacy Adult and Adolescent ARV. (2019, December 18). Retrieved July 29, 2020, from https://aidsinfo.nih.gov/guidelines/html/1/adult-and-adolescent-arv-guidelines/31/adverse-effects-of-arv
• HIV and Diabetes Understanding HIV/AIDS. (2019, October 18). Retrieved July 29, 2020, from https://aidsinfo.nih.gov/understanding-hiv-aids/fact-sheets/22/59/hiv-and-diabetes

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.

'Conscience Rule' Dead...For Now

By: Sarah Hooper,  intern, ADAP Advocacy Association, and rising senior at East Carolina University

In early November 2019, a federal district judge voided the ‘Protecting Statutory Conscience in Healthcare’, declaring it was unconstitutional, in a defeat for the Trump Administration. The former rule had allowed healthcare workers to refuse to perform lifesaving medical procedures on patients based on their personal moral and religious beliefs.

The CEO of the National Women’s Law Center, Fatima Goss Graves, released a statement shortly after the ruling was announced, stating: “We are thrilled that the court saw the Trump-Pence refusal of care rule for what it is- unlawful, discriminatory, and an unconscionable attack on our health care.” (News@Jama)

The U.S. Department of Health & Human Services ("HHS") promulgated the regulation, which delved into hot topic issues including abortion and assisted suicide.

Photo Source: MedPage Today

"This rule ensures that healthcare entities and professionals won't be bullied out of the health care field because they decline to participate in actions that violate their conscience, including the taking of human life," said HHS Office of Civil Rights Director Robert Severino after the initial law was brought up. (NPR)

Had the law been ruled constitutional, it would have applied to both state and local governments and public and private healthcare. Those under Medicare of Medicaid would have been affected as well, impacting nearly 74 million people in the United States. (Statistica)

The final ruling would have allowed health care professionals to deny services constitutionally protected, such as abortion, treatment to the LGBTQ+ community, and others. The ruling would have allowed parents to object care on religious or moral grounds for their children- including suicide prevention, child abuse prevention, and vaccines.

For the many people, this is not the first time their access to healthcare has been threatened. Since the HIVAIDs epidemic first took place in the 80s, doctors and communities alike have alienated patients from treatment for fear of transmission. Since then, medical practices have improved care for HIV-infectio drastically, but the HHS law threatened to endanger more lives.

Currently a federal court case in Wisconsin is claiming violation of federal and state anti-discrimination laws. When an HIV positive woman sought treatment for a necessary gallbladder surgery, the surgeon denied the surgery because he was worried about HIV exposure to his medical team. Another hospital then removed her gallbladder in a “routine surgical procedure, which includes universal precautions taken to prevent the transmission of bloodborne pathogens such as HIV,” said the AMA Journal of Ethics. (AMA)

According to a study conducted by the National Women’s Law Center, approximately 8% of LGB individuals, nearly 27% of transgender and nonconforming individuals, and almost 20% of HIV-positive individuals report being denied needed healthcare outright. In another case, a 53-year old man was denied a kidney transplant by his insurance company because of his HIV-positive status, putting his life at risk. (NWLC)

“A patient with HIV who was admitted to a hospital reported that after he disclosed that he had sex with men, the hospital staff ignored him, refused to allow his family to visit, and did not honor his requests for his HIV medication.16 The doctor at the hospital told the patient’s personal doctor, “This is what he gets for going against God’s will” and “You must be gay, too, if you’re his doctor.”17 Despite explaining to the nurses the importance of taking his HIV medication, the patient missed five doses.18 Because some HIV medications are highly time-sensitive, a missed or delayed dose can make the medicine less effective or even completely ineffective,” said NWLC.

“Two judges in two days have recognized the Denial of Care Rule for what it is, an egregious and unconstitutional attack on women, LGBT people and other vulnerable populations. The Denial of Care Rule targets some of our most marginalized and vulnerable communities and deserves to be relegated to the dustbin of history,” said Jamie Gliksberg, a senior attorney at Lamda Legal, after the law was ruled unconstitutional.

References:

• Anderson JD, Bebe J. (December 2019). HIV Stigma and Discrimination Persist, Even in Health Care. AMA Journal of Ethics. Retrieved online at https://journalofethics.ama-assn.org/article/hiv-stigma-and-discrimination-persist-even-health-care/2009-12. 
• Gever, John (2018, November 6). Federal Judge Voids 'Conscience Rule' - Policy would have allowed providers to refuse care because of "moral objections". MedPage Today. Retrieved online at https://www.medpagetoday.com/publichealthpolicy/healthpolicy/83166?xid=NL_breakingnewsalert_2019-11-06&eun=g1295317d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=ConscienceAlert_110619&utm_term=NL_Daily_Breaking_News_Active. 
• Gostin, Lawrence O. (2019, May 15). JAMA Forum: The “Conscience” Rule: How Will It Affect Patients’ Access to Health Services? JAMA. Retrieved online at https://newsatjama.jama.com/2019/05/15/jama-forum-the-conscience-rule-how-will-it-affect-patients-access-to-health-services/.
• Kodjak, Alison (2019, May 2). New Trump Rule Protects Health Care Workers Who Refuse Care For Religious Reasons. NPR. Retrieved online at https://www.npr.org/sections/health-shots/2019/05/02/688260025/new-trump-rule-protects-health-care-workers-who-refuse-care-for-religious-reason.
• Mikulic, Matej (2018, October 26). Medicaid - Statistics & Facts. Statista. Retrieved online at https://www.statista.com/topics/1091/medicaid/. 
• National Women's Law Center (May 2014). Health Care Refusals Harm Patients: The Threat to LGBT People and Individuals Living with HIV/AIDS. Retrieved online at https://nwlc.org/wp-content/uploads/2015/08/lgbt_refusals_factsheet_05-09-14.pdf. 

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

DHHS Reports That Majority Of Data Breaches Expose Non-Health-Related Data

By: Marcus J. Hopkins, Policy Consultant

The U.S. Department of Health and Human Services released on September 23rd, 2019, a report in the Annals of Internal Medicine that found that the majority of information accessed in the over 1,500 protected health information (PHI) breaches reported over the last decade has been sensitive demographic information (e.g. – driver’s license number and Social Security Numbers – SSNs) and financial information including billing and payment information (Hlavinka, 2019). Only 2% of data breaches were found to expose sensitive medical information, such has HIV status, cancer diagnoses, or substance abuse, but 65% of these breaches exposed general medical or clinical information (Hlavinka).

According to the findings, over half of data breaches reported to HHS could be attributed to healthcare providers’ personal mistakes or negligence. This could include anything from failing to encrypt laptops, to using “CC” instead of “BCC” when E-mailing patients (Hlavinka).

Photo Source: evidencesolutions.com

HHS proposed regulatory, in March 2019, that would modernize the way that health information is shared by implementing certain provisions of the 21st Century Cures Act, including increasing the amount of data that is entered and shared electronically. The fundamental tradeoff of this modernization, however, is that health data will naturally become more susceptible to exposure. This last point is increasingly concerning considering the recent increase in so-called “Ransomware” cyber-attacks against public computer systems. Campbell County Health in Gillette, Wyoming, was hit, this month, with one such cyber-attack affecting all 1,500 of the systems computers, including the E-mail server, which resulted in the CCH having to divert patients from ERs starting on September 20th, 2019, as well as cancelling many exams, procedures, and new patient admissions (Landi, 2019).

Healthcare systems remain one of the largest targets of hackers, and while ransomware attacks, themselves, do not access private information, instead denying access to information, the potential exists for hackers to jump from denying access to exposing sensitive data if ransoms are not paid.

These data presented by HHS come on the heels of a recent settlement announcement in the state of Ohio between state AIDS Drug Assistance Program (ADAP) clients and CVS Health, the company contracted to provide prescription drug benefits, after a CVS mailer to OHDAP (Ohio’s ADAP program) clients in an envelope that clearly announced clients’ HIV status (Hopkins, 2017). In our August 2017 coverage of this issue, one of the plaintiffs, Eddie Hamilton, head of the ADAP Educational Initiative, shared with us the envelope he received (unredacted) which clearly listed his ID number as: “PM 6402 HIV”.

“In our case, CVS used our Ryan White CAREWare numbers as their subscriber numbers,” Hamilton told me. “It has our birthdates embedded in that URN (Unique Record Number), which is not HIPAA compliant. So, not only was our HIV status on the mailer, but our names, addresses, and birthdates all visible to anyone who looked at the envelope. I do not think that the Health Resources and Services Administration (HRSA) is even aware that those numbers are being used for public consumption.”

The CVS settlement, which has yet to receive approval from a judge, agrees to pay out $4.4 million to settle the class-action lawsuit filed in June 2018 by the roughly 4,500 patients impacted. Under the settlement, each recipient of the mailer would receive a minimum of $400, those who can show they suffered non-financial harm can get as much as $2,500, and those who can prove they suffered financial harm can receive up to $10,000. The lawyers representing the plaintiffs may receive up to $1.46 million – over a third of the overall reward (Anderson, 2019).

Photo Source: UpGuard

The agreement language, itself, include some troubling clauses, such as clause 10.19 which reads:

"10.19 Non-Disparagement. The Parties and their counsel agree that neither the fact that Caremark entered into this Settlement Agreement nor its terms shall at any time, directly or indirectly, be used to disparage Caremark’s administration of OhDAP. For purposes of this Section, the term “disparage” shall mean to make comments or statements that would adversely affect the business or professional reputation of Caremark. Nothing in this Paragraph or any other Paragraph of the Agreement, precludes the Parties or their Counsel from (a) referring to public information about the above-captioned litigation, Settlement, or other publicly available documents; (b) responding to any subpoena, legal process or request for information from any governmental authority; (c) testifying truthfully under oath pursuant to any lawful court order or subpoena; or (d) pursuing any legal right they may have against each other. Nothing in this paragraph or any other paragraph of this Agreement precludes Counsel for Plaintiffs from making statements regarding signatories to this Agreement in the context of pursuing a claim or lawsuit. Nothing in this paragraph or any other paragraph of the Agreement shall be construed to restrict the right to practice in violation of applicable Rules of Professional Conduct."

Non-Disparagement clauses are frequently used as tools to prevent those who agree to settle from going public with their personal stories, particularly in the event that they come to feel that the amount they received in the settlement is not sufficient to cover their injury.

In addition to the Non-Disparagement clause, the settlement includes no admission of guilt – a common practice in settlement agreements. This, to my way of thinking, is unconscionable. CVS’ negligence in this matter had the potential to result in long-lasting impacts, both personally and financially, for those whose statuses were exposed in their mailers. That no party involved in the decision to use “HIV” in the member ID numbers – not OHDAP, not the Ohio Department of Health, and certainly not CVS Caremark – is willing to admit to wrongdoing despite clearly having done wrong is worthy of disparagement.

The reality of living in the 21st Century is that, the further along we go, the more information about us is going to be accessible to others. Data breaches have always occurred and oftentimes, it can be the result of a simple mistake. The question then becomes, “How much security are we willing to sacrifice in the name of expedience?”

Personally, because I’m very vocal and open about my status and personally invite any hacker to try to use my SSN to gain access to credit (best of luck, suckers! The joke’s on you [Marcus goes to cry over his poor credit rating]), as well as the fact that I have a tendency to relocate pretty frequently, I prefer the ease of data mobility. Others, however, are not so open, and for them, the risk of exposure – while, according to the HHS data, is slim – presents a far more daunting choice.

References:

• Anderson, Maia. (2019, September 13). CVS to pay $4.4M settlement over inadvertent HIV disclosure of 4,500 patients. Chicago, IL: Becker’s Healthcare: Becker’s Hospital Review: Pharmacy. Retrieved from: https://www.beckershospitalreview.com/pharmacy/cvs-to-pay-4-4m-settlement-over-inadvertent-hiv-disclosure-of-6-000-patients.html
• Hlavinka, E. (2019, September 23). Health Data Breaches Give Up SSN, Not HIV Status - Just 2% involved sensitive medical information. New York, NY: MedPage Today, LLC: MedPage Today: Public Health & Policy: Practice Management. Retrieved from: https://www.medpagetoday.com/publichealthpolicy/practicemanagement/82332
• Hopkins, M.J. (2017, August 28). HIPAA: Healthcare mailers violate privacy rights of people living with HIV. Washington, DC: Community Access National Network: HEAL Blog. Retrieved from: https://communityaccessnationalnetwork.wordpress.com/2017/08/28/1498/
• Landi, H. (2019, September 23). Wyoming health system hit with ransomware attack, diverts ER patients and cancels services. Framingham, MA: Questex, LLC: Fierce Healthcare: Tech. Retrieved from: https://www.fiercehealthcare.com/tech/campbell-county-health-wyoming-hit-ransomware-attack-diverts-er-patients

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.

Trump HHS Proposes Eliminating Most Non-Discrimination Protections of Section 1557

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

On June 14th, 2019, the Trump administration issued a near complete regulatory overhaul of the Patient Protection and Affordable Care Act’s (ACA) non-discrimination provisions known as Section 1557. The issued proposed rule began a 60-day public comment period, ending on August 13th, 2019.

Photo Source: thompsoncoburn.com

The public may submit comment using the following link to the Federal eRulemaking Portal: https://www.regulations.gov/comment?D=HHS-OCR-2019-0007-0001.

Or by regular, overnight, express mail, hand delivery or courier to the following address:

U.S. Department of Health and Human Services
Office for Civil Rights
Attn: Section 1557 NPRM, RIN 0945-AA
Hubert H. Humphrey Building, Room 509F
200 Independence Ave. SW
Washington, DC 20201

For a background, please visit our previous blogpost here (Laws, 2018): https://adapadvocacyassociation.blogspot.com/search?q=1557.

Stating the Trump Administration’s proposed changes to Section 1557 are a revision would be misleading. A lie actually. The proposed rule seeks to so drastically change the regulatory interpretation and applicable federal agency guidance so much, that one can only adequately describe the changes as eliminating any meaningful sense of protection offered by the Obama Administration’s interpretation.

The case made by the U.S. Department of Health & Human Services ("HHS") for these changes is embarrassingly weak. Relying near exclusively on the Trump Administration’s own refusal to defend the regulation in Franciscan Alliance, Inc. et al v. Burwell, which resulted in an unchallenged injunction issued by Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas and a second ruling from a federal district in North Dakota - which relied on the Franciscan Alliance decision. By taking an intentionally flawed approach, the listed changes would have a wide impact, including eliminating protections affecting transgender people, women, reproductive care in general, people living with HIV, people with disabilities, people who speak and read any language other than English as a primary language, and more. The move builds upon the Trump Administration’s efforts to not only reshape the judicial landscape in a politically motivated fashion but to do so with precise aims, including eliminating the ACA entirely (see Texas v. United States, another Reed O’Connor ruling – this should tell you something about “court shopping”).

If you haven’t read Nicholas Bagley’s Atlantic piece, “Rise of the Know-Nothing Judge”, you really should (Bagley, 2019). This legal philosophy is being leveraged specifically by both the judges hearing the cases and the political appointments seeking to eliminate these necessary protections in healthcare. The story goes fairly simply as “we couldn’t possibly know what Congress was thinking (despite recent and public statements to the fact on certain votes and legislation) because it wasn’t spelled out explicitly and narrowly.” This is an effort to push issues of patient protections (and other issues) to a dysfunctional Congress. This approach also explicitly seeks to push legislation, which by its very nature is not supposed to be prescriptive, into an exceptionally prescriptive design or risk non-enforcement. Overall, the process removes the role of government in regulating and protecting tax payers entirely when applied broadly. This Administration will achieve the goal of eliminating necessary government intervention by weakening public trust and establishing court precedent to inaction.

In the case of a Section 1557 re-write, HHS ignores previous precedents that stretch back 30 years (Price Waterhouse v. Hopkins) to rulings as recent as 2017 (Prescott v. Rady Children’s Hospital) which rely on the plain language of the statue due to previous precedent, not the regulatory interpretation provided by the Obama Administration. HHS goes on further to ignore recent rulings both on issues of sex stereotyping as a form of sex-based discrimination and gender identity as an issue of sex by the nature of gender identity being a part of our medical definition of sex. HHS expands further by stating that even if gender identity were an issue of sex, “Religious Freedom” and its own “Conscience” regulations should allow all entities governed by HHS regulations to deny coverage and care even on the basis sex. As such, that denial of care extends in such a way that would eliminate the pre-existing conditions protections of women in the case of pregnancy history, termination of pregnancy, false pregnancy, and genetic history. Instances of care denial that were routine prior to the ACA’s pre-existing conditions protections requirements.

Kaiser Family Foundation argues the explicit nature of these interpretations including non-protection of sex stereotyping could result in antiretroviral treatment being denied coverage by an insurance company or a provider refusing to provide care to a person living with HIV because of assumed sexual activities with a same-sex partner. The interpretation removes the right of private action so coveted by patient advocates when section 1557’s original interpretation was written; meaning patients would no longer have either an administrative path to seek remedy or an explicit endorsement of HHS to go the path of the courts to seek remedy when harmed by care and coverage denials (Musumeci, 2019).

If this sounds like a wild, wild west situation of health care and insurance structures prior to the ACA, it is. That’s the goal, the campaign promise of Donald J. Trump. While the ACA certainly needs some work, consistently, the American public, regardless of political affiliation has polled support of health care protections the ACA provides. Like a mob thug in sneaking into a back alley, this Administration is using every angle to knee cap the protections afforded by the ACA, with intentional efforts to harm those who need those protections the most.

Lastly, of particular note, HHS states in the proposed regulation, as it has in every other regulatory change affecting civil rights protections, that disparate impact does not equate to intentional discrimination. Having historical data, predictive data that already guides our funding appropriations and distribution that is so pin-point precise the government – nay, THIS Administration relies on some of the very same data to focus funding its own Ending The Epidemic plans (HIV.gov, 2019), how can we not interpret knowingly and intentionally ignoring the same data as “unintentional” when other regulatory moves by this Administration seek to allow providers and insurers to deny care and coverage to PLWH just a whim?

We live in the day and age of Big Data, disparate impact is now intentional impact.

This effort to harm is intentional.

Comment today to ensure your voice is heard! Call your Congress member. Support your patient advocacy organizations by dollar and deed. We’re in a fight for our lives here, one court ruling and one regulation at a time.

References:

• Bagley, Nicholas (2019, July 15). Texas v. United States: Rise of the Know-Nothing Judge. The Atlantic. Retrieved online from https://www.theatlantic.com/ideas/archive/2019/07/texas-v-us-rise-know-nothing-judge/593959/
• HIV.gov (2019, June). Ending the HIV Epidemic: A Plan for America. Retrieved online from https://files.hiv.gov/s3fs-public/ending-the-hiv-epidemic-flyer.pdf
• Laws, Jen (2018, February 22). Trump & HHS Sanction Healthcare Discrimination. ADAP Blog. Retrieved online from https://adapadvocacyassociation.blogspot.com/2018/02/trump-hhs-sanction-healthcare.html
• Musumeci, MaryBeth, et. al. (2019, June 1). HHS’s Proposed Changes to Non-Discrimination Regulations Under ACA Section 1557. Henry J. Kaiser Family Foundation. Retrieved online from https://www.kff.org/disparities-policy/issue-brief/hhss-proposed-changes-to-non-discrimination-regulations-under-aca-section-1557/
• United States District Court for the Southern District of California (2017, October 13). Case No.: 16-cv-02408-BTM-JMA. Retrieved online from https://www.ebglaw.com/content/uploads/2017/10/Prescott-v.-Rady-Children_s-Hospital-San-Diego_-2017-U.S.-Dist.-LEXIS-160259.pdf

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

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.

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.