Reflections from an HIV Advocate's Journey: Mark Janes

By: Mark Janes, California Advocate

My journey with HIV began in 1995, and I still remember the first time I discussed AIDS publicly, in a Speech Communication class I was attending, in 1997. The final segment was to be a Persuasion speech, and I decided to speak in favor of expanding resources for the prevention of, and more support for those living with, AIDS. My first line was, My name is Mark Janes, and I am a person living with AIDS.” I went on to discuss why prevention was money well spent, research our best hope, and why those who have it deserve support and compassion.

I had numerous struggles with opportunistic infections, including chemo for Kaposi’s Sarcoma, which was relatively mild in me, but not entirely invisible. I agreed to be involved in numerous drug trials, some of which were truly hard (like eight large capsules at a time), and at least one of which is now listed as an allergen on my chart. I remember the summer of 2002 receiving a call from my HIV pharmacist, offering a trial for a drug then called T-20, that was injected twice daily. Six months of that finally gave me viral control. The day that blood was drawn was March 3, 2003.

My re-entry into the world of HIV support and advocacy began on Facebook; I was poking around in a few HIV Groups there, when a woman by the name “Maria HIV” asked me if I would be willing to help her admin a new Group she’d started, “International Group for people with HIV/AIDS, and the people who love us.” At that time it had maybe 400 members; it currently has around 14,000 and is among the largest of its kind on Facebook. I soon found myself answering all sorts of questions from around the globe, and have learned many valuable lessons both from Maria Mejia and from the Group as a collective.

It was Eddie Hamilton who suggested that I apply to attend the ADAP Advocacy Association’s annual Conference in Washington, DC. I did so, and was approved for a partial scholarship; my parents paid for my airfare. It was the first time I’d flown since 1999, and an extraordinary welcome back: Virgin America Flight 1, from San Francisco to Washington National; a World War II Honor Flight- veterans going to see the newly-completed memorial. The flight left on time and arrived a few minutes early. The vets were treated like royalty and the rest of us weren’t forgotten. The plane was showered by the airport fire trucks on arrival. But the best was yet to come: I was paired with Bob Skinner, who is both a strong advocate and a really good man in general. I learned a lot, and grew a lot, that first time. It made me more effective online.

The following year I attended AIDSWatch, and actually met my Congressman; he was gracious enough to give us a couple minutes of his time. That September I attended USCA, and had a impromptu teaching moment with the TSA as I was going through security at Washington National. The agent told me he “felt something loose on my upper thigh” and that secondary screening was needed. We went into a small room, I pulled my pants down, and showed him the loose skin, “From just under a decade of injecting Fuzeon twice a day, to treat HIV.”

I hear from people newly diagnosed from all around the globe on an almost daily basis. I do my best to offer advice that is as accurate as possible, and I also believe it’s important that our representatives in Congress are aware of our existence and what our needs are. Simply put, no government tries to just dump money on random items; there needs to be a call, a demand, for resources. I still believe that people speaking out and asserting their needs, is part of living in a nation like the United States, and my main issue is HIV.

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.

New Study Demonstrates Value of Tesamorelin for Non-Alcoholic Fatty Liver Disease

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

The ADAP Advocacy Association since its inception has advocated for more open drug formularies under the AIDS Drug Assistance Program ("ADAP") because they promote greater access to care and treatment for people living with HIV/AIDS. By omitting therapies that are approved by the U.S. Food & Drug Administration ("FDA") for the treatment of HIV-infection and related co-morbidities, some State ADAPs are being counter-productive to the needs of the people they're intended to serve. One example is the unfair limitation often put on the drug tesamorelin for the treatment of lipodystrophy. A new study published online in The Lancet shows promise for non-alcoholic fatty liver disease, and as such it might finally change some opinions about adding it to drug formularies.

Photo Source: Drugs.com

Current restrictions on the use of tesamorelin do a disservice to the needs of people living with HIV/AIDS, and diagnosed with HIV-related abnormal accumulation of visceral adipose tissue (VAT) by concluding that the potential discontinued use of tesamorelin and its “expense” is limited its use. Yet, research has shown that between 20% and 30% of HIV-positive patients are experiencing excess VAT. For years, there's been a common misconception that this belly fat is just a physical cosmetic issue that is a side effect of earlier HIV treatments - something that must be accepted as a reality of now living longer with HIV-infection. Recent research dispels that myth so that even with newer anti-retro viral regimens this condition continues to exist.

Some states, such as Massachusetts, have long recognized the value of tesamorelin - not only within its ADAP drug formulary, but by also mandating treatment for HIV-related lipodystrophy for private insurance. The Massachusetts model was largely based on the FDA's findings: “The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy. The presence of excess fat with this condition may contribute to other health problems as well as affect a patient’s quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important.”[1]

The new study - "Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial" - yielded positive results, such as demonstrating tesamorelin can reduce liver fat and prevent scarring of the liver.[2]

According to the study, "Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD."[3]

The study's findings concluded:

"61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of −4·1% (95% CI −7·6 to −0·7, p=0·018), corresponding to a −37% (95% CI −67 to −7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localized injection site complaints than those in the placebo group, though none were judged to be serious."[4]

These findings bode well for people living with HIV/AIDS, especially as it relates to co-morbidities such as cardiovascular and type 2 diabetes risks. Now it is time for more State ADAPs to take notice.



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[1] U.S. Food & Drug Administration (2010, November 10). FDA approves Egrifta to treat Lipodystrophy in HIV patients. U.S. Department of Health & Human Services. Retrieved online at https://aidsinfo.nih.gov/news/889/fda-approves-egrifta-to-treat-lipodystrophy-in-hiv-patients---november-10--2010.
[2] Brokaw, Sommer (2019, October 15). NIH: Drug reverses liver fat, slows fibrosis in HIV-positive people. UPI. Retrieved online at https://www.upi.com/Health_News/2019/10/15/NIH-Drug-reverses-liver-fat-slows-fibrosis-in-HIV-positive-people/8621571156412/?sl=3.
[3] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.
[4] Stanley, MD, Takara L*, Lindsay T Fourman, MD*,. Meghan N Feldpausch, ANP, Julia Purdy, CRNP, Isabel Zheng, BS, Chelsea S Pan, BA, et al. (2019, October 11). Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial. The Lancet. Retrieved online at https://www.thelancet.com/journals/lanhiv/article/PIIS2352-3018(19)30338-8/fulltext.

Medicare's Low-Income Subsidy Program

By: Amy Niles, Vice President, External Relations, Patient Access Network (PAN) Foundation

Access to medically necessary healthcare is critical for successful patient outcomes, yet access is often impeded or blocked entirely by high deductibles, co-pays and coinsurance. These out- of-pocket (OOP) costs hit low-income seniors especially hard. For economically vulnerable Medicare beneficiaries and people with disabilities, the Low-Income Subsidy (LIS) program is a critical safety net that helps cover OOP costs for prescription drugs. The PAN Foundation's Issue Brief describes the LIS program, how it helps low-income seniors and people with disabilities, and what more can be done to ensure that OOP drug costs do not prevent these beneficiaries from getting the treatment they need.

WHAT IS THE LIS PROGRAM AND WHO IS ELIGIBLE?

All Medicare beneficiaries are eligible for prescription drug coverage through Medicare Part D drug plans. Medicare beneficiaries with low incomes and very few assets (e.g. bank accounts, stocks, bonds, etc.) as well as some people with disabilities may qualify for the LIS program, which helps cover OOP prescription drug costs. Also called “Extra Help,” the LIS program shields economically vulnerable and disabled beneficiaries from high OOP drug costs by helping them pay for monthly premiums, annual deductibles and co-payments for prescription medications obtained through Medicare prescription drug programs.[1]

The LIS program is divided into two parts: the “Full LIS program” and the “Partial LIS program,” and they differ based on who is eligible, how people enroll, and how much support the program provides for OOP drug costs.

To learn more about the LIS program, download the PAN Foundation's Issue Brief 11 - Medicare’s Low-Income Subsidy Program.

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.

HRSA Releases Inaugural Ryan White Patient-Level Report

By: Marcus J. Hopkins, Policy Consultant

The Health Resources and Services Administration (HRSA) – the U.S. government organization responsible for overseeing the Ryan White HIV/AIDS Program and the AIDS Drug Assistance Program (ADAP) – released its first report focused on providing client-level demographic data and how ADAP-funded services were used from 2014-2017 (Cheever, 2019).

The finding of this new annual report found that ADAP served 268,174 clients in 2017, 77.7% of whom were Male, 21.1% Female, and 1.2% Transgender. The data also indicate that over 2/3 of ADAP clients are from racial/ethnic minority populations – 39.5% African American, 25.4% Hispanic/Latinx, and less than 2% each are Asian, American Indian/Native Alaskan, Native Hawaiian/Pacific Islander, and persons identifying as multiracial – and that these racial/ethnic demographics have remained largely unchanged since 2014 (HRSA, 2019).

The data also found that racial/ethnic minority clients tend to be younger than White clients, with 56.9% of White clients being aged 50 years or older, compared with nearly 2/3 of Black and Hispanic/Latinx clients being under the age of 50. This holds consistent with HIV infection rates – the majority of new HIV infections in 2017 occurred in patients aged 20-39, with a majority of new infections occurring in African Americans and Hispanic/Latinx infection numbers coming in 3rd-highest (Centers for Disease Control and Prevention, 2019).

In addition to racial/ethnic demographic information, the report also found that more than 38.6% of ADAP clients had no health care coverage in 2017, down from 44.4% in 2014. This may be a result of state Ryan White programs being authorized by HRSA to use ADAP funds to purchase health insurance (“insurance continuation”) for clients, as well as to pay co-pays and premiums.

The most troubling data found that racial/ethnic minorities were more likely than white clients to be living at or below 100% of the Federal Poverty Level (FPL), with 51.8% of Hispanic/Latinx meeting this criteria, 49.5% American Indians/Alaska Natives, 48.3% of African Americans, 45.8% of Multiracial clients, 40.5% of Native Hawaiians/Pacific Islanders, 35.7% of Asians, and 33.7% of White clients. These data comport with long-held evidence that the people most likely to become infected or living with HIV, particularly among minorities, are those in lower income brackets.

Photo Source: njdc.info

Another concerning data point found that only one in five (20.4%) of ADAP clients received medication co-pay/deductible assistance in 2017, compared to just 12.3% in 2014. This is troubling because, even though HRSA has authorized funds to be used to purchase health insurance from clients, the vast majority were not utilizing this option which would allow them to access other healthcare services for which the Ryan White program could feasibly pay. Many of these services are already covered in urban areas under Ryan White Part A, but in more rural areas, like many Southern states where the majority of new HIV infections occur, access to Ryan White clinics is far more limited. Purchasing health insurance for clients opens far more options, in terms of places to go to receive healthcare services.

I look forward to seeing the 2018 report, once more data are available, as these reports will be an invaluable tool for tracking how Ryan White funds are utilized in the coming years.

References:

• Centers for Disease Control and Prevention. (2019, April 12). Statistics Overview – Diagnoses of HIV Infection, by Age. Atlanta, GA: United States Department of Health and Human Services: Centers for Disease Control and Prevention: National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention: Division of HIV/AIDS Prevention: HIV: Statistics Center. Retrieved from: https://www.cdc.gov/hiv/statistics/overview/index.html#targetText=Prevalence%20is%20the%20number%20of,infections%20had%20not%20been%20diagnosed.&targetText=CDC.
• Cheever, L. (2019, September 18). HRSA Releases Inaugural Report of Ryan White HIV/AIDS Program AIDS Drug Assistance Program Client-Level Data. Washington, DC: United States Department of Health and Human Services: Office of HIV/AIDS and Infectious Disease Policy. Retrieved from: https://www.hiv.gov/blog/hrsa-releases-inaugural-report-ryan-white-hivaids-program-aids-drug-assistance-program-client?utm_source=twitter&utm_medium=social&utm_campaign=blog
• Health Resources and Services Administration. (2019, September). Ryan White HIV/AIDS Program AIDS Drug Assistance Program (ADAP) Annual Client-Level Data Report 2017. Rockville, MD: United States Department of Health and Human Services: Health Resources and Services Administration: Data: Data Reports and Slide Decks. Retrieved from: https://hab.hrsa.gov/sites/default/files/hab/data/datareports/2017-hrsa-adr-data-report.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.