Monthly Archives: August 2017

HIPAA: Healthcare mailers violate privacy rights of people living with HIV

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

It came to light, last week, that Aetna – one of the largest health insurers in the U.S. – inadvertently revealed the HIV status of up to 12,000 clients by way of a mailer sent on July 28th, 2017 containing information about their options when they filled prescriptions for HIV medications. The notice was sent in the traditional envelopes sent by businesses, with the clear plastic window through which the letters “HIV” were clearly visible. The letters went out to people who are currently taking medications to treat HIV, as well as those taking Pre-Exposure Prophylaxis (PrEP), a regimen used to prevent the transmission of HIV (Kennedy, 2017).

Aetna mailer showing privacy violations.

In a similar incident, Ohio’s AIDS Drug Assistance Program (OhDAP), along with CVS/Caremark, sent out a similar mailer to roughly 4,000 clients containing their new “Insurance” cards, along with the full names, addresses, and the letters HIV above their names. In addition to that, the card provided inside the mailer contained ID numbers that included the clients’ date of birth, which creates the potential for identity theft (Hamilton, 2017).

Eddie Hamilton, who leads the ADAP Educational Initiative, was one of the victims of the privacy violations executed by OhDAP and CVS/Caremark. He provided a copy of the mailer to the HEAL Blog.

CVS/Caremark mailer showing privacy violations.

Both of these instances are a violation of Health Insurance Portability and Accountability Act (HIPAA), specifically Title II’s Privacy Rule, which regulates the use and disclosure of Protected Health Information (PHI), which prevents any information related to health status, provision of health care, or payment of healthcare that can be linked to an individual from being disclosed without the patient’s direct consent. These provisions were put in place in no small part because sensitive information, such as one’s HIV status, is something that can be used against individuals to deny access to certain benefits and jobs (which is also illegal under the Americans with Disabilities Act, or ADA), and/or have this information get into the hands of those who will use the patient’s HIV status against them in either a private or public manner.

What is most galling about these disclosures is that they were easily avoidable. While it is common business practice to use envelopes with clear windows in an effort to save a few cents per piece of mail, the relative savings compared to printing the address on a sticker and applying it to the outside of the envelope pale in comparison to the potentially high dollar amount in fines for each HIPAA violation, which can range from $100 to $50,000 per violation. And all to save a few centers per mailer.

Aetna, in response to their error, sent out a second letter informing customers of the privacy breach, and in a statement blamed an unnamed vendor for their failure to protect patients’ private health information. The letter was sent to customers in Arizona, California, Georgia, Illinois, New Jersey, New York, Ohio, Pennsylvania, and Washington, D.C. (O’Donnell, 2017). Attorneys for the Legal Action Center and the AIDS Law Project of Pennsylvania sent Aetna a demand letter that included a cease and desist order, as well as calling on Aetna to develop a plan of action to ensure that these types of incidents do not occur in the future (Legal Action Center, 2017).

Neither OhDAP, nor CVS/Caremark have made public statements regarding the disclosure of 4,000 clients’ HIV status. Additionally, the clients in question are those who rely solely upon ADAP funds to procure their medications, a program designed to help those who fall within a certain percentage of the Federal Poverty Limit (FPL) afford medications they might not otherwise be able to access. This means that these clients are less likely to have access to legal aid to help them redress the breach of their confidential PHI, and are less likely to know the appropriate steps to take in order to file HIPAA violation complaints with the Department of Health and Human Services (DHHS) Office for Civil Rights (OCR) or other state authorities.

One of the reasons why HIPAA is so vital for patients living with HIV is that it is their decision to disclose their HIV status, rather than that of healthcare workers, insurers, or any related businesses and partners. While certain areas of the U.S. tend to be more openly accepting about HIV status, other areas may be less than accommodating. Having one’s status revealed to family members, roommates, or friends without permission can have social repercussions, particularly in more religious areas of the country. It is difficult to overstate the severity of these breaches of confidentiality and privacy.

Beyond that, it is unclear whether the current administration’s OCR is going to take any actions against any of the offending parties, in which case patients and clients will have to resort to private or class-action suits against these organizations in order to properly address the situation. Normally, the OCR accepts settlements from offending parties, involving a lump sum payment and no admission of guilt (which is already assumed with the companies reveal that they’ve disclosed this information). HEAL Blog will continue to monitor these issues to see if any resolutions are met.

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Mavyret and Vosevi Fire Salvos in HCV Price Wars

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Over the past month, the U.S. Food and Drug Administration has approved two new Direct Acting Antivirals (DAAs) for use in treating Chronic Hepatitis C (HCV) – Vosevi (Gilead) and Mavyret (AbbVie). Both of these drugs are pan-genotypic, meaning that they can be used to treat HCV Genotypes 1-6, making them the second and third pan-genotypic regimens to be approved by the FDA. What makes Vosevi unique is that it’s the first drug approved by the FDA for patients who have previously been treated with other DAA drugs (Brooks, 2017). That, alone, gives Gilead some leeway when it comes to setting their Wholesale Acquisition Cost (WAC), which they set at $74,760 for twelve weeks of treatment.

That was in July 2017. Then, came Mavyret, from AbbVie. Rather than even bother to hide their intention, AbbVie seriously threw a spanner in the works by pricing their new drug just under 50% lower than Vosevi for a similar regimen length. For twelve weeks of Mavyret, the WAC is $39,600 – roughly 48% the cost of Vosevi. But, that’s not the kicker: Mavyret’s recommend dosage for treatment-naïve patients is an eight-week regimen, coming in at $26,400. Vosevi also has an eight-week regimen option, but at a significantly higher price point. Shots. Fired.

This isn’t the first time that AbbVie has played this pricing game, before, in an attempt to undercut Gilead. In 2014, they released Viekira Pak – a four-tablet regimen for use in treating HCV Genotype 1a & 1b – at a WAC of $83,319. While this is significantly more expensive, at the time, it was something of a blow to Gilead and Janssen (makers of Olysio). Individually, Gilead’s Sovaldi had a WAC $84,000 for twelve weeks; however, the drug was intended to be used in combination with Olysio (Janssen), which boasted a WAC of $66,360, making the total cost of the regimen $150,360. Gilead’s newer product, Harvoni – a single-pill regimen designed to be used without Olysio – came in at $94,500.

Despite the lower price, Viekira Pak never really caught on as the go-to treatment regimen for HCV, for a number of reasons: (1.) Gilead had already established relatively deep market penetration and brand recognition; (2.) the four-pill regimen was/is thought to be too cumbersome to ensure compliance with the regimen; (3.) the price wasn’t low enough to get payers to bite. Of these three issues, AbbVie managed to solve the multi-pill regimen part in 2016 with their single-pill Viekira XR, which is now the preferred regimen over the original formulation.

Chart showing HCV therapies available and their Wholesale Acquisition Costs

But, pricing wars are tricky, particularly in the world of HCV therapies. The first truly significantly lower price point came in 2016 with Zepatier – Merck’s single-pill answer to HCV treatment – with a WAC of $54,600. But, even that price wasn’t enough to overcome the drug’s significant barriers to treatment – it was notoriously difficult to prescribe, as it had several counterindications (negative drug interactions) with drugs used to treat other illnesses. This was particularly true in the case of HIV. In addition to individual pricing concerns, treatment indications often require that the drugs be used in combination with other medications, the most common of which is Ribavirin, which can cost between $550 – $850 for twelve weeks, depending on brand vs. generic pricing.

What Mavyret does that Viekira Pak/XR did/does not is put on the market a single-tablet regimen to treat six genotypes of HCV, making it incredibly versatile. Whether or not they will be able to overcome Gilead’s market dominance, however, is another question.

References:

  • Brooks, M. (2017, July 18). FDA Clears Pan-Genotypic Vosevi for Chronic Hepatitis C. New York, NY: Medscape, LLC: Medscape: News & Perspective: Medscape Medical News: FDA Approvals. Retrieved from: http://www.medscape.com/viewarticle/883095

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Cherokee Nation Chooses to Proactively Fight Against Hepatitis C

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award
By: Marcus J. Hopkins, Blogger

Native Americans (NAs) in the United States have largely gotten the shaft. Forced from their native lands, herded into reservations, and the victims of innumerable false promises and broken agreements on the part of the U.S. government, NAs have also had the misfortune of being disproportionately impacted by infectious disease. Such is the case with Hepatitis C (HCV). According the most recent Surveillance for Viral Hepatitis report released, this year, by the Centers for Disease Control and Prevention (CDC), NAs have by several integers the highest rate of HCV per 100,000 people out of any race demographic with a rate of 12.95 (CDC, 2017). The Cherokee Nation – the second-largest NA tribe in the U.S. – has decided to actively come out swinging against HCV.

White House honors CN physician for hepatitis C program

Photo Source: Cherokee Phoenix

Roughly 130,000 Cherokee Nation (CN) tribal citizens live in northeastern Oklahoma within the tribe’s boundaries, and within this community, aggressive measures are being taken to combat the disease. Dr. Jorge Mera (seen in the photo being honored by the Obama Administration for his Hepatitis C program), Head of Infectious Diseases at Cherokee Nation in Tahlequah, OK has worked with various agencies and private partners to create a comprehensive approach to dealing with their HCV epidemic (Taylor, 2017):

  • Using newer Direct-Acting Antivirals (DAAs) to treat and achieve Sustained Virologic Response (SVR) in infected tribe members
  • Partnering with Gilead Sciences (makers of three currently available HCV DAAs – Sovaldi, Harvoni, and Epclusa) to receive funding for screening kits and research through the Gilead Foundation
  • Adopting a proactive compulsory screening policy of screening all tribe members aged 20-69 for HCV (rather than just the Baby Boomer Birth Cohort), as well as offering tests to all children of any mother who screens positive for HCV
  • Expanding screening locations to include dental clinics to screen tribe members who may not access other healthcare services
  • Pushing and receiving approval for the establishment and funding of a tribal Syringe Services Program (SSP – Syringe/Needle Exchange) within the tribe’s territory (Hays, 2017)

This type of aggressive approach to combating HCV is, in fact, the type of action that Viral Hepatitis (VH) advocates have been pushing for years, but the unique circumstances under which tribal healthcare operates allows for more freedom than in the greater U.S. “Because Cherokee Nation citizens, under a treaty right with the United States Government have access to medical care, tracking them, and screening them is slightly easier than might be so for other US populations,” explains Dr. Mera (Taylor). Additionally, since their focus is on a smaller, specific population, the CN is able to focus its care on a smaller pool of individuals, rather than attempting to address the healthcare needs of millions of citizens.

That said, HCV transmission does not occur within a vacuum – tribe members do come in contact with people who fall outside of the tribe’s jurisdiction, meaning that, even if the CN’s efforts to screen, track, and cure all members of the tribe within its boundaries are 100% successful, they are still susceptible to new infections by way of contact with those outside of their community. This means that the types of progressive Harm Reduction, screening, and treatment measures being undertaken by CN need to be replicated in the state of Oklahoma, as well as the surrounding states (and eventually, the entire U.S.) in order for their efforts to not be undermined by failures to provide similar services on the parts of state and Federal governments.

These tactics also serve as a roadmap for dealing with HCV in some of the states hardest hit by the disease, particularly in smaller Appalachian states like West Virginia and Kentucky, where geography and smaller, more remote populations make reaching, screening, tracking, and treating not only HCV, but every health condition more difficult.

The tribe will present its progress at the World Indigenous People’s Conference on Viral Hepatitis in Anchorage, AK on August 08-09, 2017. For more information on that conference, please click on the following link: WORLD INDIGENOUS PEOPLES’ CONFERENCE ON VIRAL HEPATITIS

References:

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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Michigan Hepatitis C Surge Related to Prescription Opioid and Heroin Abuse

HEAL Blog is the recipient of the ADAP Advocacy Association’s 2015-2016 ADAP Social Media Campaign of the Year Award

By: Marcus J. Hopkins, Blogger

The Michigan Department of Health and Human Services (MDHHS) released its 2016 Hepatitis B and C Annual Surveillance Report, indicating drastic increasing in new Chronic Hepatitis C (HCV) cases in the state, particularly among residents aged 18-29. Two factors posed significant roles in the transmission of these cases – Injection Drug Use (IDU) and Incarceration.

HEAL Blog has consistently reported on HCV transmission as a result of IDU and within incarceration settings, and report is further evidence of those positions. There were 11,883 new Chronic HCV cases reported in 2016 for a rate of 119.78 out of every 100,000 people. 69% of those cases were followed up on and epidemiological profiles were made; of those IDU was a risk factor in 64% of cases, while incarceration was a risk factor in 63% (MDHHS, 2017).

More striking, however, was the vast increase in Chronic HCV in people aged 18-29 between 2005-2016 – an alarming 473%, of which 84.2% were reportedly related to IDU in that same age group. This trend is replicated all over the country, especially in areas where prescription opioid and heroin abuse levels are more prevalent.

Logo for the Michigan Department of Health & Human Services

Photo Source: MDHHS

MDHHS reported that viral hepatitis-related hospitalizations, liver cancer incidence, liver transplants, and viral hepatitis deaths have all increased over the last decade, largely driven by the impact of Chronic HCV infections (Mack, 2017). With so many of these cases ostensibly linked to opioid and heroin abuse, a robust response to the addiction epidemics is needed, as well as compulsory “Opt-Out” screening at clinics, emergency rooms, hospitals, and correctional settings.

The Lansing City Council recently voted to allow Syringe Services Programs (Syringe/Needle Exchanges), a proactive Harm Reduction measure that studies indicate reduces the rate of transmission amongst both People Who Inject Drugs (PWIDs), as well as the general population (Cook, 2017). Selling these programs to citizens who are unfamiliar with the programs, staunchly opposed to drug use, or believe that the exchanges encourage drug use remains a difficult proposition. Proponents argue that PWIDs are going to use drugs, regardless of whether or not there are exchanges; that being the case, it makes logical sense to prevent the spread of disease.

Michigan’s increase in Viral Hepatitis (VH) follows a national trend that will be replicated – possibly with farther reaching, deadlier impact – in other states.

References

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Disclaimer: HEAL Blogs do not necessarily reflect the views of the Community Access National Network (CANN), but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about Hepatitis-related issues and updates. Please note that the content of some of the HEAL Blogs might be graphic due to the nature of the issues being addressed in it.

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