Patient Access Network Foundation – A Free Financial Resource for Underinsured Patients

By Amy Niles
Director of Patient Advocacy and Professional Relations, Patient Access Network (PAN) Foundation

For thousands of patients diagnosed with cancer and chronic illnesses, one of the first questions regarding their treatment and quality of life is, “How will I pay for this?” Patients who have been just getting by or even those who consider themselves fully financially stable often find themselves unable to afford the out-of-pocket costs associated with their prescribed medications. For many, the Patient Access Network (PAN) Foundation may be able to help.

Founded in 2004, the PAN Foundation is a nationwide, independent nonprofit dedicated to providing financial assistance to underinsured patients, or patients who have insurance but still face financial hardship in affording complex specialty medications. PAN has provided nearly $400 million in assistance to more than 250,000 patients across our nearly 60 disease-specific programs including a program for patients living with HIV/AIDS.

What is PAN assistance?
PAN provides grants to qualifying patients to help pay for the out-of-pocket portions of their qualifying medication costs. There is no cost to the patient or their healthcare provider to receive assistance from PAN. Once a patient is approved, PAN allocates a certain amount of money, $500-$10,000 varying by disease, that patients have access to for 12 months. When a patient receives a treatment or medication, their healthcare provider or specialty pharmacy submits a claim to PAN for the co-pay or coinsurance amount not covered by the patient’s insurance – allowing patients the peace of mind to continue their therapy without worrying about submitting reimbursement claims to PAN. PAN also features what we call a 90-day look-back, which means if a patient has incurred qualifying expenses at any time during the 90-days prior to their grant approval, PAN will reimburse them directly through their grant.

Who can qualify for PAN assistance?
PAN eligibility is often far more generous than most charity-care type programs, as we understand that the cost of specialty medications can be a burden even for those well above the poverty level.  While criteria vary per disease-specific program, generally patients with household incomes at or below 400-500% of the federal poverty level ($62,920-78,650 for a family of two) are eligible to receive assistance. Patients must be insured and some programs require that patients have Medicare insurance. Patients must be diagnosed with one of the nearly 60 diseases for which PAN operates a program and must reside and receive treatment in the United States. Assistance is only available for mediations that treat the disease directly.

What assistance is available for patients living with HIV/AIDS?
Patients with HIV/AIDS can receive $4,000 per year to assist with the out-of-pocket costs associated with their medications. To qualify for assistance:

• A patient must be insured and insurance must cover the medication for which patient seeks assistance.
• A patient must reside and receive treatment in the U.S.
• The patient’s income must be at or below 500% of the Federal Poverty Level ($78,650 for a family of two).

How to apply for PAN assistance:
PAN has developed multiple application routes, all delivering patients’ eligibility determinations in under one minute, so patients know instantly whether they have been approved for assistance.

• To apply online, visit www.PANfoundation.org and select “Online Application.”
• To apply over the phone, call 866-316-PANF (7263). Representatives are available 9:00 am to 5:00 pm eastern time.
• Physicians and Specialty Pharmacists have access online portals where they may apply on behalf of patients and manage their grant and claims electronically. 

To learn more about Patient Access Network and PAN’s assistance programs, visit www.PANfoundation.org.

The Southern Epidemic

By Anna Meghan Nunn
Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

The ADAP Advocacy Association (aaa+®) released an important White Paper on the impact of HIV/AIDS in the South, entitled “THE SOUTHERN EPIDEMIC: Are the South’s cultural, political and societal barriers making it difficult for public health programs, such as the AIDS Drug Assistance Programs, to function effectively in this region?” Its purpose is to examine why people living with HIV/AIDS in this region of the country often must overcome major obstacles simply to access basic healthcare needs, more so than any other area.

During “The Perfect Storm” — a label used by ADAP stakeholders to describe the severity of the AIDS Drug Assistance Program (ADAP) waiting list crisis that ravaged the program from 2008-2012 —nowhere in the U.S. was the HIV/AIDS crisis more apparent than the South. At any given moment in the crisis, nearly 95% of the people living with HIV/AIDS being denied access to care and treatment resided in the South. At the height of the ADAP crisis, eight of the twelve states that instituted waiting lists were in the South; most of them in the Deep South.

The Center for Disease Control and Prevention (CDC) estimates that there are approximately 1,144,500 people aged 13 years and older living with HIV infection in the U.S. today.  The southeastern United States has seen a disproportionate impact of HIV/AIDS in their communities, especially over the last decade. In 2011, eight of the southern states accounted for the ten states with the highest new HIV infections in the country.  Furthermore, southeastern states accounted for 50% of HIV infections that year.  To put that in perspective, it is important to note that this region accounts for only 37% of the U.S. population. There are numerous contributing factors behind these alarming numbers. This region of the country has historically been known to have retained a deep and distressing culture, evidenced by violent civil rights struggles, high poverty rates, poor education systems, deeply engrained religious traditions, and limited access to healthcare.

In the South many societal, economic, and geographic constraints collide to create a “Perfect Storm,” which ultimately creates barriers to healthcare. Some of these factors include:

• Race and discrimination
• Poverty and education
• Sexual orientation and stigma

The complex dynamics of these factors not only impact access to adequate healthcare, but create a great deal of stress for State ADAPs in this region. By race African Americans are the largest group affected by HIV/AIDS. In fact, in 2010 new HIV infection rates among African Americans were 8 times that of whites. This is a trend we are beginning to see within the Latino community as well. The South is also home to a large amount of individuals living in poverty. In addition, this region typically has below average literacy levels. Both poverty and poor education are associated with lower access to healthcare and negative health outcomes. An additional cultural factor weighing on HIV/AIDS infection rates in the South is the Evangelical attitudes and traditional conservative values associated with the religious South. These traditional conservative values regarding sexual orientation can foster a climate of stigma and shame toward the largest group of people living with HIV/AIDS: men who have sex with men (MSM). These societal and cultural factors in the southern states combine to create barriers to health care.

Access to Healthcare
Societal factors are only a part of the complex issue regarding the disproportionate rates of HIV/AIDS infections in the South. The lack of access to healthcare is also a major contributing factor this crisis in the South.

This leaves many people living with HIV/AIDS in the South only two options for health care: Medicaid and the Ryan White CARE Act programs like state ADAPs. Unfortunately, it is still too early to tell how the Affordable Care Act (ACA) will play out in the months or years to come with regard to this population. While the ACA has afforded many the opportunity to gain insurance coverage through Marketplace Exchange programs, many low-income people living with HIV/AIDS are falling into Medicaid gaps. This is a result of the southern states’ rejection of federal funding to expand Medicaid eligibility to more citizens. With the exception of Arkansas, all of the “Deep South” states have made the decision not to expand their Medicaid coverage.

This leaves thousands of people living with HIV/AIDS to rely on Ryan White services like ADAPs for health care coverage. However, there is cause for concern as southern states have historically been less than generous in the amount of voluntary funds they provide to their state ADAPs. For example, nationally states contribute an estimated 14% to the total ADAP budget.   However, southern states have typically contribute lower than average or not at all. Arkansas, Louisiana, Mississippi, and Kentucky have never contributed any state funds to the ADAP programs. In 2009 South Carolina contributed 11% and Florida contributed only 9%. The recent economic recession and subsequent rises in unemployment rates has increased the demand for ADAP services. Unfortunately the recession also has resulted in deeper budget cuts in southern states. The state of North Carolina saw their ADAP budget cut by $8 million in the fiscal years 2014-15.

These imminent budget cuts have forced state ADAPs to initiate cost-containing measures like enrollment caps and reduced formularies. The unfortunate unintended consequences of these cost-containing measures is the looming threat of national ADAP waiting lists, something the programs have been successful at reducing and nearly eliminating in recent years.

CLICK HERE to download the White Paper: “THE SOUTHERN EPIDEMIC: Are the South’s cultural, political and societal barriers making it difficult for public health programs, such as the AIDS Drug Assistance Programs, to function effectively in this region?” 

When the Rubber (ACA) Hits the Road (ADAP)

By Anna Meghan Nunn
Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

The ADAP Advocacy Association, in conjunction with the Community Access National Network's Hepatitis: Education, Advocacy & Leadership (HEAL) project, held their fourth annual summit in Washington D.C. last week. The event entitled, "The Intersection Between the ACA and ADAP," was held on Monday, April 14th - Tuesday, April 15th, 2014. The summit's purpose was to “assemble stakeholders to discuss the Affordable Care Act as it relates to individuals living with HIV/AIDS and individuals living with Viral Hepatitis, especially the law’s impact on services and supports funded under the AIDS Drug Assistance Program.”

The summit was open to the public and included a variety of stakeholders from the public health, advocacy, medical, pharmaceutical and government sectors, as well as numerous patients currently receiving services under the AIDS Drug Assistance Program (ADAP). Thirty invited panelists attended, eight of which gave presentations that focused on current issues and enduring questions within the HIV/AIDS community. The presentations included:

• “A Year of Change: ADAP’s Successes and Challenges Implementing the Affordable Care Act”— Emily McCloskey, Manager, Policy and Legislative Affairs, National Alliance of State & Territorial AIDS Director (NASTAD)
• “Update on ACA Medicaid Expansion”— Matt Salo, Executive Director, National Association of Medicaid Directors
• “The Continuing Role of ADAPs as Health Insurance Coverage is Expanded by the Affordable Care Act”— Jeff Crowley, Program Director, National HIV/AIDS Initiative, Georgetown Law, O’Neill Institute for National and Global Health Law
• “ADAPs & Wrap Around Services in Marketplace Plans”— Glen Pietrandoni, Senior Director, Pharmacy Services, Walgreens & Joey Wynn, Community Relations Director, Empower U
• “Update on Blue Cross Blue Shield of Louisiana & Discriminatory Marketplace Exchange Practices”— Scott Schoettes, HIV Project Director, Lambda Legal
• “Mind the Gap: Ensuring Appropriate Care for Incarcerated Patients Transitioning Back Into Their Communities”— A. Toni Young, Executive Director, Community Education Group
• “Co-occurring Challenges: Leveraging ADAP and ACA to Address Hepatitis C and Substance Abuse Disorders”— Daniel Raymond, Policy Director, Harm Reduction Coalition

To view the individual presentations, click here.

Michael Shankle, with HealthHIV, facilitated the discussion, guiding participants through the lengthy and thoughtful conversations that helped make the summit a success.  He opened the summit by asking each panelist to use one word to describe the ACA/ADAP intersection; he used the responses to generate a word cloud.

The summit kicked off with an overview from Emily McCloskey, NASTAD. The presentation addressed the following points:

• Medical Homes
• Treatment incentives
• ADAP co-pays 
• Drugs
• Drug co-pays Possible elimination of combo drugs 
• HRSA- Purchasing insurance must match ADAP formulary

This information laid the foundation for the day’s discussion.

Matt Salo, National Association of Medicaid Directors, gave the next presentation which addressed the issues surrounding Medicaid Eligibility Expansion and the ACA. Key points from this discussion included:

• State Strategies
• In need of tools
• Patient vs. Politics
• Politics wins as state Medicaid directors are often forced to tow the line of their Governor’s agenda
• Risk pools increase cost
• Young and healthy are not enrolling 
• Private option more expensive
• Medicaid does not factor in risk pools 
• Private--> marketplace--> diversifies risk pool 
• Need 400% FPL enrollment 
• Do substitutions make plans more affordable 100% FPL to 133% FPL
• Supportive Services
• Medicaid staff with HIV-specific experience decreased
• States deliver the most medications to the most people
• Leveraging resources 
• Sub-optimal therapies
• Cheapest isn’t always best
• Essential role of community providers
• Continuity of care

Salo’s presentation allowed for a rich discussion of how Medicaid and the ACA impact Ryan White providers and State ADAPs.

Next,  Jeff Crowley, Georgetown Law's O’Neill Institute for National and Global Health Law, focused on how the ACA has expanded the role of ADAPs as insurance providers. Main points that were brought up in the discussion included the following:

• Focus on individuals 
• Falling through the cracks
• Need to provide education about available plans
• Need to educate providers
• Collecting better data
• Healthcare reform is about integration
• How do we thoughtfully distribute the funding
• How to educate new leaders 
• Develop "champions"
• Treatment as prevention
• Reauthorization needs to address funding (e.g., formulas)
• Fairness (where located)
• Must have community input
• Equity equals decreased competence 
• Emergency focus and examination
• Non-expansion states increased disparities 
• Need to create a balance between incentives and punishment of states
• Difficult conversations are necessary
• People respond  to success
• Broaden coalitions 
• Nurture younger voices
• More consumer engagement 
• Responsibility of consumers
• Agency engagement
• Consumer drive

Crowley’s presentation opened the floor to a lengthy and important conversation about the ACA and ADAP.

The afternoon began with presentations from Glen Pietrandoni, Walgreens, and Joey Wynn, , Empower U. These presentations dealt with issues related to wrap-around services in the Marketplace exchange. The discussion yielded the following points:

• Expand role providers and pharmacists
• Tools need to be developed using local assumptions and factors
• Help consumers pick plans with models and make informed decisions 
• How states make payments
• Streamline process
• Provider needs on plan
• Not always plan but office manager/system barriers
• State by state breakdown in medications
• Programs negotiate pricing based on contracts 
• Rebates vary 

These presentations spawned much debate over the role of ADAPs in these wraparound services. Many panelists contributed to this conversation, allowing for exchange of ideas among the diverse organizations represented at the event.

Scott Schoettes, Lambda Legal, followed with an update on the lawsuit against Blue Cross Blue Shield (BCBS) of Louisiana. His engaging presentation followed up on an emerging issue previously reported in February 2014. The issue involves a case by Lambda Legal in response to the discriminatory practices by BCBS of Louisiana in which the insurance company denied third-party payments, including Ryan White grantees. Schoettes’ presentation provided background information on this case, as well as information regarding the outcome. As it stands now, BCBS of Louisiana has agreed to continue accepting third-party payments from Ryan White funds through the end of the calendar year. The Centers for Medicare and Medicaid Services (CMS), in the meantime, issued a final interim rule mandating that the insurance giant reverse their policy. Schoettes’ presentation was enlightening and became a catalyst for great discussions about the need to stay vigilant against discriminatory practices in how the ACA is applied moving forward.

A. Toni Young, Community Education Group discussed the need for appropriate care for people living with HIV/AIDS who are transitioning back into the community after incarceration. Young’s presentation focused on the need for HIV testing in the lower-income areas of Washington D.C. She made a point to note that most infections happen in the community rather than in penitentiaries and jails. She stressed the importance of helping individuals gain access to healthcare upon release. Her agency's progressive plans include empowering these individuals to re-enter their communities, take control of their healthcare, and assist in HIV testing in their neighborhoods.

The final presentation of the day was delivered by Daniel Raymond, Harm Reduction Coalition, on the comorbidity of HIV, Hepatitis C, and substance abuse. The talk focused on leveraging ACA and ADAP to address these co-occurring issues. Key points that arose during the discussion include:

• AIDS still leading cause of death for people living with HIV/AIDS
• Co-infection treatment is coming 
• New drugs may be less complex than other older drugs (and more expensive)
• Drug rebates unclear 
• Re-infection and treatment rates
• Identify who should be tested/treated
• Completion of treatment is difficult (8 days to 2 weeks) 
• HCV treatment is usually not emergency
• Adherence assessment 
• Public health impact 
• Waiting for states to determine Medicaid benefit for HCV treatment
• Guidelines from national partners drive change and increase access
• Need for a structured formalized platform to discuss future of the Ryan White law 
• Model to assess formulary, out of pocket cost, provider network
• Minimize formulary STND needed for ADAP
• Access of social media in reaching target population 
• Follow up and more collaboration on discriminatory practices

These presentations summed up the first day of the summit. The second day entailed an in-depth conversation, whereby panelists and attendees came to the table to discuss the previous day’s topics and what can be done moving forward to ease the transition into the ACA. Some of the central concerns revolved around the need for more comprehensive data, the possibility of developing an “out-of-pocket cost calculator” for patients, and the need for greater consumer input. Further, attendees argued that as a community we must embrace and utilize social media and new technology to gather and disseminate information with regard to the ACA and ADAPs.

There was serious concern expressed over the Obama Administration’s proposal to merge Ryan White’s Part C and Part D, as well as the premature introduction of legislation to reauthorize the law. At the center of the concern over Ryan White reauthorization is funding may be on the chopping block in the future as a result of the implementation of the ACA. The general consensus among the group was that Ryan White funds are still very critical to affording healthcare, medications, and wraparound services. Everyone in attendance agreed that we must remain cautious and keep a watchful eye on this matter as the ACA rollout continues.

In closing, panelists agreed on the following:

• Need for more centralized, aggregated data
• Fresh faces and new blood- innovative and new ideas
• More holistic patient perspectives
• More access to information
• Community consensus around Ryan White is necessary to keep the funding 
• Collaboration and not duplication 
• Increases in engagement and volunteering

The ADAP Advocacy Association will use the summit as a spring board for its 7th Annual Conference, being held in Washington, DC on August 3-5, 2014.

Interested in a patient's perspective on the summit? Go to HEAL blog, "ADAP Summit on the Intersection Between ACA & ADAP"

United Healthcare Does 180 Degree on Mail Order Pharmacy

By Anna Meghan Nunn
Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

A lawsuit filed in June 2013 by Consumer Watchdog and handled by national law firm Whatley Kallas, LLC in Orange County federal court has reached a settlement, bringing welcome news to many United Healthcare policy holders living with HIV/AIDS. The class action lawsuit was filed against the nation’s largest health insurance company. In the lawsuit, Consumer Watchdog alleged that the insurance giant was illegally forcing its policy holders living with HIV/AIDS to order their prescription medications through their own in-house mail-order pharmacy. When United Healthcare made the decision, these policy holders were forced to make a choice: transfer their prescriptions to its in-house mail-order pharmacy or pay thousands of dollars out of pocket to continue their relationships with their local retail pharmacists.

In June 2013, PR Newswire published an article, quoting Consumer Watchdog staff attorney Jerry Flanagan as saying:

“United’s decision to force their most vulnerable members into a pharmacy program not of their choosing is harmful to the very people United is supposed to be protecting. Patients, not insurers, should be allowed to decide how, when and where they buy their medications.”

The settlement was reached on March 20, 2014; it required United Healthcare to allow patients to opt-out of the mail-order plan and resume receiving their medications at their local pharmacy.

The argument against the mail-order plan is four fold.

First, healthcare advocates fear that eliminating the patient-pharmacist relationship would have adverse effects on the patient’s ability to navigate the complications that come with taking multiple medications as part of a daily routine. Pharmacists are unable to monitor potential drug interactions when they are cut out of the healthcare process through the implementation of mail-order plans. Additionally, pharmacists offer valuable counseling and advice that many patients depend on.

Pharmacists are in a unique position to assist patients with questions they may have about their medications before they take them home. Further, they are able to develop relationships with patients that further assist with ensuring safe and proper adherence to their prescription drug routines. As it stands now, United has replaced these relationships with an 800 number.

A second concern about these mail-order plans is that they cause patients to miss out on discounts offered exclusively at retail pharmacies. In a time when rising costs of medications is increasingly burdening people living with HIV/AIDS, these opportunities to save money on medications are crucial.

A further reservation is that there is a serious issue of patient-privacy with mail-order plans. A news release issued by Consumer Watchdog (3/20/2014) clarifies this point stating, “…HIV/AIDS specialty medications often are delivered in refrigerated containers. Patients who live in apartment buildings or have medications delivered to their work-place have expressed alarm that neighbors, co-workers, and employees, who do not know that the recipient has HIV/AIDS, would come to suspect that they are seriously ill.”

Finally, there is the issue of time lag with mail delivery. Many of these medications must be refrigerated and therefore are time sensitive. In addition, these medications are often life-saving for some of the most vulnerable people living with HIV/AIDS. The issue of time lag with respect to slow delivery, mix-ups at the postal service, and mishandling of medications could potentially be life threatening.

Consumer Watchdog had also alleged that United Healthcare’s requirement was discriminatory in nature, illegally targeting those policy holders living with HIV/AIDS.

The ADAP Advocacy Association agreed. In a press release issued last year in response to another insurance carrier mandating the same policy to its policy holders living with HIV/AIDS,  Brandon Macsata said:

“Patients should be afforded as many treatment options as possible, especially when combating a chronic disease such as HIV/AIDS. Any policy that restricts the patient’s ability to interact directly with healthcare professionals, including a pharmacist, is counter intuitive to promoting better medication adherence, which is critically important to improved health.”

Although this statement was in response to another lawsuit filed by Consumer Watchdog against Anthem Blue Cross of California, its message rings true in this case as well.  

Consumer Watchdog settled a similar lawsuit against Anthem Blue Cross of California in May 2013. The difference between that lawsuit and this one is that the Anthem Blue Cross case only impacted clients in the state of California whereas this settlement will apply to, “…individual and employer-provided health plans across the country, and allows patients the right to exercise their opt-out right for a broader range of medications by written opt-out, United’s website, and over the phone” (Consumer Watchdog 3/20/2014).

The court is expected to finish its review in July 2014. They will then notify Class members of their decision and allow the opt-out process to begin. Additionally, Class members who paid more for their prescriptions due to the mail-order plan may seek reimbursement for those costs.

Download a copy of the settlement here.

The ADAP Advocacy Association welcomes the news of this settlement with United Healthcare. The reversal of United Healthcare’s decision brings less complication for patients, increased knowledge of medications, and more productive relationships between patients and their healthcare professionals.

FDA Proposes New Rule: Generic Labeling…the Controversy…and How it Affects Patients

By Anna Meghan Nunn
Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

The U.S. Food and Drug Administration (FDA) proposed a rule that is stirring up controversy, and could have serious implications for recipients of the AIDS Drug Assistance Program (ADAP). In November 2013, FDA recommends included amending a thirty-year old rule adopted by Congress in 1984. In its conception the Hatch-Waxman Act (1984) was designed to speed up the process of generic drug approval, thereby expediting consumer access to affordable prescription drugs. Under the current rule generic drug makers are restricted from making independent changes to their product labeling (also referred to as prescribing information or package inserts). Rather, they must wait for the company that developed the drug to make safety information changes before they are able to update their own labels.

The proposed new rule would allow generic drug makers to update their safety labels in light of new research and information before the FDA is able to review the changes. This is the same process that brand name drug makers have used for decades. Due to limited resources, the process of FDA review and approval of safety labels can often be long and convoluted. It is for this reason that supporters of the rule argue that it will allow consumers more immediate information about the medications they are taking.

In a recent article published by CQ HealthBeat (03/08/14), associate editor Rebecca Adams reported that a bipartisan group of 30 attorneys generals support the proposal, along with many congressional Democrats. The New York Times, in their article “Label Update May Be Allowed for Generics,” quoted Rep. Chris Van Hollen (D-MD) as saying, “This is an important consumer protection provision. It’s a long time in coming.” 

Further, Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, said in a recent press release (11/08/13):

“This proposal will help ensure that healthcare professionals and consumers have access to the latest safety information for the medications they use. More than 80 percent of prescription filled in the U.S. are for generics, so we want to make sure that generic drug companies actively participate with the FDA to ensure that product safety information is accurate and up to date.”

In 2011, consumer watchdog group Public Citizen filed a petition requesting that the FDA allow generic drug companies to revise and update product safety labeling through the same procedures available to brand name drugs. EArlier this year, Reuters quoted Allison Zieve, general counsel at Public Citizen as saying, “If generic manufacturers are not actively monitoring and proposing safety updates, no manufacture is doing so at all. As generic market share increases, the brand-name manufacturer loses incentive to devote resources to post-approval safety monitoring.”

According to Public Citizen, this statement is in response to the estimated 45% of generic medications that no longer have a brand name counterpart.

However, not everyone is on board with the proposed rule change. The generic drug industry opposes the new change, along with many congressional Republicans, some pharmacists, and several other consumer groups. Their concern centers around three issues: liability lawsuits, patient confusion, and cost increases.

In her article for CQ HealthBeat News (03/18/14), Adams sums up the anxiety of the opposition saying that they fear, “…that patients and medical professionals could become confused by non-uniform labeling based on different levels of information. Makers of generic drugs also say that multiple label changes could increase health care costs and potentially expose pharmacists and other professionals to new liability.”

The issue for generic drug companies is that they will now be susceptible to lawsuits that were historically reserved only for name brand drug companies. In the past, because generic drug makers were prohibited from updating their safety labels, they were not held accountable for failing to warn consumers about new potential risks—the name brand drug companies shouldered that burden. Generic drug companies now argue that this new rule will have unintended consequences, driving up health care costs as they are embattled in litigation and will pass that cost onto consumers.

According to FiercePharma, in their recent article “Generic Makers to FDA: Labeling Rule Risky for Patients, Adds $4B in Annual Costs” (03/03/14), claims that the Generic Pharmaceutical Association (GPhA) cited a study by Matrix Global Advisors, “which estimated that the rule, if enacted would drive U.S. health care costs up by $4 billion a year--$1.5 billion of which would be incurred by Medicare and other government payers, and the rest by private insurers and patients.” 

So what does this mean for ADAP recipients?

Depending on the state, there are a variety of different drug formularies offered to ADAP clients. Some states have more robust formularies, whereas others have limited and reduced access to medications through formularies. This is a way for ADAPs to remain cost-effective and best utilize the funds they receive in an effort to ward off waiting lists. For example, New York's ADAP formularies have a Mandatory Generic Rule, meaning that ADAP will only cover generic forms of “A-rated” or therapeutic equivalent drugs. North Carolina also stipulates in their ADAP Fact Sheet (02/03/14) that “If available, generic medications are dispensed.”

This is just an example of the many ADAP recipients across the country receiving generic drugs as part of their formulary. The proposed rule will certainly effect these ADAP clients, forcing them to navigate an already complex set of FDA standards with regard to their medications. This could turn what use to be a mechanical daily routine of taking trusted medications into a confusing and troublesome process.

Additionally, Dr. Woodcock also noted that the FDA plans to create a webpage where, “safety related changes proposed by al drug manufacturers would be posted” (11/18/13). While this is a noble idea, it raises the question of equity among some groups.

In addition to leading busy lives, most people living with HIV/AIDS are managing their health and trying to sort out the ever-changing world of public health; many more are dealing with the complexities of poverty. It is reported that 80% of ADAP clients live 200% or below the Federal Poverty Level. It begs the question, will many of these clients have access to the technology and internet service often needed to keep up-to-date with these labeling changes? Whereas pharmacists and ADAP staff will likely be able to assist patients with changing safety information, will the FDA’s web portal be sufficient for those patients who cannot access it?

The Generic Pharmaceutical Association (GPhA) assembled a panel of experts at a recent congressional briefing, who argued that changing the labeling laws would endanger patients. The House Energy & Commerce Committee plans to convene a hearing, "Examining Concerns Regarding FDA's Proposed Changes to Generic Drug Labeling," on April 1, 2014. Clearly, there is much more to come on as this debate continues...

President Obama's FY15 Budget Offers Promise & Dismay

By Anna Meghan Nunn

Intern from the University of North Carolina at Wilmington, Department of Public and International Affairs

With the implementation of the Affordable Care Act (ACA), Rep. Paul Ryan's recent House Budget Committee Report, and the reemergence of previously eliminated AIDS Drug Assistant Program (ADAP) waiting lists, President Obama’s Fiscal Year (FY) 2015 budget proposal has been highly anticipated by those in the HIV/AIDS community. So how does the President’s budget stack up with respect to the Ryan White CARE Act, in general, and ADAP, specifically? To put it in perspective, it is important to revisit the President’s previous commitments.

On World AIDS Day 2011, President Obama took to the stage of George Washington University and spoke to a packed house about his commitment to ending AIDS, saying:

“We just have to keep at it, steady, persistent, today, tomorrow and every day until we get to zero. And as long as I have the honor of being your president, that’s what this administration is going to do. That’s my pledge — my commitment — to you. And that has to be our promise to each other — because we have come so far; we have saved so many lives. We might as well finish the fight.”

Months later, President Obama unveiled his FY13 budget proposal with a $47 million increase in ADAP funding, or a total of $943 million. The final budget passed by Congress did not include the proposed increase, and ADAP received $886.3 million. In March 2013, the President laid out his FY14 budget, which again requested a $47 million increase in funding for ADAPs. The final funding passed at $900 million later that year. Fast forward...

Earlier this month the President released his FY15 budget proposal. The budget proposal calls for a $4 million increase in Ryan White Care program funding for a total of $2.3 billion. It also proposes flat-funding for ADAP programs at a continued $900 million level. The flat-funding is viewed by some to be a demonstration of the President’s ongoing commitment to the fight against HIV/AIDS in a time of federal budgetary austerity; others view it as falling short because the need is much higher. Some advocacy groups suggest that the proposed budget is $189 million short of the need. 

President Barack Obama signs copies of the FY 2015 Budget as Sylvia Mathews Burwell, Director, Office of Management and Budget, and OMB staff look on in the Oval Office, March 4, 2014. (Official White House Photo by Pete Souza)

Most notably however, it is a testament to the cost-effectiveness of Ryan White programs and ADAPs. Just as Rep. Ryan’s House Budget Committee Report found Ryan White programs to be sustainable, President Obama’s budget proposal also seems to demonstrate an understanding of the success of these programs. 

William Arnold, President & CEO of the Community Access National Network (CANN), and the ADAP Advocacy Association's board co-chair argues that:

“The country is in a state of austerity with many federal programs coming under fire in an attempt to reduce the budget deficit. The fact that Ryan White and ADAPs have fared so well under these circumstances authenticates the proven Return on Investment that these programs have demonstrated.” 

ADAP Education Initiative Director Eddie Hamilton had this to say about the recent budget proposal:

“The President’s proposal to basically flat fund the ADAP Program is a positive step in the right direction even though there is more that needs to be done for the program. With improved testing and the new treatment guidelines that are adding new patients, the Program will begin to struggle yet again after a very brief hiatus from growing nationwide waiting lists.”

Hamilton is echoing a growing number of responses to the proposed budget. While many advocates are pleased that Ryan White and ADAPs are continuing to be funded at a significant level, there are concerns about the future of ADAP programs including the following:

• Uncertainty of Medicaid Eligibility Expansion Among States
• Affordable Care Act (ACA)
• Waiting Lists & Reduced Formularies

According to the Henry J. Kaiser Family Foundation, 26 states (including the District of Columbia) have opted to accept the federal funding for expanding Medicaid eligibility offered by the ACA (as of January 28, 2014). Nineteen states have announced that they will not move forward with the expansion at this time and 6 states are still openly debating the decision. Because there is uncertainty in how many clients will transfer over to Medicaid programs, ADAPs must be flexible and reactive in how they will best disseminate funds and what needs they will have. Further, some states that have chosen not to expand Medicaid eligibility have also announced that they will cut state ADAP funding.

For example, according to Disability Rights North Carolina, Governor Pat McCrory has proposed a budget calling for an $8 million cut to the state’s ADAPs in his FY14-15 budget. Some argue that what is unfolding in North Carolina provides further evidence of why there is a need of additional federal funding of ADAPs is still necessary.

There is also a great deal of uncertainty associated with the intersection of the ACA and ADAPs. Whereas there is some uncertainty about the enrollment numbers, state ADAPs are also unsure how many clients will be transferred into Marketplace insurance plans. Clients moving into these plans may require additional ADAP funds to assist with co-payments, laboratory tests, and other out of pocket expenses. There is now an emerging question surrounding whether these types of wrap-around services will even be covered, thus potentially leaving patients in a bind.

Without additional federal funds ADAPs fear that they may once again become cash strapped and fall short of meeting these needs. In the past when this has happened states have been forced to take drastic measures, creating waiting lists and reducing formularies. A recent press release from The AIDS Institute makes the point that states have struggled in the past to keep up with low-income clients living with HIV/AIDS. They contend that enrollment in ADAP grew by 8 percent in 2013. 

Earlier this year also brought the return of ADAP waiting lists, a problem that had been eradicated in late 2013. The latest ADAP Watch, published by the National Alliance of State & Territorial AIDS Directors (NASTAD), noted these concerns:

• Utah established a new waiting list on February 19, 2014.
• Ten ADAPs have had cost-containment measures in place since April 1, 2013 (reported as of February 4, 2014).
• Louisiana reports considering implementing new or additional cost-containment measures by the end of ADAP’s current fiscal year (March 31, 2014).
• Seven ADAPs reported modifying or eliminating existing cost-containment measures since April 1, 2013 (reported as of February 4, 2014).
• Wyoming eliminated their enrollment cap on November 21, 2013.

Further federal funding would assist with thwarting these anxieties.

The other concern with the President’s budget proposal is the issue surrounding Part D of Ryan White. Part D is devoted solely to “providing family-centered care involving outpatient or ambulatory care for women, infants, children, and youth with HIV/AIDS” (U.S. Department of Health and Human Services). Grantees use this funding to help pay for costs associated with services including:

• Lab, x-ray, and other diagnostic tests.
• Pharmaceutical assistance for HIV-related medications, and vaccines.
• Oral health-care services.
• Mental health services.
• Substance abuse outpatient care.
• Medical nutrition therapy.
• Transportation for clinical care providers to provide care.

Just like the other Parts of Ryan White, funds are used as a cost-effective way to assist low-income individuals. However, unlike other Parts of Ryan White, Part D is aimed directly at assisting women, children, infants, youth, and families affected by HIV/AIDS.  The President’s budget proposes to combine Part D with Part C. The argument for the consolidation, which will administered through the same division under the Health Services & Resources Administration (HRSA), is to achieve "savings" through increased efficiencies and decreased overlap.  Many advocates are concerned that the proposed consolidation will leave these vulnerable groups without the important care they need. This translates into a coverage gap for many low-income families; families that will fall through the cracks of healthcare.

A recent press release from the AIDS Alliance for Women, Infants, Children, Youth & Families raised these concerns last week. Deputy Executive Director Dr. Ivy Turnbull had this to say:

“Ryan White Part D is the lifeline for women, infants, children and youth living with HIV/AIDS. The Part D programs are instrumental in preventing mother-to-child transmission of HIV and for ensuring that women and youth have access to quality HIV care.  Since the program’s inception in 1988, the Part D programs have been and continue to be the entry point into medical care for women and youth and, in many communities or regions, Part D programs are the only perinatal clinical service available to serve HIV-positive pregnant women and youth.  Removing Part D from the federal budget would eliminate a strong safety net for our most vulnerable populations and weaken the system of care these programs have created and invested in for more than 25 years.”

The same press release quoted HIV advocate Janet Kitchen as saying:

“I am shocked that this is happening when the services for women and children are so important and the President has invested so much in promoting health care access in this country.  I believe everyone in the HIV community should be concerned about this and the community should be involved with the administration and congress to discuss and create a system that serves the people in need.”

Although there is concern over Ryan White Part D, Hamilton makes an important distinction saying, “It appears that the reconfiguration of Part D Services will not play any detrimental role to the ADAP Program at this time.” 

This is good news for ADAP recipients who are seeing growing apprehension from the healthcare community with regard to Part D.

The overarching reaction from the public health community and HIV/AIDS advocates is that the President’s budget is congruent with his promised commitment to continue funding programs like Ryan White in an effort to eradicate HIV/AIDS in the U.S. That being said, there is a fear that the lack of additional funding for ADAPs may cause unintended consequences for states programs that are already cash-strapped and will see growing financial needs due to the transferring of clients into Marketplace plans and the uncertainty of how the Medicaid expansion will effect ADAPs. The HIV/AIDS community will continue to closely monitor the budget proposal as it moves through congress and the ADAP Advocacy Association will continue to update its followers with regard to this issue.