Friday, December 20, 2013

Improving Medication Adherence through Walgreens HIV-Specialized Pharmacies


By: Glen Pietrandoni, R.Ph., AAHIVP, senior manager, virology, Walgreens









What would it take for an HIV patient to achieve their best health and an improved quality of life? Could we…perhaps, realize an AIDS-free world? Walgreens studies show some of the ways in which better outcomes can be achieved.

Medication adherence is vital to maintaining optimal health for patients with the HIV virus and could contribute to suppressed viral loads which make the virus less likely to be transmittable. Walgreens HIV-specialized pharmacies are committed to keeping patients adherent and being a part of the solution to end AIDS.

A recent Walgreens study[1]  of more than 15,000 HIV patients showed that those who received care through one of its HIV-specialized pharmacies were significantly more adherent to their medication (74 percent) than those receiving care through a traditional, non-specialized Walgreens pharmacy (69 percent).

In examining the differences in medication adherence for HIV patients with a comorbid condition using Walgreens HIV-specialized pharmacies and those using other Walgreens retail pharmacies[2], researchers confirmed that HIV patients utilizing the specialized pharmacies were more adherent to their anti-retroviral and comorbid therapies.

This includes the nearly 30 percent of patients living with HIV and serious mental illness, a population which often experiences challenges associated with willingness and ability to take medication as prescribed such.  Of the HIV patients with serious mental illness who exclusively used HIV-specialized pharmacies, 33 percent were adherent to their anti-retroviral therapy versus 19 percent for HIV patients with serious mental illness using other Walgreens retail pharmacies.

Patients with other comorbid conditions, including hypertension and high cholesterol, also demonstrate increased adherence when using Walgreens HIV-specialized pharmacies.

So what’s our secret? It’s no secret at all. Since the beginning of the epidemic, more than 30 years ago, our pharmacists have been focused on education, counseling, testing and treatment. In the more than 700 U.S. communities impacted by HIV, our pharmacists have established deep relationships with local patients. Beyond dispensing medication, our HIV-specialized pharmacists are trained to provide confidential wellness consultations, coordinate care and benefits with physicians and insurance providers, and to help patients access financial support programs to reduce medication costs. Above all, medication adherence remains our primary objective because we know that taking the right medication at the right time is key to improving health outcomes.

Walgreens recently announced we’re leveraging the expertise of our pharmacists to collaborate with the Centers for Disease Control and Prevention (CDC) and University of North Texas (UNT) College of Pharmacy to develop and evaluate a model of HIV patient-centered care through a national project aimed at advancing clinical integration and medication therapy management.

According to the CDC, only 25 percent of Americans with HIV have the virus under control. Our more than 2,000 HIV-specialized pharmacists can plan an important role in working with patients and providers to help improve the population’s health and help make an AIDS-free world a reality.

________________


1.  Murphy P, Cocohoba J, Tang M, et al. Impact of HIV-specialized pharmacies on adherence and persistence with antiretroviral therapy. AIDS PatientCare and STDs, Volume 26, Number 9, 2012.
 2. Dr Janeen DuChane PhD,Michael Taitel PhD,Leonard Fensterheim MPH,Bobby Clark PhD,John Hou PhD,Julia Zhu MPH,Jenny Jiang MS,Adam Cannon MPH,Glen Pietrandoni RPh
The Lancet - 3 November 2013 ( Vol. 382, Page S3 )
DOI: 10.1016/S0140-6736(13)62251-5



Monday, November 25, 2013

Is the RWCA dead?

By: 
Eddie Hamilton
Director
ADAP Educational Initiative

There has been a lot of chatter and disputes in the HIV/AIDS advocacy world regarding the Ryan White Program Care Act (RWCA) expiration on September 30, 2013. Granted, there are numerous valid arguments for and against Ryan White Program RWCA reauthorization and for reprioritization. There are inherent dangers by acting now and also waiting until 2015 until the numerous impacts of the ACA are known. With the ACA enrollment issues, it may be even longer than 2015 before all of the impacts are fully understood.

However, I truly believe that there are two bigger and dangerous elephants in the room that needs to be addressed by all nationwide advocacy groups.

The first is sequestration where organizations are already feeling tremendous negative impacts in service delivery and those impacts will only get worse. There is not much being said publically about Sequestration 2.0.

The second and more immediate issue is a much bigger problem. Upon further research from credible government sources, I have found that it is very possible that the Ryan White Program no longer legally exists due to sloppy appropriations writing and Washington gridlock.

Many HIV/ AIDS organizations are relying on the argument that “Even though there is not a 'sunset' provision, the RWCA program is just fine because there is money being appropriated for the program.

I had to question that argument because it was too easy of an answer to such an important question.

Question: Is the RWCA dead? Short Answer: In other words, Maybe no but most likely so.

Long Answer: There are a few different sources of information regarding “Unauthorized Appropriations” primarily from the U. S. Government Accountability Office (GAO).  An “Unauthorized Appropriation” is where Congress has allocated money for a program whose primary authorization has since expired that could be subject to a point of order within either chamber that could possibly kill the bill.

In this toxic political atmosphere, anything can happen as it only takes one representative from either chamber to raise a point of order. In the case of the Ryan White program, the authorization had expired on 9/30/2013. The Program has already hit the list for Unauthorized Appropriations.

An authorization bill is known as an enabling statute or a program’s “organic’ authority that articulates a program parameters and an agencies’ mission within in a program. In usual course, no funds can be expended until an actual separate dedicated appropriation authority with specific language directing programs goals and requirements has been initiated.

However, when an appropriations authorization has expired, the language within a continuing resolution or appropriations bill is critical when making the determination of whether the appropriation has the force of a continuing reauthorization of its’ “organic “ authority.

In other words, unless an appropriations bill contains the explicit language reauthorizing the Ryan White Program, the “organic” authority laying out the priorities is still expired and therefore, dead. A catch-all sloppy appropriation to an agency (i.e. HRSA) on January 13th (the new appropriation date) is and will be insufficient without the adequate instructions for the Ryan White Program because there is no valid authorization on the books. The last CR that was passed to stop the shutdown does not explicitly lay out any new authority for the RWCA.

Therefore, in my opinion, the RWCA is legally dead!

Do we have a Plan B in the event the states cannot issue new operating rules (based on ACA or Medicaid expansion) based on the fact that the RWCA is dead?

I also argue at a bare minimum that the any state law and rules, Request for Proposals, bids and contracts constructed and awarded listing the RWCA 2009 as their source of authority, immediately become inoperative when the entity spends the last dollar authorized in their budgets (prior to 9/30/2013) for FY 2013 because they refer to RWCA 2009 as their source of authority. Rebate monies will not count towards this authority as this money comes from the pharmaceutical companies and not the Federal Government.

As a result, I would highly encourage that the entire HIV advocacy community do some appropriate research before coming out with blanket statements on such a vital program.

Various national HIV advocacy groups who are making assumptions that the status quo will be maintained are not viable options. It is imperative that both of these issues be addressed as our lives depend on it!   Hollow words of advocacy no longer cut it anymore.

References:





Friday, November 8, 2013

Survey Reveals Sequestration Impacting AIDS Care while Number of Patients Increase

By: 
Carl Schmid
Deputy Executive Director
The AIDS Institute

A survey conducted by The AIDS Institute found that HIV care in the United States is suffering as a result of sequestration and cuts in the Budget Control Act, while the number of AIDS patients is increasing. One hundred and thirty-one AIDS organizations in 29 states and the District of Columbia took the survey on the impact of these cuts, and the findings were troublesome.

In the last year, domestic HIV/AIDS programs have been cut nearly $380 million. As a result of these and other cuts 85% of the organizations surveyed experienced funding reductions. At the same time, 79% experienced an increase in clients.

As a result of cuts, 52% of survey respondents who detailed the impact of their lost funding indicated they have had to reduce staff, while 38% had to cut prevention education programs, and 22% cut back on HIV testing.  At least one organization had to close down completely.

Staff reductions impacted case management, administrative and clinical staff the hardest, and researchers, educators, and peer advocates were also cut from organizations. The majority of responding organizations had to lay off three to five staff members due to these cuts.

Photo of African-American man holding up a hand-made sign that reads, "Budget Cuts = Deaths HIV Poverty Total Devastation"
According to survey respondents, the funding reductions have resulted in cuts to patient services, including longer times between appointments and increased wait times at the clinic.  Some have even stopped seeing certain patients.

During the same period , the number of clients was increasing. The average increase in clients since January 1, 2012 was 18% according to surveyed organizations, compared to the average reported reduction in funding of 17%.

This survey demonstrates that the severe cuts enacted by the Budget Control Act are having real, negative consequences on HIV/AIDS organizations and their patients across the nation.  These budget cuts, coupled with an increasing number of HIV patients, have impacted their ability to provide timely, quality care and prevent future HIV infections.  If these cuts continue, they will certainly lead to increased infections, more deaths, and higher healthcare costs.

At a time when we know how to reduce an infectious disease such as HIV through prevention and treatment, and we have a National HIV/AIDS Strategy grounded in science, now is not the time to reverse the substantial progress that has been made.

There are nearly 50,000 new infections each year in the U.S. and only one third of the nearly 1.2 million people with HIV in the US have been prescribed antiretroviral treatment.

We have a long way to go before we can realize the dream of an AIDS-free generation.  We urge the Congress and the President to reverse the cuts caused by sequestration and adequately fund critical public health programs, including those that prevent HIV and provide for care and treatment for people living with HIV.

Negotiations going on right now in the Congress on the budget will directly impact if these cuts continue in the future.  The AIDS Institute hopes that these survey results, which have been forwarded to all members of congress, will help convince budget conferees that these cuts to domestic HIV programs must end.

The full survey results can be found at: http://bit.ly/1hwV52p.

Thursday, October 31, 2013

The Affordable Care Act Crystal Ball


The Patient Protection and Affordable Care Act (PPACA), or the Affordable Care Act (ACA) – also known as "Obamacare" – is supposed to see most of the law’s major provisions phased in by January 2014, with other provisions phased in by 2020. The ACA will have numerous implications generally on the United State’s health care delivery system, but more specifically on the supports and services afforded to people living with HIV-infection, or viral Hepatitis. What’s more, ongoing Medicaid expansion and the implementation of insurance exchanges will also impact nearly all healthcare providers, as well as their patients.

President Obama signs the Affordable Care Act into law on March 23, 2010.
As the full implementation of the law fast approaches, it seems to be raising more questions than providing answers. The roll-out hasn't been without its share of bumps, either. Nonetheless, many public health advocates see a lot of "positive" (no pun intended) changes coming with respect to the delivery of health care supports and services for individuals living with HIV/AIDS, as well as Viral Hepatitis.

With so many changes forthcoming under the ACA, there is no crystal ball that will show what is in store for the nation's health care system. For starters, at least pre-existing conditions will no longer prevent people from gaining access to insurance, and thus access to care. Of particular interest to stakeholders advocating for a robust AIDS Drug Assistance Program (ADAP), an ACA provision allows ADAP to count toward the true-out-of-pocket expenses (TrOOP) under the Medicare Part D program is also welcome news.

Antonio J. Carrion, PharmD, MPH, who is an Assistant Professor of Pharmacy Practice at Florida A&M University's College of Pharmacy and Pharmaceutical Services (COPPS), has outlined some of these changes in his recent blog. In fact, Carrion's analysis dispels the myth that the Ryan White CARE Act -- including ADAP -- is going away under the ACA.

The blog reads, in part: "Because of the new health care law, ADAP benefits will be considered as contributions toward Medicare Part D’s True Out of Pocket Spending Limit (TrOOP). What does that mean? ADAP clients who are Medicare Part D enrollees will be able to move more quickly through the “donut hole.” Before the ACA, this transition was very difficult for ADAP enrollees to complete" (Florida/Caribbean AETC, 10/30/13).

Another excellent resource on this topic was made available by the National Alliance of State & Territorial AIDS Directors (NASTAD), which can be downloaded here.

TheBodyPro also recently published an excellent interview with Dr. Michael Saag and Dr. Michael Wong, whereby they each shared their perspective about the upcoming ACA implementation. The article can be viewed online, here.

In the interview when asked if the law was a good or bad thing for HIV patient care, Dr. Saag pretty much summed-up the advocacy community's sentiment: "I think, overall, it's a good thing. Number one, it will put, generally speaking, more people into insurance plans, be it Medicaid or some other kind of plan. And it creates more options. In essence, there's more money flowing to clinics and flowing to cover the costs of medications, so it will give some relief to the Ryan White CARE Plan -- and we'll get back to that, I'm sure, later. But the bottom line is, it's a good thing" (TheBodyPro, 08/22/13).

Unfortunately, one other area that also tends to draw a common theme is the concern over the ACA's uneven implementation nationwide. Whereas some states, like California, Massachusetts, and New York will accept the Medicaid expansion provisions included under the law, other states, such as Alabama -- which has the largest ADAP waiting list creeping up on nearly 200 patients statewide -- plans to decline the Medicaid expansion. The South appears to be disproportionately impacted, again.

Patients, advocates, providers and healthcare professionals alike would be well-advised to obtain the latest information about the ACA, its implementation, and how it might affect the healthcare delivery for individuals living with HIV/AIDS, and/or Viral Hepatitis. One thing is for certain, it remains very fluid.

To that end, the ADAP Advocacy Association (aaa+) -- in partnership with the Community Access National Network (CANN) Great Lakes ADA Center, and HealthHIV -- is hosting an educational webinar on Wednesday, November 6th, 2013. The webinar, themed "Impact of the Affordable Care Act, Medicaid Expansion & Insurance Exchanges on HIV/AIDS and Viral Hepatitis Services," will be open to all HIV/AIDS and Virtal Hepatitis stakeholders nationwide. It is free, so there is no excuse not to participate and learn more about what changes are coming...

Learn More about the Impact of the Affordable Care Act, Medicaid Expansion & Insurance Exchanges on HIV/AIDS and Viral Hepatitis Services




Friday, October 11, 2013

SANDBOX STANDOFF: Day 11

It has now been 11 DAYS since the government closed its doors on the American people because the politicians in Washington, DC are more concerned with scoring political points and posturing on the cable news programs rather than collectively doing their job; in the meantime, people living with HIV/AIDS -- and many other underserved populations -- scramble to make ends meet, including how the shutdown is impacting their daily lives. Some political pundits have described the current partisan rancor on Capitol Hill as nothing less than a bunch of cranky children fighting over a sandbox. The ADAP Advocacy Association (aaa+) agrees.


The negative consequences of the current political stalemate between the President, House Republicans (especially the Tea Party element of the GOP) and Senate Democrats cannot be under-estimated, or maybe even truly comprehended without digging deeper. But recent new reports provide ample evidence that the budget debacle is already raging havoc on the nation's public health system.

The Washington Blade reported that the shutdown will prevent the Health Resources & Services Administration (HRSA) from properly monitoring grants administered under the Ryan White CARE Act -- including the AIDS Drug Assistance Programs. And after the debacle with the Florida ADAP several years ago, there is plenty of reason for advocates to be concerned over the loss of federal oversight. The impasse also will halt the seasonal influenza program. It even means potential delays in Food and Drug Administration (FDA) approvals of new drugs, as well as delays in clinical trials at the National Institutes of Health.

The online publication, Medical Economics, has made available a listing of healthcare agencies being affected by the shutdown.

With so much of the blame being placed at the feet of the Tea Party, it is rather ironic that one of the nation's leading coffee retailers has entered the fray. On October 10th, Starbucks launched its "Come Together" campaign designed "to harness the sentiment many of us are feeling — a growing concern about the lack of progress from our Congressional leadership to work together to resolve the business of the American people." The company is encouraging people to sign an online petition at www.ComeTogetherPetition.com.

All ADAP stakeholders -- especially people living with HIV-infection -- are encouraged to contact their elected federal lawmakers in Washington and urge them to end the government shutdown. Lives are at stake!



Friday, September 27, 2013

Medicaid Reform and a (New) New York State of Mind: Housing Is Healthcare!


By:
Christine Rodriguez, Program Associate
National Advocacy & Organizing
Housing Works

A few short days from the October 1 marketplace openings, and uncertainty and confusion linger in discussions around healthcare and implementation of the Affordable Care Act (ACA). Policy experts, providers, and consumers alike speculate, and it seems there will be more questions than answers until we at last see how reforms play out across the country.

The HIV/AIDS community knows that health reform, both affectionately and derisively referred to as “Obamacare,” certainly benefits people living with HIV/AIDS (PLWHA) and those at risk; we absolutely need to spread the word far and wide. But let us also be sure to remember the existing tools in our arsenal that can maximize those benefits. One such tool, often detrimentally omitted from conversations about health care, is unequivocally an effective, cost-saving intervention – HOUSING.

Housing is Healthcare!, Housing is Prevention!, or Housing Saves Lives!, aren’t rallying cries that Housing Works advocates causally toss into articles and testimony or banners and protest signs simply out of habit after nearly 25 years of advocacy and activism. The health and cost-related benefits conferred by access to safe, affordable housing are well demonstrated by research, both for PLWHA and to prevent transmission among HIV-negative homeless populations.

Housing Works' Housing is Healthcare Rally
Housing Works' Housing is Healthcare Rally

For marginalized communities – whether HIV-positive, living with mental illness or substance abuse issues, or others unstably housed – having housing means better holistic health. Even without the research this is common sense, right? Housing means having a place to store medications and healthy food, get a full night’s sleep, and often relief from the fear of violence. It means an address for job applications, avoiding hypothermia in the winter, and a safe space to engage with family, friends, and lovers. It means treatment adherence, safer sex, and everything taken for granted by many of us every day.

New York State, leading by example, is not taking housing for granted in its current efforts to improve the healthcare system. Governor Cuomo is proving to be a national leader in the effort to effectively utilize the Medicaid program and underscore that housing IS healthcare. New York’s Medicaid Redesign Team (MRT) was initiated in 2011, and early on an Affordable Housing work group was deemed critical and included in the process. Gov. Cuomo, thanks to MRT’s efforts, recently announced a $4.6 billion savings over the past year alone. From those savings, the Supportive Housing Initiative will be allocated $36.4 million in capital funds, $30.6 million in rental/service subsidies, and $24 million for critical new pilot programs – a total of $91 million.

New opportunities require new ways of thinking; innovation is necessary to address the complex and diverse health concerns of PLWHA, especially as the population ages. The MRT allocation for pilot housing programs begins to address this – one of several critical projects being the “Health Home HIV+ Rental Assistance Project.” Much to our collective chagrin, it is not uncommon for official policy to be somewhat disconnected from lived reality. Under current HIV/AIDS Services Administration regulations in New York City, instead of providing housing to prevent exacerbating illness, one must already have an AIDS diagnosis or advanced HIV-illness to even qualify for such services. This pilot project creates access to housing for HIV-positive individuals otherwise medically ineligible for existing programs, finally prioritizing true preventive care PLWHA.

Jason Helgerson, New York’s Medicaid Director, explained it plain and simple – that finally “[t]here is a growing national recognition that addressing the social determinants of health is critical for improving health while reducing health care costs. This is most evident in the matter of housing.” This recognition, coupled with financial commitment, is essential for homeless communities and PLWHA. States seeking to maximize Medicaid dollars – whether or not they opt for expansion – should consider adopting or (dare I say) expanding upon this model of redesign, reinvestment, and innovation. The historic opportunities created by ACA reforms present a crucial time to take full advantage of evidence-based interventions, like housing, to truly commit to realizing the end of AIDS.

Friday, September 13, 2013

Combatting HIV/HCV Co-Infection

Earlier this year on March 19th when the ADAP Advocacy Association and Community Access National Network (CANN) announced that they were co-hosting an HIV/HCV Co-Infection ADAP Summit, Bill Arnold said, "CANN has long been recognized for its commitment to promoting patient access to timely care and treatment, and we need to educate consumers, community partners, as well as congressional staff here in Washington, DC about the fastest growing public health epidemic since AIDS: Viral Hepatitis C infection. We have learned many valuable lessons from the HIV/AIDS advocacy community over the last three decades, and CANN will now apply those lessons to ensuring access to effective HCV treatments."

The Summit convened in Las Vegas, NV on April 25th-26th and various stakeholder groups participated in the conversation (only the federal government agencies were not represented because Sequestration restricted agency travel budgets). By all accounts the Summit achieved the objective laid out in Arnold's statement, but unfortunately there are some very sobering statistics behind the need for the event being held in the first place, among them:
  • About 25% of people infected with HIV in the U.S. are also infected with HCV.
  • About 80% of injection drug users (IDUs) with HIV infection also have HCV.
  • HIV/HCV co-infection more than triples the risk for liver disease, liver failure, and liver-related death from HCV.
  • Compared with other age groups, a greater proportion (about 1 in 33) of people aged 46–64 years are infected with HCV.
  • Chronic HCV is often "silent," and many people can have the infection for 20 to 30 years without having symptoms or feeling sick.
  • In the U.S., HCV is twice as prevalent among blacks as among whites.
  • New data suggest that sexual transmission of HCV between MSM living with HIV occurs more commonly than previously believed and that sexual transmission can occur undetected between HIV-infected MSM in the absence of injection drug use.[1]
Some public health experts predict that the HIV/AIDS epidemic of the 1980s will pale in comparison to what is likely to happen with the onslaught of new HCV infections. Fortunately, there is a cure for HCV infection.

Several pharmaceutical companies -- including AbbVie, Boehringer-Ingelheim, Bristol-Myers Squibb, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Therapeutics, Merck, and Vertex -- have numerous new HCV treatments on the market, or in the pipeline, which are much improved over the initial treatments that won approval by the U.S. Food & Drug Administration (FDA). The marvels of modern medicine means that many of these new treatments come with far fewer side effects, better resistance profiles, and in some cases, patients will be on the treatments for less time before achieving optimal results. But at what cost?



According to the Fair Pricing Coalition (FPC), FDA-approved HCV treatments have been extremely expensive, coupled with double digit price increases accompanying some of these drugs since 2011. The FPC has released statements on the cost of the new drugs. The debate over drug pricing will surely continue to ignite emotions once the newer treatments gain FDA approval, and at a much higher cost. In all fairness to the pharmaceutical companies, they have also expanded access...or plan to expand access...to their patient assistance and co-payment assistance programs.

The aforementioned discussion led to what amounted to be the most interesting idea accepted at the Summit: A Pharmaceutical Industry Access to Care Report Card. The "report card" idea was among the recommendations included in the HIV/HCV Co-Infection ADAP Summit Final Report, which was released last week and included both short-term and long-term recommendations.

The short-term recommendations included:

  1. Identify national coalitions (i.e., Federal AIDS Policy Partnership, National ADAP Working Group, HCV Coalition for the Cure) and their respective partners, and develop strategic objectives to advance the treatment of HIV/HCV Co-Infection, as well as access to them.
  2. Develop universal messaging campaign surrounding access to care under the AIDS Drug Assistance Programs, using “success stories” from co-infected patients. (Editor’s Note: Some of this is already being done by the Campaign to End AIDS).
  3. Analyze existing ADAPs covering HCV treatments to determine the pros/cons of recommending other ADAPs covering HCV treatments for co-infected patients. Using a mathematical model, establish guidelines and tiers for co-infected treatment options.
  4. Determine feasibility of ADAPs purchasing insurance continuation plans that cover HCV treatments.
  5. Ensure that ACA Essential Health Benefits include benchmarks for treatment guidelines, as well as sufficient appeals process.
  6. Establish emerging treatment guidelines using existing medical data and consumer experience. It is premature to evaluate “gold standard” for treatment because too many HCV treatments are in the development pipeline, including some already being evaluated by the Food & Drug Administration (FDA).
  7. Develop “Fact Sheets” on existing plans for treatment for co-infected patients, including “navigator” information and resources.
  8. Expand testing.

The long-term recommendations included:

  1. Commission study to identify the potential treatment gaps for HIV/HCV Co-Infection.
  2. Develop pharmaceutical industry “Report Card” to evaluate access to timely and appropriate care of people living with HIV/HCV Co-Infection; grading new should take into consideration drug pricing, patient assistance programs, drug rebates (if available), community education/participation initiatives, and accessibility of user-friendly product information (aside from what is legally required by the FDA).
  3. Implement “Common Portal” for ADAP.
  4. Evaluate adding a new Part under the Ryan White CARE Act, specifically addressing HIV/HCV Co-Infection modeling after the Minority AIDS Initiative.

Whereas the Summit's Final Report is not necessary endorsed by the HIV/HCV Co-Infection ADAP Summit’s sponsors, panelists or participating organizations, it does represent a significant step in ensuring that the effort to combat HCV infections learns from the ongoing struggle against HIV infections.

CLICK HERE to download the HIV/HCV Co-Infection ADAP Summit Final Report.



[1] Centers for Disease Control & Prevention, HIV and Viral Hepatitis Fact Sheet, November 2011.