Thursday, April 27, 2017

Could New Research Pave Way for Official Guidelines for the Treatment of Lipohypertrophy

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

There purports to be an "obesity epidemic" in the United States,[1] though strong evidence suggests that people can be healthy at every size.[2] Data shows from 1960-2002, in the United States the average male weighed 25 pounds more and average female weighed 24 pounds more. Putting the debate over obesity aside, undesirable weight gain for many people living with HIV/AIDS is often grudgingly accepted as normal. This paradigm could soon be changing because new research could pave the way for better guidelines for treating HIV-related weight gain — namely, Lipohypertrophy.

Example of lipohypertrophy – Man
Photo Source: myclickfine.com

Research published in the Clinical Infectious Diseases by a panel of international authors (U.S., Canada, Europe) from 12 universities represents a consensus opinion on the diagnosis, clinical consequences and treatment of excess fat in adults with treated HIV infection. The groundbreaking study offers some hope to people living with HIV-infection concerned about facial wasting, belly fat, lipomas, or the dreaded "buffalo hump" on the back of the neck.

The publication, "Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection," concludes, "Both generalized obesity and lipohypertrophy are prevalent among HIV-infected persons on ART. Aggressive diagnosis and management are key to the prevention and treatment of end-organ disease in this population, and critical to the present and future health of HIV-infected persons."

Among the research findings, management of HIV-related weight gain includes lifestyle changes in diet and exercise, though there was "insufficient data to support any specific dietary or exercise strategy in patients with HIV and abdominal obesity."[3] Changes in anti-retroviral therapy is also suggested, since some of the new medications have less side-effects.[4] Medical interventions are also identified as viable options — including Growth Hormone (GH) Axis Therapy and Metformin.[5] Finally, surgical interventions are also included in the options identified by the authors.[6]

The research findings are already gaining attention in respected HIV news publications, too.

The ADAP Advocacy Association sees promise in the report findings for patients suffering from a condition for which treating physicians are paying little attention, and in many cases where payors — including many State ADAPs — are excluding coverage for treatment options approved by the U.S. Food & Drug Administration. In late 2016, we urged the Health Resources and Services Administration ("HRSA") to update to the Guide for HIV/AIDS Clinical Care. The national sign-on letter wasn't an endorsement of a specific product or treatment, but rather an attempt to afford patients suffering from HIV-associated lipodystrophy syndrome the opportunity to access the available treatment options (all of which were identified in the aforementioned research).

HRSA now has a template for updating its treatment guidelines. It is up to the federal agency to respond to the needs to the patients!



Read our related blogs on this topic:

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[1] Rauh, Sherry (2010); Is Fat the New Normal? A rise in average body weight may be changing how we see ourselves. WebMD. Retrieved from http://www.webmd.com/diet/obesity/features/is-fat-the-new-normal#1.
[2] Bacon, Linda (2010, May 4); Health At Every Size: The Surprising Truth About Your Weight; BenBella Books. Retrieved from https://lindabacon.org/health-at-every-size-book/.
[3] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[4] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[5] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.
[6] Lake, Jordan E., et. al (2017, February 24); Clinical Infectious Diseases; Practical Review of Recognition and Management of Obesity and Lipohypertrophy in Human Immunodeficiency Virus Infection; Oxford University Press. Retrieved from https://academic.oup.com/cid/article-abstract/doi/10.1093/cid/cix178/3051856/Practical-Review-of-Recognition-and-Management-of?redirectedFrom=fulltext.

Thursday, April 20, 2017

Linkages to Care - Plugging the Treatment Gap: Navigating Patient Assistance Programs

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

In the United States, everyone hates how insurance companies "stick" it to consumers. There is pretty much universal agreement that the cost of prescription drugs are too high. There is also near consensus that the marketplace plans under the Affordable Care Act ("ACA") have caused a lot of headaches for patients with chronic conditions  including HIV/AIDS  especially with respect to the high tier drug plans. It is no wonder that so many cracks exist within the current healthcare framework. Fortunately, there also exist patient assistance programs ("PAPs") designed to plug the treatment gaps for these patients. PAPs serve as key linkages to care...and treatment!

According to PatientAssistance.com, "Commonly referred to as PAPs, Patient Assistance Programs are services offered by pharmaceutical companies for those who cannot afford their medication. Patient assistance programs are available to low-income individuals or families who are under-insured or uninsured and are provided to those who meet the eligibility guidelines. Assistance may range from reduced cost of drugs to free medicine. Each drug that a company offers will have its own unique program and may even have a different eligibility requirement than the other drugs they offer. As there is no unified standard of designation for these programs, you may also see them referred to as medication assistance programs, indigent drug programs, and charitable drug programs."[1]

Pharmacist standing in front of the pharmacy with prescriptions.
Photo Source: MedicineCoupons.net
PAPs are vitally important to patients living with chronic conditions. They not only improve access to care and treatment, but they also save consumers money and reduce lost productivity. They also benefit the drug manufacturers because PAPs keep patients (would-be consumers) in treatment. The data shared by the Partnership for Prescription Assistance ("PPA") — which connects qualifying patients with the assistance program that’s right for them — is mind-blowing.

Celebrating its 12-year anniversary, PPA recently reported that its website is visited by over 75,000 consumers per month and makes available information on more than 475 patient assistance programs. It also offers a database of nearly 10,000 free or low-cost health care clinics across the country. Over 10 million consumers have been helped since the program's inception.[2]

Aside from the resources made available to consumers directly from the drug manufacturers, there also exists other patient-centric organizations designed to assist patients with prescriptions, discount drug cards, and other patient resources. Just to name a few, they include the Patient Access Network Foundation ("PAN"), Patient Advocate Foundation ("PAF"), and NeedyMeds. Each of these organizations serve as vital linkages to care for social workers, case managers, and allied health professionals assisting patients. These organizations also each partner with the ADAP Advocacy Association.

In an effort to raise awareness about patient assistance program and how they serve people living with HIV/AIDS and/or viral hepatitis, we will host an educational training webinar on May 31, 2017. The webinar, "Plugging the Treatment Gap: Navigating Patient Assistance Program," will showcase important information about these patient-centric PAPs. It will provide webinar attendees with a greater understanding about patient assistance programs, tools for how to navigate patient assistance programs to best assist patient needs, strategies for better seamless delivery of health-related care and treatment, and useful resources and tools to plug the treatment gap.

Registration is open to all stakeholders. Registration is complimentary for PASWHA members, and it is also complimentary for patients living with HIV/AIDS. Use this scholarship link if you are a patient living with HIV/AIDS applying for a webinar scholarship.

Additional information about the webinar is available online at https://www.123signup.com/event?id=nhjqn.


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[1] PatientAssistance.com (2014); The Catalyst; What are Patient Assistance Programs?; PatientAssistance.com, Inc. Retrieved from https://www.patientassistance.com/faq.html.
[2] Mooney, Hannah (2017, April 5); 12 years of the Partnership of Prescription Assistance; Pharmaceutical Research and Manufacturers of America®. Retrieved from http://catalyst.phrma.org/12-years-of-the-partnership-of-prescription-assistance.

Friday, April 7, 2017

Is it Time for a Reset to the Ryan White CARE Act?

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

It has been almost 27 years since the mother of a young boy dying of AIDS received a phone call from the late Senator Edward Kennedy (D-MA), asking if it would be okay to attach the boy's name on federal legislation.1 That young boy's name was Ryan White, and it has become synonymous with the Ryan White Comprehensive AIDS Resources Emergency Act (Ryan White CARE Act). Since 1990, it has saved countless lives of people living with HIV/AIDS in the United States. The law is due to be re-authorized by Congress, and some are asking if the time is right for a "re-set" so that the supports and services authorized under the law better reflect the state of the epidemic.

HIV surveillance data reveals some interesting trends about the epidemiology of the disease over time. Diagnosis of HIV infection demonstrates that some things have remained constant, such as men who sex with men (MSM) and intravenous drug use (IDU) represent two of the high-risk transmissions groups. But today, HIV infection disproportionately impacts communities of color, as well as people living in rural areas of the country. Heterosexual woman and adolescents are also greatly at risk for HIV infection.

The following charts published by the Centers for Disease Control & Prevention (CDC) help to explain the trends in HIV diagnoses in the United States between 2010 - 2014:2

Photo Source: CDC

Photo Source: CDC

Photo Source: CDC
According to the CDC, "The South now experiences the greatest burden of HIV infection, illness, and deaths of any U.S. region, and lags far behind in providing quality HIV prevention and care to its citizens." It begs the question, shouldn't the federal government adopt a "money follows the person" paradigm to reflect the changing epidemiology?

Some of the important questions surrounding Ryan White reauthorization include the following:
  • should funding stream formulas count cumulative AIDS cases or only living HIV-positive people?
  • should wrap-around services be expanded for clients who have Medicare Part D, Medicaid or Veterans Affairs healthcare?
  • should coverage include inpatient hospital care?
  • should coverage include Hepatitis C (HCV) drug therapies?
  • should commercial health insurance premium assistance programs be liberalized?
"At a time when we have the most effective and simple HIV treatments and a very volatile healthcare insurance landscape, WE NEED the Ryan White safety net program for continuity - less we forget without care and treatment HIV is a deadly and transmissible disease," summarized David Poole, Director of Legislative Affairs at AIDS Healthcare Foundation."

Next week this issue will be discussed at the ADAP Advocacy Association's AIDS Drug Assistance Program Regional Summit in Raleigh, North Carolina. "Ryan White & Service Delivery Systems in the Age of Budget Austerity" is one of the topics on the agenda with leading policy stakeholders concerned about the future of the program, and potential impact on patients living with HIV/AIDS and other underserved populations.

For complete information about the Ryan White CARES Act please visit http://hab.hrsa.gov/abouthab/legislation.html.


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[1] Groppe, Maureen (2014, July 30); Future of Ryan White program not clear; JConline. Retrieved from http://www.jconline.com/story/news/2014/07/30/future-ryan-white-program-clear/13376961/.
[2] National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (2017, March 24); HIV Surveillance—Epidemiology of HIV Infection (through 2015); Centers for Disease Control & Prevention, U.S. Department of Health & Human Services. Retrieved from https://www.cdc.gov/hiv/pdf/library/slidesets/cdc-hiv-surveillance-genepi.pdf.
[3] Centers for Disease Control & Prevention (2016); HIV in the Southern United States; TheBody.com. Retrieved from: http://www.thebody.com/content/76879/hiv-in-the-southern-united-states.html. 

Thursday, March 30, 2017

340B Program: Don't throw the baby out with the bathwater

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

The pharmaceutical industry and other interest groups have lobbied Congress to "reform" the 340B Drug Pricing Program, which they claim is riddled with waste, fraud, and abuse. Abound are damaging audits and reports that certainly back up the claim, except this over-generalization can be dangerous. Whereas hospitals are the program's primary participating vendors, there are many other smaller entities that also leverage the discounts on prescription drugs to assist their clients. No better example exists than the Ryan White covered entities, including Ryan White clinics, State AIDS Drug Assistance Programs (ADAPs), and other safety net providers.

The Health Resources and Services Administration (HRSA) summarizes the 340B Drug Pricing program as follows:
"The 340B Drug Pricing Program requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. Eligible health care organizations/covered entities are defined in statute and include HRSA-supported health centers and look-alikes, Ryan White clinics and State AIDS Drug Assistance programs, Medicare/Medicaid Disproportionate Share Hospitals, children’s hospitals, and other safety net providers."[1]
It is understandable why the drug manufacturers — most of which are required by law to to provide significant discounts (20-50%) off drug pricing— would be concerned about the growth of the program. Total sales under the program increased from $1.1 billion in 1997 to more than $7 billion in 2013,[2] and quickly climbing toward $20 billion. There are plenty of shenanigans with hospitals boosting their profits rather than providing supports and services for low-income and uninsured patients.[3] A recent study concluded, “Our findings support the criticism that the 340B program is being converted from one that serves vulnerable patient populations to one that enriches hospitals and their affiliated clinics.”[4]

Some in Congress are also alarmed. Senator Charles E. Grassley (R-IA) is chief among them, arguing a few years back, "Congress needs to know the extent to which the agency believes it lacks the statutory authority to ensure that hospitals use the 340B program to help the uninsured receive affordable prescription drugs. Medicare and private insurance are paying much more for some drugs than the hospitals paid because of the program discount. Congress needs a full picture of how hospitals are using the program and how their uses affect other programs in the health care system.[5]

Photo Source: Brendan Smialowski/Getty Images
But there is an age-old saying, "Don't throw the baby out with the bathwater."

Earlier this year, Harish Thiagaraj authored a detailed report on how AIDS Service Organizations (ASOs) — some of which are Ryan White covered entities — have served as the poster child for the success of the 340B Drug Pricing Program. Thiagaraj accurately notes that proposed "reforms" to the program would leave such HIV entities largely untouched,[6] but there is no guarantee that harmful changes, or unintended consequences couldn't result from the programmatic reforms targeting large hospitals.

The study concludes:
"Those in the 340B industry realize that the 340B Drug Discount Program runs much more deeply than lower cost prescriptions. It provides treatment for those who are seriously ill. Its savings go towards valuable community services. Its creation was born out of necessity, and program growth directly correlates with better health and outcomes, which the Ryan White clinics’ achievements exemplify."[7]
Thiagaraj's assessment couldn't be more accurate, and we applaud him. Ryan White covered entities participating in the 340B Drug Discount Program have contributed to achieving viral suppression, and more needs to be done. The savings are re-invested back into the clinics, thereby allowing them to offer much needed supports and services to their clients.

ACHIEVING VIRAL SUPPRESSION: MORE PEOPLE WITH HIV NEED TO BE IN MEDICAL CARE
Source: Wellpartner
That said, it is important that the integrity of the program is protected.

"The 340B program has been challenged since its inception," summarized Jeffrey R. Lewis, President and Chief Executive Officer at Legacy Health Endowment. "The challenge today is to ensure that the program is operating the way Congress intended. To accomplish this, Legacy Health Endowment will be organizing a national commission to recommend specific ways to ensure the long term solvency of the 340B program, and to determine what changes may need to be made to ensure that the program does not exceed its Congressionally mandated purpose."

Next month this issue will be discussed at the ADAP Advocacy Association's AIDS Drug Assistance Program Regional Summit in Raleigh, North Carolina. "Ryan White & 340B Drug Access" is one of the topics on the agenda with leading policy stakeholders concerned about the future of the program, and potential impact on patients living with HIV/AIDS and other underserved populations.


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[1] Health Resources and Services Administration (2017). 340B Drug Pricing Program. U.S. Department of Health & Human Resources. Retrieved from: http://www.hrsa.gov/opa/index.html. 
[2] Vandervelde, Aaron (November 2014). GROWTH OF THE 340B PROGRAM: PAST TRENDS, FUTURE PROJECTIONS. Berkley Research Group. Retrieved from: http://www.thinkbrg.com/media/publication/524_Vandervelde_340B_GrowthDrivers_WhitePaper_20141202_FINAL.pdf.
[3] Adamopoulos, Helen (2014, October 7). Are hospitals abusing the 340B drug discount program? New study reignites controversy. Becker's Hospital CFO. Retrieved from: http://www.beckershospitalreview.com/finance/are-hospitals-abusing-the-340b-drug-discount-program-new-study-reignites-controversy.html.
[4] Myers, Nan (2016, May 31). Concerns Persist about the 340B Program. Pharmacy Times. Retrieved from: http://www.pharmacytimes.com/news/concerns-persist-about-the-340b-program.
[5] Sen. Charles Grassley (2013, October 13). Grassley: Questions Continue About 340B Discount Drug Program. United States Senate. Retrieved from: https://www.grassley.senate.gov/news/news-releases/grassley-questions-continue-about-340b-discount-drug-program.
[6] Thiagaraj, Harish (2017, January 18). The 340B Drug Pricing Program Success Story: Ryan White HIV Entities," 2017. Wellpartner. Retrieved from: http://wellpartner.com/wp-content/uploads/2017/01/WP_TPL_ThoughtLeadership_RyanWhite.pdf. 
[7] Thiagaraj, Harish (2017, January 18). The 340B Drug Pricing Program Success Story: Ryan White HIV Entities," 2017. Wellpartner. Retrieved from: http://wellpartner.com/wp-content/uploads/2017/01/WP_TPL_ThoughtLeadership_RyanWhite.pdf. 


Wednesday, March 22, 2017

Despite Trump's Troublesome Policies, HIV Advocacy Must Remain in Motion

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

Earlier this year, we highlighted a decade of accomplishment achieved by the ADAP Advocacy Association since the organization's inception in 2007. Unfortunately, there is little time to celebrate because so much uncertainty  and yes, fear  exists over some of the troubling policies being put forth by the Trump Administration, and how they could potentially impact people living with HIV/AIDS. For that very reason, HIV advocacy must remain in motion!

The ADAP Advocacy Association has long contended the Affordable Care Act (ACA) is far from perfect, but it would be a mistake to ignore how the law has expanded coverage for low income and disadvantaged Americans. In fact, according to FactCheck.org nearly 20 million Americans have gained access to health insurance thanks to the ACA. There is no fake news behind that number!

Umbrella showing who is covered by Medicaid expansion
Affordable Care Act Medicaid Expansion; KFF.org

Medicaid expansion — which was authorized by the ACA had a lot to do with the dramatic decrease in the number of people uninsured in the United States. Many people living with HIV/AIDS benefited from Medicaid expansion, and their ability to access timely, appropriate care and treatment actually saved the taxpayers money. That's not to suggest that other negative, unintended consequences haven't emerged since the ACA's passage — including insurance discriminatory design with extremely high co-payments for anti-retroviral medications, adverse selection limiting access to care, or rising premiums and cost-sharing. There is also no fake news behind these facts, either!

Repeal? Replace? Repair? It is hard to know the future of the current ACA, but the Republican plan...as it currently exists...is bad for people living with HIV/AIDS. There is little debate over that statement. In fact, four Republicans governors — Snyder of Michigan, Kaisch of Ohio, Hutchinson of Arkansas, and Sandoval of Nevada —who actually favor the ACA's repeal have come out against the GOP-sponsored American Health Care Act, as it is known. Why? Because they recognize the important role Medicaid expansion has played for the people living in their respective states.

Ohio Governor John Kaisch talking to the press outside the West Wing of the White House
Ohio Governor John Kasich has voiced concerns about
repealing the Affordable Care Act; The Atlantic 

People living with HIV/AIDS haven't been well-served by the hyper-partisanship that has swept over the nation's capitol in recent years, especially with respect to the ACA. One political party buried its collective head in the sand and ignored the law's flaws, while the other political party obsessed over repealing the law without a viable alternative to replace it. Blame can be placed at the feet of both the Democrats, and the Republicans.

But rather than trying to score political points or rehash political talking points, people living with HIV/AIDS are making their voices heard loud and clear. They are trying to be part of the solution by engaging in HIV advocacy in motion...whether is activism via social media, or the National HIV Call-In Day (which was held on March 21st), or the countless sign-on letters being sent to Congress. It is encouraging that it is happening at the national, state, and local levels.

The ADAP Advocacy Association, for its part, has a robust schedule of events and projects planned for the current year. They include:
Scholarships are available for people living with HIV/AIDS who wish to participate, so that the voice of persons living with HIV/AIDS shall always be at the table and the center of the discussion. The webinar series will include the following topics:
  • Wednesday, May 31st – Plugging the Treatment Gap: Navigating Patient Assistance Programs
  • Wednesday, June 28th – Housing is Healthcare: Linking Stable Housing & Medication Adherence
  • Wednesday, July 26th – Transgender Healthcare: Removing Barriers to Healthy Cultural Expectations
  • Wednesday, September 27th – Body & Soul: Combatting the Dual Epidemic of HIV-Infection and Substance Abuse
More information about the ADAP Advocacy Association's sponsored events is available online at http://adapadvocacyassociation.org/events.html.

These activities are designed to raise awareness, offer patient educational programs, and foster greater community collaboration. Each one is enhanced by partnering with various other organizations, such as the AIDS Healthcare Foundation (AHF), Community Access National Network (CANN), North Carolina AIDS Action Network (NCAAN), and the Professional Association of Social Workers in HIV/AIDS (PASWHA). Several other projects are also in the works for the coming year.

If one good thing has come from the Trump Administration's proposed policies, then it is an increasingly energized front by the HIV community.

ADAP Advocacy Association 10th Annual Conference - "Unchartered Water: AIDS Drug Assistance Programs in the Age of Trump"



Friday, March 17, 2017

Pharmaceutical Drug Pricing, According to President Donald J. Trump

By: Marcus J. Hopkins, Blogger

Screenshot of President Donald J. Trump speaking at January 10th press conference about the pharmaceutical industry.
Source: Fox Business News; WATCH CLIP
"I think a lot of industries are going to be coming back. We have to get our drug industry coming back. Our drug industry has been disastrous. They’re leaving left and right. They supply our drugs, but they don't make them here. To a large extent. And the other thing we have to do is create a new bidding procedures for the drug industry because they're getting away with murder. 
Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there's very little bidding on drugs. We’re the largest buyer of drugs in the world, and yet we don't bid properly. And were going to start bidding and were going to save billions of dollars over a period of time (National Public Radio, 2017)."
 President Donald J. Trump


Those two paragraphs during then-President-Elect Trump’s first press conference on January 10th, 2017, resulted in the nine biggest pharmaceutical companies (by market cap on the S&P 500) shedding $24.6 billion dollars in just twenty minutes (Shen, 2017). Fox Business Network (FBN) analysts were falling all over themselves to explain what he meant, desperate to make it seem like he wasn’t saying that there needs to be a cap on industry profits and to make it into an issue about taxes, regulations, and the Food and Drug Administration (FDA) approval process (Fox Business Network, 2017). In just two paragraphs, Donald Trump managed to place pharmaceutical companies and lobbyists on the defensive – a position few likely thought they’d be in, after his electoral win in 2016, as market-oriented Republicans have consistently been sympathetic to the industry.

But breaking beyond his rhetoric and getting at the heart of what he’s attempting to say about the way the Federal government in the U.S. deals with pharmaceutical pricing is no simple task, largely because the issue of pricing is cloaked from the public as a result of existing Trade Secrets laws at both the state and Federal levels. These laws allow companies to keep secret how they set the price for their drugs, as well as what and how prices are negotiated with private insurers and government payers, like Medicaid and Ryan White Part B – the AIDS Drug Assistance Program (ADAP). While the Centers for Medicare and Medicaid Services (CMS) are privy to this information, the exact price that each state’s Medicaid program pays is not public information, and releasing that data could result in serious consequences for those programs.

Of the three major public healthcare programs – Medicaid, the Veterans Administration, and Medicare – only the latter is barred by law from negotiating drug prices (Kertscher, 2017). This is a result of a provision inserted into the Medicaid Modernization Act (2003); the act that introduced the controversial Medicare Part D. Medicare Part D is a voluntary insurance program for prescription drugs for people on Medicare that was introduced by former President George W. Bush that has been in place since 2006. It created a market wherein private insurance companies offer various plans (at the county and zip-code-based levels) subsidized by the Federal government. One of the main provisions of the Act states that, “…in order to promote competition,” the Health and Human Services (HHS) Secretary “…may not interfere with the negotiations between drug manufacturers and pharmacies and prescription drug plans.”

There have been various attempts, since 2003, to amend this part of the legislation, as it strictly forbids the Medicare program from using its leverage to essentially force pharmaceutical companies to provide drugs for lower prices. This leverage exists in the form of the 55.3 million Medicare beneficiaries. The 59 state and territorial Medicaid programs have used their numbers – 74.165 million – to successfully negotiate considerably larger rebates from drug manufacturers than the private plans in Medicare Part D “…by a substantial margin” (Department of Health and Human Services, 2015). What differentiates Medicaid from Medicare is that the former is a Federally-funded, state-administered program, where the latter is essentially a model of what other nations refer to as “Universal Coverage.”

Opponents of Medicare drug negotiation argue that allowing the largest government-funded healthcare program to negotiate lower prices will lead pharmaceutical companies to push for higher prices for everyone else (those not enrolled in Medicare). They also argue that the private insurers have greater leverage to negotiate, despite their seeming inability to negotiate better than state governments. Others, still, argue that Medicare negotiation is essentially anti-“Free Market,” and amounts to “price controls” that would serve as a disincentive for drug makers to continue investing in the research and development that produces new drugs (Cubanski & Neuman, 2017).

What makes now-President Trump’s two-paragraph-stock-temblor difficult for pharmaceutical companies – not to mention “Free Market” Republicans – to swallow is that it is entirely heretical to the “small government” line toed by modern Republicans. That a sitting Republican president should dare utter the belief that Big Government should be allowed to use its leverage to “negotiate” (read: “force”) lower drug prices for Medicare is antithetical to everything market-based Republicans and small-government Conservatives have argued for the past forty years. And, let’s be honest: this is the kind of stuff that made and continues to make Trump so troublesome for the Republican Party. He’s unpredictable, often shoots from the hip without a filter, and leaves his mess to be cleaned up by a staff of harried, but loyal adherents who either have to step in and try to translate what he’s said into comprehensible English, or twist themselves into human pretzels to try and convince people that he didn’t actually say what he said, and then, explain what he was supposed to have meant. It’s very unsettling, and often provides political opponents enough artillery to successfully derail his (and thereby their) agenda.

Despite President Trump’s seeming willingness to work with pharmaceutical companies on the issue of FDA approval procedures and regulatory issues (Johnson, 2017), both he and his media surrogates continue to float his argument for Medicare negotiations (Daurat & Olorunnipa, 2017). He also faces considerable opposition from his own party – one that has made no bones about their opposition to the idea.  To their way of thinking, the private sector is better suited to negotiate lower prices, rather than Big Government coming in to tell them what they can charge. His Secretary of Health and Human Services, Tom Price, has, in the past, been consistent in his opposition to Medicare drug negotiations and has repeatedly blocked measures that would allow the HHS to do so. In his confirmation hearings, however, he stated that his “boss will be the President of the United States,” in response to questions on the subject. While not an overt statement in support, it came across as more of a resignation that that’s what Trump wants, despite his own wishes.

Congressional Republicans even have some evidence to back up their claims. The Congressional Budget Office (CBO) has indicated that competition among plan sponsors in Medicare Part D markets has led to lower costs (Congressional Budget Office, 2014). The caveat is that those savings are largely seen only in regions where there are a large number of sponsors – essentially, places where there is a market for their services: areas where retirees have higher incomes. Part of the reason why Medicare Part D has come in at a lower price tag than the CBO initially projected is that enrollment is 12% lower than expected (CBO). Advocates of Medicare negotiation have suggested that this lower enrollment is due to people in smaller markets being unable to afford the monthly expenditure for Part D coverage, as well as the fact that the prices in those smaller markets’ plans simply aren’t low enough to make the plans attractive. Essentially, “Why buy something you can barely afford only to still be unable to afford your medications?”

There’s little question that the coming year is likely to produce many questions about President Trump’s assertion that the drug companies are “getting away with murder,” especially as his positions continue to be amorphous. What this will mean for Medicare has yet to be seen, but you can bet that whatever it is, it will leave critics and proponents, alike, trying to figure out how they got there.


References:



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

Thursday, March 2, 2017

What is All the Fuss Over Drug Importation?

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

The rising cost of prescription drugs is on everyone's mind, and the issue is increasingly being scrutinized by the executive and legislative branches inside the Beltway. Even President Donald J. Trump has raised the issue over prescription drugs costs — though it typically ins't a signature Republican issue — and Senator Bernie Sanders (I-VT) has recently introduced legislation to allow drug importation. The debate over drug importation is a complex one, often muddled by talking points by both sides.

Here is how the American Association of Retired Persons (AARP) defines drug importation:
"Drug re-importation refers to the practice of importing back to the United States prescription drugs that were originally manufactured in the U.S. and exported for sale in another country. Most often, Americans re-import drugs for personal use by filling their prescriptions in Canadian or Mexican pharmacies, either in person, or through mail-order or Internet pharmacies."1
Proponents of the drug importation cite the need for consumers to access less expensive prescriptions drugs. According to a relatively recent national survey commissioned by Gallup, "27% of Americans name cost as top health problem."2

The U.S. Food & Drug Administration (FDA) found that one in ten Americans cannot afford their prescription drugs. That same study found approximately 1.6% of consumers have bought prescription drugs from another country.[3]

“There is no reason why drug importation should be a problem for the United States," said Eddie Hamilton of the ADAP Educational Initiative based in Ohio. "Generic Abacavir is already being imported into the U.S. from India  for domestic patients by ADAPs without issue.”

Sen. Bernie Sanders
Photo Source: Huffington Post

The Sanders legislation is only latest attempt by Congress to allow drug importation. It has also gained support from some colleagues — Senators Cory Booker (D-NJ) and Bob Casey (D-PA) — in the Senate who had previously opposed drug importation legislation.

Though AARP hasn't yet endorsed the Sanders legislation (S.469), similar legislation did receive support from the organization. In 2009, AARP Senior Vice President David Sloane argued: “AARP is committed to helping our members and all older Americans have greater access to and reduced costs for the prescription drugs they need, including both through safe importation and other important measures such as closing the dreaded coverage gap in Medicare Part D known as the ‘doughnut hole.’"[3]

Senator Sanders isn't alone in his fight over drug importation, because Senator John McCain (R-AZ) has also introduced similar legislation. The McCain legislation (S.92) has bipartisan support, unlike the Sanders legislation.

Report Cover: "Black Market HIV/AIDS Drugs in the News, 2006-2013" with the AIDS Red Ribbon next to a spoon full of prescription drugs.

Opponents have equally strong arguments against drug importation. Among them, concern over drug safety, including counterfeit or black market drugs. In 2014, a new resource for the HIV/AIDS community and their doctors was made available by the Community Access National Network (CANN) and Partnership for Safe Medicines. The resource, "Black Market HIV Drugs in the News, 2006-2013," sought to increase awareness of the severe health risks posed by counterfeit or black market medicines.[4]

Summarized Bill Arnold, CANN's President & CEO, who continues to have doubts about drug importation: "The importation or re-importation of medications from outlets other than those regulated by the FDA and other U.S. authorities is particularly dangerous for the HIV-positive patient. In the past, anti-retroviral drugs from this grey, or black, market system have turned up in many places. These drugs have turned out to be completely fake, improper potency, contaminated, and worse."

The Pharmaceutical Research and Manufacturers of America (PhRMA), who also opposes drug importation, has been very local about pitfalls over the potential lack of drug safety. The issue is characterized as "unsafe and lead to potentially dangerous outcomes for patients."[5]

PhRMA will host a policy briefing on the issue. The briefing, "Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients," will discuss the important role of the FDA in ensuring the safety of medicines from test tube to patient, the threat of counterfeit drugs to patient safety, the importance of the Drug Supply Chain Security Act and the implications of drug importation proposals. It is open to all interested stakeholders, but advance registration is required.[6]

It appears that Senator Sanders anticipated the pushback over drug safety, because his legislation requires foreign sellers to register with the FDA, as well as other safety measures. The add-ons should alleviate some concerns, but not all of them.

The ADAP Advocacy Association has also traditionally opposed drug importation, but it remains open to dialogue on the issue. Like most public policy issues, there is no easy answer or solutions. To that end, drug importation will be part of the conversation during our 10th Annual Conference later this year.

To register for the 10th Annual Conference, go to our website.
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[1] American Association of Retired Persons (AAPR), Prescription Drug Re-Importation Question and Answer Sheet, 2016; available online at http://assets.aarp.org/www.aarp.org_/articles/international/ReimportationQA.pdf.
[2] Gallup, Cost Edges Access as Most Urgent U.S. Health Problem, December 7, 2016; available online at http://www.gallup.com/poll/199169/cost-edges-access-urgent-health-problem.aspx?g_source=prescription+drug+costs&g_medium=search&g_campaign=tiles
[3] Renal & Urology News, Almost 1 in 10 Americans Can't Afford Medications Says CDC, February 4, 2015; available online at http://www.renalandurologynews.com/news/cdc-americans-can-not-afford-medications-eight-percent/article/395374/
[4] American Association of Retired Persons (AAPR), AARP Response to Senate Block on Prescription Drug Importation Legislation, December 11, 2009; available online at http://www.aarp.org/about-aarp/press-center/info-03-2010/aarp_response_tosenateblockonprescriptiondrugimportationlegislat.html.
[4] Partnership for Safe Medicines, Patient Advocates Warn of Dangers of Black Market HIV Medicines, May 21, 2014; available online at http://www.safemedicines.org/2014/05/patient-advocates-warn-of-dangers-of-black-market-hiv-medicines5-22-14.html.
[5] Pharmaceutical Research and Manufacturers of America (PhRMA), Fact Check Friday: The truth about drug importation and patient safety, February 24, 2017; available online at http://catalyst.phrma.org/fact-check-friday-the-truth-about-drug-importation-and-patient-safety.
[6] Pharmaceutical Research and Manufacturers of America (PhRMA), Safety and the Supply Chain: Ensuring Prescription Medicines are Safe for Patients, February 23, 2017.