Wednesday, April 13, 2016

Overpriced drugs hurting seniors


by Sen. Al Franken, D-Minnesota

April 12,  2016--Many budget-strapped seniors are being forced to choose between buying doctor-prescribed medications and paying for other basic necessities
  • Companies should not be allowed to delay generic drugs from hitting market
At a recent meeting in St. Cloud, some older Minnesotans shared stories that they should never have to tell.

Like millions of other Americans, these seniors feel powerless as their health and financial well-being is often jeopardized by ever-rising prescription drug prices. Recent double-digit increases – far beyond the U.S. inflation rate – are putting essential, even life-saving, medicines out of reach for too many people.

In short, many budget-strapped seniors are being forced to choose between buying doctor-prescribed medications and paying for other basic necessities like food, rent or gas. For some, it means cutting their pills in half to make them last longer, or even taking the risk of forgoing medications altogether.

At the St. Cloud meeting, a local woman shared the price of just one of her husband’s many medications has increased by $100 per month since January. 

Now, to save money, he no longer takes it each day as recommended by his doctor, but is spreading each dose over two or three days.

Her story was gathered as part a “Prescription Drug Cost Listening Tour” my office conducted throughout the state to hear about the impact of skyrocketing drug prices.  

As a member of the Senate Health Committee, I plan to share stories like hers with my congressional colleagues so they can hear firsthand about the urgent need to address this problem.

Real problem

Rising prescription drug costs are a very real and growing problem for many nationwide. Lack of competition has allowed drug companies to hike prices exorbitantly – even on generics. 

And a number of new specialty drugs come with staggering prices that are being passed on from insurers to everyone else.

Last fall, Americans were enraged when Turing Pharmaceuticals hiked the price of one life-saving drug by more than 5,500 percent  – from $13.50 to $750 per pill. 

The company was able to game the system because there is little or no competition. As outrageous and excessive as this was, it’s not the only example of an exorbitant price increase. In short, it showed millions of Americans – especially vulnerable seniors – can be devastated by sudden spikes in drug prices.

And with Americans spending hundreds of billions each year on prescription drugs, the problem of isn’t going away soon. Since January, Pfizer raised the prices of 60 brand name drugs by an average of 10 percent. 

Eight of those drugs went up by at least 20 percent. With treatments for some diseases like cancer costing more than $100,000 annually, out-of-pocket costs can quickly cripple the financial well-being of elderly Americans, even those with comprehensive insurance. Such increases are also driving up insurance premiums for everyone else.
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My solutions
We have to fight back. That’s why I’m taking several steps to slow the advance of drug costs.

First, I am pressing legislation to “pay-for-delay,” where brand-name drug manufacturers pay generic drug makers to delay bringing cheaper, generic alternatives to market. 

By eliminating generic-drug competitors, big drug companies can reap large profits by keeping brand-name prices high. My bill would help millions of Americans by stopping these deals and bringing affordable medications to the market sooner.

I also plan to re-introduce a measure to cut drug prices and save taxpayers up to $24 billion by allowing the federal Medicare program to negotiate lower prices for drugs used by older Americans. 

Unlike other federal health programs like Medicaid and those run by the Veterans Administration, Medicare officials are banned by law from negotiating lower prices with drug manufacturers.

Most industrialized countries use their buying power to negotiate lower prices for their citizens. In fact, many drugs developed and manufactured in the United States cost much less in other countries. 

That’s why we need to lower barriers to importing lower-cost drugs from countries like Canada, so seniors can save money and import their medications safely and legally.

In March, I introduced a measure to end a tax break that allows drug companies to write off the billions of dollars they spend on television, magazine and Internet advertisements to sell more expensive brand-name drugs, even when cheaper, equally effective drugs are on the market. 

The United States is one of only two countries that allows these “direct-to-consumer” ads, which ultimately drive up health care costs. American taxpayers spend too much to fund this tax break – that’s money that can be put to better use.

We have to do more to bring down prescription drug prices that disproportionately hit seniors. 

That’s why I’m working in Washington to enact common sense measures to cut the cost of the prescriptions that Minnesotans need.  And it’s why I’ve been listening to them in communities across Minnesota and sharing their stories in Washington.



Thursday, April 7, 2016

Sugar Shock: Insulin Costs Tripled in 10 Years, Study Finds

Both yearly spending by people with diabetes, and cost per milliliter, up sharply – outpacing costs for other blood sugar medications

Insulin Costs triple in 10 yearsNewswise, April 7, 2016 — People with diabetes who rely on insulin have seen the cost of that drug triple in just a decade -- even as doctors have prescribed higher doses to drive down their blood sugar levels.

Meanwhile, the cost of other diabetes drugs has stayed about the same or even gone down.

The rise in insulin costs was so large that since 2010, the per-person spending on insulin has been higher than per-person spending on all other diabetes drugs combined.

Published today in the Journal of the American Medical Association, the findings estimate in constant dollars what patients and their insurance plans paid from 2002 to 2013 for all antihyperglycemics, or medicines that reduce blood sugar levels.

The authors of the study say the rise in insulin compared with other therapies means it’s time to look again at the effect, and the cost-effectiveness, of non-insulin therapies. 

They also note that the price of insulin is not likely to drop because of competition from generic forms, because of the way it is regulated.

The research was done by a team from the University of Melbourne in Australia and the University of Michigan, using data from the federal Medical Expenditure Panel Survey that asks patients and insurers about care and costs.

“In the United States, the more than 3-fold increase in the cost of insulin over the past decade is alarming. It is a burden to both patients and payers and may deny some people access to a lifesaving therapy,” says William Herman, M.D., MPH, the Michigan co-author and a longtime diabetes care researcher. 

“Although the newer, more expensive insulin analogs appear to have incremental benefits compared to older, less expensive insulin preparations, their premium price requires us to ask whether they are really necessary, and if so, for whom?”

Herman, a professor of internal medicine at the Medical School and of epidemiology at the School of Public Health, is a member of the U-M Institute for Healthcare Policy and Innovation.

“What our study shows is how quickly things can change and why there is a need to focus on the costs as well as the benefits when deciding treatment options for people with diabetes,” says Philip Clarke, Ph.D., the study’s senior author and a professor in Melbourne’s School of Population and Global Health and Centre for Health Policy.

Rising prices & doses

Insulin injections keep people with Type 1 diabetes alive, and they take multiple daily injections often starting in childhood. 

In adults with advanced Type 2 diabetes, doctors prescribe it to control blood sugar and stave off devastating damage throughout the body – usually after diet and exercise, and other medications, have failed to reduce blood sugar levels enough.

In the time period studied, the total cost of insulin more than tripled, from $231 a year to $736 a year for each patient, in 2013 dollars. The cost per milliliter of insulin nearly tripled in that same time, from $4.34 to $12.92.

And in the same period, the average annual usage went from 171 mL to 206 mL, as prescribed doses went up. This likely happened due to increasing overweight and obesity, which increase the amount of insulin needed by a person, as well as new national recommendations that stress lower sugar levels for all people with diabetes.

Meanwhile, the per-person spending on all other blood sugar medications was $502 in 2013, down from about $600 in 2002 in constant dollars. The cost of these medications combined dropped over the first nine years, bottomed out in 2011 and rose slightly since then.
The cost of metformin, which is available as a generic drug, plummeted from $1.24 per tablet in 2002 to just 31 cents in 2013. Even the newer class of drugs known as DPP4 inhibitors only got 34 percent more expensive since they hit the market in 2006.

The researchers analyzed data from nearly 28,000 people who received treatment for diabetes in the 11-year period, a time when diabetes was rising steadily. The average age was around 60.

About one in four of the participants used insulin to control their blood sugar, and two-thirds were taking an oral medication. In the latter part of the study period, a small percentage began taking new injectable drugs designed to complement oral drug use.

More study needed

The researchers could not separate out users of synthetic human insulin, the least expensive form currently available, from those who use the more recently introduced “analog” forms that act more slowly or quickly in the body depending on the desired effect. 

They also didn’t have data on what insulin users spent on the needles and other devices used to inject insulin, except when that cost was included in drug costs, such as for pre-filled insulin pens.

And, they didn’t have information on which oral medication users took generic forms, which are less expensive. 

But they note that prices of oral medications are likely to drop over time as generics become available, while the fact that insulin is regulated as a biologic medication by the Food and Drug Administration means that prices won’t likely drop as generic competitors enter the market and encounter the strict rules governing biologics.

Further research using data that includes these details could further enhance understanding of how costs have changed for people with diabetes over the years.


In addition to Clarke and Herman, the research team included three Melbourne researchers: first author Xinyang Hua, M.Sc., Natalie Carvalho, PhD, and Michelle Tew, MPH; and Elbert S. Huang, MD of the University of Chicago. The study was supported by grants from the U.S. National Institutes of Health (DK090435) and the Australian National Health and Medical Research Council (1028335 and 1079621). Reference: JAMA, doi:10.1001/jama.2016.0126

Tuesday, April 5, 2016

Big Pharma Settlements Highlight the Need for Tougher Enforcement

Public Citizen Report Catalogues 25 Years of Pharmaceutical Industry Lawbreaking; Sharp Decline in Settlements, Penalties in 2014-2015

WASHINGTON, April 5, 2016 - Stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs, according to a Public Citizen report released today.

The report – an update to a previous study released in 2012 with additional data through 2015 – catalogues all major financial settlements and court judgments between pharmaceutical companies and federal and state governments from 1991 through 2015, which totaled $35.7 billion.

Of the 373 settlements over those 25 years, 140 were federal settlements totaling $31.9 billion, and 233 were state settlements totaling $3.8 billion. GlaxoSmithKline and Pfizer reached the most settlements and paid the most in financial penalties – $7.9 billion and $3.9 billion, respectively.
From 1991 through 2015, 31 companies entered into repeat settlements with the federal government. The violation resulting in the most federal penalties was unlawful promotion, usually off-label marketing.

Twenty-nine states and the District of Columbia reached at least one single-state settlement with a pharmaceutical company during the 25-year period studied. The most common violation was drug-pricing fraud against state Medicaid programs.
Hawaii recovered the most money as a proportion of Medicaid drug expenditures; South Carolina recuperated the most money per enforcement dollar spent; Louisiana claimed the most single-state settlements; and Texas finalized by far the most whistleblower-initiated settlements.

Another key finding is that both the number and size of settlements decreased significantly in 2014 and 2015. Just $2.4 billion in federal financial penalties were recovered in 2014-2015, less than one-third of the $8.7 billion in 2012-2013 and the lowest two-year total since 2004-2005.
Moreover, there were just 20 state settlements in 2014-2015, the lowest two-year total since 2006-2007. This reflected a dramatic decrease in federal financial penalties for unlawful drug promotion and a similarly sharp decline in the number of single-state settlements stemming from overcharging government health programs.

The report explores several possible reasons for this drop in settlement activity. The possibilities include a decline in federal enforcement; a shift in the focus of federal prosecutions away from off-label marketing and toward other forms of illegal activity, asalluded to (PDF) by U.S. Department of Justice officials in 2012; changes in state Medicaid pharmaceutical reimbursement strategies; and shifts in industry marketing strategies.

“We don’t yet know why there were fewer and smaller settlements in the 2014 to 2015 period,” said Dr. Sammy Almashat, researcher with Public Citizen’s Health Research Group and lead author of the report.

“But we do know that, in addition to the rarity of executive accountability, previous penalties never have been large enough to deter the most common types of pharmaceutical fraud. So it would be surprising if the industry suddenly decided, of its own accord, to comply with laws it has routinely violated for decades.”

The pharmaceutical industry’s $711 billion in global net profits from just one decade (2003-2012) dwarf the $35.7 billion in penalties recovered over the last quarter century.

The largest settlement announced since Public Citizen’s last report – and the third-largest health fraud settlement in history – demonstrates the stark imbalance between the penalties for and the profits made on implicated products.

In 2013, Johnson & Johnson paid $2 billion after pleading guilty to off-label promotion of its antipsychotic Risperdal for use in elderly patients with dementia.

Risperdal brought in $11.7 billion in sales for the company in just the first 12 years after its approval (1994-2005), nearly six times the total settlement amount.

“Breaking the law shouldn’t be profitable, especially not when patients’ health and lives are on the line,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group.

“The recently reduced settlement activity is still indicative of ongoing, systematic wrongdoing, which is costing American consumers and taxpayers enormous sums and endangering patients. Larger financial penalties, especially for repeat offenders, and jail time for executives implicated in criminal activity might actually change the calculus, so that the consequences of lawbreaking are no longer just a cost of doing business for Big Pharma.”

The report’s authors conclude that federal and state governments need to ramp up enforcement and discuss several more effective strategies to deter future fraud.

Legislation introduced by U.S. Sen. Bernie Sanders (I-Vt.) and U.S. Rep. Elijah Cummings(D-Md.) in September 2015 would terminate any remaining marketing exclusivities, granted by the U.S. Food and Drug Administration, for drugs implicated in illegal activity.

“Time and time again, drug companies defraud American taxpayers while making billions off government-granted monopolies,” Sanders said in response to Public Citizen’s report.


“Enough is enough. The greed of the pharmaceutical industry must end. I urge my colleagues to stand up to the pharmaceutical industry and pass legislation to send a clear message that crime will no longer pay.”

Thursday, March 31, 2016

HHS and NIH must act to define standards for ‘march-in’ implementation to help lower drug prices as part of comprehensive national policy

The publisher of RxforAmericanHealth says that the Department of Human and Health Services (HHS) and National Institute of Health (NIH) must act to define standards for implementation of ‘march-in’ rights to help lower prescription medicine prices.  
In an open letter to Secretary Sylvia Burwell posted on RxforAmericanHealth, Daniel Hines says such action coupled with other initiatives including price negotiation for medicines, reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries, criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy, greater transparency in Pharma pricing practices, and an end to direct-to- consumer advertising for prescription medicines, will ensure a ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumers,  advocates and private citizens in policy development and hearings.
He notes that HHS Secretary Burwell recently denied a request from 50 members of Congress to implement march-in provisions leading to a number of Senators joining in support of the request aimed at cost increases of the Cancer drug Xtandi.
“While this issue has surfaced again as a request for similar action from even more Congressmen and advocacy groups regarding the Xtandi patent, it is the failure of HHS and NIH to face up to their responsibilities to take action in the public interest that is the greater concern,” Hines explains.
He says the “requests themselves are an exercise of the authority of Congress, as they are based upon long-standing (30 years) existing legislation that makes it evident that it is incumbent upon the agencies to take action when Congress believes it is appropriate.” 
He cites a number of reasons in support of his contention:
·       The function of the Health and Human Services is to ostensibly protect the health and well-being of Americans, while the National Institute of Health is the primary agency of the United States government responsible for biomedical and health-related research.
·       A major responsibility of each is that is must address not only the safety and efficacy of medicines, but their availability as well since if a medicine is unavailable for any reason it creates a health care crisis for those patients who are derived of the potential benefit of the denied medicine;
·       As the Congressional letter notes: ‘march-in rights’ should be asserted under 35 U.S.C. § (203) (a)(2) “when action is necessary to alleviate health and safety needs are not being reasonably satisfied” or “benefits of a patented product are not available to the public on reasonable terms”;
·       The current pricing crisis of vital medicines clearly not only do not ‘reasonably’ alleviate health and safety needs of Americans, but are actually contributing to endangering the health of patients who are denied the benefits of access to the benefits to be derived from a regimen of vital medicines;
·       Likewise, this means that the “benefits” of a patented medicine are not available to the public since a product that is unaffordable is, in and of itself, unavailable and is “not available to the public on reasonable terms”;
·       The linchpin for implementation of ‘march in’ action is the definition of ‘extraordinary circumstances’.  Webster’s defines extraordinary as unusual or different from the usual.  We can only hope that so many Americans being denied access to unaffordable medicines, the disastrous burden upon individual health, outrageous price increases over the past few years, and Direct-to-Consumer advertising of medicines that exceeds pharmaceutical industry research and development, are not considered to be usual, and that, instead, an ‘extraordinary’ situation does indeed exist.

“This places the responsibility upon HHS and NIH not to decide whether a circumstance is ‘extraordinary’ based upon personal whim and observation, devoid of any factual studies that represent standards,” Hines says.

“With that in mind, we urge steps be taken to clearly define standards that would constitute an ‘extraordinary’ situation, not only for higher-priced specialty medicines but for vital lower-priced maintenance prescriptions that have been priced beyond the reach of untold numbers of Americans leading to adverse health complications.”


Wednesday, March 30, 2016

An Open Letter to Secretary Burwell: What 'extraordinary circumstances' demand HHS 'March-In' action to lower prices?

Sylvia Mathews Burwell,
Secretary of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Washington DC artwork stained glass effect capitol domeDear Secretary Burwell:

I am writing in my capacity as publisher of TodaysSeniorsNetwork, a long-standing and widely followed group of blogs dealing with issues facing aging Americans, and RxforAmericanHealth, which deals with the pricing abuses of Pharma and supports steps to ensure availability of vital affordable medicines for all American patients, to express my chagrin—and that of countless others—over your denial from Congress to the request for the Department of Health and Human Services and The National Institute of Health to implement ‘march-in rights’.

While this issue has surfaced again as a request for similar action from even more Congressmen and advocacy groups regarding the Xtandi patent, it is the failure of HHS and NIH to face up to their responsibilities to take action in the public interest that is the greater concern.

The requests themselves are an exercise of the authority of Congress, as they are based upon long-standing (30 years) existing legislation that makes it evident that it is incumbent upon the agencies to take action when Congress believes it is appropriate,  The reasons for this are:

·       The function of the Health and Human Services is to ostensibly protect the health and well-being of Americans, while the National Institute of Health is the primary agency of the United States government responsible for biomedical and health-related research.
·       A major part of responsibility of each must address not only the safety and efficacy of medicines, but their availability as well since if a medicine is unavailable for any reason it creates a health care crisis for those patients who are derived of the potential benefit of the denied medicine;
·       As the Congressional letter notes:  ‘march-in rights’  should be asserted under 35 U.S.C. § (203) (a)(2) “when action is necessary to alleviate health and safety needs are not being reasonably satisfied” or “benefits of a patented product are not available to the public on reasonable terms”;
·       The current pricing crisis of vital medicines clearly not only do not ‘reasonably’ alleviate health and safety needs of Americans, but are actually contributing to endangering the health of patients who are denied the benefits of access to the benefits to be derived from a regimen of vital medicines;
·       Likewise, this means that the “benefits” of a patented medicine are not available to the public since a product that is unaffordable is, in and of itself, unavailable and is “not available to the public on reasonable terms”;
·       The linchpin for implementation of ‘march in’ action is the definition of ‘extraordinary circumstances’.  Webster’s defines extraordinary as unusual or different from the usual.  We can only hope that so many Americans being denied access to unaffordable medicines, the disastrous burden upon individual health, outrageous price increases over the past few years, and Direct-to-Consumer advertising of medicines that exceeds pharmaceutical industry research and development, are not considered to be usual, and that, instead,  an ‘extraordinary’ situation does indeed exist.
·       This places the responsibility upon you, HHS and NIH not to decide whether a circumstance is ‘extraordinary’ based upon personal whim and observation, devoid of any factual studies that represent standards.
·       Rather, it is incumbent up governmental agencies to meet their responsibilities to do their job as Congress has determined them in legislation and called for in the recent Congressional requests, as well as those of the advocacy groups whose latest appeal is now being ‘considered.’
·       With that in mind, we urge steps to clearly define standards that would  constitue an ‘extraordinary’ situation, not only for higher-priced specialty medicines but for vital lower-priced maintenance prescriptions that have been priced beyond the reach of untold numbers of Americans leading to adverse health complications, making them available to the American public and allow stakeholders—including patient/clients—to present comments.  Such action coupled with other initiatives including price negotiation for medicines, reciprocal Memorandums of Understanding between regulatory agencies of Tier One Countries as validation of the safety and efficacy of the oversight of personally imported medicines from those countries, criminal penalties for abuse of pricing practices based on a ‘what the traffic will bear’ philosophy, greater transparency in Pharma pricing practices, and an end to direct-to- consumer advertising for prescription medicines, will ensure a ‘stakeholder’ role for the American public that supports so much of Pharma R&D, by an increased presence of consumers,  advocates and private citizens in policy development and hearings. 

Sincerely,

Daniel Hines
Publisher
TodaysSeniorsNetwork
RxforAmericanHealth


Monday, March 28, 2016

More elderly using dangerous drug combinations

March 28, 2016--One in six older adults now regularly use potentially deadly combinations of prescription and over-the-counter medications and dietary supplements — a two-fold increase over a five-year period, according to new research at the University of Illinois at Chicago.

Deadly Combinations of Medicines for ElderlyDima Mazen Qato, assistant professor of pharmacy systems, outcomes and policy, and her colleagues examined changes in medication use in a nationally representative sample of older adults between the ages of 62 and 85.

In contrast to many existing studies of medication use by the elderly, these investigators conducted in-home interviews to accurately identify what people were actually taking.

According to the study, older adults using at least five prescription medications (a status known as polypharmacy) rose from 30.6 percent in 2005 to 35.8 percent in 2011.

Factors that may account for the rise include the implementation of Medicare Part D, changes in treatment guidelines, and the increased availability of generics for many commonly used drugs.

As an example, the use of simvastatin (Zocor) — the most commonly used prescription medication in the older adult population, which became available as a generic in 2006 — doubled from 10.3 percent to 22.5 percent, Qato said. Zocor is used to treat high cholesterol and may reduce the risk of heart attack and stroke.

Despite limited evidence of their clinical benefit, dietary supplements are being used by a growing number of older individuals, the study found — an increase from 51.8 percent to 63.7 percent over the same time period, with nearly a 50 percent growth in the number of people using multiple supplements. The largest increase was found in the use of omega-3 fish oils — a dietary supplement with limited evidence of cardiovascular benefits — which rose from 4.7 percent of people surveyed in 2005 to 18.6 percent in 2011.

Fifteen potentially life-threatening drug combinations of the most commonly used medications and supplements in the study were also identified. Nearly 15 percent of older adults regularly used at least one of these dangerous drug combinations in 2011, compared to 8 percent in 2005.

More than half of the potential interactions involved a nonprescription medication or dietary supplement, Qato said. Preventative cardiovascular medications such as statins (cholesterol-lowering drugs, particularly simvastatin), anti-platelet drugs (such as clopidogrel and aspirin, used to prevent blood clots), and supplements (specifically omega-3 fish oil) accounted for the vast majority of these interacting drug combinations.

Cardiovascular prevention efforts and treatment guidelines promoting primary prevention may be undermined by these interactions, Qato said.

“Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk,” she said.

“For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen — all over-the-counter medications — is associated with an increased risk of heart attacks, bleeding complications, or death. However, about 1.8 percent — or 1 million — older adults regularly use clopidogrel in interacting combinations.”

Health care professionals should carefully consider the adverse effects of commonly used prescription and nonprescription medication combinations when treating older adults, Qato said, and counsel patients about the risks.

“Improving safety in the use of interacting medication combinations has the potential to reduce preventable, potentially fatal, adverse drug events,” she said.

While it is not known how many older adults in the U.S. die of drug interactions, Qato said, “the risk seems to be growing, and public awareness is lacking.”

Co-authors of the research, published in JAMA Internal Medicine, are Jocelyn Wilder of UIC; L. Philip Schumm and Victoria Gillet of the University of Chicago; and Dr. G. Caleb Alexander of the Johns Hopkins School of Public Health.


The National Social Life, Health and Aging Project is supported by grants R01AG021487 and R01AG033903 from the National Institutes of Health, including the National Institutes on Aging, the Office of Women’s Health Research, the Office of AIDS Research, and the Office of Behavioral and Social Sciences Research.

Monday, March 7, 2016

NHeLP Urges Action on High Drug Pricing

WASHINGTON, March 7, 2016--The National Health Law Program (NHeLP) sent a letter to Senators Ron Wyden and Chuck Grassley supporting the Senate Finance Committee's investigation into high prices for hepatitis C prescription drugs and barriers to access for Medicaid beneficiaries. 

The committee requested public comments in January 2016 on its investigation into biopharmaceutical company Gilead and Sovaldi and Harvoni, Gilead's breakthrough hepatitis C treatments. 

"As we have seen with HIV treatments, drug company profiteering and high costs prevent people from getting the care they need," said Wayne Turner, NHeLP staff attorney who led the successful 2014 HIV anti-discrimination complaint against four insurance companies. 


"When people with chronic diseases like hepatitis C are unable to afford treatments due to state restrictions or discriminating company policies, federal action is necessary."

In 2014, The AIDS Institute and NHeLP filed a complaint with the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) charging four Florida health plans with unlawful discrimination against people living with HIV and AIDS by placing all HIV medications, including generics, on the highest cost sharing tier, thus requiring enrollees to pay as much as 50 percent co-insurance for every HIV drug. 


In the complaint, the groups contend that such practices discourage people with HIV/AIDS from enrolling in the plans and violate the Affordable Care Act's (ACA) non-discrimination provisions. The ACA bans plans from discriminating against individuals based upon disability and prohibits them from discouraging enrollment by people with significant health needs.

"Since the passage of the Affordable Care Act, we have monitored Medicaid enrollment efforts across the country to ensure states are making every effort to help residents obtain adequate health insurance coverage, which should include affordable prescription drugs," said Jane Perkins, NHeLP legal director. 


"Restrictions on breakthrough treatments are blatantly illegal and violate federal Medicaid requirements and the ACA's non-discrimination provisions."

"Low-income individuals so often are the most in need of breakthrough treatments and are the least likely to afford them," said Abbi Coursolle, NHeLP staff attorney. "It is inherently unfair for Medicaid beneficiaries to be both denied treatments simply because they are expensive and unable to afford the two most widely used medications because of the company mark-up."