Health
care advocates said on Thursday that four insurers offering plans in
the new federal marketplace discriminated against people with H.I.V. or
AIDS by requiring them to pay high out-of-pocket costs for drugs to
treat H.I.V., including generic medications.
Two groups, the AIDS Institute and the National Health Law Program, filed a complaint
on Thursday with the Department of Health and Human Services’ Office
for Civil Rights, saying the insurers had violated a provision in the
new health care law that prohibits discriminating against consumers
because of their medical conditions. They said the insurers had
subjected people infected with H.I.V. to restrictions on medications
that most patients take daily to keep the virus in check.
“This
practice has no rational reason other than to drive people with H.I.V.
and AIDS away from their plans,” Wayne Turner, a staff lawyer with the
National Health Law Program, said in a conference call with reporters.
The
complaint asserts that the four insurers — CoventryOne, Cigna, Humana
and Preferred Medical Plan — placed H.I.V. drugs on the highest payment
tier for midlevel, or silver, plans on the federal health insurance
exchange in Florida.
CoventryOne,
for example, placed every H.I.V. drug, including generics, on the most
restrictive tier, which meant consumers were required to exhaust a
$1,000 deductible and were then asked to contribute 40 percent toward
the cost of their drugs, the groups said. Similarly, Humana requires
that members spend their $1,500 deductible and then contribute 50
percent, they said. Many of the plans, the groups said, also placed
other requirements on the drugs, like advance authorization by a doctor
or a limit of a 30-day supply.
Representatives
for all four insurers said their plans’ H.I.V. drug coverage was in
line with accepted medical practice and met requirements for coverage.
Karen
Eldred, a spokeswoman for Cigna, noted that the company, like many
other insurers, offers an array of plans in the federal marketplaces,
including some that offer more comprehensive coverage.
A
spokesman for Humana, Alex Kepnes, also noted that drugs for other
diseases, like rheumatoid arthritis and multiple sclerosis, were also on
a high payment tier.
Insurers
have been asking consumers to pay more for the most expensive so-called
specialty drugs, a trend that accelerated in the new marketplaces as
insurers competed fiercely to keep premiums low. Patients with serious
conditions, like cancer or rheumatoid arthritis, are finding that their pharmacy bills are skyrocketing.
Advocates
for people with other serious — and costly — medical conditions are
likely to be watching this case closely, said Jennifer Kates, director
of global health and H.I.V. policy at the Kaiser Family Foundation. If
the federal office were to side with the patient advocates, “it would
have broader implications because it would say this couldn’t happen for
those with diabetes, or any other kind of condition,” she said.
The
health care groups said what made this case different was that not
every insurer placed such across-the-board restrictions on H.I.V. drugs.
“What
is unique here is that it’s every single drug, no matter whether it is
generic or not,” said Carl Schmid, deputy executive director of the AIDS
Institute. “Other plans don’t do this for H.I.V., and that’s why we’re
proving that it’s discrimination.”
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Neurology. 2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.
Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.
Ristori G1, Romano S, Cannoni S, Visconti A, Tinelli E, Mendozzi L, Cecconi P, Lanzillo R, Quarantelli M, Buttinelli C, Gasperini C, Frontoni M, Coarelli G, Caputo D, Bresciamorra V, Vanacore N, Pozzilli C, Salvetti M.
Abstract
OBJECTIVE:
To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).METHODS:
In a double-blind, placebo-controlled trial, participants were randomly assigned to receive BCG or placebo and monitored monthly with brain MRI (6 scans). Both groups then entered a preplanned phase with IM interferon-β-1a for 12 months. From month 18 onward, the patients took the disease-modifying therapies (DMTs) that their neurologist considered indicated in an open-label extension phase lasting up to 60 months.RESULTS:
Of 82 randomized subjects, 73 completed the study (33 vaccinated and 40 placebo). During the initial 6 months, the number of cumulative lesions was significantly lower in vaccinated people. The relative risks were 0.541 (95% confidence interval [CI] 0.308-0.956; p = 0.03) for gadolinium-enhancing lesions (the primary endpoint), 0.364 (95% CI 0.207-0.639; p = 0.001) for new and enlarging T2-hyperintense lesions, and 0.149 (95% CI 0.046-0.416; p = 0.001) for new T1-hypointense lesions. The number of total T1-hypointense lesions was lower in the BCG group at months 6, 12, and 18: mean changes from baseline were -0.09 ± 0.72 vs 0.75 ± 1.81 (p = 0.01), 0.0 ± 0.83 vs 0.88 ± 2.21 (p = 0.08), and -0.21 ± 1.03 vs 1.00 ± 2.49 (p = 0.02). After 60 months, the cumulative probability of clinically definite multiple sclerosis was lower in the BCG + DMT arm (hazard ratio = 0.52, 95% CI 0.27-0.99; p < 0.05), and more vaccinated people remained DMT-free (odds ratio = 0.20, 95% CI 0.04-0.93; p = 0.04).CONCLUSIONS:
Early BCG may benefit CIS and affect its long-term course.CLASSIFICATION OF EVIDENCE:
BCG, as compared to placebo, was associated with significantly reduced development of gadolinium-enhancing lesions in people with CIS for a 6-month period before starting immunomodulating therapy (Class I evidence).Comment in
- BCG vaccine for clinically isolated syndrome and MS: infections and protective immunity. [Neurology. 2014]
- Multiple sclerosis: disease activity is reduced in CIS after BCG vaccination. [Nat Rev Neurol. 2014]
- PMID:
- 24306002
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC3873620
- [Available on 2015/1/7]
Supplemental Content
- Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.[N Engl J Med. 2000]
- United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates. Multiple Sclerosis Study Group and the MRI Analysis Center.[Mult Scler. 2001]
- Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial.[Lancet Neurol. 2012]
- Review Mitoxantrone: a review of its use in multiple sclerosis.[CNS Drugs. 2004]
- Review Glatiramer acetate: a review of its use in relapsing-remitting multiple sclerosis and in delaying the onset of clinically definite multiple sclerosis.[Drugs. 2010]
Other
insurers offering silver plans in Florida’s marketplace, including
Florida Blue, Ambetter and Molina Healthcare, offered more generous
coverage, with most out-of-pocket costs ranging from $10 to $25 a
prescription, often after meeting a deductible, the groups said.
Mr.
Schmid said many people with H.I.V. and AIDS welcomed the arrival of
the new health care act because it meant they would have access to
insurance after years of being shut out; before the law took effect,
insurers could deny coverage to people with existing medical conditions
like H.I.V. infection.
But
he said some patients were shocked when, newly covered, they were asked
to pay pharmacy bills of up to $1,000 a month, in addition to the
premiums they were paying. Some popular drugs, like Truvada, sell for
$1,500 a month. Another therapy, Atripla, costs $2,400 a month,
according to recent prices posted on the website of the National Institutes for Health.
Under
the new health care law, out-of-pocket costs cannot exceed $6,350 a
year, and some people with H.I.V. and AIDS can receive assistance for
out-of-pocket costs through the federal Ryan White Program. But help is
limited to those whose income falls below certain levels, which vary by
state, and the federal funding must be appropriated each year by
Congress.
Of
the more than 1.1 million people living with H.I.V. or AIDS in the
United States, about 400,000 are receiving treatment, and of those,
about 23,000 are uninsured and eligible for coverage in the new
marketplaces, according to a recent study
by the Kaiser Family Foundation. Some in the exchanges may also have
been previously covered through individual plans, and thousands more
could begin receiving treatment now that they have insurance.
But
although these patents’ numbers are small, insurers have most likely
taken note of the costs associated with treating H.I.V. patients: in a recent study
of the first two months of prescription-drug use by people enrolled in
new exchange plans, H.I.V. drugs accounted for 55 percent of all
specialty drug claims, compared to 21 percent of claims made through
employer plans during the same period.
Mr.
Turner said the groups took action partly to ensure that other plans
did not follow in the footsteps of the insurers in the complaint.
“What
we may be seeing is a race to the bottom,” he said. “Plans don’t want
to be the preferred plan for people with H.I.V. and
AIDS.”
All Staff
202.289.7661, ext. 307 | turner@healthlaw.org
Wayne Turner is a staff attorney in NHeLP’s Washington, DC, office, where he focuses on issues related to federal health reform, consumer protections in managed care, and the Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program.
Wayne came to NHeLP from the DC Appleseed Center for Law and Justice, where he was a staff attorney. His project areas included Blue Cross Blue Shield reform, children’s health, and improving end of life care for District of Columbia residents. He also served as a co-facilitator of the Children are Healthy working group at the DC Promise Neighborhoods Initiative in a project that sought to provide an opportunity for Medicaid enrollees and local providers to meet with top policy officials and elected leaders.
Wayne is a longtime HIV/AIDS and healthcare consumer advocate. Before making the transition to a legal career, he spent more than a decade working to advance the health care rights of atrisk populations. He co-founded ACT UP (AIDS Coalition to Unleash Power) in Washington, DC, and successfully lobbied to include greater consumer participation and accountability measures in Ryan White CARE Act-funded services. He also ran the campaign for DC’s Initiative 59, which provides legal protections for seriously ill patients and caregivers and was approved by voters in 1998.
Wayne earned his B.A. at Reed College and graduated magna cum laude from the University of the District of Columbia David A. Clarke School of Law. In law school, Wayne worked as a fellow in the HIV/ AIDS Legal Clinic, where he prepared living wills and standby guardianships for clients with HIV/AIDS and their children. He is a member of the DC Bar Health Law Section.
Wayne is featured in the 2011 PBS documentary Out in America, in which he describes the impact of the AIDS pandemic on the LGBT community through his personal account of losing his life-partner Steve to the disease.
AIDS.”
All Staff
Wayne Turner
Staff Attorney202.289.7661, ext. 307 | turner@healthlaw.org
Wayne Turner is a staff attorney in NHeLP’s Washington, DC, office, where he focuses on issues related to federal health reform, consumer protections in managed care, and the Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program.
Wayne came to NHeLP from the DC Appleseed Center for Law and Justice, where he was a staff attorney. His project areas included Blue Cross Blue Shield reform, children’s health, and improving end of life care for District of Columbia residents. He also served as a co-facilitator of the Children are Healthy working group at the DC Promise Neighborhoods Initiative in a project that sought to provide an opportunity for Medicaid enrollees and local providers to meet with top policy officials and elected leaders.
Wayne is a longtime HIV/AIDS and healthcare consumer advocate. Before making the transition to a legal career, he spent more than a decade working to advance the health care rights of atrisk populations. He co-founded ACT UP (AIDS Coalition to Unleash Power) in Washington, DC, and successfully lobbied to include greater consumer participation and accountability measures in Ryan White CARE Act-funded services. He also ran the campaign for DC’s Initiative 59, which provides legal protections for seriously ill patients and caregivers and was approved by voters in 1998.
Wayne earned his B.A. at Reed College and graduated magna cum laude from the University of the District of Columbia David A. Clarke School of Law. In law school, Wayne worked as a fellow in the HIV/ AIDS Legal Clinic, where he prepared living wills and standby guardianships for clients with HIV/AIDS and their children. He is a member of the DC Bar Health Law Section.
Wayne is featured in the 2011 PBS documentary Out in America, in which he describes the impact of the AIDS pandemic on the LGBT community through his personal account of losing his life-partner Steve to the disease.
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