[Ip-health] VA to outsource care for 180, 000 vets with hepatitis C

Jamie Love james.love at keionline.org
Thu Jul 23 15:13:57 PDT 2015

This story is about a month old.  Yesterday the Senate Veterans Committee
discussed the issue, and I'll post some notes on that debate.



VA to outsource care for 180,000 vets with hepatitis C
Dennis Wagner, The Republic
June 19, 2015

U.S. Department of Veterans Affairs


The VA is moving to outsource care nationwide for up to 180,000 veterans
with hepatitis C
The VA spent weeks developing the transition as patient loads surged and
funding ran out
The sickest veterans generally will get top priority to receive the costly

The Department of Veterans Affairs is moving to outsource care nationwide
for up to 180,000 veterans who have hepatitis C, a serious blood and liver
condition treated with expensive new drugs that are costing the government
billions of dollars.

The VA has spent weeks developing a dramatic and controversial transition
as patient loads have surged and funding has run out. Those efforts were
not disclosed until records were released this week to The Arizona Republic.

Instructions on how to carry out the program show that the sickest veterans
generally will get top priority for treatment. However, patients who have
less than a year to live or who suffer "severe irreversible cognitive
impairment" will not be eligible for treatment.

That provision, and the mass shifting of patients, drew immediate criticism
from veterans advocates.

Tom Berger, executive director of a health council established by Vietnam
Veterans of America, ripped the VA for launching a "faulty plan" and
blasted the idea of medical teams deciding which patients will be denied
antiviral remedies.

"They've set up what I would call, in Sarah Palin's words, 'death panels.'
... Maybe rationalization panels is a better term," Berger said.

"... To halt hepatitis C treatment at VHA facilities now would be
unconscionable," they wrote. "We can and must end the epidemic. Once we
have treated every veteran with hepatitis C, the costs will go away. ...
Give us the ammunition, and we will win this war."

HCV funding runs out

The transition plan for so-called HCV patients was developed in a working
group chaired by Kenneth Berkowitz, acting executive director of VHA's
National Center for Ethics in Health Care. In an April e-mail, he told
colleagues they needed to develop an "ethical framework" in anticipation of
a complete depletion of funds for drugs. "A fair and transparent plan that
can be consistently applied is better than having no plan," he wrote.

The shift to private providers through the VA's Choice Plan enables the VHA
to pay for HCV with bailout money from the Veterans Access, Choice and
Accountability Act, a $16.3 billion funding and reform measure passed last
year. About $10 billion of that money was earmarked for private care, but
the Choice Plan has been so lightly used that it remains untapped. The
money was intended to ease the backlog of veteran appointments for health

E-mails show Dr. David Ross, the VA's director of HIV, HCV and
public-health pathogens programs, resigned from the working group. "I
cannot in good conscience continue to work on a plan for rationing care to
veterans," he wrote.

In a separate e-mail to top VA officials, Ross wrote, "There is no doubt in
my mind that exclusively relying on Choice, rather than seeking
supplemental funding, will be a disaster for patients, providers and VA."

VHA administrators concede they implemented the plan without a cost-benefit
analysis or studies on provider availability and patient impacts. Records
indicate only eight HCV veterans received antiviral therapy through the
Choice Program from August 2014 through May 31, while more than 16,000 were
getting treatment in VA medical centers.

The VA had set aside nearly $700 million this year for HCV antiviral drugs.
In documents and a written statement, department officials confirmed
soaring patient loads and medication expenses have nearly wiped out that
budget with several months to go in the federal fiscal year that ends Sept.
30. That's an estimated $400 million shortfall with more dramatic costs
expected, beginning in October.

RELATED:The Republic's investigation of the VA crisis

A VA clinician who asked not to be named for fear of retaliation stressed
that department leaders "haven't told anybody how it works. They've sent
out a solution with no way to implement it."

The clinician added that VA leaders were warned months ago that
pharmaceutical funds were being wiped out, but they did nothing until the
decision to move patients into a community-care program that has been
underutilized and heavily criticized.

"It's not working now, and you're expanding it? ... I'm like nauseous over

In an official statement on the hepatitis dilemma, VHA officials said they
remain "committed to ensuring America's veterans have access to the health
care and benefits they have earned and deserve." They stressed that "no
patients on current therapy will be stopped," but declined to clarify how
many patients are being moved to private providers or how many will not be
eligible for cure.

Demand for treatment soars

Hepatitis C is a blood-borne virus that attacks the liver. According to the
Centers for Disease Control and Prevention, about 3 million Americans are
infected, though many have not been diagnosed. The virus is most commonly
transmitted through hypodermic needles shared by narcotic-drug users, and
before blood-screening improved in 1992, it spread dramatically via
transfusions. It also may be transmitted by sexual contact.

The disease is considered epidemic among Vietnam-era veterans due to
transfusions and blood contact in combat or training. More than 60 percent
test positive, while 1 in 10 veterans overall has the infection — a rate
five times higher than the general population. Last year, about 3,000
veterans died in VA care as a result of HCV infection, according to
internal records.

Roughly 400 veterans are treated for hepatitis C in the Phoenix VA Health
Care System, a spokeswoman said.

Hepatitis C patients today are treated with a breakthrough medication,
sofosbuvir, approved in late 2013 under the brand names Sovaldi and later
as Harvoni. In combination with other drugs, sofosbuvir cures the HCV
infection in about nine of 10 patients while reducing risks of cirrhosis
and liver cancer.

However, the pills reportedly cost about $1,000 each retail, or $600 per
dose to the VA at a discount. A typical treatment regimen of 12 to 24 weeks
costs $50,000 to $100,000. The price tag to serve VA patients could exceed
$10 billion.

Despite the cost and controversy, sofosbuvir is widely regarded as a modern
medical victory: Records show the VA has cured nearly as many HCV patients
in the past 15 months as during the previous 15 years. Healed patients not
only mean fewer deaths but reduced medical costs over the long haul.

In the short term, however, success has spawned a six-fold increase in
demand for treatment by veterans, creating a huge funding gap.

The drug is so critical to care, and the expense so high, that U.S. Sen.
Bernie Sanders, I-Vt., former chair of the Senate Committee on Veterans
Affairs and a Democratic presidential candidate, during a recent hearing
urged the VA secretary to break the patent due to the manufacturer's
"excessive profits."

Sovaldi and Harvoni are manufactured by Gilead Sciences Inc., which made
$22.8 billion on antiviral sales during 2014, according to the California
company's annual earnings report.

In a written statement, Gilead said high prices reflect the "innovation of
the medicines" and are comparable to other antiviral drugs. The statement
emphasized that Gilead offers discount rates for government health programs
and assistance for patients in financial need.

VA turns to Choice Program

During a hearing last month of the Senate Committee on Veterans' Affairs,
Deputy VA Secretary Sloan Gibson pleaded with lawmakers for "additional
flexibility" to use Choice Program funds to pay for the hepatitis remedy.

There was no official action by Congress. But, a week later, on May 21,
Undersecretary for Health James Tuchschmidt issued national orders to begin
shifting HCV patients out of VA care "effective immediately."

Instructions accompanying that internal directive stressed the process
should be "ongoing and transparent," but it was not publicized outside the

Patients already receiving the antiviral therapy in veterans' facilities
will continue. The remainder will be contacted by their VA doctors, told of
the Choice Program and evaluated to determine whether they meet eligibility
for treatment.

Decisions on who will be first in line for treatment, and who will be
denied the cure, are to be made by teams at Veterans Integrated Service
Networks, regional offices also known as VISNs.

According to directives, those panels must follow strict protocols "to
avoid decision-making that is based on real or perceived conflicts of
interest, preferential treatment or nepotism." An appeals process also is
being devised for veterans who are denied the medication.

The VA has set up a detailed priority system to determine which patients
get the HCV cure first, and which are not eligible. Veterans already
receiving antiviral drugs are the No. 1 priority, followed by those with
severe conditions such as cirrhosis of the liver, compromised immune
systems or B-cell lymphoma.

Patients with a prognosis of living less than 12 months will not be
eligible for the drugs. Veterans in a vegetative state or with advanced
dementia also are excluded, along with those who have hepatitis C strains
resistant to antiviral therapy.

The instructions note that, "based on the principles of equity and human
dignity," ineligible patients "should be provided all other appropriate
medical care and support."

The VA clinician knowledgeable about the new program said it is not clear
whether the patient transfer to the Choice Plan is legal.

The Choice Plan was developed to provide private care for veterans who
could not get timely treatment in more than 1,000 VA hospitals and clinics
nationwide. Program rules allow veterans to see private doctors if they
live more than 40 miles from a VA facility or cannot obtain an appointment
there within 30 days.

The HCV patients apparently are being enrolled in Choice based on a
determination that, because there is no more money to pay for drugs, they
qualify under the wait-time criteria. Department officials did not directly
respond when asked if the strategy is lawful.

The Department of Veterans Affairs has enough doctors to treat hepatitis C
patients in house, but not enough cash to pay for drugs. Shifting HCV
veterans outside the system is a money maneuver, the clinician said, and
"the exact reverse of what Choice was created for."

Berger, of the Vietnam veterans group, predicted major backlogs. He said
some states have no physicians who are qualified to treat hepatitis C and
enrolled with the Choice Plan. "Where the hell are they going to send these
patients?" he asked.

Hepatitis C facts

What is hepatitis? It is an inflammation of the liver. Hepatitis C is a
type that can result in chronic disease of the liver and cause long-term
damage, including cirrhosis.

Can it be spread? Yes, most commonly when an infected person's blood is
transmitted to someone who is not infected. Many veterans contracted it
from blood transfusions and organ transplants before the start of routine
blood screenings in 1992.

Source: CDC

How to reach the reporter:

E-mail: dennis.wagner at arizonarepublic.com

Phone: 602-444-8874

Twitter: @azrover

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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