Transcript here - National Viral Hepatitis Roundtable

STRATEGIES FOR CONVINCING STATE
MEDICAID AGENCIES TO FULLY COVER
NEW GENERATION HCV MEDICATIONS
Sheldon Toubman, Staff Attorney
New Haven Legal Assistance Association
[email protected]
(203) 946-4811, ext. 1148
June 17, 2016
In May, 2015, CT Medicaid Reversed Several Severe
Restrictions on Access to Sovaldi Imposed in November of
2014, without Litigation Being Commenced.
Restrictions Included:
•
Requirement of Metavir score of F3 or F4
•
Absolute bar if pregnant
•
Absolute bar if patient has any type of cancer
•
Prohibition on being treated more than once
•
Absolute bar on use if patient taking other drugs which may
reduce effectiveness of Sovaldi
•
Prohibition on any use outside of narrow FDA-approved
indications
•
Only certain specialists allowed to prescribe
•
Not allowing providers even to request prior authorization
unless they certify above restrictive criteria are met
Multi-faceted strategy to try to persuade
agency to reverse course without litigation:

Legal aid and Yale Law School/Public Health School clinic wrote to
agency in February 2015 laying out state and federal law
violations inherent in the new policies

Coalition of advocates formed and wrote to state agency two
weeks later, on Feb. 19, 2015, advising of all of the legal and
policy problems with restrictions, including incorporation of legal
analysis in first legal letter from advocates

Advocates coordinated with HCV clinicians experiencing access
problems for patients

HCV clinicians reached out to agency’s medical director to try to
persuade to advocate internally for reversal, emphasizing high
cost of not treating with Sovaldi

Use of media to call attention to severe access issue

Encouragement for state to negotiate with manufacturers

Advocates’ two letters available at http://nvhr.org/hepatitis-ctreatment-access/advocacy-resources#sample
Violations of federal law cited in legal advocates’
Feb. 3, 2015 letter to agency:
• Federal law requirement that states must provide all FDA-approved
medications subject to a rebate agreement (except for certain narrow
categories of excludable medications, not applicable to HCV drugs),
unless a drug has no significant, clinically meaningful therapeutic
advantage over other medications, 42 U.S.C. § 1396r-8(d)(4)(C) and
(D).
• Federal law requirement that states must provide FDA-approved
medications not only for all FDA-approved usages but also for
recognized off-label usages, 42 U.S.C. § 1396r-8(d)(4)(C).
• Federal law requirement that all categories of Medicaid services
must be provided in sufficient amount, duration, and scope to
achieve their purpose, 42 C.F.R. § 440.230.
• Federal law requirement that all covered services, including
prescription drugs, must be provided with reasonable promptness,
42 U.S.C. § 1396a(a)(8).
• Federal law requirement that there is a right to a written notice
and hearing whenever any service requested under Medicaid is
denied, 42 U.S.C. § 1396a(a)(3), 42 C.F.R. § 431.200 et seq.
Violations of state law cited in legal advocates’
Feb. 3, 2015 letter to agency:

State law requirement that broad medical necessity statutory
standard must be applied to all categories of Medicaid services,
including the provision of services to prevent medical conditions
from occurring

State law requirement barring denial of a requested treatment in
favor of different treatment unless substitute is “at least as likely
to produce equivalent therapeutic or diagnostic results” to
requested treatment
-Conn. Gen. Stat. Section 17b-259b(a)
Problems with state position identified in
advocate coalition’s Feb. 19, 2015 letter to
agency:

Legal issues identified in earlier letter

Restrictions on access will interfere with public health goals of (a)
reducing transmission of HCV and (b) providing treatment prior to
permanent harm which may require long-term expensive
treatment

Restrictions on access undermine state legislation passed the
previous year mandating screening for HCV, for the propose of
determining whether individuals, including those who are
asymptomatic, should receive curative treatment

Restrictions on access specifically for Medicaid enrollees
threaten to exacerbate health disparities, in that these
enrollees are disproportionately African-American and
Latino

Restrictions on access will cost state more compared with
older treatments, which also are expensive, have a high
incidence of expensive complications, and are far less likely
to bring a permanent cure eliminating need for further
treatment
CT News Junkie:
http://www.ctnewsjunkie.com/archives/entry/advocates_urge
_easier_access_to_expensive_drug_for_medicaid_patients/
(March 19, 2015)
Hartford Courant:
http://www.courant.com/politics/hc-sovaldi-more-accessible0516-20150515-story.html
(May 15, 2015)
http://www.courant.com/opinion/letters/hc-expensivehepatitis-c-cure-is-a-bargain-20150521-story.html
(May 21, 2015)
Developments Since May 2015 Which Enhance
Threat of Litigation as a Strategy:
1. CMS guidance issued Nov. 5, 2015, including applicability
to managed care organizations,
https:/www.medicaid.gov/Medicaid-CHIP-ProgramInformation/By-Topics/Benefits/PrescriptionDrugs/Downloads/Rx-Releases/State-Releases/state-rel172.pdf
2. Litigation success in Washington state, see B.E. v. Teeter,
Case No. C16-227-JCC (W.D. Wash. May 27, 2016)
3. Increasing number of states which are eliminating
restrictions in response to threats to sue (e.g., Delaware,
New York, Florida)
Hepatitis C Treatment Access
Advocacy in California
Emalie Huriaux
Director of Federal & State Affairs, Project Inform
Chair, California Hepatitis Alliance
June 17, 2016
Californians with Hepatitis C
Estimate of Californians
living with the hepatitis C
virus (HCV) = 750,000
State Public Payers Rationing Care


In 2014, the state of California had treatment
utilization policies that limited access to new
medications.
Our position is that these types of requirements are
purely rationing and cost-containment measures and
many of them are illegal
 Not
based on the FDA-approved labels, clinical
evidence, or guidance developed by the American
Association for the Study of Liver Diseases/Infectious
Diseases Society of America
FY 14-15 Policies in Medi-Cal & ADAP

Medi-Cal (state Medicaid program):
 Authorized
treatment ONLY for people with advanced
liver disease (i.e., F3-F4) or certain extrahepatic
conditions.
 Prohibited treatment for people who use drugs or
alcohol unless they they have six months of abstinence
or are “actively engaged in drug treatment”

The AIDS Drug Assistance Program (ADAP):
 Authorized
treatment ONLY for people with advanced
liver disease (i.e., F3-F4) or certain extrahepatic
conditions.
Medi-Cal Managed Care Issues

1 out of 3 Californians has Medi-Cal (11 million)
 75%-80%
are in “managed care” plans, rather then
“fee-for-service”

Medi-Cal managed care (MMC) plans instituted
additional restrictions beyond the treatment
utilization policy
 e.g.,
limiting to one specialist in a large county,
requiring abstinence only, denying every initial request,
refusing to allow infectious disease or primary care
docs to prescribe
Positive Changes Spurred by Advocacy

Medi-Cal: Updated policy, effective July 1, 2015:
Allows for treating F2-F4
 Allows for treating many people regardless of “F score”

Including people w/ certain extrahepatic conditions and cooccurring conditions (e.g., HIV, HBV, diabetes, debilitating
fatigue due to HCV).
 Including populations at high risk for transmitting the virus (e.g.,
people who inject drugs, women of childbearing age who wish
to become pregnant, gay men who have “high-risk sex”)


ADAP: Updated policy for FY 15-16, allows for
treatment of all regardless of “F score”
How We Advocated for Improved Tx Access

Public Comment to Department of Health Care
Services (Medi-Cal) and Office of AIDS (ADAP)
 We
coordinated and submitted sign-on letters in
response to DHCS and ADAP proposed HCV treatment
utilization policies.
 Included
public comment with suggestions for how the
policies could be improved and aligned with clinical best
practices and professional guidelines.
 To
inform these comments, we consulted with experts in
the field, including hepatologists, infectious disease
specialists, and primary care providers who have been
treating HCV for a number of years.
Sign-on letters to state agencies
How We Advocated for Improved Tx Access


Consulted with clinicians about “on the ground”
access issues, including issues with MMC plans
and connected clinicians and their patients to
legal aid through the Health Consumer Alliance
(HCA).
Partnered with legal groups
 Such
as the National Health Law Program (NHeLP) and
the Health Consumer Alliance (HCA), to track these
issues and work to have them reported to DHCS. This is
an ongoing area of advocacy.
How We Advocate for Improved Tx Access

Meetings with DCHS
 Started
in response to original policy
 Brought clinicians to these meetings
 Now an ongoing area of advocacy as we bring
clinicians to DHCS to explain the issues they are seeing
on the ground

Participation on Advisory Committees
 Governor’s
High-Cost Drugs Work Group
 Medi-Cal Managed Care Advisory Group
How We Advocate for Improved Tx Access

Talk with the press directly and connect
journalists to providers and patients.
Covered California & Commercial Payers

Covered California is state exchange
 Tiering
of drug formularies, Tiers 1-4
 Tier
1 is low-cost generics
 Tier 4 is “specialty” or high-cost drugs



Cost-sharing up to 30% on “specialty” medications
In 2015, all new HCV drugs were tier 4 in every
Covered California plan. In 2016, this is still largely
true, with a few exceptions.
Many Covered California and private payers are
engaged in similar rationing as the public programs
Addressing Cost-Sharing in Covered CA

Encouraged Covered California to institute a cap on
“specialty” drugs
 Worked
in coalition with other healthcare advocacy
groups through participation in the Covered California
Specialty Drug Work Group

Since January 2016, most people now pay $250
per drug per month
 Platinum
plan pays $150 per drug per month
 Bronze plan pays $500 per drug per month
Work Remains
Medi-Cal Access Challenges Remain

Utilization of HCV drugs in Medi-Cal is low

Est. ~200,000 Medi-Cal beneficiaries with HCV and only 4%
have been treated *
MMC
FFS
2014
1719
430
2015
5255
561
* There may be some overlap
between individuals treated in 2014
and 2015, so the total number
treated may be less than 7,965.

Still reports of disparate fidelity to the state policy by MMC
plans, which translates into inequitable access for MMC
beneficiaries around the state.

Discussion with legal advocates about whether to continue
administrative advocacy approach or engage in legal
advocacy.
Other Challenges

Getting a handle on what is happening in the
private marketplace.
 Numerous
plans.
 Difficult to get access to their prior authorization forms.
 Difficult to get data to know how many Californians
total have been treated for HCV in recent years.

Understanding treatment access in the state prisons.
 State
prisons still have F3-F4 restriction.
 Don’t know what utilization has been.
Advice for Other Advocates
Suggestions for Advocacy

Stay on message


Everyone with HCV deserves a cure
Work in coalition

With other organizations and individuals affected by HCV

Collaborate with legal and medical experts

Don’t recreate the wheel


Talk to journalists


Talk to folks on this call and in other states to get examples of letters and other materials
They may not quote you, but they often use what you say to direct their reporting and use you
as a resource for referrals to patients and providers
Be invovled with the bureacuracy


Go to your Medicaid program’s meetings, get on email lists
Ask state leadership the hard questions and be tenacious
Thank you for being part of the movement to cure all*
*Thanks to Daniel Raymond at Harm Reduction Coalition for coming up with this phrase
Contact Information
Emalie Huriaux
Director of Federal & State Affairs, Project Inform
Co-Chair, California Hepatitis Alliance
(415) 580-7301
[email protected]
www.projectinform.org
www.calhep.org
Hepatitis C Treatment Access:
State-Level Advocacy Successes
Dawn Fishbein, MD, MS
Scientific Director, Viral Hepatitis Research
MedStar Health Research Institute
June 17, 2016
Disclosures
• Advisory Boards: BMS, Gilead
• Grant Funding: Gilead
• Stock ownership: Gilead, Abbvie
MedStar TLC Navigation
Approach
• Living in Washington, DC has its advantages …
• Staying involved with local and national government efforts
and advocacy organizations
– HAHSTA
– HHS – Action Plan (stakeholder from NVHR and IDSA)
– AfPA's (Alliance for Patient Access) Hepatitis Therapy Access
Physician's Working Group
– NVHR Best Practices Workgroup
– Collaborations through research – PCORI, CTSA, Gilead FOCUS
– DC Health Finance and DC Medicaid; MedStar Medicaid
• Not sure what this approach would be considered?
Process for change
• Ongoing process
• Got involved when DC Medicaid was not spending as much
as they planned in 2015
• DC Medicaid did not approve Harvoni until 2-13-15
• DC Health Finance had a meeting for HAHSTA, NIH and clinicians
• DC not as restrictive as other states, small and reasonable
• Prior: F2 and greater (including HIV/HBV patients), urine drug screen
(including marijuana), LMN for all patients
• Now: providers will work with patients on adherence and abstinence
• F1-F2, HIV and HBV at any stage, no urine tox, no LMN if for
preferred drug
Current Status & Future Efforts
• New PBM – Magellan
– Dramatic improvement over Xerox
– Website; approvals in 48-72 hours
• Continue to attend the DURB meetings; send emails with
any changes from other states
– discuss new medications
• Managed Medicaid – conversations with MedStar MCO
• Future:
– Universal testing
– ED testing and linkage to care
– Goal towards elimination
Lessons Learned: Physicians/Providers
• Get involved!
• Other Physician Advocates:
– Cami Graham, Lynn Taylor, Stacey Trooskin, others?
• Give the patient prospective … be their clinician expert
• Pharmacy Benefit Managers make a difference
• address your concerns with the State Medicaid team not
PBM
• Get invited and GO to drug utilization review board meetings
• Go regularly
• Other: P&T, quarterly approval, HHS Stakeholder
• Put in the PA packet regardless
• Advocate for all patients and providers
• Not solely your own
Questions
Dude, Where’s My Cure?
Getting to Universal Coverage for HCV
June 17, 2016
Michael Ninburg
Executive Director
Hepatitis Education Project
www.hepeducation.or
g
Efforts in Washington State
• Q1 2014 - MCO’s start denying coverage for SOF, SOF/SIM; most
commercial payors will follow suit by Q3/Q4
1. Individual advocacy
2. Appeal letter for cirrhotic patients
3. Work with WA Medicaid on HCV carve-out
www.hepeducation.or
g
Q1-Q3 2015
• January 1, 2015 – HCV carve-out starts
• Summer, 2015 - White paper for regulators, including WA
OIC
• Begin work with Washington State Insurance Commissioner
• Letter from CMOs and leading specialists to OIC
Q4 2015 – Q1 2016
• In late 2015, successfully persuaded the Washington State OIC to
survey national and regional insurance carriers that operate in
Washington State regarding their HCV coverage policies and forward
latest update to IDSA/AASLD HCV Guidance to carriers.
• Subsequent to OIC survey of insurers, several carriers removed fibrosis
restrictions consistent with HCV Guidelines effective January 1, 2016
including e.g., Aetna, United, Anthem, and Premera Blue Cross
• Large commercial plans in WA now have polices consistent with HCV
Guidance. (Some smaller plans still holding out.)
Early 2016 - Other States, Nat’l Carriers
•
Letters to United Health Care and Cigna regarding discriminatory HCV coverage restrictions,
cc’ing several state insurance departments (WA, Illinois, Texas, NY, CA, NM) and U.S. Dept. of
Labor (EBSA)
•
As result of letter to carriers, NY, Illinois, and NM Departments of Insurance requested more
info on coverage restrictions.
•
Held tele-conference with the United Health Medical Director and their Legal and Regulatory
team regarding our argument that their sobriety restrictions constitutes illegal and unethical
discrimination. To date, no change.
•
Cigna informed us that effective March 1, 2016 they had removed abstinence requirement.
Q1-Q2 2016 - New York and Illinois
• In early 2016, successfully persuaded the Illinois Department of Insurance to
formally review the HCV access issues
• In early 2016, successfully persuaded the NY Department of Financial Services
to actively initiate an investigation and survey insurance carriers that do
business in NY state regarding their HCV coverage policies and practices
• In June 2016, Illinois Department of Insurance informed us that they were in
conversations with HCSC (BCBS Illinois, Texas, Montana, NM) and HCSC had
updated their HCV prior authorization policy and removed the reference to
fibrosis levels as a condition for authorization; the forwarded policy also did not
include any sobriety restrictions.
Q1-Q2 2016 - Florida
• In early 2016, drafted and submitted requests to Large non-profit Blue
Cross Blue Shield carriers (Health Care Service Contractor and Florida Blue)
to remove inappropriate HCV coverage restrictions based on F2 fibrosis or
greater, copying insurance regulators
• In spring 2016, continued discussions with Florida Department of Insurance
regarding concerns regarding HCV access
• Turnover at FL OIR; we were contacted to discuss requirements for
commercial plans’ coverage of HCV drugs in Florida. Recommendations to
OIR include guidelines consistent with HCV guidance and consideration of
out-of-pocket max for patients.
U.S. Dept. of Labor
• In Winter 2015-2016, drafted letters and correspondence with Department of Labor
(Employee Benefits Security Agency) regarding HCV access issues including White
Paper
• In early 2016, successfully persuaded the Department of Labor to formally review
HCV access issues
• In Spring 2016, at their request, provided suggested language to Department of
Labor regarding guidance to carriers stating that HCV abstinence and sobriety
restrictions illegally violate ERISA’s non-discrimination provisions
• Next call with DOL is June 22, 2016
Washington State Lawsuits
• Coordinated with Washington State plaintiff’s attorney on class action
lawsuit filed against two major northwest regional insurance carriers
(Regence and Group Health) in early 2016. Lawsuit resulted in Regence
and Group Health reversing their position and updating their coverage
criteria consistent with HCV Guidelines.
• Coordinated with Washington State plaintiff’s attorney on lawsuit
against WA HCA (PEBB). To date, not settled. Hearing on motion for
preliminary injunction (and motion to dismiss) on June 17, 2016.
Washington State Lawsuits - Medicaid
• Coordinated with Washington State plaintiff’s attorney and
CHLPI on lawsuit against WA HCA (Medicaid).
• In May 2016, a federal Court in Washington granted
plaintiff’s motion for a preliminary injunction barring the
HCA from denying coverage for HCV drugs to Washington
state Medicaid patients based on their fibrosis scores.
Washington State Lawsuits - Medicaid
• 60 days to report back on compliance with court order
• First updated protocol non-starter, substituted fibrosis for
other restrictions
• Plaintiff’s attorney will not settle until HCA meets its
obligation