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: IPRO Fax : 516-328-2310 OCT-29-2015-07: 44 Page:002 of 005

Berke-Weiss Law PLLC | www.berkeweisslaw.com

Corporate Programs Department ISO


1979 Marcus Avenue


Lake Success, NY 11042-1002
9001 :2008
www.ipro.org CERTIFIED

Phone: (516) 326-7767, ext. 411


lmprolllng Healthcare Fax: (516) 326-1034
for 1he Common Good

October 29, 2015

Re: External Appeal Application


Reference#:

Dear :

IPRO has completed review of all documentation submitted relative to your request for external appeal
and has determined that the decision of Oxford Health Plans-NY to deny coverage for Harvoni should
be reversed.

Review of this appeal was conducted by a clinical reviewer in current, active practice, who is Board
Certified in Internal Medicine and Infectious Diseases. and is licensed in New York. This physician is in
current practice at a major medical center. Professional organizations include the American Medical
Association, American College of Physicians, and the Infectious Diseases Society of America . IPRO
has screened this clin ical reviewer for any prohibited material affiliation and has determined that none
exists. IPRO has no organizational conflict of interest in the review of this appeal.

The case was rece ived by IPRO on 10/26/15. The review was conducted on 10/29/15. A decision was
rendered 10/29/15.

Documentation submitted for review included:

Letter from Charin Baum-Martinez, New York State Department of Financial Services to T. Giorgio,
IPRO dated 10/26/15
Letter from Charin Baum-Martinez, New York State Department of Financial Services to Abby Seay,
Appeals and Grievances, Oxford Health Plans of New York dated 10/26/15
New York State External Appeal Application filed by for self undated
Patient Consent for the Release of Records for NYS External Appeal Application signed by
dated 10/23/15
Letter from Clarissa R, Resolving Analyst, United Healthcare Oxford to dated
10/6/15
Letters from dated 10/23/15, 9/30/15
Letter from Margaret Williams, Regulatory Affairs Analyst/External Agent, United Healthcare Oxford
to T . Giorgio, IPRO dated 10/27/ 15
United Healthcare Pharmacy Clinical Programs
United Healthcare Oxford Administrative Policy. Experimental/lnvestigational Treatment
Retreatment of Persons in Whom Prior Therapy has failed. American Association for the Study of
Liver Diseases and Infectious Diseases Society of America
Section XIV - Freedom EPO Schedule of Benefits Gold Plan
Medical Records from for
To: FaxServer Fro.: IPRO Fax : 516-328-2310 OCT- 29-2015- 07: 44 Page: 003 of 005

Berke-Weiss Law PLLC | www.berkeweisslaw.com

October 29, 2015

Page 2

The basis for this determination is as follows:

Issue:

According to the patient's medical chart this is a patient with a past medical
history of chronic hepatitis C virus. genotype is 1a. Lab report dated was significant
for hepatitis C viral load of 29260 iu/ml. Lab report dated notes the patient's fibrosis
score is 0.54 and fibrosis stage as F2.

The insurer has denied coverage for Harvoni as not medically necessary. In their final adverse
determination letter dated 10/6/15 they note the patient has chronic hepatitis C genotype 1. The
insurer stated there is not enough information submitted by the patient's physician to show that
meets the health plan's criteria for coverage of this treatment. They explain the plan will
approve coverage if the patient has stage Ill or stage IV liver fibrosis which must be
documented by testing. They add that a patient may also be covered if there is a serious
complication of hepatitis C virus outside of the liver. The insurer indicated since the patient
does not have this, Harvoni is not considered to be medically necessary in this case.

Gastroenterologist and Hepatologist is appealing the decision on


behalf of the patient. In an appeal letter dated 10/23/15 stated the patient has a diagnosis of
chronic hepatitis C genotype 1a. notes the patient's viral load is 29260 iu/ml and fibrosis
score is 0.54 stage F2. is requesting treatment with Harvoni for 12 weeks for this patient
explaining that this is currently recommended by the American Association for the study of
Liver Diseases for patient's that are not cirrhotic and treatment experienced. stated that the
first time the patient was treated for 13 months with a negative viral load but relapsed after
discontinuation. Subsequently was treated again with Interferon for 6 months but the virus
relapsed again.

Reviewer Findings:

Brief clinical summary:

The patient is a with a past medical history significant for chronic hepatitis C
virus (HCV) genotype 1a, viral load-29,260 IU/ml, FibroSure revealed a fibrosis score was 0.54
and fibrosis stage-F2 disease. Urine toxicology was negative. The patient had relapsed on
prior treatment with interferon and ribavirin.

Assessment:

At issue is the medical necessity of Harvoni for treatment of chronic HCV in a patient who has
failed previous therapy. This patient apparently failed a course of an interferon-containing
regimen.

According to guidelines by the American Association of the Study of Liver Diseases (AAS LO)
and the Infectious Diseases Society of America (IDSA)- "daily fixed-dose combination of
ledispavir and sofosbuvir (Harvoni) for 12 weeks is recommended for patients without cirrhosis,
in whom a prior PEG-IFN and ribavirin treatment has failed. "
To: FaxServer Fro.: IPRO Fax : 516-328-2310 OCT- 29-2015- 07: 44 Page: 004 of 005

Berke-Weiss Law PLLC | www.berkeweisslaw.com

October 29, 2015

Rating: Class I, Level A.


Page3

Based on the patient's history, HCV viral load measurement, cllnlcal status, and other
laboratory parameters, this patient Is an appropriate candidate for Harvoni treatment.

The carrier's denial of coverage for Harvoni is reversed. The medical necessity is
substantiated.

References:

1. Recommendations for Testing, Managing, and Treating Hepatitis C. Joint Panel from the
American Association of the Study of Liver Diseases and the Infectious Diseases Society of
America. January 2015 http://www.hcvguidelines.org/ (Accessed on October 26, 2015).

2. Chopra, S and Muir A. "Treatment regimens for chronic hepatitis C virus genotype 1."
UpToDate. http://www.uptodate.com/contents/treatment-regimens-for-chronic-hepatitis-c-
virus-genotype-1. (Accessed on October 26, 2015)

Should you have any questions in regard to this review determination, please do not hesitate to
contact me or Terese Giorgio at (516) 209-5411 , fax number 516 326-1034 .

Sincerely,

Monty M. Bodenheimer, MD
Medical Director, Health Care Assessment

MMB:jg

cc: Charin Baum-Martinez, New York State Department of Financial Services


Abby Seay, Oxford Health Plans-NY

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