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Medicare proposes coverage for hepatitis C screening
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By: MARY ELLEN SCHNEIDER, Family Practice News Digital Network
Medicare officials propose to cover screening for hepatitis C virus for adults at high risk of infection as well as a one-time screening for Baby Boomers.
The plan, announced in a coverage memo on March 4, would provide Medicare coverage for all screening tests approved by the Food and Drug Administration when they are ordered by a primary care physician or other primary care clinician.
Officials at the Centers for Medicare & Medicaid Services initially floated the idea of hepatitis C (HCV) screening coverage last September. The response was overwhelmingly positive, with nearly all of the 65 public comments advocating in favor of coverage.
HCV screening is already recommended by the U.S. Preventive Services Task Force and the American Academy of Family Physicians. The AAFP recommends screening for HCV infection in high-risk adults. But the 2013 USPSTF recommendation goes further, calling on physicians to screen high-risk adults as well as to provide a one-time screening to all patients born between 1945 and 1965.
The Medicare proposal echoes the USPSTF recommendations.
This week, the Centers for Medicare and Medicaid Services (CMS) released their proposed decision memo for the National Coverage Analysis (NCA) on Medicare coverage for Hepatitis C virus (HCV) screening in adults. They find that "the evidence is adequate to conclude that screening for Hepatitis C Virus (HCV), consistent with the grade B recommendations by the U.S. Preventive Services Task Force, is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under [Medicare] Part A or enrolled under Part B." The proposed decision memo then discusses CMS' proposal to cover HCV screening in primary care settings for Medicare beneficiaries who meet either of the following conditions:
1. High risk for HCV - defined as "persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk persons is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test."
2. Persons born from 1945-1965, who do not meet the 'high risk' definition above, are eligible for a single screening test.
CMS is accepting public comments on the proposed decision memo until April 3, 2014. Instructions on submitting public comments can be found here. You can also submit a public comment directly from the page containing the proposed decision memo using the "Comment" buttons found at the top and bottom of the page. The expected NCA completion date is June 2, 2014.
For the proposal, the CMS deems the following patients as at high risk for HCV infection: adults who use illicit injection drugs or have a history of such drug use, as well as individuals who had blood transfusions before 1992. The proposal calls for coverage of an initial screening test for high-risk adults, followed by annual rescreening for those who continue to use illicit injection drugs after the first test.
"We acknowledge the limited evidence concerning health outcomes of HCV screening," agency officials wrote in the coverage memo. "However, CMS believes that screening for HCV infection provides an opportunity for appropriate interventions to benefit the infected person by permitting for the early detection of, and potentially the prevention of, HCV-related liver disease."
Treatment options for hepatitis C are expanding, the CMS noted in its coverage memo. Over the past several years, the FDA has approved three protease inhibitors, boceprevir (Victrelis), telaprevir (Incivek), and simeprevir (Olysio), for the treatment of patients with genotype 1 infection. Each of these three drugs can be used in combination with pegylated interferon and ribavirin for the treatment of genotype 1 infection.
Last year, the FDA approved sofosbuvir (Sovaldi), which is indicated for the treatment of hepatitis C infection from genotypes 1, 2, 3, or 4. But access to that drug could be impacted by its hefty price tag, which is $1,000 a pill or about $84,000 for a 12-week course of treatment.
Comments on the CMS screening proposal can be made until April 3. The CMS is scheduled to issue a final decision on coverage in June.
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CMS Proposes to Pay for HCV Screening
The Centers for Medicare & Medicaid Services (CMS) proposes the following:
The evidence is adequate to conclude that screening for Hepatitis C Virus (HCV), consistent with the grade B recommendations by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B, as described below.
Therefore, CMS proposes to cover screening for HCV with the appropriate U.S. Food and Drug Administration (FDA) approved/cleared laboratory tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary's primary care physician or practitioner within the context of a primary care setting, and performed by an eligible Medicare provider for these services, for beneficiaries who meet either of the following conditions.
1. A screening test is covered for adults at high risk for Hepatitis C Virus infection. "High risk" is defined as persons with a current or past history of illicit injection drug use; and persons who have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk persons is covered annually only for persons who have had continued illicit injection drug use since the prior negative screening test.
2. A single screening test is covered for adults who do not meet the high risk as defined above, but who were born from 1945 through 1965.
The determination of "high risk for HCV" is identified by the primary care physician or practitioner who assesses the patient's history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided.
For the purposes of this decision memorandum, a primary care setting is defined by the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. Emergency departments, inpatient hospital settings, ambulatory surgical centers, independent diagnostic testing facilities, skilled nursing facilities, inpatient rehabilitation facilities, clinics providing a limited focus of health care services, and hospice are examples of settings not considered primary care settings under this definition.
For the purposes of this decision memorandum, a "primary care physician" and "primary care practitioner" will be defined consistent with existing sections of the Social Security Act (1833(u)(6), 1833(x)(2)(A)(i)(I) and 1833(x)(2)(A)(i)(II)).
1833(u)
(6) Physician Defined.-For purposes of this paragraph, the term "physician" means a physician described in section 1861(r)(1) and the term "primary care physician" means a physician who is identified in the available data as a general practitioner, family practice practitioner, general internist, or obstetrician or gynecologist.
1833(x)(2)(A)(i)
(I) is a physician (as described in section 1861(r)(1)) who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or
(II) is a nurse practitioner, clinical nurse specialist, or physician assistant (as those terms are defined in section 1861(aa)(5));
CMS is seeking comments on our proposed decision. We will respond to public comments in a final decision memorandum, as required by 1862(l)(3) of the Social Security Act.
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