Transcript From Guidelines to Coverage

From Guidelines to Coverage
How are guidelines for health care
policy to be reconciled with
guidelines for clinical practice?
Louis B. Jacques, MD
E-GAPPS Day 1, Theme I, Breakout 3
Challenges
• Guidelines reflect wording to achieve consensus.
– May consider…alternative…YMMV*
– Practitioners or interventions are not always clearly defined
– Studied patient populations may not align with Medicare
beneficiary population
• Medicare regulations are interpreted with a
precision not found in clinical guidelines.
–
–
–
–
–
You WILL or you WILL NOT…
Defined practitioner types
Content at the coding level of specificity
Real penalties
Elderly, permanently disabled, ESRD population
YMMV: Your mileage may vary.
Outline
• Medicare
– Statute and regulation
– NCD process
• An Example (STIs)
– Transparent development of guidelines and
coverage policy
– Historical record is available
– Reflects recent practices
MIPPA (2008)
SEC. 101. IMPROVEMENTS TO COVERAGE OF PREVENTIVE SERVICES.
(a) Coverage of Additional Preventive Services(1) COVERAGE- Section 1861 of the Social Security Act (42 U.S.C. 1395x),
as amended by section 114 of the Medicare, Medicaid, and SCHIP
Extension Act of 2007 (Public Law 110-173), is amended-(A) in subsection (s)(2)-(i) in subparagraph (Z), by striking ‘and’ after the semicolon at the end;
(ii) in subparagraph (AA), by adding ‘and’ after the semicolon at the end; and
(iii) by adding at the end the following new subparagraph:
‘(BB) additional preventive services (described in subsection (ddd)(1));’;
and
(B) by adding at the end the following new subsection:
More Statute
Additional Preventive Services
‘(ddd)(1) The term ‘additional preventive services’ means services not described in subparagraph (A) or
(C) of paragraph (3) that identify medical conditions or risk factors and that the Secretary
determines are-‘(A) reasonable and necessary for the prevention or early detection of an illness or disability;
‘(B) recommended with a grade of A or B by the United States Preventive Services Task Force; and
‘(C) appropriate for individuals entitled to benefits under part A or enrolled under part B.
‘(2) In making determinations under paragraph (1) regarding the coverage of a new service, the
Secretary shall use the process for making national coverage determinations (as defined in section
1869(f)(1)(B)) under this title. As part of the use of such process, the Secretary may conduct an
assessment of the relation between predicted outcomes and the expenditures for such service and
may take into account the results of such assessment in making such determination.’.
(3) The term “preventive services” means the following:
(A) The screening and preventive services described in subsection (ww)(2) (other than the services
described in subparagraph (M) of such subsection).
(B) An initial preventive physical examination (as defined in subsection (ww)).
(C) Personalized prevention plan services (as defined in subsection (hhh)(1)).
***Note: highlighted language – modifications authorized by Section 4104 of the Affordable Care Act.
MEDICARE NATIONAL COVERAGE PROCESS*
Preliminary
Discussions
Reconsideration
6 months or
Benefit
Category
National
Coverage
Request
Staff Review
Proposed
Decision
Memorandum
Posted
Public
Comment
Final Decision
Memorandum
and
Implementation
Instructions
External
Technology
Assessment
Departmental
Appeals Board
Staff Review
MEDCAC
* SSA 1862(l)(1) –(l)(4)
6
42CFR 410.64
(a) Medicare Part B pays for additional preventive services not described in
paragraph (1) or (3) of the definition of “preventive services” under §410.2, that
identify medical conditions or risk factors for individuals if the Secretary
determines through the national coverage determination process (as defined in
section 1869(f)(1)(B) of the Act) that these services are all of the following: (1)
reasonable and necessary for the prevention or early detection of illness or
disability.(2) recommended with a grade of A or B by the United States
Preventive Services Task Force, (3) appropriate for individuals entitled to benefits
under Part A or enrolled under Part B.
(b) In making determinations under paragraph (a) of this section regarding the
coverage of a new preventive service, the Secretary may conduct an assessment
of the relation between predicted outcomes and the expenditures for such
services and may take into account the results of such an assessment in making
such national coverage determinations.
N.B. Emphasis added
USPSTF
Created in 1984, the U.S. Preventive Services Task Force
(USPSTF or Task Force) is an independent group of national
experts in prevention and evidence-based medicine that
works to improve the health of all Americans by making
evidence-based recommendations about clinical preventive
services such as screenings, counseling services, or preventive
medications.
The USPSTF is made up of 16 volunteer members who come
from the fields of preventive medicine and primary care,
including internal medicine, family medicine, pediatrics,
behavioral health, obstetrics/gynecology, and nursing. All
members volunteer their time to serve on the USPSTF, and
most are practicing clinicians.
N.B. Emphasis added
USPSTF and Primary Care
The USPSTF conducts scientific evidence reviews of a
broad range of clinical preventive health care services
(such as screening, counseling, and preventive
medications) and develops recommendations for primary
care clinicians and health systems.
The USPSTF strives to make accurate, up-to-date, and
relevant recommendations about preventive services in
primary care.
Recommendations issued by the USPSTF are intended for
use in the primary care setting.
http://www.uspreventiveservicestaskforce.org/
National Coverage Analysis (NCA) for Screening for Sexually
Transmitted Infections (STIs) and High-Intensity Behavioral
Counseling (HIBC) to prevent STIs
USPSTF A or B Recommendations
• Screening for chlamydial infection for all sexually active non-pregnant
young women aged 24 and younger and for older non-pregnant women
who are at increased risk (A)
• Screening for chlamydial infection for all pregnant women aged 24 and
younger and for older pregnant women who are at increased risk (B)
• Screening for gonorrhea infection in all sexually active women, including
those who are pregnant, if they are at increased risk for infection (B)
• Screening for syphilis infection for all pregnant women (A) and for persons
at increased risk (A)
• Screening for hepatitis B virus (HBV) infection in pregnant women at their
first prenatal visit (A)
• HIBC for the prevention of STIs for all sexually active adolescents, and for
adults at increased risk for STIs (B)
http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=250&
Chlamydia and Gonorrhea
• Pregnant women who are 24 years old or younger when
the diagnosis of pregnancy is known, and then repeat
screening during the third trimester if high-risk sexual
behavior has occurred since the initial screening test.
• Pregnant women who are at increased risk for STIs when
the diagnosis of pregnancy is known, and then repeat
screening during the third trimester if high-risk sexual
behavior has occurred since the initial screening test.
• Women at increased risk for STIs annually.
Syphilis
• Pregnant women when the diagnosis of pregnancy is known,
and then repeat screening during the third trimester and at
delivery if high-risk sexual behavior has occurred since the
previous screening test.
• Men and women at increased risk for STIs annually.
Hepatitis B
• Pregnant women at the first prenatal visit when the diagnosis
of pregnancy is known, and then rescreening at time of
delivery for those with new or continuing risk factors.
HIBC
• In addition, effective for claims with dates of service on or after
November 8, 2011, CMS will cover up to two individual 20- to 30minute, face-to-face counseling sessions annually for Medicare
beneficiaries for HIBC to prevent STIs, for all sexually active
adolescents, and for adults at increased risk for STIs, if referred for
this service by a primary care physician or practitioner, and
provided by a Medicare eligible primary care provider in a primary
care setting. Coverage of HIBC to prevent STIs is consistent with the
USPSTF recommendation.
• HIBC is defined as a program intended to promote sexual risk
reduction or risk avoidance, which includes each of these broad
topics, allowing flexibility for appropriate patient-focused elements:
– education,
– skills training,
– guidance on how to change sexual behavior.
What is Primary Care for Medicare?
•
•
For the purposes of this NCD, a primary care setting is defined as 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 NCD, a “ primary care physician” and “ primary care
practitioner” will be defined based on 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));
Implementation: Paying Claims
A new HCPCS code, G0445, high-intensity behavioral counseling to prevent
sexually transmitted infections, face-to-face, individual, includes: education, skills
training, and guidance on how to change sexual behavior, performed semiannually, 30 minutes, has been created for use when reporting HIBC to prevent
STIs effective November 8, 2011, to be included in the January 2012 Medicare
Physician Fee Schedule Database (MPFSDB) and Integrated Outpatient Code Editor
(IOCE) updates.
Code G0445 may be paid on the same date of service as an annual wellness visit,
evaluation and management (E&M) code, or during the global billing period for
obstetrical care, but only one G0445 may be paid on any one date of service. If
billed on the same date of service with an E&M code, the E&M code should have
a distinct diagnosis code other than the diagnosis code used to indicate
high/increased risk for STIs for the G0445 service. An E&M code should not be
billed when the sole reason for the visit is HIBC to prevent STIs.
The appropriate screening diagnosis code (ICD-9 V74.5 – screening, bacterial –
sexually transmitted, or V73.89
N.B. This is only 2 paragraphs from a 30 page set of contractor instructions. See the rest at:
http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R2476CP.pdf
Ongoing Challenges
• Subspecialists want to be classified as a primary care
practitioners.
• Non-physicians want to be recognized as physicians.
• Facilities lacking bona fide primary care support
infrastructure want to be classified as primary care
practices.
• Proprietary “sort of like” programs want to be
recognized.
• Coverage for FDA approved diagnostic tests versus
“any” test.
The debate continues…