A Presentation For: HFMA’s Invitation to Innovation Conference

Assessing the Value

This Document is Proprietary and Confidential. Do Not Print or Distribute Without Permission.

Daniel Halevy, MD Senior Medical Director Medical Policy

Define Medical Policy and the development process

Discuss evidence reviews and coverage criteria

Explore potential for coverage with evidence development

2

Agenda

Summary

• 3 Key points

– To Achieve Coverage, Must Show Value

– To Show Value, Need Relevant Outcomes

– To Support Impact on Outcomes, Need Good Quality Evidence

3

Assessing Innovation

4

What Medical Policy is…

The guidelines that define medical appropriateness of Technologies.

• Technologies refer to:

– Services

– Surgical Procedures

– Pharmacy

– Equipment

– Durable Medical Equipment

5

What Medical Policy is not…

• Utilization Management Guidelines (e.g., MCG)

• Claim Policy (e.g., CXT, incidental logic)

• Reimbursement Policy (e.g., application of modifiers, medical supply limits)

• Benefit Design (e.g., physical therapy visit limits, excluded services)

• Contract Language (e.g., authorization requirements)

7

Medical Policy Development - General Considerations

• Technology is safe

• Technology is effective

• Health outcome is equal to or better than any alternative.

• Allowed by Federal and/or New Jersey State laws or regulations

• Support business and enterprise priorities (e.g., MCR initiatives).

8

Medical Necessity Definition

“Medical necessity” or “medically necessary” means or describes a health care service that is: – in accordance with the “generally accepted standards of

medical practice”; – clinically appropriate, in terms of type, frequency, extent,

site and duration, and considered effective for the covered person’s illness, injury or disease;

– not primarily for the convenience of the covered person or the health care provider; and

– not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that covered person’s illness, injury or disease

9

Medical Policy Development

• Identification of potential new technology

• Review of preliminary information

• Financial/actuarial/operational impact analysis

• Research of published medical literature

• Compilation and presentation of data to the Clinical Policy Working Group

• Review of draft policy by the Cross-Departmental Working Group

• Presentation of the final version to the Clinical Policy Subcommittee

10

Medical Policy Maintenance

• Annual and ad-hoc review (e.g., new evidence or FDA indication)

• Ongoing monitoring of evidence

• Feedback from internal and external sources

• Review of utilization data with significant impact on medical policy

• Consideration for policy development or for revision/update of existing medical policy

11

Mandates

Cancer Screening – Colorectal Cancer

New Jersey State Mandate requires coverage:

– For all persons 40 years of age or older, an annual stool examination for presence of blood;

– For all persons 45 years of age or older, a left-sided colon examination of 35 to 60 centimeters every five years.

12

ASO/Self-Insured

• Benefit definitions may vary and supercede medical policy

• Exceptions to medical policy (e.g., acupuncture)

Evidence Development

• UPHS Proton Therapy

• RCCA/COTA/Foundation Medicine NSCLC study

• RWJ/CINJ RT and Brain Metastases

13

14

First component: Defining Clinical Utility

• Describes the impact of the test on patient management and outcomes compared to usual care

• Lack of a universally accepted definition

– US National Institutes of Health (NIH)

• defined clinical utility based on “the balance of benefits to risks.”1

• Currently, the NIH defines it based on “whether the test can provide information about diagnosis, treatment, management, or prevention that will be helpful to a consumer.”2

– US Centers for Disease Control and Prevention

• defines it as “how likely the test is to significantly improve patient outcomes,”3

– World Health Organization

• defines it as “whether a test results in information that can be used to develop a clinical intervention.”4

• All of these published definitions refer to genetic testing, which generally pertains to disease genetics

15

First component: Defining Clinical Utility

1Holtzman NA, Watson MS. Promoting Safe and Effective Genetic Testing in the United States. Final report of the Task Force on Genetic Testing. J. Child Fam. Nurs. 1999;2:388–390. 2US National Library of Medicine, National Institutes of Health. Genetics Home Reference Handbook: How Can Consumers Be Sure Genetic Testing Is Valid and Useful? Available at: http://ghr.nlm.nih.gov/handbook/testing/validtest. Accessed July 24, 2014. 3Centers for Disease Control and Prevention. Genomic Testing: ACCE Model Process for Evaluating Genetic Tests. Available at: http://www.cdc.gov/genomics/gtesting/ACCE. Accessed June 30, 2014. 4World Health Organization. Quality & Safety in Genetic Testing: An Emerging Concern. Available at: http://www.who.int/genomics/policy/quality_safety/en/index1.html. Accessed June 30, 2014.

16

Second component: Grading scientific evidence

• ACCE Model System1

– Developed by the Centers for Disease Control and Prevention (CDC) Office of Public Health Genomics

– Became the standard for evaluating scientific data on new genetic tests

– Provides an evaluation framework that is applicable to a variety of genetic tests

– The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) used the ACCE framework and established this process as a way of evaluating an evidence-based method for assessing genetic tests and other types of genomic technology as they transition from the research arena to the practice arena

17

Payer process for evaluating new genomic tests

1CDC: ACCE: A CDC-sponsored project (2000–2004). http://www.cdc.gov/genomics/gtesting/ACCE/acce_proj.htm#T1.

• ACCE Model definitions1

• Analytical validity: Measures specific test performance characteristics and whether the test accurately and reliably detects the gene marker(s) of interest

– Refers to how well a test performs in the laboratory, how well it measures the property or characteristic it is intended to measure and whether it produces the same results repeatedly in different laboratories given the same set of procedures

• Clinical validity: Refers to the associations of the test result(s) with patient outcomes – Expressed as clinical sensitivity, specificity, and predictive value for the outcome

– This component refers to the accuracy with which a test predicts the presence or absence of a clinical condition or predisposition

• Clinical utility: Determines whether the use of the test to modify medical management decisions improves patient outcomes

– Best evidence is prospective, from randomized clinical trials of standard management procedures versus test-directed management

– If a test has utility, it means that the result (positive or negative) provides information that can be used in the formulation of an effective treatment or preventive strategy

• Ethical, Legal, and Social Implications: Determines what, if any, ethical, legal, or social implications may arise from the use of this test and its results

.

18

Key elements of the ACCE Model

1Haddow JE, Palomaki GE. ACCE: A Model Process for Evaluating Data on Emerging Genetic Tests. In: Human Genome Epidemiology: A Scientific Foundation for Using Genetic Information to Improve Health and Prevent Disease. Khoury M, Little J, Burke W (eds.), Oxford University Press, pp. 217-33, 2003.

19

Medical Policy Resources

Research of the Peer Reviewed Literature

National Specialty Guidelines

CMS and AHRQ

UpToDate and ECRI Technical Assessments

Industry Information (Sister Blues, National Commercial Plans)

• The technology must have final approval from the appropriate governmental regulatory bodies

• The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes

• The technology must improve the net health outcome

• The technology must be as beneficial as any established alternatives

• The improvement must be attainable outside the investigational settings

20

BCBSA Technology Evaluation Center (TEC) criteria

• Models to develop evidence – Comparative Effectiveness Research (CER)1

• Compare two or more alternative care approaches

• Focus on relative effectiveness instead of relative efficacy

• Help make informed decisions about choices while improving outcomes

– Coverage with Evidence Development (CED)1

• Provide conditional coverage for new tests while it collects additional evidence on the technology’s effectiveness

• Grant access to promising technology before evidence base is complete

– Demonstration Project (DP)2

• Test and measure the effect of potential program changes

• Study the impact of new service delivery methods, coverage of new technologies, and new payment approaches

21

Types of collaboration projects

1Tunis SR, Berenson RA, Phurrough SE, et aI. Improving the Quality and Efficiency of the Medicare Program Through Coverage Policy. Robert Wood Johnson Foundation Urban Institute. August, 2011. Available at: http://www.urban.org/UploadedPDF/412392-Improving-the-Medicare-Program-Through-Coge-Policy.pdf

2Centers for Medicare & Medicaid Services. Medicare Demonstration Projects & Evaluation Reports. Available at: http://www.cms.gov/Medicare/Demonstration-Projects/DemoProjectsEvalRpts/index.html?redirect=/DemoProjectsEvalRpts/MD/list.asp.

• Who should pay for test/technology during project? – If there is a negative medical policy, payer cannot pay due to limitations

for reimbursing “investigational/experimental” procedures within their insurance certificate

– Company will have to pay unless can get payer to retire negative medical policy

• IRB involvement – Payer will require one, but may accept the evaluation of an IRB the

company selects so long as their legal and regulatory teams sign off

22

Other important items

Clinical utility is critical

23

Summary

Remember who is ultimately paying the bill (and it’s not the health plan!)

Consider collaborative initiatives such as CED or Demo projects

Horizon Blue Cross Blue Shield of New Jersey is an independent licensee of the Blue Cross and Blue Shield Association.

The Blue Cross® and Blue Shield® names and symbols are registered marks of the Blue Cross and Blue Shield Association.

The Horizon® name and symbols are registered marks of Horizon Blue Cross Blue Shield of New Jersey.

© 2016 Horizon Blue Cross Blue Shield of New Jersey.

Three Penn Plaza East, Newark, New Jersey 07105. The entire document is proprietary & confidential.