Clinical Evidence to Support Reimbursement Presented to WBBA Reimbursement 101 The Buck Stops Here

1
Clinical Evidence to Support ReimbursementPresen
ted to WBBA Reimbursement 101The Buck Stops
Here

• JUDY ROSENBLOOM
• APRIL 15, 2004

2
COVERAGE

• CMS and other payers (local and national)
  evaluate relevant clinical evidence to determine
  whether or not the evidence is of sufficient
  quality to support a finding of reasonable and
  necessary. The evidence may consist of
• external technology assessments
• internal review of published and unpublished
  studies
• recommendations from the Medicare Coverage
  Advisory Committee (CMS)
• evidence-based guidelines
• professional society position statements
• expert opinion, and
• public comments.

3
CASE STUDY FDG PET- THYROID

• PET is a non-invasive imaging procedure used for
  measuring the concentrations of positron-emitting
  radioisotopes within the tissue of living
  subjects.
• 12/2001 - CMS published a Decision Memorandum on
  a request for broad coverage oncological
  indications, heart disease, and neurological
  disorders.
• While several new indications for the use of PET
  could be covered, CMS had insufficient evidence
  to support coverage for the management of thyroid
  cancer.
• 6/2001 - formal request for reconsideration of
  this issue from the American Thyroid Association
• 9/2001 - Technology Assessment sent to Agency For
  Healthcare Research And Quality (AHRQ)

4
SUMMARY OF EVIDENCE

• AHRQ contractor conducted a Medline search for
  studies about the diagnostic performance of PET
  or clinical outcomes of subjects who had PET for
  management of thyroid cancer. These questions
  were asked
• What is the test performance of PET for
  localization or staging of previously treated
  thyroid cancer suspected to be metastatic for
  which standard imaging modalities have failed or
  not been helpful?
• In the same population, what is the evidence that
  PET affects health outcomes or alters management?
• What are the test performance and effect on
  clinical management of PET for initial,
  pre-treatment, staging of patients differentiated
  thyroid cancer types that commonly do not take up
  radioiodine?

5
SUMMARY OF EVIDENCE

• Overall, sample size of studies were small and
  quality of data was poor.
• Medicare Coverage Advisory Committee (MCAC)
  Executive Committee discuss assessing evidence
  for diseases that affect small populations such
  as those in this request.
• MCAC recommended that, even for diseases that
  affect small populations of patients, Medicare
  coverage should still be based on solid,
  scientific evidence

6
SUMMARY OF EVIDENCE

• Additional Articles - CMS extended its
  independent review of evidence to include a large
  meta-analysis not included in the assessment
• Clinical Guidelines - Updated clinical guidelines
  were developed and submitted by American
  Association of Clinical Endocrinology, the
  American College of Endocrinology, and the
  American Association of Endocrine Surgeons.
• Outside Experts - CMS considered the opinions of
  other experts in the field of thyroid disease
• Final Answer Coverage and Non Coverage

7
CMS NATIONAL COVERAGE DECISION

• Evidence is not adequate for the initial staging
  of post-surgical thyroid cancer of cell types
  that are known
• Evidence is adequate to conclude that the use of
  FDG PET for staging of thyroid cancer of
  follicular cell origin previously treated by
  thyroidectomy and radioiodine ablation...is
  reasonable and necessary
• Evidence is not adequate to conclude that the use
  of FDG PET for re-staging of previously treated
  thyroid cancer of medullary cell origin...
• Use of PET for identifying patients with
  metastatic thyroid cancer who are at highest risk
  for death over the following three years is for
  informational purposes only and not for changing
  patient management, and, is not reasonable and
  necessary

8
IF YOU HAVE POSITIVE COVERAGE, CODING AND PAYMENT
ARE LIKELY TO FOLLOW

• For services furnished on or after October 1,
  2003, Medicare covers the use of FDG PET for
  Thyroid Cancer for certain indications.
• Effective October 1, 2003, HCPCS code G0296 is
  added for PET scan of the thyroid gland
• National Coverage, HCPCS code (temporary code),
  and payment became effective at the same time

9
OBTAINING COVERAGE - PRIVATE PAYERS

• Humanas policy is specific for heart, breast,
  lung, but not revised for thyroid
• Aetna and most other payers mimic Medicare policy

10
ANALYSIS

• Request for broad indications turned into
  individual coverage decisions based on equipment
  type, and specific organ systems.
• Partial coverage allowed some adoption of
  technology
• The combination of various technology assessment
  methods was helpful, as the data wasnt strong
• Lessons Learned - Be Prepared
• Perform a thorough evaluation of all relevant
  literature
• Obtain opinions from leaders and outside the
  investigational setting
• Pursue advocacy from medical societies
• Provide clinical and outcomes data
• Consider comparative analyses of
  competitive/conventional devices
• Plan a systematic approach to ensure payer data
  is up to date to revise existing coverage
  decisions
• Note If working with a local payer, initiate
  advocacy from local respected physicians

11
CASE STUDY WOUND HEALING TECHNOLOGY

• Medicare coverage for electrical stimulation for
  wound healing was historically left to carrier
  discretion
• 1981 - CMS issued a national non-coverage
  determination, which barred coverage of current
  electrical stimulation used for the treatment of
  pressure sores
• Carrier discretion to cover other forms of
  electrical stimulation.
• 1995 - CMS ordered a technology assessment of
  electrical stimulation for wound healing.
• 1997 - CMS issued a national non-coverage policy
  for electrical stimulation for the treatment of
  wounds. (based on literature review)
• Policy not implemented. Federal district court in
  Massachusetts remanded the national coverage
  determination and coverage of electrical
  stimulation for wounds remained at carrier
  discretion based on beneficiaries law suit.

12
CASE STUDY WOUND HEALING TECHNOLOGY

• After the courts decision, CMS performed a new,
  analysis
• AHRQ confirmed the studies previously assessed
  were not adequate.
• American Physical Therapy Association (APTA)
  requested CMS re-evaluate for broad indications
  which the literature could support
• CMS re-evaluated the literature submitted by APTA
  , and referred to the MCAC
• MCAC looked at the literature more broadly
• CMS separated electrical stimulation and
  electromagnetic therapy from their own analysis

13
SUMMARY OF EVIDENCE

• Is evidence adequate to draw conclusions about
  effectiveness of electrical stimulation as an
  adjunctive therapy for chronic
• pressure ulcers, venous ulcers, arterial/diabetic
  ulcers
• Consider the following
• Adequacy of study design Any evidence that the
  studies do not over or underestimate the effect
  of the intervention?
• Do patients who received the intervention differ
  from the control group in ways that might affect
  outcomes?
• Do studies permit conclusions about technology
  health outcome effects?
• Results consistency Study results consistent or
  contradictory?
• Applicability to the Medicare population Are
  the results of the studies applicable to the
  various Medicare populations?

14
SUMMARY OF EVIDENCE

• MCAC modified the questions by deciding not to
  distinguish between the types of wounds.
• Panel members believed there was adequate
  evidence, in the aggregate, to draw a conclusion
  as to the effectiveness of electrical stimulation
  used for treatment of pressure ulcers.
• Some members of the panel stated that the
  evidence is clearly best for pressure sores and
  that aggregating the data enabled them to vote in
  the affirmative.
• With regards to the 2nd question, the panel
  concluded that the use of electrical stimulation
  for the treatment of chronic, non-healing wounds
  would be considered more effective, which means
  this intervention improves health outcomes by a
  significant, albeit small, margin as compared
  with established medical items or services

15
COVERAGE DECISION

• 7/2002 - CMS announces a positive coverage
  decision on the use of electrical stimulation for
  chronic Stage III and IV pressure ulcers,
  arterial ulcers, diabetic ulcers and venous
  stasis ulcers.
• In addition, Medicare will not cover any form of
  electromagnetic therapy for the treatment of
  chronic wounds.
• 10/2002 - A manufacturer of a electromagnetic
  device, submitted a reconsideration request of
  the electrical stimulation policy. Asserts
• electromagnetic therapy is the same as electrical
  stimulation and, therefore, should be covered
  under the current national policy and
• clinical studies support national coverage
  whether or not electromagnetic therapy is the
  same as electrical stimulation.

16
SUMMARY OF EVIDENCE

• The manufacturer believes CMS erred in concluding
  that electrical stimulation and electromagnetic
  therapy be treated differently.
• Evidence-based guidelines - In 1994 the Agency
  for Health Care Policy and Research issued a
  Clinical Practice Guideline for the Treatment of
  Pressure Ulcers. This recommendation was based on
  4 studies, none of which used electromagnetic
  therapy.
• Professional Society Position Statements - No
  society has published guidelines or consensus
  statements addressing electrical stimulation or
  electromagnetic therapy for wounds.
• Expert Opinion - The experts disagreed as to
  whether or not electromagnetic therapy and
  electrical stimulation were the same and had the
  same clinical effect on chronic wounds.
• Public Comments - 11 letters from beneficiaries,
  2 letters from nurses and 2 letters from
  physicians in support

17
SUMMARY OF EVIDENCE

• In the prior decision memo, electromagnetic
  therapy was considered apart from traditional
  electrical stimulation, largely due to the
  differing methods of applying therapy.
• Taken together, the studies, while with various
  flaws, were consistent in the support of
  electromagnetic therapy. In general, the evidence
  on electrostimulation, whether direct or induced,
  is more substantial when considered together.
• There appears to be adequate evidence on the
  improvements in net health outcomes of
  electromagnetic therapy for the treatment of
  chronic wounds under the supervision of
  appropriately trained health care professionals.
• In contrast, there is insufficient evidence from
  unsupervised electromagnetic therapy for the
  treatment of chronic wounds provided by patients
  themselves in the home.

18
OBTAINING COVERAGE EVEN WHEN CONTROVERSIAL

• Electrical stimulation for the treatment of
  wounds is covered
• Chronic Stage III or Stage IV pressure ulcers,
• Arterial ulcers, diabetic ulcers and
• Venous stasis ulcers.
• Electrical stimulation will not be covered as an
  initial treatment
• Unsupervised use of electrical stimulation for
  wound therapy will not be covered
• For services performed on or after July 1, 2004,
  Medicare will cover electromagnetic therapy for
  the treatment of wounds only for chronic stage
  III or stage IV pressure ulcers, arterial ulcers,
  diabetic ulcers and venous statis ulcers

19
CODE CHANGES

• CPT codes were available since 1995
• Codes changed in 2003 with new decision
• Since procedure is not covered for unsupervised
  use, existing codes no longer applicable
• New G temporary codes established by CMS at the
  time policy was released

20
OBTAINING COVERAGE - PRIVATE PAYERS

• Electric stimulation coverage is the same as
  Medicare for most payers
• Aetna (national) considers high-frequency pulsed
  electromagnetic stimulation experimental and
  investigational for the treatment of wounds or
  acute postoperative pain and edema because its
  effectiveness has not been established.
• Blue Cross/Blue Shield GA - (local) same as above
  

21
ANALYSIS

• Legal suit by beneficiaries affected coverage
  decision
• Manufacturer for electrical magnetic therapy was
  persistent. Presented plausible reasoning and
  evidence
• Lessons Learned - Be Prepared
• Dont assume that the expert panels understand
  the technology, its benefits or application
• Clinical improvement is subjective
• Consider having outside parties review your
  information for objectivity and different
  perspectives to help anticipate objections before
  submitting
• Think long term - establishing a dialogue in the
  absence of strong data

22
DRUG ELUTING STENT

• CMS approved payment and codes for drug eluting
  stents prior to FDA approval because the clinical
  and economic evidence was compelling.
• This allowed immediate adoption upon FDA
  clearance
• CMS did not initiate a formal coverage decision
• Most local Medicare carriers have not initiated
  local policies except to instruct what codes to
  report
• Some private payers have initiated positive
  coverage policies (Code instructions are
  different than Medicare)
• Lessons Learned
• Exceptions to rules are possible (when big)
• While there isnt a formal CMS coverage policy
  DES meets coverage criteria

23
REIMBURSEMENT CONSIDERATIONS

• Clinical Evidence
• evidence of improved outcomes by patient
• Quality of life, mortality, morbidity
• as good or better than current standard
• evidence is applicable to payer population
• Meet with payers
• FDA and CMS working together
• Local carriers and payers

24
CHECKLIST FOR CLINICAL EVIDENCE

• 510 (k) or PMA clearance
• Peer reviewed literature showing clinical utility
  and medical necessity
• Technology Assessments
• Clinical Outcomes
• Guidelines from medical societies
• Opinions from national and local physician
  leaders
• Economic comparisons to gold standard