Fact Checking Janice Raymond: The NCHCT Report

“It was only after the NCHCT [National Center for Health Care Technology] published Raymond’s bigotry in 1980 that the US government reversed course in 1981 and took up Raymond’s views and rhetoric. Raymond’s hate became the government’s stance. Raymond – a Catholic ethicist, not a clinician – was the architect of the anti-trans stance the US government adopted in the 1980s”

1. The government never funded any trans medical care, therefore her contribution didn’t actually change funding of trans care.
2. Her contribution to the report in question was simply one voice among many.
3. Her contribution was small.
4. She’s not a Catholic ethicist.

• “Historically federal and state aid has not funded transsexual treatment for anyone so it could not be ‘eliminated’ by any paper I or anyone else wrote.”
• “My paper was never published by the NCHCT but was treated as a consultative paper among many that were solicited from other experts and groups at the same time.”
• “Whenever such papers are commissioned, there are multiple individuals and organizations also requested to submit reviews.”
• “Others asked in 1980 to present opinions were the-then National Institute of Mental Health of the Alcohol, Drug Abuse, and Mental Health Administration who performed a literature review and provided an opinion of the efficacy of sex change surgery.” Plus several other organizations.
• “I was not then, nor am I now, a Catholic.”
• “The NCHCT took these submissions and published a report on “Transsexual Surgery” in its 1981 Assessment Report Series.”
• “My findings were quoted neutrally in one sentence of the 15 page final report. “Some have held that it would be preferable to modify society’s sex role expectations of men and women than to modify either the body or the mind of individuals to fit these expectations. (Raymond 1980).” This was the only part of my paper that made it into the published report.”
• “The conclusion of the report was that transsexual surgery is “controversial” and “must be considered experimental.”

Raymond’s rhetorical sleight-of-hand

1.  The report the National Center for Health Care Technology (NCHCT) commissioned Raymond to write; and,
2. The report the Office of Health Technology Assessment (OHTA) issued which drew upon Raymond’s work to support one of three basic fact claims it made about trans care.

“Providers, generally; physicians; acute facility administrators; long-term care facility administrators; other care givers; health/medical professional associations; consumer associations; employers; unions and other employee organizations; third party payers; government regulators; biomedical researchers; public policy-makers, legislators; policy research organizations; Federal health programs.”[2]

“Congress passed legislation in 1978 establishing the National Center for Health Care Technology (NCHCT) to conduct, sponsor, and coordinate the assessment of new and existing technologies. The government’s Health Care Financing Administration, as well as other third-party payers used the information generated by the NCHCT to help in making decisions about coverage and payments. However, the NCHCT was abolished in 1981. The office of Health Technology Assessment, based in the National Center for Health Services Research of the U.S. Public Health Service, has assumed some functions of the NCHCT.”[4]

“With the creation of NCHCT and the development of a formal assessment process, these third-party payers began to request the results of evaluations. These insurance carriers included both those in the government (CHAMPUS and the Federal Employees Health Benefits Program) and those in the private sector such as Mutual of Omaha, Nationwide, Travelers, Aetna Life and Casualty,  Connecticut General Life, Equitable Life Assurance Society, John Hancock Mutual Life, Metropolitan Life, Prudential Life, and Lincoln National Life. “[5]

• Description: An overview of what it means, clinically speaking, to be a transsexual and what treatment is available.
• Review of Available Information: A review of peer-reviewed papers and books concerning medical outcomes, noting that the medical research from the 60s and 70s wasn’t very sophisticated.
• Discussion: Assertions about what is observable about trans care. (Raymond)
• Summary: Statements of fact (Raymond)
• Acknowledgement: Noting the major sources which informed the report (Raymond)
• Bibliography: Noting the cited materials (Raymond)

1. One paragraph supporting the claim that trans care is “experimental”
2. One paragraph supporting the claim that trans care is “controversial”
3. Four paragraphs supporting the claim that trans care is “expensive.”

“Over and above the medical and scientific issues, it would also appear thattranssexual surgery is controversial in our society. For example, Thomas Szasz has asked whether an old person who desires to be young suffers from the “disease” of being a “transchronological” or does the poor person who wants to be rich suffer from the “disease” of being a “transeconomical?” (Szasz 1979). Some have held that it would be preferable to modify society’s sex role expectations of men and women than to modify either the body or the mind of individuals to fit those expectations. (Raymond 1980).”

The National Institute of Mental Health of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) performed a literature review and provided an opinion on the efficacy of sex change surgery for transsexualism. The information database on transsexual surgery prepared under contract for HCFA by Health Information Designs, Inc., and a National Center for Health Care Technology commissioned paper on the social and ethical aspects of transexual surgery by Janice G. Raymond, Ph.D., of Hampshire College, University of Massachusetts, were used in this assessment.

Health Information Designs, Inc., contacted the American College of Obstetricians and Gynecologists, American College of Surgeons, American Medical Association, American Psychiatric Association, American Psychological Association, and the American Society of Plastic and Reconstructive Surgeons. None of these organizations had an official position on transsexual surgery when surveyed in 1979.

1. Trans care is controversial.
2. Trans care is experimental.
3. Trans care is expensive.

“Poor dissemination of information from good technology assessment contributes to the rising costs of health care. Conversely, the Blue Cross and Blue Shield Association, for instance, estimates that its Medical Necessity Program has saved premium payers as much as 500 million dollars in its first five years. Studies at UCLA and Harvard commissioned by the NCHCT estimated that 100 to 200 million dollars per year could be saved by the Medicare program if NCHCT recommendations not to reimburse for six technologies were followed (Harvard, 1981; UCLA, 1981). Also, in the training of health professionals, the lack of coordinated dissemination of valid technology assessment information means that curricula quite possibly will not include current clinical knowledge.”[6]

“The tremendous economic burden associated with health care poses major dilemmas for providers, patients, third-party payers, industry, health planners, and policymakers in and out of the government. Many measures are under consideration to deal with the problems. Recognizing that health care technology and its application, while not the sole cause of the rise in health care costs, were significant factors in the increase, the Congress passed legislation in 1978 to establish the National Center for Health Care Technology (NCHCT) to serve as a focus for examining selected new and existing technologies with the aim of assembling the best current evidence and information about their clinical effectiveness and cost, and the social and ethical issues associated with their use.”[7]

Fact Checking:

Raymond’s assertion: “In 1981, the U.S. government did not ‘reverse course’ by withdrawing federal funds available for transsexual treatment and surgery. Historically federal and state aid has not funded transsexual treatment for anyone so it could not be ‘eliminated’ by any paper I or anyone else wrote.”

Raymond’s assertion: “The U.S. NCHCT commissioned this paper, among other reasons, to determine ‘whether specific procedures are ‘reasonable and necessary’ and thus appropriate for reimbursement by Medicare.’ Whenever such papers are commissioned, there are multiple individuals and organizations also requested to submit reviews. Others asked in 1980 to present opinions were the-then National Institute of Mental Health of the Alcohol, Drug Abuse, and Mental Health Administration who performed a literature review and provided an opinion of the efficacy of sex change surgery. The American College of Obstetricians and Gynecologists, American College of Surgeons, American Medical Association, American Psychiatric Association, American Psychological Association, and the American Society of Plastic and Reconstructive Surgeons were also asked to provide reviews.”

Raymond’s assertion: “The NCHCT took these submissions and published a report on ‘Transsexual Surgery’ in its 1981 Assessment Report Series. My findings were quoted neutrally in one sentence of the 15 page final report. “Some have held that it would be preferable to modify society’s sex role expectations of men and women than to modify either the body or the mind of individuals to fit these expectations. (Raymond 1980).” This was the only part of my paper that made it into the published report. The conclusion of the report was that transsexual surgery is “controversial” and “must be considered experimental.” To give my submission credit for these conclusions is fatuous in the context of reading a report that was obviously informed by multiple sources.”

1. Trans care is controversial.
2. Trans care is experimental.
3. Trans care is expensive.

Raymond’s assertion: “I was not then, nor am I now, a Catholic.”

A statement that’s completely true.	A statement designed to hide some pertinent facts.	A misleading statement designed to hide the truth.

Raymond’s bloody hands

One of the most severe results of denying coverage of treatments to transgender insureds that are available to non-transgender insureds is suicidal ideation and attempts.

A meta-analysis published in 2010 by Murad, et al., of patients who received currently excluded treatments demonstrated that there was a significant decrease in suicidality post-treatment. The average reduction was from 30 percent pretreatment to 8 percent post treatment.

De Cuypere, et al., reported that the rate of suicide attempts dropped dramatically from 29.3 percent to 5.1 percent after receiving medical and surgical treatment among Dutch patients treated from 1986-2001.

According to Dr. Ryan Gorton, “In a cross-sectional study of 141 transgender patients, Kuiper and Cohen-Kittenis found that after medical intervention and treatments, suicide fell from 19 percent to zero percent in transgender men and from 24 percent to 6 percent in transgender women.)”

Clements-Nolle, et al., studied the predictors of suicide among over 500 transgender men and women in a sample from San Francisco and found a prevalence of suicide attempts of 32 percent. In this study, the strongest predictor associated with the risk of suicide was gender based discrimination which included “problems getting health or medical services due to their gender identity or presentation.”According to Gorton, “Notably, this gender-based discrimination was a more reliable predictor of suicide than depression, history of alcohol/drug abuse treatment, physical victimization, or sexual assault.”

These studies provide overwhelming evidence that removing discriminatory barriers to treatment results in significantly lower suicide rates. – State of California Department of Insurance, 2012

I did not then or now believe that federal or state funds should subsidize transsexual surgery for anyone because, in my view, it is unnecessary surgery and medical mutilation. I would argue the same about healthy limb amputations now justified in some of the clinical literature for those designated as suffering from a Body Integrity Identity Disorder (BIID). BIID subjects have threatened suicide or taken matters into their own hands if deprived of the surgery, as have transgendered persons who desperately pursue hormones and surgery.

HHS Appeals Board Decision, page 3

The NCD directly quotes from or paraphrases portions of an 11-page report that the former National Center for Health Care Technology (NCHCT) of the HHS Public Health Service (PHS) issued in 1981, titled “Evaluation of Transsexual Surgery.” NCD Record 4 Service (PHS) issued in 1981, titled “Evaluation of Transsexual Surgery.”3 at 13-23. The NCHCT forwarded its 1981 report to officials of the Health Care Financing Administration (HCFA), now called CMS, with a memorandum dated May 6, 1981 recommending “that transsexual surgery not be covered by Medicare at this time.” Id. at 10-12. HCFA issued the NCD language as part of its Coverage Issues Manual of coverage instructions for Medicare contractors; CMS published the manual in the Federal Register on August 21, 1989.4 Id. at 11; 76-129; 54 Fed. Reg. 34,555, 34,572.

The NCD record also includes three letters that the Transsexual Rights Committee of the American Civil Liberties Union (ACLU) of Southern California sent to HCFA in April 1982 disagreeing with HCFA’s non-coverage policy. NCD Record at 24-26, 41-42. The ACLU letters enclose letters and affidavits from physicians and therapists supporting the medical necessity of transsexual surgery and taking issue with the non-coverage determination. Id. at 27-76. On May 11, 1982, a HCFA Physicians Panel, which had referred the issue of coverage to the NCHCT in September 1980, recommended against referring the ACLU’s submissions to PHS, “on the basis that it does not contain information about new clinical studies or other medical and scientific evidence sufficiently substantive to justify reopening the previous PHS assessment.” Id. at 1, 4, 7, 9, 10. The NCHCT’s May 6, 1981 memorandum, the 1981 NCHCT report, and the notes of the HCFA Physicians Panel meeting on May 11, 1982, are the materials in the NCD record containing analysis by HCFA or PHS of the issue of Medicare coverage of transsexual surgery. Although the NCD was not issued until 1989, it is clear that the NCD was based on the NCHCT report and memorandum from 1981. 

From Raymond’s Transsexual Empire (1979)

Shape the CPT® Proprietary Lab Analyses Code Set

Invited Speakers of NCI 9/29-9/30/2016 Workshop on ctDNA.

Invited Speakers

Luis Alberto Diaz, Jr, M.D.

Associate Professor of Oncology, Johns Hopkins University

Maximilian Diehn MD, PhD.

Assistant Professor of Radiology Oncology Stanford University

Peter Kuhn, PhD.

Dean's Professor of Biological Sciences and Professor of Medicine, Biomedical Engineering, University of Southern California

Tony E. Godfrey, PhD

Associate Chair, Surgical Research and Associate Professor of Surgery, Boston University

Abstract Title: Detection of Tumor-specific Mutations in Circulating, Cell-free DNA: Potential for a Biomarker in Esophageal Adenocarcinoma

Tza-Huei (Jeff) Wang

Professor, Department of Mechanical Engineering, Department of Biomedical Engineering, Institute for NanoBioTechnology, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University

Abstract Title: Translating Nanotechnology and Microfluidics for Analysis of DNA Methylation

Julie E. Lang, MD, FACS

Director, USC Breast Cancer Program
Associate Professor of Surgery, University of Southern California

Abstract Title: Advantages and Disadvantages of ctDNA vs CTC Assays

Geoffrey R. Oxnard, MD.

Assistant Professor of Medicine, Harvard Medical School

Katherine Varley, PhD

Assistant Professor, Oncological Sciences, University of Utah

Abstract Title: Patch PCR: A targeted sequencing approach to quantify breast cancer ctDNA

Muhammed Murtaza MD, PhD

Translational Genomics Research Institute, Mayo Clinic Arizona

Abstract Title: Capturing tumor heterogeneity and clonal evolution using ctDNA analysis

Jamie Holloway, PhD

Breast cancer Survivor, patient Advocate

Abstract Title: Patient advocacy perspective in the use of ctDNA in clinical trials and beyond

Theresa Zhang, PhD

Vice President, Research Services, Personal Genome Diagnostics

Kelli Bramlett

Director, R&D, Thermo Fisher Scientific

Abstract Title: Oncomine™ cfDNA Assays – experiences in development and technical validation

Travis Clark, PhD

Principal Scientist, Molecular Biology and Sequencing, Foundation Medicine.

Abstract Title: Development of a Clinical Cell-Free Circulating Tumor DNA Assay for Cancer Molecular Profiling

Martin Horlitz

Manager Molecular Diagnostic Development, Qiagen

• Extraction of circulating nucleic acids from plasma and serum for applications in prenatal diagnosis and cancer detection ("Liquid Biopsy")
• Stabilization technologies for circulating nucleic acids in blood in clinical workflows "between blood draw and nucleic acid extraction"
• Viral nucleic acid extraction for diagnostic applications.
• Automated pre-analytical workflows for NGS, including liquid biopsy analysis
• Development of manual and automated nucleic acid purification solutions under Design Control, as required for IVD application development

Reena Philip, PhD

Division Director, CDRH/OIR/DMGP, FDA

Abstract Title: Regulatory considerations: cfDNA IVD as a companion diagnostic

Lisa M McShane, PhD

Chief of the Biostatistics Branch, Biometric Research Program
Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI).

Abstract Title: Statistical Considerations for Trials Designed to Determine Clinical Utility of cfDNA Assays

Paul "Mickey" Williams, PhD

Director, Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research

Christopher D. Gocke, M.D.

Associate Professor of Pathology, Director of Molecular Pathology Division ,Johns Hopkins University

Abstract Title: Challenges for the validation of ctDNA for use in clinical trials

Shivaani Kummar, MD, FACP

Director, Phase I Clinical Research Program, Division of Oncology, Stanford School of Medicine

Abstract Title: Role of Circulating Tumor DNA Profiling in Cancer Management

David Polsky, MD, PHD

Professor of Dermatologic Oncology, Director of the Pigmented Lesion of the Department of Dermatology, New York University School of Medicine

Abstract Title: Utility of ctDNA monitoring in metastatic melanoma disease surveillance

Gary Spitzer, MD

Director Clinical Validity and Clinical Utility Evaluation MolDx Palmetto GBA

Abstract Title: Clinical Utility Needs of ctDNA Assays Versus Research Utility

David Wong, DMD, DMSc.

Professor, Associate Dean for Research, UCLA

Abstract Title: EFIRM Liquid Biopsy (eLB)

1. D. Pu et al., Evaluation of a novel saliva-based EGFR mutation detection for lung cancer: a pilot study. Thoracic Cancer, 1-8 (2016).
2. F. Wei et al., Noninvasive saliva-based EGFR gene mutation detection in patients with lung cancer. Am J Respir Crit Care Med 190, 1117-1126 (2014).
3. L. M. Sholl et al., Liquid Biopsy in Lung Cancer: A Perspective From Members of the Pulmonary Pathology Society. Arch Pathol Lab Med, (2016).

Nitzan Rosenfeld, PhD

Senior Group Leader, University of Cambridge, UK; CSO, Inivata Ltd. UK

Abstract Title: Genomic analysis of circulating tumor DNA: pushing the limits for cancer applications

Richard B. Lanman, MD

Chief Medical Officer, Guardant Health, Inc

Abstract Title: Lessons Learned from ctDNA NGS Testing in 25,000 Advanced Cancer Patients in Clinical Practice

MolDX General Questions (M00086, V10)

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• MolDX General Questions
• MolDX Registration
• Technical Assessment (TA)
• Billing and Coding
• Reimbursement
• Coverage Issues

• Lab developed tests (LDT’s) performed using either established or novel technology with un-established clinical utility 
• Molecular or genetic testing that has not been validated for clinical and analytical validity
• Tests using modified versions of FDA registered kits
• Tests using a new molecular or genetic technological testing platform
• Genetic or molecular target with un-established clinical utility 
• Tests reported with one of the following CPT codes: 

• State of New York (NYS) certified tests that are industry accepted and have established clinical utility. However, MolDX may request the package used to determine the NYS certification to make a coverage decision. The approval letter or a copy of the NYS listing may be used to demonstrate NYS approval.
• Test that use FDA approved kits in an unmodified form
• New tests approved under a Premarket Approval (PMA)-(which under FDA policy from the early '90s requires evidence of clinical utility) and the test is reported with the stacking codes, a unique identifier is required, but a TA is not
• Tests that using existing or novel technology for molecular or genetic targets with established clinical utility

• Complete a Self-Audit
• Identify incorrect submissions
• Prevent further claim submission errors
• Consider Self-Disclosure Protocol
• Self-disclosure guidelines available on the OIG website  

Bookmark Email Print Font - Font + 

 

• MolDX General Questions
• MolDX Registration
• Technical Assessment (TA)
• Billing and Coding
• Reimbursement
• Coverage Issues

• Lab developed tests (LDT’s) performed using either established or novel technology with un-established clinical utility 
• Molecular or genetic testing that has not been validated for clinical and analytical validity
• Tests using modified versions of FDA registered kits
• Tests using a new molecular or genetic technological testing platform
• Genetic or molecular target with un-established clinical utility 
• Tests reported with one of the following CPT codes: 

• State of New York (NYS) certified tests that are industry accepted and have established clinical utility. However, MolDX may request the package used to determine the NYS certification to make a coverage decision. The approval letter or a copy of the NYS listing may be used to demonstrate NYS approval.
• Test that use FDA approved kits in an unmodified form
• New tests approved under a Premarket Approval (PMA)-(which under FDA policy from the early '90s requires evidence of clinical utility) and the test is reported with the stacking codes, a unique identifier is required, but a TA is not
• Tests that using existing or novel technology for molecular or genetic targets with established clinical utility

• Complete a Self-Audit
  • Identify incorrect submissions
  • Prevent further claim submission errors
• Consider Self-Disclosure Protocol
  • Self-disclosure guidelines available on the OIG website  

    (b) Promoting Evidence-Based Care.--
            (1) In general.--Section 1834 of the Social Security Act (42 
        U.S.C. 1395m), as amended by subsection (a), is amended by 
        adding at the end the following new subsection:

    ``(q) Recognizing Appropriate Use Criteria for Certain Imaging 
Services.--
            ``(1) Program established.--
                    ``(A) In general.--The Secretary shall establish a 
                program to promote the use of appropriate use criteria 
                (as defined in subparagraph (B)) for applicable imaging 
                services (as defined in subparagraph (C)) furnished in 
                an applicable setting (as defined in subparagraph (D)) 
                by ordering professionals and furnishing professionals 
                (as defined in subparagraphs (E) and (F), respectively).
                    ``(B) Appropriate use criteria defined.--In this 
                subsection, the term `appropriate use criteria' means 
                criteria, only developed or endorsed by national 
                professional medical specialty societies or other 
                provider-led entities, to assist ordering professionals 
                and furnishing professionals in making the most 
                appropriate treatment decision for a specific clinical 
                condition for an individual. To the extent feasible, 
                such criteria shall be evidence-based.
                    ``(C) Applicable imaging service defined.--In this 
                subsection, the term `applicable imaging service' means 
                an advanced diagnostic imaging service (as defined in 
                subsection (e)(1)(B)) for which the Secretary 
                determines--
                          ``(i) one or more applicable appropriate use 
                      criteria specified under paragraph (2) apply;
                          ``(ii) there are one or more qualified 
                      clinical decision support mechanisms listed under 
                      paragraph (3)(C); and
                          ``(iii) one or more of such mechanisms is 
                      available free of charge.
                    ``(D) Applicable setting defined.--In this 
                subsection, the term `applicable setting' means a 
                physician's office, a hospital outpatient department 
                (including an emergency department), an ambulatory 
                surgical center, and any other provider-led outpatient 
                setting determined appropriate by the Secretary.
                    ``(E) Ordering professional defined.--In this 
                subsection, the term `ordering professional' means a 
                physician (as defined in section 1861(r)) or a 
                practitioner described in section 1842(b)(18)(C) who 
                orders an applicable imaging service.
                    ``(F) Furnishing professional defined.--In this 
                subsection, the term `furnishing professional' means a 
                physician (as defined in section 1861(r)) or a 
                practitioner described in section 1842(b)(18)(C) who 
                furnishes an applicable imaging service.
            ``(2) Establishment of applicable appropriate use 
        criteria.--

[[Page 128 STAT. 1066]]


                ``(A) <<NOTE: Deadline. Regulations. Consultation.>>  In 
                general.--Not later than November 15, 2015, the 
                Secretary shall through rulemaking, and in consultation 
                with physicians, practitioners, and other stakeholders, 
                specify applicable appropriate use criteria for 
                applicable imaging services only from among appropriate 
                use criteria developed or endorsed by national 
                professional medical specialty societies or other 
                provider-led entities.
                    ``(B) Considerations.--In specifying applicable 
                appropriate use criteria under subparagraph (A), the 
                Secretary shall take into account whether the criteria--
                          ``(i) have stakeholder consensus;
                          ``(ii) are scientifically valid and evidence 
                      based; and
                          ``(iii) are based on studies that are 
                      published and reviewable by stakeholders.
                    ``(C) <<NOTE: Review. Deadline.>>  Revisions.--The 
                Secretary shall review, on an annual basis, the 
                specified applicable appropriate use criteria to 
                determine if there is a need to update or revise (as 
                appropriate) such specification of applicable 
                appropriate use criteria and make such updates or 
                revisions through rulemaking.
                    ``(D) Treatment of multiple applicable appropriate 
                use criteria.--In the case where the Secretary 
                determines that more than one appropriate use criterion 
                applies with respect to an applicable imaging service, 
                the Secretary shall apply one or more applicable 
                appropriate use criteria under this paragraph for the 
                service.
            ``(3) Mechanisms for consultation with applicable 
        appropriate use criteria.--
                    ``(A) Identification of mechanisms to consult with 
                applicable appropriate use criteria.--
                          ``(i) In general.--The Secretary shall specify 
                      qualified clinical decision support mechanisms 
                      that could be used by ordering professionals to 
                      consult with applicable appropriate use criteria 
                      for applicable imaging services.
                          ``(ii) Consultation.--The Secretary shall 
                      consult with physicians, practitioners, health 
                      care technology experts, and other stakeholders in 
                      specifying mechanisms under this paragraph.
                          ``(iii) Inclusion of certain mechanisms.--
                      Mechanisms specified under this paragraph may 
                      include any or all of the following that meet the 
                      requirements described in subparagraph (B)(ii):
                                    ``(I) Use of clinical decision 
                                support modules in certified EHR 
                                technology (as defined in section 
                                1848(o)(4)).
                                    ``(II) Use of private sector 
                                clinical decision support mechanisms 
                                that are independent from certified EHR 
                                technology, which may include use of 
                                clinical decision support mechanisms 
                                available from medical specialty 
                                organizations.
                                    ``(III) Use of a clinical decision 
                                support mechanism established by the 
                                Secretary.
                    ``(B) Qualified clinical decision support 
                mechanisms.--

[[Page 128 STAT. 1067]]

                          ``(i) In general.--For purposes of this 
                      subsection, a qualified clinical decision support 
                      mechanism is a mechanism that the Secretary 
                      determines meets the requirements described in 
                      clause (ii).
                          ``(ii) Requirements.--The requirements 
                      described in this clause are the following:
                                    ``(I) The mechanism makes available 
                                to the ordering professional applicable 
                                appropriate use criteria specified under 
                                paragraph (2) and the supporting 
                                documentation for the applicable imaging 
                                service ordered.
                                    ``(II) In the case where there is 
                                more than one applicable appropriate use 
                                criterion specified under such paragraph 
                                for an applicable imaging service, the 
                                mechanism indicates the criteria that it 
                                uses for the service.
                                    ``(III) The mechanism determines the 
                                extent to which an applicable imaging 
                                service ordered is consistent with the 
                                applicable appropriate use criteria so 
                                specified.
                                    ``(IV) The mechanism generates and 
                                provides to the ordering professional a 
                                certification or documentation that 
                                documents that the qualified clinical 
                                decision support mechanism was consulted 
                                by the ordering professional.
                                    ``(V) The mechanism is updated on a 
                                timely basis to reflect revisions to the 
                                specification of applicable appropriate 
                                use criteria under such paragraph.
                                    ``(VI) The mechanism meets privacy 
                                and security standards under applicable 
                                provisions of law.
                                    ``(VII) The mechanism performs such 
                                other functions as specified by the 
                                Secretary, which may include a 
                                requirement to provide aggregate 
                                feedback to the ordering professional.
                    ``(C) <<NOTE: Deadlines.>>  List of mechanisms for 
                consultation with applicable appropriate use criteria.--
                          ``(i) <<NOTE: Publication.>>  Initial list.--
                      Not later than April 1, 2016, the Secretary shall 
                      publish a list of mechanisms specified under this 
                      paragraph.
                          ``(ii) Periodic updating of list.--The 
                      Secretary shall identify on an annual basis the 
                      list of qualified clinical decision support 
                      mechanisms specified under this paragraph.
            ``(4) Consultation with applicable appropriate use 
        criteria.--
                    ``(A) Consultation by ordering professional.--
                Beginning <<NOTE: Effective date.>> with January 1, 
                2017, subject to subparagraph (C), with respect to an 
                applicable imaging service ordered by an ordering 
                professional that would be furnished in an applicable 
                setting and paid for under an applicable payment system 
                (as defined in subparagraph (D)), an ordering 
                professional shall--
                          ``(i) consult with a qualified decision 
                      support mechanism listed under paragraph (3)(C); 
                      and

[[Page 128 STAT. 1068]]

                          ``(ii) provide to the furnishing professional 
                      the information described in clauses (i) through 
                      (iii) of subparagraph (B).
                    ``(B) <<NOTE: Effective date.>>  Reporting by 
                furnishing professional.--Beginning with January 1, 
                2017, subject to subparagraph (C), with respect to an 
                applicable imaging service furnished in an applicable 
                setting and paid for under an applicable payment system 
                (as defined in subparagraph (D)), payment for such 
                service may only be made if the claim for the service 
                includes the following:
                          ``(i) Information about which qualified 
                      clinical decision support mechanism was consulted 
                      by the ordering professional for the service.
                          ``(ii) Information regarding--
                                    ``(I) whether the service ordered 
                                would adhere to the applicable 
                                appropriate use criteria specified under 
                                paragraph (2);
                                    ``(II) whether the service ordered 
                                would not adhere to such criteria; or
                                    ``(III) whether such criteria was 
                                not applicable to the service ordered.
                          ``(iii) The national provider identifier of 
                      the ordering professional (if different from the 
                      furnishing professional).
                    ``(C) Exceptions.--The provisions of subparagraphs 
                (A) and (B) and paragraph (6)(A) shall not apply to the 
                following:
                          ``(i) Emergency services.--An applicable 
                      imaging service ordered for an individual with an 
                      emergency medical condition (as defined in section 
                      1867(e)(1)).
                          ``(ii) Inpatient services.--An applicable 
                      imaging service ordered for an inpatient and for 
                      which payment is made under part A.
                          ``(iii) Significant hardship.--An applicable 
                      imaging service ordered by an ordering 
                      professional who the Secretary may, on a case-by-
                      case basis, exempt from the application of such 
                      provisions if the Secretary determines, subject to 
                      annual renewal, that consultation with applicable 
                      appropriate use criteria would result in a 
                      significant hardship, such as in the case of a 
                      professional who practices in a rural area without 
                      sufficient Internet access.
                    ``(D) Applicable payment system defined.--In this 
                subsection, the term `applicable payment system' means 
                the following:
                          ``(i) The physician fee schedule established 
                      under section 1848(b).
                          ``(ii) The prospective payment system for 
                      hospital outpatient department services under 
                      section 1833(t).
                          ``(iii) The ambulatory surgical center payment 
                      systems under section 1833(i).
            ``(5) Identification of outlier ordering professionals.--
                    ``(A) <<NOTE: Effective date. Determination.>>  In 
                general.--With respect to applicable imaging services 
                furnished beginning with 2017, the Secretary shall 
                determine, on an annual basis, no more than five percent

[[Page 128 STAT. 1069]]

                of the total number of ordering professionals who are 
                outlier ordering professionals.
                    ``(B) Outlier ordering professionals.--The 
                determination of an outlier ordering professional 
                shall--
                          ``(i) be based on low adherence to applicable 
                      appropriate use criteria specified under paragraph 
                      (2), which may be based on comparison to other 
                      ordering professionals; and
                          ``(ii) include data for ordering professionals 
                      for whom prior authorization under paragraph 
                      (6)(A) applies.
                    ``(C) Use of two years of data.--The Secretary shall 
                use two years of data to identify outlier ordering 
                professionals under this paragraph.
                    ``(D) Process.--The Secretary shall establish a 
                process for determining when an outlier ordering 
                professional is no longer an outlier ordering 
                professional.
                    ``(E) Consultation with stakeholders.--The Secretary 
                shall consult with physicians, practitioners and other 
                stakeholders in developing methods to identify outlier 
                ordering professionals under this paragraph.
            ``(6) Prior authorization for ordering professionals who are 
        outliers.--
                    ``(A) <<NOTE: Effective date.>>  In general.--
                Beginning January 1, 2020, subject to paragraph (4)(C), 
                with respect to services furnished during a year, the 
                Secretary shall, for a period determined appropriate by 
                the Secretary, apply prior authorization for applicable 
                imaging services that are ordered by an outlier ordering 
                professional identified under paragraph (5).
                    ``(B) Appropriate use criteria in prior 
                authorization.--In applying prior authorization under 
                subparagraph (A), the Secretary shall utilize only the 
                applicable appropriate use criteria specified under this 
                subsection.
                    ``(C) Funding.--For purposes of carrying out this 
                paragraph, the Secretary shall provide for the transfer, 
                from the Federal Supplementary Medical Insurance Trust 
                Fund under section 1841, of $5,000,000 to the Centers 
                for Medicare & Medicaid Services Program Management 
                Account for each of fiscal years 2019 through 2021. 
                Amounts transferred under the preceding sentence shall 
                remain available until expended.
            ``(7) Construction.--Nothing in this subsection shall be 
        construed as granting the Secretary the authority to develop or 
        initiate the development of clinical practice guidelines or 
        appropriate use criteria.''.
            (2) Conforming amendment.--Section 1833(t)(16) of the Social 
        Security Act (42 U.S.C. 1395l(t)(16)) is amended by adding at 
        the end the following new subparagraph:
                    ``(E) Application of appropriate use criteria for 
                certain imaging services.--For provisions relating to 
                the application of appropriate use criteria for certain 
                imaging services, see section 1834(q).''.
            (3) Report on experience of imaging appropriate use criteria 
        program.--Not later than 18 months after the date of the 
        enactment of this Act, the Comptroller General of the United 
        States shall submit to Congress a report that includes

[[Page 128 STAT. 1070]]

        a description of the extent to which appropriate use criteria 
        could be used for other services under part B of title XVIII of 
        the Social Security Act (42 U.S.C. 1395j et seq.), such as 
        radiation therapy and clinical diagnostic laboratory services.

....SEC. 219. USING FUNDING FROM TRANSITIONAL FUND FOR SUSTAINABLE 
                        GROWTH RATE (SGR) REFORM.

• designing 1115 waiver programs
• supporting the waiver development and negotiation process with CMS
• assuring that the proposal is structured appropriately, contains all the required elements and aligns with the state’s political needs
• leading implementation efforts for waiver programs, including implementing policy, eligibility system changes and developing request for proposals to contracting with managed care companies
• developing stakeholder education materials
• ensuring vendor readiness for go-live