Department of Health and Human Services
NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS
Subcommittee on Standards and Security
January 29-30, 2003
Washington, D.C.
_______________________________________________________________________________
- Minutes -
The Subcommittee on Standards and Security of the National Committee on Vital and Health Statistics (NCVHS) held hearings on January 29-30, 2003, at the Hubert H. Humphrey Building in Washington, D.C. The meeting was open to the public. Present:
Subcommittee members
Others
· Melissa Bartlett, Amer. Assn. of Health Plans
· Sue McAndrew, Office for Civil Rights, HHS
· Patsy McElroy, Natl. Council for Prescription Drug Programs
EXECUTIVE SUMMARY
Dr. Nachimson noted the Secretary approved Alternative Link’s and the Foundation for Integrative Health Care’s request for an exception from the use of HIPAA code sets to test the ABC code set’s ability to describe products and services delivered by complementary and alternative medicine and nursing practitioners.
Introduction to the Topic of the Day -- Complementary & Alternative Medicine
· Richard Nahin, M.D., Senior Advisor for Scientific Coordination and Outreach, National Center for Complementary and Alternative Medicine
Dr. Nahin explained that Congress created and charged the National Center for Complementary and Alternative Medicine (NCCAM) to study CAM across all disease areas. NCCAM catalogued hundreds of different treatments into five broad domains and studied interventions along the entire continuum, using science to identify and move along safe, effective therapies. Dr. Nahin discussed six national surveys of populations who either used alternative providers or CAM. Many using alternative therapies self-medicated and provider services centered on acute and chronic pain and debilitating diseases resistant to conventional treatments. Dr. Nahin emphasized the variability among modalities and the difference between the medical profession’s and the public’s perspectives.
Panel 1: Providers -- Complementary & Alternative Medicine
Dr. Kail said evaluation management and procedure codes ideally described the service provided. Because naturopathic physicians practiced primary care medicine, he said most existing codes were appropriate. The preventive medicine codes best described much of what naturopathic physicians did, although third-party payers didn’t usually reimburse them. Some things needed modification for specific modality use, but most coding used by naturopathic physicians only had to be modified.
Ms. Bickford noted the imploding U.S. healthcare system and that half the personal bankruptcies resulted from an inability to pay healthcare bills. Hewlett Associates and UCLA surveys projected that 2003 premiums would increase 20 percent for healthcare insurers and smaller businesses would pay 30-70 percent more for unchanged coverage. The uninsured population was anticipated to increase 50 percent. Ms. Bickford emphasized that the most important concept was creating accountability and that this required data. She discussed the recommendations in the latest Institute of Medicine (IOM) report for national action to transform healthcare quality. Noting integrative healthcare was one solution, Ms. Bickford emphasized that the coding systems didn’t reflect total care in the reporting data and the code sets didn’t reflect concepts that defined nursing.
Dr. Milliman emphasized that precise definitions needed to come from each profession and their specific therapy, modality and system training. The American Association of Naturopathic Physicians (AANP) supported Alternative Link’s pilot study of the ABC code set and CPT’s update of the descriptors for documenting physician work and E & M coding. Dr. Milliman stressed that advisory committees and editorial panels had to truly represent provider groups affected by the codes.
Mr. Dumoff explained that Integrated Healthcare Policy Consortium (IHPC) explored the concept of an integrated healthcare system and achieving it through a defined national policy framework. Coding had a profound impact on IHPC’s constituent organizations. Mr. Dumoff focused on four points: (1) significant gaps in available code sets hindered proper reporting and practice of integrative and CAM therapies; (2) difficulties in coding arose not merely from an absence of codes for many CAM procedures, but also from the guidelines, structure and application of codes to the health information infrastructure; (3) greater representation by professional associations whose members delivered CAM services was needed to develop codes that properly described this care; and (4) IHPC was positioned and available to further this representation.
Dr. Faust said he lived and practiced in Maryland, but was licensed in Washington State, because Maryland currently didn’t offer licensure for naturopathic physicians. Dr. Faust was unable to contract with insurance carriers or submit for third-party payment and his patients couldn’t receive insurance reimbursement. They also incurred additional healthcare costs, because he couldn’t order even routine laboratory tests. Because licensing wasn’t available, Dr. Faust said he was potentially at risk for liability. Dr. Faust voluntarily restricted the scope of his practice. He said these restrictions degraded the quality of naturopathic care available and increased overall healthcare costs. Dr. Faust said his patients wanted to choose from both conventional and naturopathic medical services and assurances that practitioners were qualified. Dr. Faust noted other significant barriers to public access to naturopathic medical services in Maryland including distribution and availability of local naturopaths, regulation and credentialing policies concerning coverage and reimbursement, and disparity in the existing healthcare delivery system).
Dr. Culliton explained that the division was the first integrative or alternative medicine clinic in the United States accredited through the Joint Commission on Accreditation of Health Care Organizations. Since 1997, the division’s ambulatory care clinic provided 52,477 visits to 4,623 individuals who’d been documented with CPT and ICD-9 codes. (They also provided over 150,000 off-site patient visits paid through contractual agreements with public health facilities.) Chiropractors, acupuncturists, and massage therapists provided direct service. Appointment and billing services were shared system wide. Integrated medical charts enabled every physician to know who was being treated and how.
Dr. Freiberg expanded on the need for additional comparative analysis quantifying and qualifying services of each provider. He explained that, under the Florida statutes, licensed acupuncturists (acupuncture physicians) were primary healthcare providers and performed a full scope of healthcare services. Within Alternative Link’s ABC code system, the full scope of practice for acupuncture physicians in Florida was assigned codes with Rave’s, enabling production of worthwhile data collection with real dollar costs directly associated with services. Dr. Freiberg noted that the World Health Organization (WHO) had just held its International Health Care Symposium and the United States again came in as the most expensive country and number 37 out of 140 countries in quality of healthcare. Noting acupuncture and oriental medicine were embraced worldwide as a key international standard of healthcare, Dr. Freiberg said approval of ABC codes as a national standard would help reduce the high cost of healthcare.
Panel 2: Health Plans
Mr. Stevans said Landmark Healthcare had 2.2 million insured lives and another nine million members under discount or infinity programs throughout the 15 states where they offered insured products with chiropractic, acupuncture, herbal therapies, massage therapy, and nutritional counseling benefits. Wherever possible, Landmark used standardized HIPAA-adopted data code sets. When inadequate, Landmark looked for a standardized code set: in other regulatory bodies and agencies, the CPT codebook for unlisted or unspecified modality procedures, or a proprietary code set. Mr. Stevans discussed Landmark’s chiropractic, acupuncture, and therapeutic massage benefits. Claims were submitted via the HCVA 1500 form. The reimbursement methodology was either a CPT line item or a per-visit method.
Mr. Hegetschweiler said American Specialty Health (ASH) was a full service benefits company for complementary healthcare that offered direct access benefit programs for chiropractic, acupuncture, massage therapy, naturopathy, and nutrition services nationwide for health plans, insurance carriers, employer groups and trust funds. ASH covered nine million people. Working almost exclusively with health plans, ASH services included utilization and quality management, member/provider services, claims processing, and provider credentialing. ASH affiliates held individual contracts with over 20,000 providers including 13,000 chiropractors, 2,500 acupuncturists, 4,300 massage therapists, 240 naturopathic physicians, and 700 registered dietitians. Medically necessary services were billed through HVCA 1500 forms using CPT terminology to describe services performed. ASH used ICD-9 and HCPC codes for other procedures and diagnosis. All services were CPT coded. E & M and specialty procedure codes delineated under the medical or medicine section in the AMA CPT manual were the most common codes used. Mr. Hegetschweiler said it was important that CAM providers participate in the committees the AMA used regarding CPT codes.
Code Set Overlap
Dr. Feinberg presented a technical review and evaluation of the Alternative Link code set, assessing the code set using a set of criteria the Committee specified that called for a hierarchical structure and a code set that was expandable, comprehensive, non-overlapping, easy-to-use, setting-and-provider neutral, multi-axial, and limited to classification of procedures.
Day TWO
Dr. Cohn said the main focus of the day was continuing an investigation into ways to improve and stabilize the HIPAA process. He noted two major concerns: soliciting from industry and others ways to improve the process and, recognizing that there was less than ten months until implementation of the administrative and financial transactions, identifying any major show stoppers or issues they should be aware of and deal with.
Subcommittee Discussion: Improving the HIPAA Process
· Harold Reynolds, Vice President, Blue Cross/Blue Shield of North Carolina
Mr. Jones said three major areas provided context for that day’s discussion and encompassed WEDI's recommendations: Congress and HHS hadn’t allocated sufficient financial and personnel resources for a timely, predicable and successful implementation; consequently the set of standards comprising HIPAA administrative simplification were released haphazardly, creating confusion, frustration and skepticism in the healthcare marketplace; the current federal regulatory process that underpinned HIPAA administrative simplification standards was too slow and impeded compliance and innovation in a dynamic healthcare marketplace; failure of timely publication of transaction and code set addenda impeded testing; third and perhaps most important, looking beyond HIPAA administrative simplification standards at a new collaborative process driven by the healthcare industry with government participation as a payer.
Mr. Reynolds said there was no competitive advantage to any one becoming HIPAA compliant, because HIPAA was re-engineering the way the industry did business. Mr. Reynolds said interpretations of the IGs were among the significant issues they faced. Mr. Reynolds asked for clear direction and decisions. The addenda hadn’t come out and many in the industry were saying they’d implement 4010. 4010A, which was supposed to fix 4010, was to be implemented in October. Both couldn't be done at once. Mr. Reynolds noted similar issues with DDE and reiterated the need for answers.
DAY ONE
Dr. Cohn welcomed everyone to the first of two days of hearings of the Subcommittee on Standards and Security of NCVHS, noting this is the main public advisory committee to HHS on national health information policy. He said the first day focused on provider, payer, and research needs for code sets for CAM. Noting the Subcommittee had received correspondence from other specialties, Dr. Cohn said they’d hold at least one more hearing with others involved in coding CAM. That day, they’d also review the Subcommittee’s priorities and issues for 2003 and gain the panelists’ sense of how they might prioritize activities and focuses for the year. The next day the Subcommittee would continue their investigation into ways to improve and stabilize the HIPAA process.
Dr. Nachimson read a letter from the Secretary approving Alternative Link’s and the Foundation for Integrative Health Care’s request for an exception from the use of HIPAA code sets to test the ABC code set used in conjunction with HCPCS codes to describe products and services delivered by complementary and alternative medicine and nursing practitioners. Approval covered the use of the ABC code set by HIPAA-covered entities (health care providers, health plans, and health care clearinghouses) to describe products and services in HIPAA transactions. Participants must include health care providers and at least one health plan. Electronic transactions must be included. The pilot’s start date (any time prior to October 16, 2003) will be determined by Alternative Link and the foundation after consultation with participants. Duration will be two years.
Introduction to the Topic of the Day -- Complementary & Alternative Medicine
· Richard Nahin, M.D., Senior Advisor for Scientific Coordination and Outreach, National Center for Complementary and Alternative Medicine
Dr. Nahin explained that NCCAM was one of 27 institutes that made up the National Institutes of Health (NIH). Congress created and charged NCCAM in 1999 to study every aspect of CAM across all disease areas. NCCAM defined CAM as medical and healthcare practices outside the realm of conventional medicine that had yet to be validated using scientific methods. Complementary treatments were defined as treatments used with conventional practices; alternative treatments were those used instead.
NCCAM catalogued hundreds of different treatments into five broad domains: biological-based systems (e.g., diet therapies, herbal products, other dietary supplements); manipulative-and-body-based systems (e.g., massage, chiropractic); mind-body medicine (e.g., yoga, prayer, spirituality, meditation); whole alternative medical systems (naturopathy, homeopathy and oriental medicine); and energy therapies (reiki, magnet therapy, and qi gong). NCCAM used these categories to organize their research portfolio into administratively and scientifically manageable units.
NCCAM saw these therapies lying on a continuum ranging from most to least studied and integrated. Their goal was to study interventions along the entire continuum, using rigorous science to identify and move along safe, effective therapies. Dr. Nahin noted a practice could fall anywhere on the continuum, depending on how it was used (e.g., vitamin E was well integrated into standard care for preventing and treating deficiencies; evidence indicated a higher dose might reduce risk of coronary heart disease, but use of vitamin E to increase immune function was far less integrated).
Dr. Nahin reported that NCCAM used six main criteria to evaluate different alternative practices and establish their research agenda: use of interventions by the general public; public health significance of the disease or condition, priority to diseases associated with high mortality and chronic disabling morbidity; whether credible preliminary data supported intervention, and the data’s quality and quantity; availability of interested scientific experts; clinical trials with individuals willing to be randomized to a conventional or alternative medicine intervention; and the cost of projects considered candidates.
NCCAM assessed public use utilizing: surveys and marketing/sales data; queries to their clearinghouse, and information provided by health insurers and alternative medicine association groups. Dr. Nahin noted that six national surveys published in scientific literature looked at the percent of the population surveyed who either used alternative providers or CAM. Results varied with 29-47 percent using an alternate method and 8.3-19 percent using an alternate provider. Dr. Nahin pointed out that many people using alternative therapies self-medicated.
Dr. Nahin also noted that the Eisenberg survey indicated that people used alternative therapies mostly for chronic, debilitating diseases. Many of the diseases were resistant to conventional treatments. The top four conditions (back pain [11 percent], neck pain, osteoarthritis and headaches) involved chronic pain. Others were allergies, insomnia, depression, anxiety, GI disorders, and high blood pressure (2-3 percent).
The surveys indicated that herbal medicine, chiropractic and massage therapy were used at a much higher rate than homeopathy, acupuncture and naturopathy. Dr. Nahin noted variations in each category (e.g., surveys varied between 2-17 percent for herbal medicine). The five most used dietary supplements and botanical products were ginkgo, St. John’s Wort, ginseng, garlic, and Echinacea. Some 24 percent of those surveyed in Herbgram had used an herbal product within the last year; 15 percent in Kaufman used an herbal product during the last week. Sales data confirmed the herbal surveys and data from NCCAM’s clearinghouse confirmed the use of dietary supplements. The topic requested most from their clearinghouse was herbal medicine as a group, followed by diet/nutrition therapies, acupuncture, dietary supplements, MNG-3 (a supplement used for cancer), glucosamine and condriten (both used for osteoarthritis, PC-SPES (used for prostate cancer), St. Johns Wort (for depression), massage therapy as an intervention, and soy-based products. Seven of the ten were dietary supplements.
Dr. Nahin emphasized the variability among modalities, noting herbal medicine was the most highly used type of alternative medicine treatment (25 percent in one study) and acupuncture was used least (.4-2 percent). Dr. Nahin noted the medical profession’s and public’s different perspectives. Physicians thought more highly of acupuncture (40-60 percent) than herbal medicine (15-25 percent), reversing the public’s view. Dr. Nahin encouraged the Committee to reach as many communities and perspectives as possible.
Dr. Nahin presented a 1997 survey of alternative and complementary medicine services HMOs provided. Thirty percent of respondents supported some coverage for acupuncture, 65 percent for chiropractic, 4-5 percent for homeopathy, 11 percent for massage therapy, and 2-3 percent for naturopathy. Dr. Nahin noted that this, too, was different than the public’s perception of use.
He noted that, similar to conventional medicine, alternative medicine was regulated at the state level. All 50 states licensed chiropractors, 43 states licensed non-M.D. acupuncturists, 25 states licensed or certified massage therapy, 11 states and Washington D.C. certified or licensed naturopaths, and three states licensed homeopaths. Medicaid reimbursed for a number of these practitioner types. Some 46 states reimbursed for chiropractic care, eight states reimbursed for acupuncture, one for homeopathy. Dr. Nahin said that in 1998 there were 55,000 licensed chiropractics with $8 billion of estimated charges, 150,000-200,000 certified massage therapists with a market of about $6 billion, between 5,000 and 8,000 non-M.D. licensed acupuncturists, and about a thousand M.D.s who’d taken additional courses on acupuncture. The combined acupuncture market was between $500 million and $1 billion dollars. Some 3,000 practicing homeopaths (500 of them M.D.s) produced a total service of about $2 million dollars. Between 1,000-3,000 licensed naturopaths generated about $2 million dollars. Dr. Nahin emphasized that these practices’ rates of growth were geometric. A paper by Cooper et al projected there would be 40,000 practicing licensed non-M.D. acupuncturists and 140,000 chiropractics by 2015. Dr. Nahin predicted more people would use these practitioners as they became more available.
Asked how nurse practitioner interventions fit in, Dr. Nahin said the priority for the National Institute of Nursing Research was interventions close to becoming part of standard care. He added that how the modalities were applied was also a factor.
Dr. Nahin clarified that, from a national perspective, there were two focuses: self-medication and how provider services centered on acute and chronic pain. However, looking at specific disease conditions (e.g., cancer, HIV/AIDS), these groups were seen to use alternative medicine at a higher rate. Some 50-100 percent of HIV/AIDS patients surveyed reported using complementary or alternative medicine. Cancer also was high. Dr. Nahin emphasized that, when standard care didn’t bring one back to full health, one was more likely to turn to alternative therapies. But he noted only a small population solely used them. Dr. Nahin said his impression was that there had been an increase in integrative and interdisciplinary practices.
He said the surveys also indicated about half of the patients shared their use of alternative complementary modalities with their conventional clinical physicians. Communications were highest at pain clinics. Rheumatologists, for example, had a more positive reaction to using acupuncture than an oncologist because the latter communities found each other’s interventions contrary. Dr. Nahin said much of NCCAM’s portfolio looked at alternative medicine treatments for pain management, and he noted that anything considered standard care couldn’t be removed to do a trial. For example, non-steroid anti-inflammatory drugs were considered standard care for osteoarthritis and patients in a trial at the University of Maryland looking at the use of acupuncture for treating knee osteoarthritis continued that treatment. The outcome measure was a reduction of conventional medication in the acupuncture group.
Dr. Nahin reported that some third-party payers covered some alternative medicine and investigators were beginning to analyze claims data. Ms. Giannini said Alternative Link and the Foundation for Integrative Health care found a lot of coverage for acupuncture and massage therapy on the workers’ comp and property and casualty side, but much less on the healthcare side. When looking at the date, she said one had to separate the healthcare and workers’ comp claims.
Panel 1: Providers -- Complementary & Alternative Medicine
Dr. Kail said naturopathic physicians provided primary healthcare services and utilized conventional diagnostic techniques including physical examination, laboratory evaluation, diagnostic imaging, and pathologic diagnosis. Assessment often included determination of nutritional status and toxic burden. The patient’s mental, emotional, social and spiritual status was evaluated and a more conventional history and physical exam using other laboratory techniques was conducted.
Traditional naturopathic therapeutics included lifestyle interventions; prescription of natural medicines of animal, mineral, and plant origin; therapeutic diet; homeopathy; physical modalities; and counseling. Naturopathic physicians also provided in-office minor surgical procedures, administered vaccinations, and prescribed a range of drugs depending on jurisdiction. They referred for evaluation and management by specialists, using the same criteria as conventional primary care providers. They met public health requirements and, utilizing a primary care model, worked with a multi-specialty referral network. Dr. Kail said a natural evolution of naturopathic care models resulted in the emergence of integrated clinics, including the full range of licensed providers.
Dr. Kail reported that Washington State had a directive from its insurance commissioner to cover every category of licensed providers. The states of Hawaii, Arizona, and Connecticut also had insurance parity mandates for naturopathic physicians. Montana’s law defined them as practicing a primary care system of medicine, ensuring coverage for naturopathic physicians.
Dr. Kail suggested that conventional medicine wasn’t a healthcare system because it focused on acute interventions and didn’t effectively prevent or reverse chronic degenerative disease. At best, he said it was a detection and disease management system. Because of this, healthcare costs rose, the population became sicker, and one-out-of-every-three Americans sought an alternative approach to medicine. Dr. Kail described a naturopathic physician as a primary care physician focused on wellness and disease prevention, thereby creating a cost effective service. He said naturopathic physicians were good risks for professional liability: they had close relationships with their patients, used safe therapies, and didn’t perform invasive procedures. Dr. Kail said this also made them a desired part of any managed care system that sought to assure quality and services, while limiting costs.
He cited a Michigan State University study that indicated the majority of Medicaid programs provided coverage of alternative therapies for children in low-income families. Chiropractic was reimbursed in 74 percent of the states, biofeedback in 22 percent, acupuncture in 15 percent, and hypnosis in 13 percent, and naturopathy in 11 percent. On the average, these states currently spent less than $500,000 a year on alternative therapies for Medicaid recipients. Seven states planned to expand alternative medicine coverage over the next three years.
Dr. Kail noted that the most populous practitioners (chiropractors, acupuncturists and massage therapists) had specialty practices mostly focused on pain. He predicted there would be more utilization because more patients were covered by third-party payers. Looking at more primary care services, one found a different perspective. Utilization information was available, but mostly proprietary, and not easily shared by third-party reimbursers. Few demonstration projects existed. Recently, NIH called for papers regarding utilization and keeping it proprietary, so third-party reimburses could contribute data in a better venue.
Dr. Kail said evaluation management and procedure codes ideally described the service provided. Because naturopathic physicians practiced primary care medicine, Dr. Kail said most existing codes were appropriate. Preventive medicine codes best described much of what they did, although third-party payers didn’t usually reimburse them. Some things needed modification for specific modality use, but the broad amount of coding used by naturopathic physicians didn’t need to be changed, only modified.
Panel 1: Providers -- Complementary & Alternative Medicine
Ms. Bickford said she was a registered nurse and responsible for addressing informatics and telehealth initiates in the Department of Nursing Practice and Policy for the American Nurses Association (ANA). She noted the imploding U.S. healthcare system and that an inability to pay healthcare bills resulted in at least half of the nation’s personal bankruptcies. Hewlett Associates and UCLA surveys projected that 2003 premiums would increase at least 20 percent for healthcare insurers, meaning smaller businesses will pay 30-70 percent more for unchanged coverage or elect to not provide healthcare benefits. The uninsured population will jump 50 percent to some 60 million uninsured people.
Considering how to resolve these issues, Ms. Bickford referenced Brian Klepper’s work for the Center for Practical Health Care Reform (www.practicalhealthreform.org) that envisioned immediate actions including: establishment of universal coverage of basic care (which needed to be defined), re-balancing medical liability, standardization of information technologies long term, and adoption of evidence-based best practice guidelines. Ms. Bickford emphasized that the most important concept was creating accountability and this required data.
Ms. Bickford discussed the recommendations in the latest IOM report for national action to transform healthcare quality. The first recommendation was to establish priorities for national action that represented the population’s healthcare needs. She noted it had to be across the entire life span, involve multiple healthcare settings and many types of healthcare professionals. The extension had to encompass the full spectrum of healthcare, keep people well, and maximize their overall health. Treatment needed to cure disease and health problems; help the chronically ill live longer, more productive and comfortable lives; and provide dignified end-of-life care respectful of individual and family values and preferences.
Other recommendations included the need for criteria for an evidence-based approach (the burden on patients, families, communities, and societies; the gap between current and evidence-based practice; the question of inclusiveness; and relevance to a broad range of consumers) and addressed the importance of data collection in priority areas. Ms. Bickford said they needed to include data on health and functioning and cover demographic and regional groups that identified disparities in care between those who had insurance plans, Medicare, paid out-of-pocket, or couldn’t pay at all.
Ms. Bickford said the IOM report’s priority areas (preventive care, behavioral health, chronic conditions, end of life, children and adolescents, and impatient/surgical care) were consistent with the HealthePeople 2010 requirement’s goals of eliminating health disparities and increasing the quality and years of healthy life. Noting integrative healthcare was one solution, Ms. Bickford emphasized that the coding systems didn’t reflect total care in the reporting data. Some 59 percent of the 2.2 million registered and currently employed nurses worked in hospital settings, and weren’t involved in CPT and ICD codes. And reporting codes for the 157,000 Advanced Practice Registered Nurses most usually involved with those codes were often bundled within a practice.
Ms. Bickford said the code sets didn’t reflect the concepts that defined nursing: prevention of illness; alleviation of suffering and protection; and promotion and restoration of health in the care of individuals, families, groups, communities, and populations. In practice, nursing looked at the components of assessment, diagnosis or problem definition, outcomes identification, planning, implementation and evaluation including progress towards obtaining outcomes. Implementation in practice involved coordination of care, health teaching, health promotion, consultation, and for Advanced Practice Nurses, prescriptive authority and treatment. Ms. Bickford said ANA had identified 13 supporting terminologies that reflected diagnosis, interventions, and outcomes.
She gave the example of a clinician who provided modalities in conjunction with counseling for a client with a DMS-IV diagnosis. That clinician could only code and bill for the counseling, though clients referred for prescriptive integrative healthcare services received integrative therapies (e.g., self-healing, relaxation, stress management, pain reduction or pain relief). Insurance companies and Medicare wouldn’t pay and the clinician reduced fees or used other strategies and was paid only $35 to $50 an hour for these services.
Ms. Bickford explained the primary health clinic service for the under and uninsured. Often a sliding scale was integrated. Therapy was reimbursed under E& M, based on time. Third- party payers didn’t know what actually occurred. Clients sought services for pain reduction or interventions that allowed them to keep going. Nurses used therapeutic touch, reiki, imagery and visualization, aromatherapy, and reflexology. Some engaged in healing touch, herbal therapy, or acupuncture. Infusion therapies, inadequately supported, were for nutrition as well as chemotherapy. There weren’t code sets to support who did what, when, and why and nurses weren’t able to talk about outcomes or address best practices or costs. And now nurses had to deal with an increasing regulation component.
Panel 1: Providers -- Complementary & Alternative Medicine
Dr. Milliman said he’d been in private practice for more than 20 years in a multi-disciplinary office setting in one of the oldest integrated medical centers comprised of licensed acupuncturists, naturopathic and medical physicians, massage practitioners, and licensed psychologists. Patients were co-managed when it was to their benefit. His practice included acute and chronic conditions and was about 60 percent managed care. Dr. Milliman’s range of responsibilities fell under the aegis of a full service physician-level provider, though he didn’t have an M.D.
He defined a licensed naturopathic physician as a graduate of a four-to-five year curriculum at an accredited naturopathic medical school. Naturopathic medical services were generally describable in terms of evaluation and management as well as procedural code components. Naturopathic medical services were billed utilizing ICD-9 and CPT on a standard HCFA 1500. Most primary and specialty naturopathic medical services were reimbursed by third- party payers in jurisdictions where N.D.s were contracted providers. As research mounted in support of nutritional counseling, lifestyle modification, and exercise education as alternatives to long-standing drug therapy and appropriate interventions for chronic dysfunction/disease, Dr. Milliman noted many of these interventions looked mainstream and showed true value. He reported that contemporary medical practices included more interventions commonly used in naturopathic and other CAM forms of medicine. Noting that existing components in E & M of the history of presenting illness, physical exam and complexity might inadequately describe the emerging nature of physician work in this era, especially considering patient advocacy through shared decision making and condition specific education via interpretation of laboratory and other reports, records, and studies, Dr. Milliman said naturopaths wanted these other interventions reflected in the descriptors for physician work in E & M. He said stress management counseling, exercise and physical education, spiritual and relationship counseling, nutritional evaluation and counseling, and the increased use of electronic communication as a frequent mechanism of patient follow-up care demonstrated the importance of reexamining and redefining components of E & M.
Dr. Milliman defined a therapy as a particular item in naturopathic medicine (e.g., an herb). A modality was a collection of therapies gathered together under one umbrella (e.g., botanical medicine or nutritional supplements). A system of medicine was an entire comprehensive system with its own philosophy, school of thought, and sets of practices, whether defined scientifically in modern Western or other terms. AANP wanted to assist in developing parameters to help code for the coordination and delivery of care that might utilize CAM therapies, modalities, and systems of healthcare. Dr. Milliman emphasized that precise definitions needed to come from each profession and their specific therapy, modality and system training.
AANP supported Alternative Link’s pilot study of the ABC code set and CPT’s update of the descriptors for documenting physician work and E & M coding. Dr. Milliman stressed that advisory committees and editorial panels had to truly represent provider groups affected by the codes. He noted that the naturopathic profession participated in numerous studies on outcomes and utilization supported by grants and carried out by naturopathic medical schools and conventional medical institutions. Many private practitioners self-funded research and gathered the data for office-based research, and much of it was published in peer review literature.
Panel 1: Providers -- Complementary & Alternative Medicine
Mr. Dumoff explained that IHPC, a national working group of the Collaboration for Healthcare Renewal Foundation, was charged with articulating and advocating public policy to improve access to high quality integrated healthcare services. Founded early in 2002 after a summit identified common ground among conventional and CAM healthcare providers, representatives from nearly 60 national organizations explored the concept of an integrated healthcare system and how to achieve it through a defined national policy framework.
IHPC found coding had a profound impact on their constituent organizations. Gaps in CPT code sets were a significant concern. Comprehensive coverage and precision required for accurate communication of the provider/patient encounter wasn’t available under the CPT system, and lack of representation by licensed CAM professionals on CPT panels seemed unilaterally biased. Alternative Link’s proposed ABC code set introduced more concerns, including the uncertainties of coding CAM services with a code set separate from the CPT biomedical codes. An IHPC task force formed to explore inequities in the current system met with CPT and Alternative Link and would collaborate to overcome barriers to integrated and CAM services.
Mr. Dumoff focused on four points: (1) significant gaps in available code sets hindered proper reporting and practice of integrative and CAM therapies; (2) difficulties in coding arose not merely from an absence of codes for many CAM procedures, but also from the guidelines, structure and application of codes to the health information infrastructure (e.g., Relative Value Unit scales); (3) greater representation by professional associations whose members delivered CAM services was needed to develop codes that properly described this care; and (4) IHPC was positioned and available to further this representation.
He said numerous widely practiced CAM procedures with demonstrable clinical efficacy offered legitimate, cost effective alternatives to mainstream care, but were represented poorly, if at all. Many procedures had no code including oriental medicine techniques (e.g., cupping), chiropractic therapies (e.g., closed joint adjustments), or bodywork therapies (e.g., Asian Massage). Physicians faced numerous gaps in codes (e.g., allergen immunotherapies aimed at alleviating non-IgE mediated sensitivities). Coding difficulties faced by CAM practitioners, nurses, and integrated physicians often arose from uncertainty about whether an approach to care based on different theories of health and healing relationship could be fairly represented by a code written for a biomedical procedure.
Mr. Dumoff emphasized that editorial development needed to provide an inclusive and pluralistic approach to writing guidelines. Decisions about E & M, bundling of procedures, and coding categories affected collection of outcome data and reimbursement. Mr. Dumoff said the ability to submit CPT code requests was an inadequate means of representation; he emphasized that these guidelines had enormous impact and must be addressed by those delivering care, so those paying for these services could understand the components of these encounters.
Alternative Link’s process closely matched the criteria IHPC identified for representative coding sets and IHPC supported the authorization of a demonstration project for ABC codes. IHPC believed concurrent development of CPT and ABC was critical, regardless of whether they merged.
Mr. Dumoff emphasized that any editorial process that developed codes for CAM services needed to be representative, transparent, and allow autonomous control by each profession in determining descriptors for their own services. Participation should be inclusive, pluralistic, heterogeneous and even-handed. All professions licensed in any state and offering services that could be billed to a third party should have a seat in the process. Noting there were complex issues in identifying proper representatives, Mr. Dumoff offered IHPC’s expertise in moving CAM constituencies toward consensus. He emphasized that the process had to be accountable and available to each profession. While the CPT process wasn’t open to the public, he noted that CPT agreed to review and provide IHPC with requested codes for CAM services, communicate the status of requests and, if rejected, explain why. Mr. Dumoff stressed that potential conflicts of interest between AMA and health professions with alternative approaches had to be closely managed.
He said it was critical that determinations for RVUs be equitable. IHPC’s concern was that distinct codes for biomedicine and CAM could create separate and inferior pay structures for CAM services. He urged the Subcommittee to recommend that regulatory language ensure studies of time, skill, and practice investments were equivalent and not undervalue CAM services.
Mr. Dumoff also noted the threshold for code adoption was a central issue. CPT required a proposed code be supported in the literature, but Mr. Dumoff said the extent to which the CPT process accurately defined minimal levels of evidence for CAM procedures was questionable. He suggested that outcomes tracking might be more effective in evaluating cost and clinical effectiveness. Alternative Link sought a comprehensive listing of procedures to track outcomes without a priori determination of value, and Mr. Dumoff suggested that approach offered an important strategy in learning how CAM could be fully evaluated. But he also cautioned that a separate code set might negatively impact investments and payments for CAM services. This concern was heightened where codes for CAM services might not meet any initial threshold of evidence. Mr. Dumoff said relegation of ABC codes to Category III status wasn’t an acceptable solution and the tension between CPT and ABC code thresholds be addressed head on.
Panel 1: Providers -- Complementary & Alternative Medicine
Dr. Faust said he lived and practiced in Maryland, but was licensed in Washington State, because Maryland currently didn’t offer licensure for naturopathic physicians. Dr. Faust was unable to contract with insurance carriers or submit for third-party payment and his patients couldn’t receive insurance reimbursement. They also incurred additional healthcare costs, because he couldn’t order even routine laboratory tests. Dr. Faust said he didn’t provide ICD-9 or CPT codes for his naturopathic services because he wasn’t sure if he’d risk state censure utilizing those codes. Because licensing wasn’t available, Dr. Faust said he was potentially at risk for liability. He carried professional liability insurance, limited to the scope of his Washington license.
Dr. Faust voluntarily restricted the scope of his practice, excluding services he was authorized to provide in Washington State (e.g., breast, pelvic and rectal exams; prescriptions for barrier contraceptive devices; intramuscular nutrient administration; ordering and interpreting clinical lab tests, x-rays electrocardiograms; minor surgery; and pharmaceutical drug prescription). He said these restrictions degraded the quality of naturopathic care available and increased overall healthcare costs. Dr. Faust said his patients wanted to choose from both conventional and naturopathic medical services and assurances that practitioners were qualified.
He provided an invoice for naturopathic consultations. His fees were paid out of pocket, even though most his patients had insurance for conventional healthcare. Coverage of and reimbursement for most healthcare services were linked to a provider’s ability to furnish services legally within a scope of practice. Insurers who wanted to cover naturopaths couldn’t unless there were properly licensed practitioners in a state. Dr. Faust said the health system should give equitable consideration to safe and efficacious interventions for both conventional healthcare and naturopathic medical services.
Dr. Faust said he frequently co-managed care with other licensed healthcare providers (e.g., medical and osteopathic doctors, chiropractors, acupuncturists, and counselors) when it benefited the patient. He noted this presented challenges because licensed providers couldn’t make official referrals to those without a license within the Maryland healthcare system. Dr. Faust said he’d received many unofficial referrals from conventional physicians, and many physicians and their families were his patients.
Dr. Faust said he trained conventional physicians in the philosophy and practice of naturopathic medicine by having them observe and participate in the services provided in his practice. He also provided preceptorships for naturopathic medical students and elective training in CAM practices for fourth year medical students from the University of Maryland School of Medicine. Dr. Faust said he’d tried several times to establish an integrative health center with conventional doctors, but the professional license for medical doctors in Maryland prohibited sharing patients with an unlicensed provider. He’d also been invited by the director of the Complementary Center for Healing at the University of Maryland School of Medicine to join their clinical faculty at Kernan Hospital but couldn’t because no one knew how to code or bill for his services.
He noted that partnerships were increasingly common and essential for delivering integrative healthcare. Noting that good healthcare required teamwork among patients, healthcare practitioners, regulatory bodies, and health insurance providers, he said the absence of licensing for naturopathic physicians in every state was an obstacle to inclusion and prohibited the integration of naturopathic medical services into conventional healthcare. Currently, less than 10 naturopathic physicians practiced in Maryland who were also members of AANP, graduates of a naturopathic medical college accredited by the CNME, and passed the naturopathic physicians licensing examination. Others used the title N.D., but hadn’t met these requirements. Dr. Faust said most consumers were unaware of the significant differences in the level and types of training in these categories. Establishing legal authority for naturopathic physicians to practice through mandatory licensure, which prohibited the practice of a profession without a license, would protect the public from inappropriate practice of healthcare. Licensure also provided opportunities for appropriately trained and qualified health practitioners to offer their full ranges of services.
Dr. Faust noted other significant barriers to public access to naturopathic medical services in Maryland including distribution and availability of local naturopaths, regulation and credentialing policies concerning coverage and reimbursement, and disparity in the existing healthcare delivery system. Because health insurance programs didn’t cover naturopathic medical practices and products in unlicensed states, access was often limited to those with higher discretionary incomes.
Panel 1: Providers -- Complementary & Alternative Medicine
Dr. Culliton explained that she’d done acupuncture research in the Hennepin system since the early 1980's and developed the Alternative Medicine Division in 1993, offering services that had CPT codes to facilitate self-pay and reimbursements. The division was the first integrative or alternative medicine clinic in the United States accredited through the Joint Commission on Accreditation of Health Care Organizations. They provided service; education to medical students, residents, and allied health professionals; and did extensive research in oriental medicine including acupuncture, herbal medicine research, and chiropractic.
Dr. Culliton said the division developed a database for tracking utilization, outcomes, referral patterns, and safety issues. Since 1997, the division’s ambulatory care clinic provided 52,477 visits to 4,623 individuals who’d been documented with CPT and ICD-9 codes. They also provided over 150,000 off-site patient visits paid through contractual agreements with public health facilities. Some 86.3 percent of those 52,477 visits related to a pain complaint: 76 percent were musculoskeletal, the rest were function or headache disorders.
Three job categories within the division provided direct service: chiropractors, acupuncturists, and massage therapists. Competencies, job descriptions, scopes of practices, credentialing and privileging were developed for each position. Dr. Culliton gave the Subcommittee a copy of the CPT codes used. Complementary and alternative medicine services provided but not coded included reflexology, reiki, energy treatments, and things relative to acupuncture (e.g., moxibustion, electrical stimulation and cupping, magnet therapy, aromatherapy, and other self-care and relaxation techniques).
Part of a large healthcare organization, appointment and billing services were shared system wide. Dr. Culliton said integrated medical charts enabled every physician to know who was being treated and how. Encounter forms were generated electronically as each patient presented for care. Providers completed the form with a listing of the CPT code (or an identifier for non-CPT code modalities) and the ICD-9 codes for that service. The medical reception staff electronically sent them to the billing department. Numerous payers (e.g., HMO’s, commercial companies, auto insurance, workman’s compensation, and state of Minnesota Medicaid) reimbursed for at least some of the therapies in the three categories. The aggregate rate of reimbursement for 2001 was 57.31 percent. Most services were billable under existing CPT codes. Those without CPT codes were billed directly to the patient.
Patients were asked to sign a consent-to-research form when they initially presented. Follow-up interviews were conducted. Two outcomes articles were published and a third was in process. Pricing was set through community standards. As part of their mission statement, the division tended the underserved.
Panel 1: Providers -- Complementary & Alternative Medicine
Dr. Freiberg expanded on Dr. Nahin’s comments on the use of individual CAM modalities, noting the need for additional comparative analysis quantifying and qualifying services of each provider. He said 80 percent of the licensed acupuncturists in the United States were primary care providers with a wide scope of practice that included herbal medicine, massage therapy, homeopathy, needle and non-needle therapies. Dr. Freiberg said the reason there appeared to be incongruity in HMOs covering specific CAM intervention was that, although HMOs covered acupuncture, they only included a small network of minimally trained unlicensed practitioners who used needles adjunctively. Dr. Freiberg said the study had to be expanded by reimbursement and ABC codes that further delineated practitioner types.
Responding to the Subcommittee’s questions on reimbursement, Dr. Freiberg explained that, under the Florida statutes, licensed acupuncturists (acupuncture physicians) were primary healthcare providers and performed a full scope of healthcare services (e.g., office visits; lab and imaging tests; a wide range of therapies [needle and non-needle, acupoint injection, electro-stimulation, heat and cold; oriental body work; exercise, diet and nutrition]; internal and external application of Chinese material media; homeopathy; homeotoxicology; and lifestyle counseling). Dr. Freiberg pointed out that it took from the 1970's until 1998 just to get two acupuncture codes through the AMA/CPT code system--and they still didn’t have relative value units (RVU) assigned. Without being able to apply a dollar cost factor to a missing RVU, these codes were virtually worthless.
Dr. Freiberg said Alternative Link’s ABC code system assigned codes with RVUs to the full scope of practice for acupuncture physicians in Florida, enabling production of worthwhile data collection with real dollar costs directly associated with services. Practitioners who continued to build CAM services under acupuncture licensing using codes that weren’t specifically assigned (e.g., CPT codes) received denials for reimbursement stating the insurance policy didn’t cover these services when provided by this type of provider, potentially exposed themselves to fraud charges. He said HMOs blocked inclusion of licensed acupuncturists even when they included acupuncture as a covered benefit, denying reimbursement unless performed by an M.D., D.O. or P.T. Dr. Freiberg said CAM services were increasingly denied and were beginning to be written in as an exclusion in some new Blue Cross/Blue Shield policies.
He added that some PPOs and self-insureds paid only minor amounts for acupuncture needle usage, partly because there weren’t RVUs and payers could arbitrarily assign a figure as “usual and customary.” He noted these same payers denied reimbursements to licensed acupuncturists in Florida for the balance of coding and scope of practice therapies, while reimbursing M.D.s and Duo’s for most identical procedures.
Using ABC codes, Dr. Freiberg said they’d received denials from auto PIP carriers, claiming that they didn’t use CPT codes. Noting that when referred for legal collection and accusations of restraint of trade, they’d paid quickly, he predicted that if ABC code became a national standard, payers would be less inclined to deny or shrink reimbursement and cost and outcome data would be collected.
Dr. Freiberg noted that WHO had just held its International Health Care Symposium and the United States again came in as the most expensive country ($5,185 dollars per capita per year) and number 37-out-of-140 countries in quality of healthcare. The country that spent the least amount of dollars was 39.
Noting acupuncture and oriental medicine were embraced worldwide as a key international standard of healthcare, Dr. Freiberg said approval of ABC codes as a national standard would help reduce the high cost of healthcare in the United States. He clarified Dr. Milliman’s point about oriental medicine being a system. Acupuncture was a nomenclature used, as NIH observed, as a family of procedures that involved the stimulation of anatomic locations on the skin by a variety of techniques. It also meant use of acupuncture needles. One useage designated the family of therapies; the other designated a particular therapy within that group.
Asked what Hennepin planned to do because they couldn’t continue to use CPT codes with Minnesota-specific exceptional modifiers, Dr. Culliton said they planned to use the new CPT codes. She said they’d never been reimbursed for exceptional modifiers, but used them for their tracking system. She said she didn’t know how the billing department would handle this. Dr. Feinberg said that Medicaid was working with the HCPCS Committee to get the local codes (e.g., the WW code) converted as national NCPCS codes. This was broader than alternative medicine. Codes would be added. Their highest present priority was becoming HIPAA compliant.
Dr. Dumoff explained that the issue of coding also came up when the same procedure might be billed for different reasons and more than one CPT code was needed to avoid confusion. Dr. Kail noted there were no indicators to show whether acupuncture was used as an adjunct (e.g., physical therapy) or a complete acupuncture treatment. Dr. Bickford added that nurses couldn’t keep adequate records because the codes weren’t imbedded in their software. A group practice nurse used the ABC codes to document instead. ANA recognized 13 terminologies that supported nursing practice. The issue was the identification of information systems that supported the full display of the diagnosis and the outcome. Different terminologies for diagnosis, intervening, and outcomes were integrated in systems and couldn’t be pulled out. Interventions were also identified in the Nursing Interventions Classification System.
Dr. Milliman clarified that in states where insurance third-party billing was used, procedures incidental to the basic patient interactions weren’t typically billed separately as a procedure. Many procedures naturopaths did weren’t identified as billable, but were rolled into the evaluation and management code as a component of complexity. Each profession having a unique, separate code set would give a broader procedural change within the CPT, capturing more conventional interventions. However, if they separated out every procedure, a larger issue revolving around many incidental procedures that were part of a basic evaluation and management interaction would need to be billed individually. Dr. Kale noted that procedures varied depending on who rendered them. Dr. Dumoff added that depending on the techniques used and by which practitioners, both the time of each service and how long it took to properly put the treatment into effect might be different. Dr. Zubeldia asked if different consultations or procedures could be crossed, knowing specific procedures were different, based on the specialty of the provider. Either way, Dr. Kail said a necessary constitutionally based interview would take time.
Dr. Bickford said that nurses’ increasing reliance on information systems provided detail to track their professional performance for peer review or reflection on practice. Secondly, previous philosophy was based on each person presenting for care only having one problem. Dr. Bickford emphasized that it took complexity to deal with the whole person with and multiple components that couldn’t be separated.
Regardless of how a person was licensed, Dr. Milliman pointed out that basic components of the patient/practitioner interaction would take place, as they always needed to gather information. Noting that all practitioners had some form of physical exam component, he asked how specific the coding should be. Dr. Cohn weighed both sides: it was convenient to code a visit in E & M single code, but they lost information and obscured what occurred. He questioned whether one code set could do both without being too much for people to realistically use. Once studies were done to validate it, they’d find ways to conveniently represent it.
From a research perspective, Dr. Nahin noted the need for a granular system. It was important to know whether cupping or moxabustion was used in acupuncture and the length, frequency, and number of needles in treatments. Noting that diagnosis, procedures and interventions weren’t outcomes, Dr. Cohn said they needed to come up with outcomes and how they would code them. Dr. Nahin said outcome measures had to be accepted by their primary audience, which because of the research NCCAM funded, was the conventional medical community.
Dr. Kail brought forward the issue of pharmacy, noting conventional medicine worked because it captured what was used through their coding system. However, the physician often dispensed alternative medicine. Dr. Kail said they needed to be distinct about pharmacy coding if they were to capture treatments that usually were a combination of homeopathic, herbal and nutritional therapies. Dr. Bickford noted that more patients requested natural therapies in lieu of pills. Dr. Milliman reminded the Committee that the purpose of the codes was to characterize a service for reimbursement and was different than the diagnosis.
Dr. Faust clarified that he was unable to order blood work, but could incorporate it through primary care providers to monitor the effects of an herb or other substances.
Dr. Dumoff said five peer-reviewed studies the panel supported as valid were required for CPT to assign a CPT code. There was a minimal level of determination of medical acceptability or necessity. The interest in ABC codes was in broader tracking and they didn’t have that standard. When AMA didn’t have five studies but considered a code important to track, they made it a Category Three, which meant tracking only. Dr. Fitzmaurice noted that insurance companies were saying they’d only pay for CPT codes. Dr. Cohn clarified that they weren’t paid if they didn’t get RVUs.
Dr. Kail said utilization was a deciding factor in whether codes were put in or taken out. Until they had a better sense of who utilized which services, they would have difficulty designing efficient codes and describing the practice with most patients.
Dr. Saba emphasized that care was moving from the hospital to the community and home health was a significant segment of this shift. Many nurses and others provided service in this arena and used the Home Healthcare Classification System that hadn’t been approved as a HIPAA code set. It primarily accommodated patient care procedures provided by nursing and other Medicare provided providers. Home Healthcare was registered with Health Level Seven (HL7) and approved by ANSI HIS. It was in the UMLS and in SNOMED.
Panel 2: Health Plans
Mr. Stevans said Landmark Healthcare had 2.2 million insured lives and another nine million members under discount or infinity programs throughout the 15 states where they offered insured products with chiropractic, acupuncture, herbal therapies, massage therapy, and nutritional counseling benefits. Wherever possible, Landmark used standardized HIPAA-adopted data code sets. When those were inadequate, Landmark looked to other regulatory bodies and agencies for a standardized code set. If unavailable, Landmark looked to the CPT codebook for unlisted or unspecified modality procedures. Mr. Stevans noted this made tracking difficult, increased the administrative burden, and required manual review of claims with an unlisted code. Landmark looked to a proprietary code set if neither alternative proved beneficial.
Mr. Stevans said the conditions covered for chiropractic benefits were neuromuscularskeletal and neuromuscular and were identified by standard ICD-9 codes. Reimbursable services included examinations, manipulation, physical medicine modalities and procedures, radiology services, DME, preventative and wellness visits. Identification was through CPT or HCPCS codes.
Landmark identified select neuromuscularskeletal and other NIH-validated conditions by standard ICD-9 codes for their acupuncture benefit. Covered conditions included nausea due to chemotherapy or pregnancy, allergies, asthma, and allergic rhioitis. Total reimbursable services included evaluation, acupuncture, electro-acupuncture, acupressure, cupping, moxibustion, herbal remedies, and preventive and wellness visits. Landmark relied on prospective and concurrent review for the authorization process. Acupuncturists provided traditional oriental medicine diagnoses on the authorization forms and the case manager used them to evaluate the case and authorization. Landmark also asked that the standard code be used for reimbursement. An internal code set identified an approved manufacturer and the herbal remedy.
Mr. Stevans said Landmark’s therapeutic massage benefit covered acute musculoskeletal conditions upon medical referral. Landmark didn’t ask massage therapists on their Specialty Network to diagnosis, but tracked with the referral form passed along with the claim. Landmark reimbursed for both deep tissue and gentle therapeutic techniques, stratifying them with either a 97124 or 97140 code.
As a health plan, one of Landmark’s goals was to streamline administrative procedures. Claims were submitted via the HCVA 1500 form. Paper claims were converted and a clearinghouse processed electronic claims. The reimbursement methodology was either a CPT line item or a per-visit method. Landmark applied an auto adjudication process and tracked utilization. Noting that between 14 and 35 percent of all current visits to chiropractors were routine or wellness visits unrelated to a specific problem, Mr. Stevans said the consumer and a desire for wellness and preventative care drove the demand for CAM services.
Panel 2: Health Plans
Mr. Hegetschweiler said ASH was a full service benefits company for complementary healthcare that offered direct access benefit programs for chiropractic, acupuncture, massage therapy, naturopathy, and nutrition services nationwide for health plans, insurance carriers, employer groups and trust funds. ASH covered five million people outside of California and in state, as a Knox-Keene licensed specialty health plan, they covered another four million people. Working almost exclusively with health plans (e.g., Blue Cross/Blue Shield, Cigna, Kaiser, HealthNet, PacifiCare), ASH services included utilization and quality management, member/provider services, claims processing, and provider credentialing. The American Accreditation HealthCare Commission accredited their network affiliates.
Mr. Hegetschweiler said ASH affiliates held individual contracts with over 20,000 providers including 13,000 chiropractors, 2,500 acupuncturists, 4,300 massage therapists, 240 naturopathic physicians, and 700 registered dietitians. Providers were reimbursed on a fee-for-service basis. Medically necessary services were billed through HVCA 1500 forms using CPT terminology to describe services performed. ASH used ICD-9 and HCPC codes for other procedures and diagnosis.
All services were CPT coded. E & M and specialty procedure codes delineated under the medical or medicine section in the AMA CPT manual were the most common codes used by their providers (e.g., chiropractic manipulative therapy codes, acupuncture codes, physical medicine and rehab codes, radiology codes, pathology and laboratory codes). Providers were required to use available CPT codes that most accurately and closely described services provided. From July 1, 2001 to June 30, 2002, their CAM providers were reimbursed for 2.86 million CPT code services representing about 1.2 million claims.
Mr. Hegetschweiler explained that CAM needed a coding system understood by health plan clients and providers, regardless of specialty. He said the accuracy of CPT codes and their longstanding use in provider and health plan communities met this requirement. CPT allowed rapid processing of large volumes of codes and use of a common language understood by all parties. Mr. Hegetschweiler reported few complaints from providers, who he described as happy to be part of the CPT system, though he noted the CAM community worried that isolation, rather than integration, could result. He said the CPT system provided some integration for CAM providers; most felt they could appropriately code services provided and easily use the same codes with secondary payers.
He said most the 60-to-70 health plans in ASH’s alliance delegated clinical management and claims administration to ASH. He emphasized that data interoperability, uniformity, and integrity between payers was of paramount importance and noted that the Committee’s report to the Secretary in July 2000 on uniform data standards for patient medical record information (PMRI) covered these attributes and was a crucial link.
Mr. Hegetschweiler said the coding needs of insurance were best met through existing AMA CPT coding systems. Efforts were underway with CPT and AMA to add additional necessary codes and ASH favored having them within that system. He said it was important that CAM providers participate in the committees the AMA used regarding CPT codes.
Mr. Hegetschweiler said ASH favored the scientific route CPT and AMA followed and adding more codes for procedures used by CAM practitioners to scientifically measure the coverage and show its scientific validity. Noting research would be published later in the year indicating it was less costly to a health plan to have alternative or complementary healthcare coverage, Mr. Hegetschweiler said CPT codes were needed to compare codes and procedures and costs.
Discussion
Mr. Hegetschweiler clarified that ASH used E & M codes and acupuncturists’ needling codes for procedures on interventions lacking a specific CPT code. If the provider didn’t code it appropriately, the case manger would. He said E & M code choices seemed adequate and ASH had few problems with the system.
Dr. Zubeldia asked how many needed manual intervention before payment. Mr. Stevans said Landmark’s auto adjudication process handled about 25 percent of the miscellaneous codes; 75% percent were reviewed manually. Mr. Hegetschweiler noted that virtually all procedures and services were automated and most billed electronically with minuscule manual adjustments. Providers used a small number of codes by choice. Acupuncturists had an E & M code available, but didn’t use it. He said managed care was forcing everyone to grow and many professions were just starting to learn how to do examinations. He said the chiropractic profession was most advanced and knew how to code.
Mr. Stevans said V code allowed for tracking but didn’t accurately describe the service, which was different for preventative care than acute problems. Mr. Stevans said only 25 percent of the miscellaneous codes were auto adjudicated because the codes weren’t helpful and they strove to ensure they were appropriately authorized for prospective payment. Mr. Stevans said Landmark wanted to stratify services so they could track utilization and sometimes unlisted codes were needed for granularity.
Mr. Hegetschweiler and Mr. Stevans agreed that medical directors of health plans looked closely at CAM services and the procedures put in place internally to justify their coverage services were rigorous and possibly beyond what AMA required. Mr. Hegetschweiler also noted the importance of using codes that they understood.
Mr. Stevans said he’d attempted to participate in the coding process with the standard and the acupuncture code sets. He suggested that the Category Three code would initially expedite the process.
Asked how he would use the preauthorization process to collect the oriental medicine diagnosis under HIPAA, particularly since they have to use the HIPAA 278 transaction, Mr. Stevans noted that the traditional oriental diagnosis they collected was a matter of the history and examination findings as well, and was included in that. They also had the ICD-9 codes that were coded for that purpose on the authorization form. He reported that a task force was looking into overall HIPAA compliance and moving forward.
Code Set Overlap
Dr. Feinberg presented a technical review and evaluation of the Alternative Link code set. She explained that the CAM and nursing coding system was a proprietary code set. The ABC code set was comprised of five letter codes designated to report acupuncture, iervedic medicine, body work, botanical medicine, chiropractic, clinical nutrition, conventional nursing, holistic medicine, holistic nursing, homeopathic medicine, indigenous medicine, message therapy, mental healthcare, midwifery, naturopathic medicine, oriental medicine, osteopathic medicine, physical medicine, and semantic reeducation.
Dr. Feinberg assessed the code set using a set of criteria reflecting what the Committee specified the code set should do. The criteria called for a hierarchical structure and that the code set be expandable, comprehensive, non-overlapping, easy to use, setting-and-provider neutral, multi-axial, and limited to classification of procedures.
She said the layout of the ABC code set appeared hierarchical: there were categories within subdivisions and subdivisions within categories. Wording was different for each code. She cautioned that subtle distinctions between the services might be difficult to discern. Five-letter code-distinction designations created unique code identifiers. Subsequent bullets described the substance of the codes.
Addressing expandability, Dr. Feinberg said there was flexibility to add procedures at the end of each section. She noted that alphabetical ordering couldn’t continue with new products added this way, but she pointed out that many coders used computerized systems and this might not be as important as it would be to anyone using a book. She cautioned that some products had multiple names and that (because of all the subsections that indicated something about the service) there were multiple unlisted codes.
In terms of cohesiveness, Dr. Feinberg noted an extensive listing of procedures and products. She reported that it wasn’t possible to assess whether any were missing and that some procedures listed might be too granular for payers (e.g., the HCPCS code set had only one code for child safety teaching; the ABC code set had 15).
Dr. Feinberg said the Committee’s statement that a code set shouldn’t contain insignificant procedures needed clarification. She noted some procedures that could be performed quickly typically accompanied more substantial procedures. That day, a provider gave the example of a short-term nasal procedure; Dr. Feinberg pointed out that, in the E & M coding, giving an oral medicine wouldn’t be reported separately, though the medicine itself would be. The administration of minor procedures was bundled with the visit, unless it was the only one done. There were HCPCS codes for patients who only came in for medication administration.
Dr. Feinberg remarked that many services definitions were difficult to understand without units describing the extent of the service and she suggested timing them. Noting she’d have trouble deciding whether a service was, for example, coping enhancement, hope instillment, or mood management, Dr. Feinberg said payers worried that, without clear limits and definitions, a service might be coded all three.
She also said a code set needed to be limited to services delivered to patients or clients billed electronically. And she said codes that described staff training didn’t need coding for electronic transmission because they were included in the organization’s overhead. She suggested there could be a difference between descriptions of service used internally and those transmitted to a payer.
Dr. Feinberg described a service in the massage category as it appeared in CBEAI and CBEAN. One called it integrative neuromuscular technique; the other tagged it neuromuscular reeducation. The first was “capacity neural responses with point pressure friction, position and movement.” The other was “increasing appropriate neural response capacity using point pressure friction, position and movement.” Reiterated the idea of paying someone to provide a specific service for a particular period of time, Dr. Feinberg said she wanted a code set that allowed her to pay fairly for the service delivered, but only described it in unique ways.
Dr. Feinberg said many of the codes seemed to describe overlapping procedures within the code set (e.g., codes for both abdominal and postural exercise) or to overlap with codes in CPT and HCPCS Level Two. Dr. Feinberg also expressed concern about codes in the F and G section. She emphasized the need for a code set based on the Homeopathic Pharmacopoeia of the United States’ compendium.
Although multiple sections contributed to ease of use, Dr. Feinberg noted some sections contained a code that didn’t seem to fit (e.g., under test and measurement was a treatment for wound care, BDAAE, a service vasineneumatic devise). And some codes were so granular Dr. Feinberg said it would be difficult to decide how to code them. For example, there were over 50 message codes and many didn’t contain units. She suggested that every code set have a more inclusive range of services giving a defined session, appointment, and treatment.
Considering setting and providing neutrality, Dr. Feinberg noted the original goal of the code set was to provide information on the licensing and provider status of the person delivering the service. She pointed out that information was available elsewhere on the bill, either through the specific provider ID or an extensive taxonomy code that identified the type of provider. Noting that having that in the code could lead to additional codes, Dr. Feinberg advocated having that information in a different place in the electronic transaction.
Dr. Feinberg said neither CPT nor HCPCS was multi-axial or specified body systems affected, technology used, techniques, or approaches.
Noting many of the codes contained diagnostic information and did a procedure to accomplish a goal, Dr. Feinberg encouraged the Committee to look into an analysis that revealed sets of services that currently weren’t easily coded in any of the code sets. Dr. Feinberg said the key question was whether health plans had the need to receive such detail in their electronic transaction for services and products described. She said the pilot demonstration would provide tools to evaluate the code set and highlight issues they needed to address. This evaluation would begin two years after the code set was first used.
Discussion
Dr. Feinberg said evaluation and management was broad under CPT and the preventive care codes were essentially wellness codes. She suggested that the first and return visits might be a single code in each category billed in multiple units. Dr. Feinberg suggested starting either with the overlap or her list of code sets that she couldn’t code.
Dr. Kail questioned the quality of the data they’d receive. Noting that the ABC codes were extensive and diverse, he cautioned that the learning curve would be steep and, at first, using these codes would be inefficient.
Dr. Feinberg reported that lab testing had the most consistent overlap. Ms. Giannini said Alternative Link would retire those codes. However she contended that the specific nature of the messages therapy codes was needed to capture various additional trainings for the therapy techniques. Massage therapists wanted to differentiate between a therapist with 500 hours of education and one with an additional 2,500 hours of training. Mr. Stevans contended that granularity belonged in the credentialing process, not reimbursement. Participants noted that practitioners had different training requirements that resulted in variations of services (e.g., there was both a basic therapeutic massage code and a massage code plus two Rolfing codes for one service). Mr. Hegetschweiler suggested the interest was in the overall category and how much time was spent. He said specific education belonged in the credential process. Dr. Zubeldia pointed out that the HIPAA transaction now had taxonomy codes that described the provider services including specialty and training. They could map between the provider modifier and taxonomy areas. Mr. Blair said the question was whether this was appropriate from a billing or a patient care/outcomes standpoint, noting that the criteria were separate.
Ms. Molina said the ABC codes were developed with levels of precision and granularity appropriate for research, administrative, management, and commerce tools and were hard to evaluate adhering strictly to the HIPAA transaction evaluation criteria. While the insurance company would only utilize a fraction of the codes that described acupuncture or chiropractic (the same prerogative was exercised in evaluating and processing CPT codes on HIPAA or CMS 1500 forms), Ms. Molina said the ABC code set could address HHS priorities for a more health promoting approach to care while meeting insurance companies’ claims adjudication, contracting and benefit design, utilization and clinical practice management, and outcomes research and actuarial analysis needs. She noted that the code set met the guiding principles outlined for code sets in the Congressional and regulatory language.
Ms. Giannini reported that Alternative Link had worked extensively with the Nursing Intervention Classification, Home Health Classification and Omaha (a public healthcare code set) systems and determined there wasn’t overlap. Dr. Huff reported that less than ten percent of the overlap were exact matches, but noted the percentage increased in categories where the exact same intent wasn’t captured. She emphasized that it was harder to reproduce and assign codes when people had a choice. Ms. Giannini said Alternate Link considered retiring codes where the meaning was an exact match. The only match in Level Three was on a non-listed procedure in the other code set. No matches existed in Level Four.
Ms. Bebee expressed concern about vendors putting these codes into their systems. Ms. Giannini acknowledged that SNOMED would cause a lot of overlap in clinical terminologies and a lot of ABC codes would have to be eliminated or mapped into the SNOMED codes. She affirmed that the NIC nursing code set looked different than ABC. An index mapped each NIC, HHS, and Omaha code.
Ms. Giannini said about 150 codes would be retired and another 150-200 might be reworded or have their granularity changed to weed out duplications before starting this process. The industry would be informed with file updates. Ms. Molina clarified that the intent was to separate the cost/benefit analysis focused on commerce application and electronic transactions from the cost/benefit analysis in other areas.
Noting that many Medicaid codes overlapped, Dr. Feinberg urged the Subcommittee to ensure they had a vehicle to look at the 2002 HCPCS and their quarterly update to help eliminate duplicate codes. Ms. Molina said several government organizations expressed interest in participating in the pilot and Alternative Link would work closely to prevent overlapping. She requested that HCPCS be identified as part of the study.
Asked if they’d track the decision of each specific code, Ms. Molina said they’d drill down by health industry participant type and ask each to identify the cost/benefit criteria for that segment. Ms. Molina said the drill-down approach focused on: coding participants, collaborating with representative organizations in each health industry participant group to identify hypotheses and cost/benefit criteria, collecting secondary data (to ensure they developed appropriate primary data collection methodologies), and committing to quarterly reports of findings to the Secretary and major trade journals.
Ms. Molina clarified that Alternative Link was committed to testing both the code set and the RVUs in practices. Noting that RVUs were a business decision of the organization paying the bills, Dr. Feinberg said she considered the code set and payments for codes separate issues. Ms. Molina concurred. She said the challenge was being asked to use them in electronic transactions; without RVUs, giving the codes value would be difficult.
Participants discussed that the pilot wasn’t a demonstration project and was unfunded. The expectation was that because of its promise people would want to participate. Ms. Molina noted they’d been granted up to a two-year study that would end upon: proof of a widespread cost/benefit ratio for ABC codes, HHS naming or rejecting ABC codes as a HIPAA standard, or the end date.
Roundtable Discussion
The Subcommittee discussed next steps. Dr. Zubeldia said at least one more hearing was needed to discuss specialties still unaddressed and to hear more about and begin tracking Alternative Link’s pilot. Dr. Zubeldia said he’d like that hearing soon, but their plate already overflowed with HIPAA implementation, PMRI and ICD-9. One or two more panels on CAM had to be scheduled in 2003. Anticipating that the demonstration project would capture issues about implementability, Mr. Blair suggested Alternative Link provide feedback at the December meeting. Dr. Zubeldia also noted that Alternative Link and the designated standards maintenance organizations (DSMOs) or X-12 had to address the technical infrastructure necessary to run the pilot (a new code set lacked a qualifier in the existing transactions).
The Subcommittee discussed an updated list of issues and questions, listing what had to be done in 2003: (1) tracking implementation of HIPAA administrative and financial rules and issues (including issues around security and identifiers) and what had to be done to assure successful implementation of the administrational and financial transactions final rule; (2) changes/updates to current and new standards, including the DSMO's yearly report and other requests for changes and modifications to the HIPAA standards; (3) evaluating what, if anything, to do about the electronic signature; (4) PMRI and terminology standards including working with Consolidated Health Informatics Initiative (CHI); (5) the Administrative Simplification Compliance Act (ASCA) requirements (issues pending include publishing reports on effective solutions to compliance plans and analysis of sample plans); (6) code set issues (overseeing the cost benefit study for ICD-10, residual issues from DSM, CAM, the relationship between the HCPCS National Panel and CPT around coordination, dental codes, optician codes, and local code set issues; (7) letters on NPRMs (e.g., enforcement and compliance) for the full Committee; and (8) improving the HIPAA process.
Hearings scheduled for March 25 and 26 focused on PMRI work and other discussions; an ICD study update would be given at a breakout session. Time was allotted during the May 21-22 meeting for a report on ICD and determining recommendations for the full Committee, as well as issues of administrative and financial transactions implementation. Members will be queried about meeting dates for the rest of the year.
Members concurred that the Subcommittee’s main responsibility in 2003 was to assure successful implementation of the administrative and financial transaction rules. Dr. Fitzmaurice suggested they ask about and possibly hold a mini-hearing on issues the industry hadn't yet brought to the Committee. Ms. Greenberg noted this related to ASCA and the charge that the Committee oversee, if not directly publish, reports on effective solutions for compliance problems. Dr. Cohn noted the analysis would be completed in February. While the database indicated that many providers were waiting for the transactions and for vendors to provide systems to help them become compliant and measured what was spent, members cautioned that it wouldn’t provide enough information to identify compliance problems or determine recommendations. The Subcommittee would engage representatives of WEDI in this discussion the next day.
The Subcommittee noted they couldn’t say much about implementation of HIPAA until the modifications and final security rule came out. Dr. Steindel depicted the ASCA database as a cart-and-horse situation. Plans and providers waited on vendors, and vendors waited for final codification of the regulations. Dr. Steindel contended that the Committee had done all it could about that part of the process. Dr. Fitzmaurice suggested that they offer the opportunity at the February meeting to address any new issues on the HIPAA transactions and security. Dr. Zubeldia added that the next day they could have an information discussion with WEDI and other industry leaders.
Dr. Cohn cautioned that the time had passed when they could go through a reasonable rulemaking process, identifying and solving problems; at this stage, if major issues rippled through the industry, people had to be alerted. Dr. Zubeldia said the Internet discussion meeting lists gave as much or more information than the ASCA database. But he emphasized that there were issues (e.g., the implementation guides, even with the addenda, still had errors) they couldn’t do anything about other than recommend a resolution process. Noting that the DSMO process was instituted, in part, to look at some of these issues, Dr. Steindel suggested they focus on improving that process and a resolution mechanism, so more issues could be resolved. Dr. Zubeldia reported that an X-12 group had worked on defining the resolution process since October, adding it would be next October before the process was defined and issues began to be resolved.
Dr. Cohn noted that they needed to listen carefully the next day to the issues. He suggested reserving time at every meeting until implementation for people to bring forward major issues so they might alert the Secretary and the Centers for Medicare and Medicaid Service’s (CMS). Dr. Fitzmaurice pointed out that within the government they had the largest health plan in the world and suggested that they might also hear CMS’s implementation plans and difficulties. If CMS and WEDI had similar issues (e.g., the implementation guide) there might be a common way to resolve or deal with them. They also needed to talk with vendors programming these transactions into their system.
Members discussed that, without the addenda necessary for implementation, people had waited and the timeframe for implementation was compressed to six months, making it difficult for everyone. Addenda making corrections necessary for implementation would be an incremental step. It took three years for one large practice management vendor to deploy Y2K changes, which hadn't required testing with trading partners. Everyone had to do HIPAA in six months.
Remarking that they were hopeful that they’d see the modifications to the final rule (and perhaps security) by the February full Committee meeting, Dr. Cohn noted that, if it wasn't released by then, the Secretary had to be alerted in writing. In order to have the 180 days before October 16, the final rule for the addenda had to be effective by April 16. If it wasn't published in two weeks and Congress took 60 days, the 180 days would push the compliance date for the addenda past October 16. The industry would have to technically comply with the law, implementing the May 2000 version until it got the addenda.
Ms. Trudel reported that CMS had been talking through comments with the Office of Management and Budget on an almost daily basis. She said she was hopeful both regulations soon would be published. Reflecting on three reasons the Subcommittee wanted to address things (to provide the Secretary with information or recommendations; their requirement for a yearly report; the need to keep a finger on the pulse), Ms. Trudel said her question about the nine items was for which reason was each needed. For example, there might be a need to provide additional recommendations to the Secretary on the electronic signature. In terms of tracking, was the intent to send recommendations to the Secretary or was it almost too late and the Subcommittee was keeping a finger on the pulse?
Dr. Zubeldia contended that forcing the industry to go through two versions within months would be extremely disruptive and, if the addenda/final rule didn't come out in two weeks, they’d have to recommend that the Secretary postpone the October 16 date. Noting HIPAA gave the Secretary emergency authority about anything on that level, members discussed identifying major issues or show stoppers and alerting the Secretary and government about issues that they might deem to ward off.
Recalling that the National Health Information Infrastructure (NHII) testimony urged everyone to adopt a requirement for an electronic signature with one of the attachments, in order to drive that field, Dr. Fitzmaurice suggested that the only high-level reason would be that one needed a signature and electronics made it easier and cheaper. He said they might want to look at and reaffirm or change their decision when the attachments came out. Members recalled that Mr. Marshall testified the day before that the group they’d encouraged to work with ANSI HIS on ISO and ASTM standards to see if everyone could agree on a common electronic signature lacked funding and couldn’t implement enough to determine if they worked. Both the vendor and user communities lacked any sense of urgency and venders weren’t ready to take leadership and wanted the government to adopt for the industry. Mr. Blair questioned that the Subcommittee could effectively push anyone forward who didn't see an urgency. Mr. Blair doubted that many of Mr. Marshall’s recommendations were actionable then. Even if it didn't come out in a claims attachment, Dr. Zubeldia said Mr. Marshall wanted them to recommend that, as a security measure, all attachments be signed, even though that signature might not convey acknowledgement. Mr. Marshall had contended that, with such a mechanism in place, the signature would be used for all things. Once that NPRM came out, Mr. Blair said they could raise the issue, ask for action plans and feedback, and facilitate and encourage it being done. Until then, he said they didn’t have leverage.
Mr. Blair recounted that the vehicle to gather information from the PMRI terminology developers was sent out January 6, giving developers just under six weeks to respond. He noted that the due date of February 14 was a more aggressive timeframe than for the PMRI message format standard questionnaire. Dr. Sujansky would only have five weeks to compile, analyze and develop recommendations to present at the March Subcommittee meeting. Vendors would provide testimony in May. Dr. Sujansky’s contract allowed time at the end of May for additional input from industry experts, but didn't call for a Subcommittee meeting for testimony. Mr. Blair noted the first draft of the recommendations could be reviewed in July.
Mr. Blair expressed concerns that he hoped were manageable within the current construct. Some 56 questionnaires had been sent to over 30 developers. They’d made efforts to verify that people received the questionnaire and understood it would take time to fill out. They didn't know how many terminology developers would respond by February 14. Despite one developer’s initial expectation, they hadn’t scheduled time for developers to testify separately. Mr. Blair emphasized that, with both the message format and terminology standards, they’d asked for input before creating the questionnaires and sought critiques. He personally thought the questionnaire was comprehensive, would be a good vehicle for enabling them to analyze the capabilities of the terminologies, and that additional testimony from developers wasn’t likely to add much. However, if on February 14 one or more terminology developers expressed concern that the questionnaire didn’t allow fair consideration, Mr. Blair suggested that it would be unfair to have only one or a few terminology developers testify. So far, no one had requested. But if they did, either the March or May timeframe could be expanded for testimony.
Mr. Blair anticipated that Dr. Sujansky would have a lengthy presentation on March 25 that would take time to digest, and clarifications might be needed from some terminology developers in April with Dr. Sujansky reporting back in May. Mr. Blair noted that the work plan called for three drafts (July, August, and September) of the final recommendations. Final recommendations by the full Committee were targeted for September.
Dr. Steindel contended that, after the questionnaire, Dr. Sujansky should bring any further concerns from terminology developers along with his report in March and formal testimony from the terminology developers should be discouraged. If there was a hue and cry for testimony, a five-minute time limit should be set. Mr. Blair essentially agreed: if somebody asked to testify, Dr. Sujansky and he would try to understand what others felt needed to be said and evaluate if it could be communicated another way. If not, he said they’d deal with it. Ms. Trudel pointed out that 20 testifiers were about the most that could be packed into a day. She suggested that if people completing the written documentation knew they wouldn’t have another opportunity, they’d be more careful and craft the survey so they made their case.
Ms. Bebee reported that she’d talked with almost everyone that received the questionnaire and the response was positive. People were ready and able to fill it out and collaborations were responding. Some (e.g., home health and nursing) were filling out separate questionnaires. Others provided additional comments in free text.
Dr. Cohn noted the CHI group would make a presentation at the February full Committee meeting. Dr. Steindel said CHI would also participate in the March hearings.
Ms. Trudel reported that CMS had just completed and unduplicated the ASCA database. Dr. Steindel will do an evaluation and report. Members discussed merging the conclusions with what they heard the next day. Noting the industry expressed interest in the results, the Subcommittee pointed out that this was a public forum. Ms. Trudel suggested that best practices identified in ASCA and some statistics (e.g., the American Hospital Association was interested in aggregated numbers for the hospitals) could be posted on the CMS and NCVHS Web sites. Dr. Cohn noted they’d see what problems surfaced the next day and in the analysis. Observing that WEDI SNIP had identified many problems and prepared reports on different aspects of implementation (e.g., issues with code sets, the roles of translators and clearinghouses), the Subcommittee discussed bridging between identified problems and these findings/potential solutions with links or references to further suggestions and Web sites.
Considering code set issues, participants confirmed they were still working towards a May end-date for the ICD-10 project. The legal department had reviewed the issue and was seeking an additional opinion. The Subcommittee hoped to receive an update during the February breakout. Dr. Cohn noted they’d receive an update on CAM late in the year. A report back from the HCPCS panel on the issue of coordination with CPT was pending. The Subcommittee was tracking implementation in terms of Medicaid and local code set issues. The next day they would ask Frank Pokorny about the status of the dental codes. Dr. Zubeldia reported that there were many proprietary codes but not one standard code set that could be adopted for vision codes. Dr. Cohn said a follow-up hearing on the code sets could probably be held late in the year. The Subcommittee will respond with letters as the proposed rules come out. Dr. Cohn noted that the next day they’d discuss improving the HIPAA process.
Turning to NPRMs, Ms. Bebee noted the HL7 workgroup was considering having both an XML and 2/3 version of the attachment during the comment period. Dr. Zubeldia reported that a draft for comment on the X-12 version 4050 included additional non-HIPAA standards for new functionality (e.g., new transactions for coordination of benefits between two payers, acknowledgement responses with improved reporting). The Subcommittee will look at NCPDP script, already considered for PMRI, for purely administrative X-12 transactions.
Noting that adoption implied falling into the regulatory process, the Subcommittee considered recommending to the Secretary that he “endorse” rather than “adopt.” For example, Dr. Zubeldia explained that with the generic transaction that acted as an acknowledgement to other transactions, a payer receiving an 834 enrollment transaction today had no way to identify and report errors to the submitter, and a provider receiving an incorrect ineligibility response couldn’t report back to the payer that the response was invalid. A lot of entities and industries were looking at the 824 administrative transaction that could act as a control transaction for adoption, even if it wasn’t mandated by HIPAA, simply for the coordination of benefits. Some payers already said the 824 was the only way to coordinate benefits properly and that they'd implement it, even if it wasn’t a HIPAA mandate. Dr. Zubeldia suggested recommending that the industry implement the 824 voluntarily, pointing out that, otherwise, there might be a need for a regulatory mandate. Dr. Cohn said this might be another approach to improving the process and that they’d ask the groups the next day.
Dr. Zubeldia noted a related issue. The NCPDP implementation guide adopted by the Secretary had many optional fields, and a segment of the pharmaceutical industry that wanted situational fields instead sought a new guide through the DSMO process. Dr. Steindel suggested that this was one of the issues Dr. Zubeldia alluded to when he spoke about developing a reconciliation process. Others noted an appeal was part of the standards developing organizations (SDO) and DSMO process.
While, on the PMRI side, the Committee had made recommendations to industry to voluntarily adopt things, Ms. Trudel pointed out that their charter called for the Committee to make recommendations to the Secretary, not the industry. Mr. Blair recalled their earlier wording that HHS would provide guidance to the industry regarding PMRI standards. Technically agreeing with Ms. Trudel, Ms. Greenberg observed that the reason HIPAA was passed was that voluntarily carrying out the administrative simplification provision wasn't working. She questioned that doing these types of standards, which were quite different than electronic medical records standards, on a voluntary basis would be successful. In its 50-plus-year history, the Committee had made broad recommendations that the health industry heeded, but that hadn’t resulted in everyone using a standard uniformly.
Ms. Greenberg noted that the Populations Subcommittee had identified what they considered HIPAA-related standards issues that they’d ask the Subcommittee to consider. Dr. Cohn suggested considering at the February meeting whether they should hold joint hearings. Noting that the Subcommittees on Populations and on Standards and Security made up about 80 percent of the full Committee, members discussed suggesting at the February full Committee meeting that they utilize some of their time and combined expertise for focused work on areas of mutual interest.
DAY TWO
Dr. Cohn said the main focus of the day was continuing an investigation into ways to improve and stabilize the HIPAA process. He noted two major concerns: soliciting from industry and others ways to improve the process and, recognizing that there was less than ten months until implementation of the administrative and financial transactions, identifying and dealing with any major show stoppers or issues.
Subcommittee Discussion: Improving the HIPAA Process
Mr. Jones provided context for that morning’s discussion. Last May in testimony before the Secretary's Advisory Committee on Regulatory Reform, WEDI recommended: (1) creating a predictable process (e.g., tying new HIPAA regulations and/or major version changes to HIPAA regulations to the type of predictable process Medicare uses, (2) taking minor maintenance processes out of the federal regulatory mode (e.g., maintenance changes in the standards become effective 180 days after publication of the revised implementation guides, and an accompanying notice in the Federal Register), (3) identify a high-level HHS official with the responsibility and authority to assure that all HIPAA regulations were processed in a timely fashion (Mr. Jones said WEDI was glad that designation was made), (4) convene a joint WEDI-government task force to review available options that could improve the process (WEDI was examining government-private sector relationships in other industries with similar responsibilities), and (5) WEDI believed it was positioned through its regional organizations and intellectual property resources developed through its strategic national implementation process to help the industry implement HIPAA on a more comprehensive basis than previously undertaken with WEDI's limited resources.
WEDI subsequently submitted a grant application through the WEDI Foundation to HHS and CMS to fund HIPAA education. Mr. Jones said WEDI was well positioned with content, faculty and regional special interests, and delivery infrastructure to reach an extensive audience including minorities, rural areas and non-traditional segments (e.g., employees, local governments).
Mr. Jones said WEDI’s purpose that day was to provide some context to questions posed at WEDI's recent board meeting: “If HIPAA administrative simplification were enacted today, what would they do differently--and what had they learned in the more than six years since enactment?” Mr. Jones reported that three major areas provided context for their discussion and encompassed WEDI's earlier recommendations. First, Congress and HHS hadn’t allocated sufficient financial and personnel resources for a timely, predictable and successful implementation. Consequently: the set of standards comprising HIPAA administrative simplification had been released haphazardly, creating confusion, frustration and skepticism in the healthcare marketplace. Only months before compliance deadlines for several of the standards, a significant number of affected parties continued to believe that HIPAA administrative simplification wouldn’t occur or didn’t affect them.
He said a significant number of affected parties were still unaware of HIPAA administrative simplification standards requirements, reflecting both insufficient resources allocated to education and outreach efforts and delivery of inconsistent messages. Mr. Jones emphasized that CMS and OCR had stretched scarce resources in making best efforts in education and outreach, but the size of the industry and diversity of stakeholders dwarfed the federal government's commitment of resources.
Mr. Jones reported that at WEDI’s board meeting it was noted that the significant levels of noncompliance with HIPAA administrative simplification deadlines had consequences that included potential for cessation of Medicare payments for noncompliant providers and disruption of current electronic transmission by providers and payers. Mr. Jones noted this was a big concern for larger players at the table and a potential disruption of cash flow to healthcare providers. He said these concerns were contingencies that shouldn’t be addressed as inevitabilities, but emphasized that greater care on compliance, timing and deadlines was necessary when education and outreach efforts were insufficiently funded.
A second major area of context was that the current federal regulatory process that underpinned HIPAA administrative simplification standards was too slow and impeded compliance and innovation in a dynamic healthcare marketplace. The failure of timely publication of transaction and code set addenda impeded testing.
Mr. Jones said the federal government and industry had to design alternative innovative methods and processes to expedite modifications to HIPAA administrative simplification standards that weren’t structural in nature. He stressed the word structural, noting an example would be to present non-structural issues in public hearings scheduled at regular intervals and forwarding findings as recommendations to NCVHS for review and consideration within a specified time schedule, followed by a 30-day public comment period. Within a specified time period (e.g., 60 days), HHS would have the opportunity to consider public comments and issue modifications.
He said the third and perhaps most important area WEDI wanted to discuss as context, was looking beyond HIPAA administrative simplification standards at a new collaborative process driven by the healthcare industry with government participation as a payer, not a regulator. Mr. Jones said WEDI felt this was necessary to foster innovation in healthcare and realize efficiency benefits.
Mr. Jones said this approach recognized that regulatory processes involving application of technology lagged behind market deployment in a competitive business environment and that return on investment (ROI) was a catalyst for business to embrace new cost effective, efficient tools. As a payer, the federal government benefited when it fostered innovation driven by ROI determinants. This approach also recognized that current regulatory efforts had focused on transactions to the detriment of encouraging the industry to redesign its business models to innovate and attain more efficient, cost effective interchanges of information. Mr. Jones said it also acknowledged that the federal government’s regulatory process relating to healthcare industry developed transactions standards had stifled innovation and had the potential for disrupting business operations around compliance deadlines. Finally, this approach recognized that in an era of unfunded federal mandates, the only way to insure predictable, timely and successful deployment of technology was when businesses were willing to make investments in technology that had a positive ROI.
Mr. Jones said his colleagues would discuss those issues further, and how consequences of existing processes affected their organizations and changes to these processes might lead to a more efficacious implementation of HIPAA administrative simplification standards. Panelists would also discuss how a new collaboration between private industry and the federal government might alleviate impediments to innovation in healthcare.
Subcommittee Discussion: Improving the HIPAA Process
· Harold Reynolds, Vice President, Blue Cross/Blue Shield of North Carolina
In terms of transactions, Mr. Reynolds said Blue Cross/Blue Shield of North Carolina (BCBSNC) would be HIPAA compliant when the providers, practice management systems, clearinghouses, payers and all business associates became HIPAA compliant. He said there was no competitive advantage to any one becoming HIPAA compliant, because HIPAA was re-engineering the way the industry did business. Everyone had to minimally get there in October 2003. Then they could move on with improvements they’d gathered through implementation or hoped to get going forward.
Mr. Reynolds said he spent a lot of time educating employers on how privacy would affect them. He noted an innovation BCBSNC put into their system; whenever anyone in customer service helping administer to $2.8 million North Carolinians keyed in a member’s number, information popped up telling whether a confidential communication authorization was in place. Mr. Reynolds noted BCBSNC had 340 different customer letters and everyone had to be adjusted to deal with confidential communications and the privacy situations. Noting providers sometimes incorrectly said they could no longer give the payer information they used to give, Mr. Reynolds emphasized that education was going to be key.
He agreed there had to be a clear, precise decision-making process. He said WEDI loved the frequently asked questions and would like to go further to clear and final decisions.
Mr. Reynolds said interpretations of the IGs was among the significant issues they faced. Noting that Dr. Zubeldia and he had different views, he said it wasn’t a question of which of them or the 5,500 entities that BCBSNC received claims from was right, but that everyone had to pick the same interpretation. He said if people didn’t remember anything else that day, he wanted them to remember a ping-pong table with one side up. That way, the ball always came back. If they didn’t designate an interpretation, every time it came in, it would fail the IG edits. Noting that North Carolina had prompt pay laws that required them to get claims in and out or pay interest, Mr. Reynolds said he’d sent thousands of transactions through three vendors, and got three different answers. Ninety percent of BCBSNC’s hospital claims and 75 percent of their physicians’ claims were automated. That needed to be maintained.
Two months ago, Mr. Reynolds said he’d given an education class to 50 physicians and their office staffs. None of them had yet talked with their vendors. Mr. Reynolds asked for clear direction and decisions. The addenda hadn’t come out and many in the industry were saying they’d implement 4010. 4010A, which was supposed to fix 4010, was to be implemented in October. Both couldn't be done at once. Mr. Reynolds noted similar issues with DDE and reiterated the need for answers.
Mr. Reynolds estimated that he spent 40-50 percent of his time getting his providers ready, instead of dealing with his own industry. He said he had to. BCBSNC already worked with the clearinghouses and practice management systems. Their board gave a two-digit multi-million dollar approval for 2003 to continue working on HIPAA. BCBSNC had to be private and they had to maintain their automation. Noting that CMS and OCR were grouping up with WEDI in many ways, Mr. Reynolds asked the Subcommittee to listen to what they and WEDI said.
Subcommittee Discussion: Improving the HIPAA Process
· Michael Tate, American Dental Association
Mr. Tate said that by April 2003 ADA staff would have conducted over 60 seminars on the HIPAA privacy rule at the state level. ADA also continually provided information in ADA News and at ada.org. But a couple times a week dentists would call asking what HIPAA was. Mr. Tate said he had three minutes to explain HIPAA on the phone before he numbed people out, but often when he mentioned that HIPAA pertained only to practitioners who transmitted transactions electronically, or had someone do that for them, the dentist would hang up, telling the staff to turn off the computer.
He said ADA would appreciate it if answers came back faster and he noted they constantly put out addenda. ADA developed their own privacy kit with abbreviated addenda and errata sheets that members receive at seminars.
Mr. Tate urged the Subcommittee to keep the small practitioner in mind. He said eight-out-of-ten dentists were sole practitioners with a staff of about four who wanted him to put HIPAA on two pieces of paper and put it in their hand. They were chairside and wanted to do their work and get reimbursed. They only wanted to know what they had to do to comply. Mr. Tate asked the Subcommittee to keep in mind these people who had to implement the rules.
Subcommittee Discussion – Improving the HIPAA Process
Dr. McElroy said NCPDP programs felt an urgency; the industry was moving forward and they had to accommodate. NCPDP expressed concern that the industry be able to name developed versions. Dr. McElroy noted Medicare was dealing with retrofitting issues while maintaining the standard's integrity.
Ms. Trudel balanced minority views against needs and proposals on the table. Some people doubted that the DSMO process would represent them. Others felt the regulatory process guaranteed everyone openness because they had the ability to comment in a public forum. Ms. Trudel commented on the difficulty of defining insignificant change.
Noting that employers were a lost entity in terms of privacy, Mr. Reynolds said conveying information through OCR would carry the most weight. Mr. Jones identified WEDI's three primary issues: (1) lack of consistency with the regulations across the board (all were interrelated and coming out timely would allow business to investment more efficacious); (2) while enormous effort and investment went on with the transactions, the final outcome was uncertain; and (3) investments were being made, but the security rule still wasn’t out and the final rule could alter the framework so much that initial investments were wasted.
Dr. Cohn noted that consensus around a predictable process; the question was how they did it and what it meant. He agreed that code set changes were a major issue for plans. An external code set generally could be changed at will, but an X12 code set external to the standard was mired in the regulatory process. Dr. Cohn noted they were moving toward forcing many decisions around X12 to be done through external code sets. Noting they wanted predictability and less regulatory overhead, Dr. Cohn asked how they’d find a balance. Dr. Schuping said he didn’t know how much latitude there was putting certain innovations through a fasttrack process, but he said it would be interesting to know what little adjustments that sped up the process could be done without Congressional action.
Dr. Zubeldia clarified that the external code sets were maintained by external entities (e.g., UBC, CMMS, HHS). When these code sets changed, no regulation change was necessary. External transactions, their implementation guides, and the HIPAA implementation guides were maintained by X-12, an external entity. Implementation guide changes followed the same path as the code set changes and were maintained externally, outside of the process. Dr. Cohn noted one option was to recommend that the Secretary consider X12 code sets to be external.
Members noted that they didn’t have definitions for structural, nonstructural, minor or major maintenance. Mr. Jones said the focus was on developing a process for making those definitions. Noting that the publication date of the final version was always uncertain when realizing a more expeditious process with a set of guidelines, Mr. Jones suggested that HHS doing a predictable yearly update process would solve numerous concerns. He noted banks were investing substantially in the innovation transforming the industry and shared IMAC’s and WEDI’s concern about how to integrate healthcare and payment clearinghouse functions without becoming mired in an unpredictable regulatory process.
Mr. Jones noted that there needed to be a melding of the processes for testing innovation and implementing change. He said there was a vehicle for this in X12. The question was how to meld the processes outside of and within healthcare, so the processes had commonality and efficiency. Financial institutions on the verge of investing billions of dollars in new payment mechanisms had issues due to HIPAA. Mr. Jones asked how institutions could pull together so they had a smoother track for moving forward.
Mr. Reynolds pointed out that X12 and the others present implementation challenge was to standardize. He agreed in speeding up the process, but cautioned that they had to ensure that everyone was in on the process. If X-12 made the decisions, Mr. Reynolds asked how he’d implement with big hospitals and medical centers in North Carolina: X-12 would be telling them how to do business.
The Subcommittee discussed what they might offload from HHS regulation. External code sets were handled by external entities and could be changed at will, while internal elements of the standard fell into the process. Noting that many didn’t think the clinical message standards had to be regulated, but instead needed to be stimulated and encouraged, Dr. McDonald suggested that some fields in some of the standards could be identified as code sets that could change outside of the regulatory process (similar to external codes like diagnoses). Dr. Cohn expressed concern about the voluntary model for financial transactions and the direction they were advocating.
Dr. Zubeldia remarked on the ROI and the value of a comment period when smaller voices could be heard. But he noted many of those voices expressed concern that the EDI and X121 CAPT transactions couldn’t be changed through the regulatory process and had to go back to X12 and an open consensus process. He pointed out that there was an additional level of checks and balances with the DSMO process, which offered opportunities for little voices to be heard throughout the whole process. A simple notice stating that the DSMO had come up with a new version could replace the regulatory steps.
Ms. Trudel pointed out that there hadn’t been a complete runthrough of the entire DSMO process and Committee hearings. She suggested that after a full cycle others’ would have the comfort level of those already actively involved.
The Subcommittee agreed to come up with a letter for the full Committee in February with recommendations that, hopefully, conveyed the consensus of a fair amount of the industry contributing to greater predictability.
Mr. Jones said they needed to look at the relative ROI of this processes in context. Enhancing predictability was important in an escalating environment. He suggested they focus on how costs escalated because of the regulation.
Mr. Reynolds said the timeliness and preciseness of a decision determined whether the whole industry lined up behind it. The process had to be precise, clear and understand the industry. He suggested standardizing and getting in front of the process or getting another that would move faster.
Dr. McElroy clarified that there wouldn’t be a new version of the implementation guides for NCPAP 5.1 that included retrofits. Medicare wasn’t at the table when version 5.1 was developed and they were looking at where some of its needs and requirements could be met (e.g., small minutiae things like Ids) while maintaining the standard’s integrity. What they could address was in the editorial document through clarifications. It compared with the companion guides in X12, except that NCPAP had one for the entire industry.
Ms. Ward said X-12 didn’t have any companion guides for payers. Payers who thought it would be helpful were creating them and causing frustration for the provider community. Ms. Ward explained that the companion guides were intended to be for clarification and guidance. There was still some degree of flexibility within the implementation. For particular data elements within an implementation guide, one could have some set of valid values. It was intended to be a reflection of their edits and their specific requirements for certain things. WEDI and CAQH, through outreach to the industry, created a standard template and feel for a companion guide. They encouraged all payers to look at and consider whether they could live with that standard. Ms. Ward said providers were receptive, so long as they didn’t have to read 300 different guides.
Mr. Reynolds noted there wasn’t an edit in X-12 to enter the date of service in the date of admission, and so it had been put in the companion guide. Many situational elements under HIPAA also had to be defined based on the procedures each provider did, what their agreements were, and whether it was contractual. Electronic transactions had to clearly state how this could be done. There could be inconsistencies between payers, but the hospitals had contracts with payers based on the procedures done, and these were reflected in the companion guide in their original format in an effort to make things consistent and reasonable.
Noting he’d received emails about companion documents that contradicted X-12 or the implementation guide, Dr. Zubeldia said there was a was moving toward payers asking for whatever they pleased. Dr. Cohn said HHS needed to monitor whether the implementation guides were starting to change the standard. Mr. Reynolds pointed out that most the payers understood what X12 meant, the requirements, and that they could be audited by CMS. Trading partner agreements had to deal with valid information as well. The original purpose of companion guides was to help the provider know the payer’s edits, so providers didn’t need to have their claims rejected in order to know they were inappropriate.
Dr. McDonald said technically it would be fairly easy to create a set of messages HCFA could run: they could send messages, monitoring for rejections based on egregious differences (e.g., size, dimensions and format specs) with the standard. Mr. Reynolds suggested a Web site where people could report those doing this.
Mr. Pokorny said his first reaction to the companion guide being a tool to help providers prepare an accepted transaction was that would be an imposition of payer-specific requirements to the transaction--but than he reflected that that wasn’t necessarily bad. HIPAA sought to remove waste in the administrative process, speeding it up so information was exchanged, claims processed, and reimbursement occurred efficiently. Companion guides meant to make financial transactions more efficient contradicted another aspect of HIPAA: sending everyone the same thing. Mr. Pokorny asked if they wanted providers to learn by rejection or chose to boost the education of every sector of the healthcare community, so these transactions could be used most effectively.
Mr. Pokorny suggested that stability was key in implementing and accepting 4010 transactions and that companion guides might be the first piece of feedback to guide the evolution of the standard transactions. Although there was continual tweaking of the transactions at X-12 meetings, Mr. Pokorny said they weren’t refining the transactions based on mass implementation, and he urged that more effort go toward developing transactions that more properly represented dollars that should go towards the implementation side.
Dr. Zubeldia contended that the companion guides provided the best feedback on what needed to be changed. The DSMO and HHS could track what payers asked and improve the next version. Dr. Schuping suggested a task group could review these issues and get the templates and companion guides out so people could learn from them. Mr. Reynolds suggested that posting a frequently asked question about whether the companion guides could stray from the IGs would have immediate impact. Dr. McDonald advocated a test set by which the mechanical parts could be challenged, if the fields were limited. Dr. Cohn suggested Dr. McDonald work on that. Dr. McDonald said an agency or organization could caution that they’d probe with a test set at unpredictable intervals. He distinguished that from “enforcement,” noting that providers and payers would play by the same rules; if payers cut back, providers would want to send diagnoses to make the matches work. He said UFA might be the answer to a potentially destructive process.
Revisiting the issue of predictable and stable processes, Dr. Cohn speculated that suggestions requiring legislative changes were less likely to happen than those requiring regulatory changes. Things requiring Secretarial redefinition also were more likely to happen than those requiring further work.
Dr. Schuping considered whether it would be possible to lay out a schematic of the different regulatory processes they went through and examples of what could be done different ways. Entities who had to interact with that process could help them visualize the problems and delays and lead them to realistic solutions.
Noting that the Committee had included wording in previous recommendations about the need for the final regs to be on time and for the process to be improved, Mr. Blair asked for HHS’s guidance on how to craft a more successful recommendation. Dr. Cohn said part of the question was whether there were re-interpretations of existing laws. He suggested that the Secretary advise SDOs that they could convert more to external code sets. He said the difference between a code set and structural change was melding, adding a way to add flexibility in a system that didn’t require legislation. Dr. McDonald noted they first had to be restricted by fields. He said, typically, it was most useful to make things with large catalogs external. He noted they could also be treated like an external code set within the body. Dr. McDonald pointed out that if UPC became the codes for labeling everything in an institution, they wouldn’t want to go through a regulatory process every time someone made a new product. Ms. Ward said they’d established the DSMO steering committee to most broadly and appropriately input changes in implementation guides. If they expressed a significant amount of this data using external code sets rather than actual discrete data within the standards, the process for changing these code sets wouldn’t be subject to the broader DSMO procedure. Ms. Ward cautioned that they wouldn’t have control over definition changes and subtractions to the condition and revenue codes. This was something to consider when thinking of expressing any of these data using code sets. Mr. Pokorny pointed out that external code sets could be managed from a HIPAA perspective by instructions in the implementation guide.
Dr. Zubeldia suggested that, rather than “mess with” whether the code sets were internal or external, the attachment guides could be an experiment for this environment with the DSMO approval process and publication of the version adopted by the DSMOs in the Federal Register as the end point. The rule could come out in an abrogated manner (e.g., a one-page rule identifying however the DSMOs defined the attachments). The six attachments adopted by HHS as the HIPAA standard could be maintained through HL-7 and X-12 and share the DSMO approval process
Mr. Blair said eliminating a layer in the process could be beneficial, but giving the DSMOs responsibilities without funding would put them in the same position as HHS. Dr. Zubeldia contended they already did it with present funding. Ms. Ward said the Department suggested a comment period preceding a final DSMO decision rather than the formal NRPM process. Mr. Reynolds pointed out that the masses didn’t know what a DSMO was and their decisions wouldn’t have the power of federal regulation or be in the Federal Register.
Mr. Blair suggested that these committees could be extensions of resources available through the Department. Regardless of whether the period of review was reduced, the Committee’s recommendations could come afterwards. Mr. Blair reminded everyone that the goal was mass implementation.
Mr. Pokorny suggested that they follow up on Dr. Zubeldia’s idea of an attachment guide as a DSMO product resulting in a process that yielded a HIPAA standard. Having the DSMOs administer the public comment period could save time.
Mr. Pokorny cautioned about the legal liability that might come with pursuing this path and queried whether the government needed to extend protection.
Dr. Schuping asked if the Committee would support an informal task group charged with reviewing the current regulatory process and looking at pros and cons of Dr. Zubeldia’s suggestion and its impact. Noting the HIPAA office had focused on the initial implementation, Dr. Cohn expressed concern about diverting resources. He suggested that a session sponsored by WEDI could become a forum for increased understanding of the options. However Dr. Cohen pointed out that they’d tried self-standardization with the 300 UB-92 implementation guides in 1996. He said he wasn’t optimistic about removing the government completely. Dr. Schuping said WEDI would facilitate and find ways to recommend innovations for the upkeep and maintenance of claims attachments. Mr. Blair recommended focusing exclusively on the HIPAA financial administrative transactions and the privacy regulation. Remarking on the numerous interdependent and interrelated healthcare information standards initiatives underway and that the Committee also had recommended funding to support NHII, Mr. Blair suggested that their recommendations focus on a broader group then the HIPAA financial administrative transactions and the privacy regulation.
Ms. Trudel advocated finding a way around the DSMO process and the due process of regulations. Noting there were industry experts (i.e., the DSMOs and SDOs), she said it would be helpful to know when there was consensus about the difference between standards or a change in code sets, structure, or business purposes for a transaction. Ms. Trudel suggested that they might be at the point that, instead of adopting specific versions, they’d automatically implement each subsequent version annually.
Responding to Dr. Zubeldia’s proposal, Ms. Ward discouraged using claims attachments as a test bed. HL7 had been creating their version for claims attachments since 1997 and Ms. Ward said they’d be remiss not to consider if a better way would be available when people implemented in three-four years. Mr. Jones added that the set of rules came out piecemeal and the compliance deadline was only three-or-four months away. Looking at alternate procedures, he said they were looking to get away from these problems in the future.
Dr. McDonald reported exploring what could become a new attachment without the full procedure and it only looked feasible for those that already requested a lab test. He said that could be used to define fields or new content (e.g., the AMIS attachment), but they’d decided any changes would require the same NPRM process.
Noting that HIPAA required that addenda not be more frequent than once per year and that it be implemented in a minimum of 180 days, Dr. Zubeldia said the feedback was that this wasn’t enough time for these changes. Mr. Reynolds said the big players like Medicare could move as needed, but he questioned the affect on smaller entities. BCBSNC could probably do it in six months. Ms. Trudel reported that Medicare did system changes quarterly, but had to have their instructions on the street five months before the effective date, making an eight-month lead time.
Mr. Reynolds reported that BCBSNC didn’t yet have a provider in North Carolina that could receive a clean 837, but the vendors and clearinghouses were beginning to work with them. BCBSNC was working on an automated way to help providers be able to test with them and get immediate answers back, because they couldn’t manually handle 5500 responses. Mr. Reynolds said he’d decided to go to 4010A and stopped work on 4010. He asked how he could test with providers without 4010A out yet. Mr. Reynolds requested that the Committee not put out anything new before learning whether the industry could at a quality level implement what they already had.
Ms. Ward expressed doubt about when people could be ready but estimated six-to-eight months. She predicted that some payers would reject any claim that wasn’t HIPAA compliant from a content and syntax perspective. Others would accept claims because they didn’t want to stop business. She noted a grace period had been suggested for payers who continued to accept transactions that weren’t completely compliant, allowing people to determine what was wrong with the transactions and correct them. Noting a grace period might diminish the industry’s sense that they needed to be compliant, Ms. Ward suggested a grace period that wasn’t so open ended and that the payer be required to state what was wrong with a rejected transaction.
Noting how long it took to implement any regulation depended on the circumstances of the entity, Mr. Pokorny said he’d been hearing that longer (eight months) was better. He contended that a grace period wasn’t the answer: they’d already had the one-year extension. He reiterated that the providers couldn’t know what had to be corrected without adequate feedback. Dr. McDonald cautioned that entities could go bankrupt, grinding the system to a halt and causing a political backlash against standards, if no one was paid for six months.
Mr. Reynolds expressed concern that many organizations had spent considerable time filing for the extension, but in North Carolina providers who hadn’t become compliant could go to paper and not be penalized. That meant he had to hire more people to respond to the paperwork, and the state prompt payment law further penalized him for not having it done in time. Mr. Jones cautioned that if the Subcommittee even hinted at a grace period they’d reinforce and accelerate this notion.
Dr. Fitzmaurice noted three issues. The first issue wasn’t whether more Congressional and HHS funding were needed, but setting priorities. Industry had to decide what it wanted the government to do and what it would do for itself. And resources had to be found for whatever government was to do. Second, the government was too slow but APA also provided checks and balances and the regulatory process brought uniformity and time-certain compliance. High-level priorities were subject to change, depending upon consecutive administrations. Thirdly, in seeking a collaborative process, Dr. Fitzmaurice suggested they provide more forums. He noted they’d learned from them in the past and people looked to the Committee as the place where issues were first discussed.
Dr. Cohn concluded that there was considerable angst over implementation and it was hard to anticipate beyond October. Noting that a number of premature issues had been brought up that would become more appropriate as they moved forward, he said the Subcommittee had to provide time on a regular basis for ongoing conversations. The Committee favored making the process more predictable and stable and Dr. Cohn suggested they have someone educate them about ways of simplifying and streamlining it.
Dr. Schuping will work with HHS to develop as quickly as possible a dialogue and task group review of the current process. The Committee discussed meeting in other forums (e.g., The Committee participating in a roundtable discussion with a clear agenda at a WEDI meeting). Members noted they would still follow the Federal Advisory Committee Act’s requirements for open meetings. Ms. Ward will, consolidate and provide a summary of clients’ experiences. The meeting was adjourned at 12:42 p.m.
I hereby certify that, to the best of my knowledge, the foregoing
summary of minutes is accurate and complete.
/s/ 3/3/04
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Chair Date