Therapeutic Practices Review Inventory practitioners, procedures, services, drugs, supplements, devices, labs.

Transcription

1 SUMMARY CHECKLIST FOR LEGAL AUDIT OF INTEGRATIVE AND CAM PRACTICES Therapeutic Practices Review Inventory practitioners, procedures, services, drugs, supplements, devices, labs. Sources of regulation: Food and Drug Administration, State statutes and regulations, professional boards; also Federal Trade Commission, CLIA laboratory and OSHA requirements. Issues State health professional board concerns. Specific practices can be of concern, including: - Particular therapies, such as chelation, bio-oxidative therapies, alternative cancer treatments, vitamin IVs, unapproved drugs imported from other countries. - Approaches to ACM, such as steering patients from appropriate conventional care, aggressive critiques of conventional medicine, one-size fits all diagnostic and treatment approaches, implied guarantees. - Misrepresenting training, credentials or scope of practice. - Suspect business methods, such as supplement sales. - Poor charting, including lack of documented informed consent. - Improper billing methods, such as upcoding Drugs. Some pharmaceuticals may be outside the standard of care, some may be illegal. The following are examples of products for which safeguards should be in place, or which need to be abandoned. - Importing unapproved drugs, such as Carnivora. - Hot spot treatments, such as chelation, vitamin IV therapies. - Holistic approaches to hormonal therapies, such as T3/T4 products, natural hormones. Using experimental therapies or unusual off-label uses without proper support, such as approval by an Investigational Review Board. Supplements. Vitamins, minerals, botanical and herbal products raise numerous issues. For example: - Health claims promoted outside the treatment room may be illegal. - Prescriptions for supplements may be outside the standard of practice. - Prescriptions for supplements may exceed scope of practice. - Supplement sales may be considered unethical, the view of the AMA; some medical boards impose discipline. Copyright 2004 Page 1

2 Devices. Many widely used devices are legally questionable, such as: - EAV/meridian analysis devices and related energetic, resonance and electromagnetic or homeopathic devices have some legal basis but their use can be problematic. - Unapproved devices, which are routinely but improperly used to diagnose, cure, treat or mitigate disease. Scope of practice. Scope of practice is principally a concern for the non-physician practitioner: - State law violations; common state-to-state variations include whether an acupuncturist can recommend herbs, a chiropractor give nutritional advice. - Nonlicensed practitioners (e.g., holistic health care practitioners, colonics) may be practicing without authorization, exceeding educational services and diagnosing and treating disease. Standard of care concerns. Standards of care is most often a concern for integrative physicians, but all practitioners need to be aware of their scope. - Differing views of nutritional care, diet, other therapies - Hot spot areas of CAM treatment, including cancer, HIV, chronic infection, metabolic or hormonal issues, environmental sensitivity. - Off-label use of medications and vitamins. Other issues: There are a range of other federal and state requirements of concern, including: - CLIA/laboratory regulations: Many practitioners are unaware that tests they do may be unapproved, such as Live Cell Blood Analysis and BTA. - OSHA compliance: Integrative physicians and ACM practitioners handling blood/fluids need to follow OSHA facility and personnel training requirements. - FTC compliance: FTC has occasionally taken action against ACM methods, such as supplements, chelation, Darkfield. Steps to minimize these concerns, such as: - Know federal and state regulation of drugs, supplements, devices, laboratory, occupational safety rules as they apply to practice. - Determine legal status for particular therapies. - Awareness of state board prohibitions, hot button issues. - Know current standards of practice. - Understand documentation and billing requirements. - Carefully word therapeutic claims and marketing materials. - Document basis for use. - Properly use informed consent. - Apply the DSHEA structure/function language rather than make disease claims. Copyright 2004 Page 2

3 Risk Management Assessment Review practice risks, malpractice insurance, informed consent practices, marketing materials, quality assurance efforts; history of complaints, referral practices, practitioner credentials. Sources of law: State tort law, state consent and other health law requirements. Risk assessment. Assess potential risks to patients of the services offered, including: - Known risks by method (e.g., chelation, prolotherapy, nutraceuticals, energetic work, osteopathic work, hormonal therapies). - Litigation history, federal or state actions against practitioners. - Litigation history, cases, federal or state actions against specific practices. Informed consent process/forms. Proper use of informed consent forms is particularly important for ACM practice of any kind. - Forms should include nature of treatment, purpose, risks, benefits, conventional or ACM options, education/experience of practitioner. - Assess tendency to minimize risks. - Forms signed in context of conversation with practitioner. Quality assurance. Improving quality and minimizing risk are key, including: - Supervision/review of methods, including minimizing expansive or wayward practices. - Communication problems, including difficulties with semantics, charting methods. - Methods of follow-up on positive lab findings, missed visits, etc. Negligent referral/credentialing. Referral or the failure to refer can each present some risk: - Awareness of credentials, problems with practitioners to whom they refer. -Indications of medical conditions outside the scope or expertise of the practitioner should be referred to an appropriate specialist, follow-up to ensure compliance. Management of vicarious liability. Liability of others can be shared - Direct liability for clinical errors and for failure of due diligence checking credentials of colleagues within Center - Vicarious liability for mistakes made by practitioners working for Center. Malpractice coverage. Malpractice coverage is becoming more widely available for non-physicians while increasingly difficult for physicians. - For physicians, describing their practice to their carrier can cause problems, while failure to do so can cause denial of a claim. Copyright 2004 Page 3

4 Marketing materials/web site review. Regulatory complaints are often triggered by advertising claims considered troubling or misleading: - Aggressive attacks on conventional medicine. - Extravagant or improper health claims, unapproved drugs or devices, guarantees, and inducements. Patient management. Patient relations are a central part of risk management strategy: - Strategies should be in place for difficult to manage patients, who are high risk to practice, - Good practice management, tracking of patients and their concerns, follow-up on important conditions a critical part of patient care/risk management. Malpractice insurance. Malpractice insurance is a central protective strategy. - Does the malpractice carrier know the type of practice? - Are non-physicians covered? Steps to minimize these concerns, including: - Assure that good lines of communication exist. - Patient involvement in decisionmaking. - Locate best malpractice coverage, use exclusions of particular practices if necessary to keep insurance. - Proper training for clinical and practice management in place. - Proper procedures for sharing of patient information, referral, lab result follow-up, etc. - Quality assurance measures in place (such as clean needle technique for acupuncturists). - Proper use of shared charts. Scope of Patient Care/Collegial Interaction Review delegation, supervision, orders, information sharing, referral, Sources of regulation: State health care law, tort law, Medicare requirements, HIPAA privacy requirements Primary care/specialty responsibilities. Especially for physicians, and for those with independent scopes of practice, defining the extent of responsibility taken is critical: - Extent of responsibility that should be taken in light of nature of practice, admitting privileges in hospital, etc. - Practitioner conduct, marketing, patient agreements. - Network of available practitioners for referral/support. Copyright 2004 Page 4

5 Delegated duties. Where physicians, and in some cases, other independent licensed practitioners, delegate duties to another practitioner, it may resolve scope of practice limitations and improve reimbursement. Such activities need to satisfy requirements for: - Physician training/oversight. - Sufficient physician contact with patient. - In-suite presence when necessary, physician orders, etc. Sharing of information. Particularly given HIPAA concerns, sharing of information requires attention: - Determination if HIPAA applies to practice (when required to file electronic reimbursement claims) - Compliance with forms and release practices, information security, etc. Steps to minimize these concerns, such as: - Use of signed notice/consents limiting scope of responsibility. - Documenting training for any staff receiving delegated authority. - Proper privacy policies. Business Structure Review Review organizational structure; track payments from patients to center and practitioners, review practitioner and payor agreements and participating provider agreements. Sources of regulation: CMS, federal fraud statutes, state health care, corporation, insurance and contract law. Organizational structure, including ownership, practitioner/supplier contracting. Organizational structure and contracts between clinic owners and providers need to protect both parties and conform to a number of regulatory requirements: - Limitations of liability/risk management. - Liability insulation via separate structures, as appropriate. - Quality management to reduce risk of adverse incidents. - Steps to prevent negligent hiring, including credential review, other due diligence. Kickback and self-referral prohibitions. These concerns are often overlooked, but may affect the legality of: - Employee ownership, profit sharing arrangements. - Percentage/volume based payment arrangements with practitioners. - Percentage/volume based payment arrangements with marketing companies. - Percentage/volume based payment arrangements with off-site billing companies. - Organization of internal lab services. - Discount arrangements with laboratories. - Discount arrangements with supplement and device manufacturers. Copyright 2004 Page 5

6 - Referrals for laboratory/physical therapies, etc. where physician ownership interest (Stark liability). Organizational entity concerns (Corporation, Partnerships, LLC, etc.). The organizational structure should be accomplished to ensure: - Compliance with doctrine prohibiting corporate practice of medicine (structured to avoid claim that corporation overseeing medical decisions.) - Entity structure to ensure minimal exposure to liability. - Contracting with staff in manner that reduces liability. Participating provider agreements with payors. Practitioners who enter such agreements may have conflicts when: - a cash practice for ACM services when seeing patients who are members of the plan. Steps to minimize these concerns, such as: - Careful review of flow of ownership, money, contracts for red flags. - Careful structure, such as use of management service organization. - Meeting group practice exception to avoid Stark concerns Billing Practices Evaluation Review superbills, medical records, claims and EOBs, Medicare status, participation agreements, claim submission methods, Sources of law: Medicare requirements, state insurance law, HIPAA privacy requirements (if applicable), payor participating agreements. Coverage issues. A great many complex issues affect whether ACM services are reimbursable. Legal review first ensures that money is not collected by means that violate the law, and then determines if there are billable services/methods that are overlooked. Review includes: - Non-covered and excluded services: many services, such as acupuncture, massage therapy or homeopathy are generally expressly non-covered. - Many services covered with on conventional basis are non-covered when used in functional approaches; B12 for fatigue is not generally covered, while it is reimbursed for documented B12 deficiency. - Medically unnecessary care: differences in viewpoint bring denials for many claims; homeopathic care may be denied as medically unnecessary even when provided by a physician. Fraud and abuse concerns. Misrepresenting the nature of services performed can lead to insurance audits or fraud and abuse investigation; practitioners can unwittingly violate these laws: - E&M codes - Notes support level of office visit; an involved area involving complexity of Copyright 2004 Page 6

7 decision-making, morbidity, and extent of systems review. - Upcoding: billing for a higher level of office visit that can be justified is a common fraud concern. - Unbundling: Some charges are assumed to be part of a service and can t be billed separately. - Discounts, waiving co-pays, professional courtesies can be considered fraud, as it implies that the practitioner has overstated their usual charges. - Submitting claims for payment that the practitioner knows are considered medically unnecessary. - Lab discount arrangements need to be correctly structured. CPT use for ACM services. Nonphysicians can generally use CPT codes within their scope of practice unless specifically reserved for a physician, but the code must fit the service. - codes are frequently misapplied, such as would (muscle testing) for applied kinesiology. - codes can exceed scope of practice, such as use of (range of motion therapy) by a massage therapist would be misapplied. - E/M coding for ACM consultations can be done, but must fit requirements regarding complexity, morbidity, and systems review. - ICD-9/CPT pairs: insurance companies scan for medical necessity by checking if procedure codes are appropriate for the diagnosis. Incident to billing. Non-physicians may be able to bill under the name of a physician if requirements are followed, including: - Physician supervision, initial MD visit, order, countersignatures of notes, physician in-suite. - Billing professional component services requires more care than technical component. Medicare status. Physicians and other Medicare eligible practitioners are non-participating by default, can participate, or opt-out and privately contract with patients. Medicare status should be carefully considered, including: - range of covered v. non-covered, medical necessity of services. - opt-out must be properly maintained, and Medicare rules followed for referrals to potentially covered services. Medicare issues. Submitting claims to Medicare is complex, and errors or inadvertent fraud are easy to commit. Review should include: - Submission for claims that fully represent care delivered, whether submitted for payment or denial, and Medicare rulings about any unusual treatment. - Electronic submission of claims unless under 10 FTE staff. - Adherence to limiting fees unless services are non-covered or practitioner is opted out. - Notice to beneficiaries when services may be non-covered. - Adherence to same day rules and other Medicare specific requirements. Copyright 2004 Page 7

8 Steps to minimize these concerns, such as: - Re-examination of coding, billing methods, review of carrier, insurer policies. - Careful consideration of best Medicare status. - Structures such as splitting billing between covered and noncovered services (such as billing smaller, covered office visit and non-coded, non-covered portion for cash payment. Medical Record Review Many concerns about a practice can be detected in the charts. Review medical record for proper SOAP notes, orders, authorization to treat, informed consent privacy/release and other forms. Sources of law: State medical board requirements, Medicare and state insurance requirements, HIPAA/privacy requirements. Review paperwork for completeness and support of practice: - Patient name, Date of Service (DOS), on each page. - Supporting documentation, note for each DOS billed. - Legible progress notes using SOAP format. - Orders in chart for non-physician work, labs, as needed. - Any necessary countersignatures. - Authorizations to treat, financial responsibility, practice disclosure forms. - Informed consent forms for CAM treatments. - Privacy forms/releases/authorizations, either specific to HIPAA or non-hipaa practice as appropriate. Review charting for billing concerns, including: - SOAP entry, orders, for each date for which there is a bill, and vice versa. - ICD-9/CPT pairs and medically unnecessary care. - Consistency of charges for CPT codes. - CMS 1500 form correctly filed out. Substantive concerns: - Follow-up documented for abnormal findings, labs. - Documentation of reasonable basis for decisions, particularly for CAM approaches used by physician. Special concerns with shared charts: - Balancing privacy protection and shared requirements. - Ability of practitioners to decipher each others notes. Steps to minimize these concerns, such as: - Conduct regular internal audits of practitioner charts. - Develop methods of cross-training, cycling charts as needed between practitioners. - Training of staff in privacy concerns. Copyright 2004 Page 8