SOLVE & WIN
PROFESSIONAL CORPORATION
ATTORNEYS AT LAW
"We Solve Problems and Win Cases."
2491 Purdue Avenue, Ste. 221
Los Angeles, California 90024
D: (310) 478-6251
Healthcare Law
Health care law encompasses health care regulations, licensing and practice issues, privacy and confidentiality/HIPAA, sale acquisition of practice, telemedicine and e-wellness, kickback rules, bioethics, and Medicare/Medicaid regulations. By drawing on the Law Office’s talents and experiences, clients will be aware of nuances of health law and will comply with the requirements of state and federal fraud and abuse laws and other statutory and regulatory challenges unique to health care professional entities. With both in-house and firm experience, the Law Office provides comprehensive array of legal services to health care providers, including:
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Legal Review & Advice Relating to the Practice
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Malpractice liability risks relating to therapies the practitioner offers.
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Risk of prosecution for unlicensed practice of medicine or other professions.
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Claims and/or guarantees made in the practice.
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Use of any potential “medical devices” under the federal Food, Drug & Cosmetic Act.
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Dietary supplement recommendations.
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Dietary supplements sales.
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FDCA risks relating to off-label or experimental therapies.
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Primary/integrative vs. CAM-only care (for MD/DO).
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Disciplinary issues (including standard of care).
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Scope of practice issues.
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Insurance (Medicare) issues (par v. non-par v. opted out).
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Insurance (CPT and E&M coding for super-bill; issues of upcoding, unbundling, medical necessity, scope of practice, discounts and waivers, fraud and abuse “incident to” billing
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Facilities license (if applicable).
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Professional liability insurance (coverage of CAM; medically necessary v. experimental)
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General liability insurance (e.g., spa liability; general business liability; employee benefits liability; group health insurance; healthcare billing errors and omissions; directors and officers; employment practices; workers compensation).
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Vicarious liability for acts of associated practitioners.
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“Medical mall” vs. “center” model.
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Analysis of Stark and federal anti-kickback issues for illegal business arrangements (such as splitting fees between MD, Center and practitioner).
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Write memo analyzing Stark, anti-kickback and fee-splitting issues and outlining compliant compensation arrangements.
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State self-referral and anti-kickback issues and design of flow-of-payments.
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Contract between MD/DO and Center/Clinic/Practice/Spa.
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Legal and contractual issues involving service as medical director.
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Contract between non-medical Practitioner and Center/Clinic/Practice/Spa.
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Medical supervision issues (e.g., Botox, spa therapies).
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Legal Review & Advice Relating to Marketing Materials (including brochures and main website).
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FDA (Food and Drug Administration) issues concerning claims and labeling
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FTC (Federal Trade Commission) issues concerning claims, testimonials & endorsement
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Draft Legal Forms.
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General Informed Consent Form for medicine, chiropractic, acupuncture, massage, etc. (or non-licensed practitioner if state law mandates disclosures).
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Nutrition Notice (if applicable—e.g., CA).
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FTC/FDA Disclaimer for main website and marketing materials.
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Privacy Form (non-HIPAA, mirror form; or HIPAA manual if billing electronically).
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Medicare ABN Notice and Patient Assignment or Waiver Forms.
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Non-participation letter for insurance companies with whom MD/DO has contract through medical school or hospital affiliation, managed care or MSO contracts.
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Letter to malpractice carrier regarding coverage of CAM.
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Recommended Additional Services: Advice and Drafting
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Advice on Choice of Entity & Incorporation (including professional service or professional medical corporation).
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Advice on intellectual property protection (copyright, trademark, trade secrets).
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HIPAA Manual and Forms (including Business Associate form).
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Agreements covering speaking/consulting, distribution, other services.
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Chart review (MD/DO only).
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Specialized consent forms (e.g., Lyme disease, IV therapies, IPT, heavy metal challenge diagnostic testing, etc.).
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Review of facilities lease.
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Develop or review credentialing & quality assurance plan for practitioner selection, and documentation.
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CLIA advice (chemical services, lab tests, blood fluids); scope of practice and standard of care issues regarding lab tests.
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Physician Employment Agreements
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Management Services Organizations (MSO) Agreements
Representative Matters
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General Counsel for a multi-state medical spa, including advising on corporate governance issues, forming new entities, healthcare regulatory compliance, drafting agreements, advising on transactions, intellectual property, advertising and employment law issues.
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Structured many medical spas, both the professional medical corporation for the physician(s) (or other professional entities, including nursing corporations and physician assistant corporations), along with the contracted management services organizations (“MSO”), including entity formation, drafting the management services agreement (“MSA”), medical director agreement, license agreement, sublease, business associate agreement, restricted stock purchase agreement, security agreement, and other medical practice and corporate documents, not only in California, but with co-counsel, in other states, including, Nevada, Arizona, New York, Florida, and Texas.
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Negotiated numerous partnership agreements, including a physician partnership agreement, while advising the client about Stark/Anti-kickback laws.
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Negotiated a clinical study agreement for a physician, along with corresponding billing arrangement.
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Advised physician client about the issues with becoming the medical director for a medical spa, while also counsel for medical spas and able to seal the deal with physicians to become medical directors for the medical entities entering into management services agreements with medical spa (management services organizations).
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Assisted plastic surgeons and other professionals with contracting with aestheticians/estheticians and other allied health professionals by putting proper agreements in place.
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Composed memo about risks and legality of a medical device.
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Assisting physician with HIPAA and Power of Attorney issue with medical record issue.
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Assisted numerous physicians with whether to apply for, applying for, and obtaining fictitious name permit applications from the Medical Board and Osteopathic Board.
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Conducted research for Medical Spa regarding a possible complaint made to medical board.
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Advised client with a mobile health technology platform about California healthcare laws and regulations related to California health plans vs. independent physician associations (IPAs) and composed their client agreement, physician agreements, app terms and privacy policy, while revising website language for compliance.
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Drafted and negotiated medical device sale, lease and usage agreements.
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Prepared sales agreements including the purchase agreement, purchase order and receipt of delivery for client’s health, wellness and beauty products.
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Assisted clients with hospital and surgical facility incident reports and responses.
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Assisted complementary and alternative medicine (CAM) providers (including, chiropractors, acupuncturists, homeopaths, naturopathic doctors and more) on practice issues, including startup legal services, leases/shared space agreements, intakes and consents, claims on websites, regulatory questions, contractor/employment agreements, and patient issues.
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Counseled primary care healthcare management company on how to deal with a physician who was attempting to weasel out of the management service agreement and assisted with resolving the issue.
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Counseling numerous clients on California laws as they relate to legal payment structures between management companies and physicians/professional corporations.
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Assisted nurse client with research and placement of a medical director and facilitated their negotiation of the terms of the deal, while composing final medical director agreement.
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Instructed client how to setup a medical device leasing service in California.
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Represented client in becoming a medical director of a medical spa and partnering with a registered nurse, and assisted with all documents necessary to form a new professional medical corporation, including shareholders and medical directorship agreement.
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Drafted numerous HIPAA compliant documents for various clients, including business associate agreements, privacy policies and patient consents.
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Advised clients about HIPAA rules related to encrypted communications and compliance with HITECH, including when dealing with chargebacks and patient disputes.
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Composed numerous consulting agreements for healthcare professionals, including drug rehabilitation facilities, medical spas, medical device companies, and imaging centers.
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Drafted and negotiated term sheet as well as resulting management services agreement for the practice of clinical laboratory pathology services, which provided toxicology testing for drug/medication screening.
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Researched oral procedure scope of practice issue for Doctor of Osteopathy.
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Worked with co-counsel to resolve medical board complaints and investigations of managers, physicians and others appearing on medical spa website regarding corporate practice of medicine issues.
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Advised dentists and potential affiliates about limitations on medical spa ventures.
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Advised clients about good faith exam requirements.
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Assisted drug rehab consultant with services contract and insurance coverage issues.
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Structured and setup agreements between three entities to provide services, space and apportioning fees and payments in a legally compliant fashion between a professional medical corporation, rehabilitation facility and management services organization.
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Advised client about Medicare surgery center rules regarding physician ownership.
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Advising physicians about supervision and delegation issues as they relate to staff, such as medical assistants, registered nurses, nurse practitioners, physician assistants, and other allied health professionals, in California and Nevada (with the assistance of co-counsel).
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Reviewing standardized procedures and protocols for clients, along with delegation of services.
agreement, AKA “practice agreement.” -
Counseled clients about proper titles and roles in medical vs. MSO entities
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Advising clients about medical record ownership and requirements upon death and acquisitions
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Researching various state laws about compliance issues for physicians, physician assistants, and nurses in terms of remote practice, telehealth, and demonstrating procedures at training schools.
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Drafted refund agreements, comped service agreements, barter/trade agreements and other creative agreements for patients.
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Collaborated with medical malpractice lawyers, arbitration administrators, and professional liability insurers to revamp the standard, generic one-page physician-patient arbitration agreement into a comprehensive but succinct three-page arbitration agreement for medical practice clients.
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Advised clients on proper patient termination and handled the resulting termination
correspondence with hostile patients. -
Drafted supervision agreement between physician and naturopath doctor, and advised about supervising naturopath doctor.
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Advised client about structuring Partial Hospitalization Program (PHP) and Intensive Outpatient Program (IOP) with psychiatrist as the supervisor of the services.
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Counsel to Vitamin-IV infusion clinics through advising about supervision issues, including
paramedics and other compliance matters, along drafting requisite patient forms. -
Counseled nurse-injector client on canceling a fictitious name permit with one practice and forming new practice with almost the same name and obtaining new fictitious name permit in record time.
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Advising client about how to handle and respond to a Department of Consumer Affairs (“DCA”) letter.
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Advising client on how to work with providers who are licensed in California, but have a professional entity in another state, when they are licensed in more than one state.
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Advised client on treating a complication caused by a preceding physician in preparing proper informed consents and complication treatment release, along with a financial responsibility agreement.
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Drafted nurse injector agreement for independent contractor practice and employment agreement.
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Counseled physician client about working with aftercare nurses.
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Advised international client about expanding medical practice to the U.S. using a management services organization and contracting with physicians.
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Assisted physician client with all legal work to setup a mentorship/e-course ecommerce platform, including drafting the instructor and member agreements.
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Advised numerous medical clients about standard of care issues in terms of preventing legal issues.
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Drafted many public responses to negative reviews that empathetically acknowledged shortcomings, but stuck the facts, without revealing HIPAA protected personal information, a vast majority of which resulted in the patient removing the review.
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Advised physicians about having white label products or their own product line of cosmetics, supplements, and other value add-on services to their practice, in terms of entity structure, FDA compliance, and intellectual property protection,
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Assisted clients with drafting informed consents for various procedures, including against medical advice, and an out of area waiver and follow-up care consent.
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Assisted several physician clients with setting concierge medical practices, even though they take Medicare, and drafted concierge practice agreements, and correspondence with patients.
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Represented client in setting up mobile wound healing business.
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Represented physician assistant corporations and nursing corporations in medical spa practice issues.
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Advised clients about medical records requests to the California Medical Board (“MBC”) and corresponded with investigator and other MBC personnel to resolve potential and actual complaints.
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Drafted many supervising and collaborating/collaboration agreements between nurses and physician assistants and physicians.
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Advised practitioners about prescribing and prescription compliance issues.
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Provided dual representation of clients with signed conflict waivers to facilitate transactions to save clients money and provide a balanced and more efficient deal.
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