Global Vision Law Group

Health Care – Complementary, Alternative & Integrative Medicine / Medical Spas / Holistic, Natural Health
Legal Audit — Project Fees [1]
Type of client				Non-licensed Practitioner	Licensed Practitioner	Group Practice, Integrative Care or Wellness Clinic or Center, Medical Spa, or other Facility
Representative clients [2]				Energy healer; Hypnotherapist; Homeopath; Lay Naturopath; Herbalist or Nutritional consultant.	Clinical Psychologist, Therapist or Counselor; Dentist; MD/DO; DC; NP/RN.	Group practice, Integrative care center (such as MD, DC, LMT, Nutritionist, and Reiki Practitioner); Multidisciplinary Wellness Clinic; Medical Spa; Health Care Practitioner who joins one of the above.
Flat fee				$2,500	$6,000	$10,000
						Services include advise & drafting concerning all the practitioners in the practice, center, clinic or spa.
Legal Services for Flat Fee	Legal Review & Advice Relating to the Practice.		Malpractice liability risks relating to therapies the practitioner offers.
			Risk of prosecution for unlicensed practice of medicine, psychology or other professions.

			Claims and/or guarantees made in the practice.
			Use of any potential “medical devices” under the federal Food, Drug & Cosmetic Act. [3]
			Dietary supplement recommendations.
			Dietary supplements sales.
			FDCA risks relating to off-label or experimental therapies.
			Primary/integrative vs. CAM-only care (for MD/DO).
			Disciplinary issues (including standard of care).
			Scope of practice issues.
			Insurance (Medicare) issues (par v. non-par v. opted out).
			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.
			Facilities license (if applicable).
			Professional liability insurance (coverage of CAM; medically necessary v. experimental)
			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).
			Vicarious liability for acts of associated practitioners.
			“Medical mall” vs. “center” model.
			Analysis of Stark and federal anti-kickback issues for illegal business arrangements (such as splitting fees between MD, Center and practitioner).
			Write memo analyzing Stark, anti-kickback and fee-splitting issues and outlining compliant compensation arrangements.
			State self-referral and anti-kickback issues and design of flow-of-payments.
			Contract between MD/DO and Center/Clinic/Practice/Spa.
			Legal and contractual issues involving service as medical director.
			Contract between non-medical Practitioner and Center/Clinic/Practice/Spa.
			Medical supervision issues (e.g., Botox, spa therapies).
		Legal Review & Advice Relating to Marketing Materials (including brochures and main website).	FDA (Food and Drug Administration) issues concerning claims and labeling
			FTC (Federal Trade Commission) issues concerning claims, testimonials & endorsements
	Draft Legal Forms.		General Informed Consent Form for medicine, chiropractic, acupuncture, massage, etc. (or non-licensed practitioner if state law mandates disclosures).
			Nutrition Notice (if applicable—e.g., CA).
			FTC/FDA Disclaimer for main website and marketing materials.
			Privacy Form (non-HIPAA, mirror form; or HIPAA manual if billing electronically).
			Medicare ABN Notice and Patient Assignment or Waiver Forms.
			Non-participation letter for insurance companies with whom MD/DO has contract through medical school or hospital affiliation, managed care or MSO contracts.
			Letter to malpractice carrier regarding coverage of CAM.
Recommended Additional Services (a la carte project fees or hourly)	Advice and Drafting.		Advice on Choice of Entity & Incorporation (including professional service or professional medical corporation).
			Advice on intellectual property protection (copyright, trademark, trade secrets).
			HIPAA Manual and Forms (including Business Associate form).
			Agreements covering speaking/consulting, distribution, other services.
			Chart review (MD/DO only).
			Specialized consent forms (e.g., Lyme disease, IV therapies, IPT, heavy metal challenge diagnostic testing, etc.).
			Review of facilities lease.
			Develop or review credentialing & quality assurance plan for practitioner selection, and documentation.
			CLIA advice (chemical services, lab tests, blood fluids); scope of practice and standard of care issues regarding lab tests.

[1] This is not an offer or a contract, but a menu of possible options, and is subject to a mutually signed legal services agreement between the Global Vision Legal Group and the client. Any additional services not described in this chart may be provided, at Law Firm's option, on an hourly fee basis.

[2] We also represent clients that may not fit the chart below, such as, in the health care arena, manufacturers and distributors of dietary supplements, cosmetics, and medical devices.

[3] Preliminary advice only (i.e., as to whether therapy could constitute a medical device requiring FDA registration).

Forming a Professional Medical Corporation
Project Fees
Service	$2,500 [1]	Est. Hours
Select name. Check name requirements (for example, in CA the name of a medical corporation is restricted to the name or surname of one or more of the present, prospective, or former shareholders who are physicians). Check with the Secretary of State or other office on availability of selected name.		0.5
Prepare articles of incorporation or other founding document.		0.5
Prepare bylaws.		1.5
Have incorporator(s) and named first director(s), if any, sign articles.
File articles with the Secretary of State.		0.25
Order corporate package, including seal, stationary, etc.
Give required notice of first meeting of board of directors or secure waiver of notice.		1.0
Hold first meeting of board of directors.		2.5
Prepare corporate books and minutes of first meeting.		1.5
Prepare and submit application for certificate of registration (including required data, documents, and registration fee) to appropriate professional board.		4.5
Issue stock with appropriate legend as specified in rules of appropriate board (for example, in CA the share certificate must contain a legend setting forth the restrictions of subsection b of Section 1345 of Title 16 California Code of Regulations).		0.5
Obtain federal employer identification number.		0.5
If desired, file S election with IRS.		.75
	$2,500 [1]	14 hours mulitplied by a typical firm's hourly rate of $350 could have cost you $4,900!

[1] $2,500 flat fee is exclusive of state and professional board filing and associated fees, which can be in the $400 range depending on the state.

Business Legal Advice
Project Fees [1]
Legal Service	Flat Fee	Includes
Contract Drafting Contract Review	$2,500 per contract $1,500 per contract	Distribution agreement Employment agreement Film distribution agreement Independent contractor agreement Joint venture agreement Licensing and royalty-sharing agreement Marketing and sales agreement Partnership agreement Publishing agreement Technology transfer agreement Stock purchase agreement Other agreements
Specialized contracts	$500 per contract $4,000 per contract	Nondisclosure agreement Buy-sell agreement
Federal Trademark	$1,250 per application	90 minutes of intake/advice regarding strategy Trademark searches Classification of goods or services Initial application/filing to USPTO [2]
E-commerce forms	$1,000	Disclaimer, privacy policy, user agreement/terms of use
Investor Issues	Click here	Whenever you are seeking investment in your company, no matter what size, you will need to comply with the federal and state securities laws. Unless your company intends to launch an IPO, this means you will need to provide your investors a private placement memorandum or, if you are offering stock options to your employees or executives, a stock option plan and agreement that meets the exemption under Rule 701 of the federal securities laws. Failure to strictly adhere to the federal and state securities laws could result in a civil action from the Securities and Exchange Commission as well as lawsuits from investors to recover the full amount of the investment obtained.

[2] Follow-up publication and Response to USPTO if necessary are available by separately hourly fee arrangement.

Forming a General Corporation [1]
Project Fees
Service	$1,500 [2]	Est. Hours
Prepare Articles of Incorporation		0.5
Minutes of Action by Incorporator		0.4
Prepare bylaws.		2.5
Waiver of Notice and Consent to Holding of Organizational Meeting of the Board.		0.25
Script for Organizational Meeting of the Board.		1.25
Minutes of Organizational Meeting of the Board.		0.75
Statement of Information filing with the California Secretary of State.		0.3
EIN.		0.45
Investment Representation Letters for founding shareholders.		0.75
Sub-chapter S election filing (Form 2553).		0.5
Preparation of stock certificates (including appropriate legends).		1.0
Notice of Transaction filing with the California Department of Corporations.		0.65
	$1,500 [2]	9.3 hours mulitplied by a typical firm's hourly rate of $350 could have cost you $3,255!

[1] This chart is for a general corporation and is not for the formation of a LLC, LP, or LLP, all of which are different.

[2] Does not include the state filing fees or the fees for purchasing a corporate records/minute book. Those fees are an additional $200 approximately. Also does not include: registered agent service; business license; zoning permit and seller’s permit or any specialized licenses or permits if applicable; state employer number and payroll arrangements; buy-sell or shareholder agreement; trademark, accounting, or securities law advice.

Preparation of Labeling for Manufacturer of Dietary Supplement or Cosmetic Product
Project Fees [1]
Service	Prepare Labels and Advise Company Regarding Product Requiring FDA/FTC-Compliant Labeling
Type of client				Manufacturer of a dietary supplement, nutraceutical, or cosmetic product [2]
Flat fee - 1^st label				$3,000
Flat fee - 2^nd label				$2,000
Flat fee - subsequent labels				$1,500
	1. *Review and Advise on Product Names and* Claims/Indications for Health or Nutrient Content Claims**	Review for nutrient content claims.
		Review for health claims.
	2. *Review Product Names and* Claims/Indications for Implied Disease Claims (vs. allowed structure/function claims) and Advise**	Check whether product names and claims make product meet the FDCA definition of "drugs" by making implied disease claims. Include all labeling in review (i.e., website material within one click of product claims and any brochures). Specifically, check product names and claims against:	FDA, Certain Types of Statements for Dietary Supplements.
			FDA Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure of Function of the Body (Jan. 6, 2000).
			Guidance for Industry: Structure/Function Claims, Small Entity Compliance Guide (Jan. 9, 2002).
			FDA warning letters.
			Case law.
			Law review articles/FDLI website.
			Comparable products as appropriate.
	3. Review Product Names and Claims/Indications against State Law and Advise	Review State food and drug law.
		Review State consumer protection act.
		Review state law governing deceptive advertising and false/misleading claims.
	4. *Review Product Names, Claims/Indications, and* Ingredients, for OTC Drug Regulation and Advise**	Review OTC regulations to assess how impermissible claims relating to disease categories and ingredients might bear on structure-function claims and necessary disclaimer.	Review against Regulation of Certain Active Ingredients.
			Review against OTC Ingredient List (by Monograph Category).
			Review against Status of OTC Rulemakings by Therapeutic Category.
	5. Draft (or review and revise existing) Labels Against Federal Labeling Requirements	Review labels in light of:	FDA, Guidance for Industry: A Dietary Supplement Labeling Guide (April 2005).
			FDA, Guidance for Industry: Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Small Entity Compliance Guide.
			21 CFR 101-Food Labeling , especially 101.9 (Nutrition labeling of Food) and 101.36 (Nutrition labeling of dietary supplements).
	6. Address Substantiation and Notice Requirements	Review client's evidence of substantiation of claims in light of:	FDA substantiation requirements.
			FTC substantiation requirements.
			Consumer Protection Act in relevant state.
			Food, Drug & Cosmetic Act in relevant state.
		Notify FDA within 30 days of marketing any new dietary supplement claims. Also notify if any new dietary ingredients.
	7. Review Client Website and Draft Compliant Disclaimers	Review client's website and draft:	FDA-compliant disclaimer re statements and claims.
			FTC-compliant disclaimer re testimonials and opinions.

[2] Please contact us for flat fees relating to projects involving homeopathic products, medical devices, and other health and wellness industry projects and products