CAMLAW: Complementary and Alternative Medicine Law Blog

What is the future of Complementary and Alternative Medicine under the Affordable Care Act?

Michael H. Cohen — Fri, 14 Jun 2013 12:25:33 -0500

The Complementary and Alternative Medicine Law Blog is pleased to published the following guest article on integrative medicine and healthcare reform:

What is the future of Complementary and Alternative Medicine under the Affordable Care Act?

Complementary and Alternative Medicine is a growing segment of the U.S. healthcare system. According to a 2011 survey from Consumer Reports, every year 38 million Americans receive more than 300 million CAM treatments. Since most insurance plans have limited coverage for CAM, patients are usually paying for them out-of-pocket.

On average insurance coverage for CAM treatment depends on several factors like state mandates, your health insurance company, and the local licensure or certification of CAM practitioners. Most plans at the moment limit coverage to specific conditions as well as the number of visits you can make to a practitioner each year.

Historically, health insurers have preferred to cover only low-risk, proven medical practices. Before even considering coverage for a CAM treatment most insurers will require proof of its effectiveness and safety from peer reviewed medical literature.

Sadly though, that research can be hard to come by. It’s no secret that research in many areas of CAM lags far behind so-called "evidence-based" medicine. Still, an increasing number of people choose to seek out CAM practitioners for treatment each year.

Now with the upcoming full implementation of the Affordable Care Act on Jan. 1, 2014, we will finally see some changes in the way CAM treatments are covered by insurance.

Inside the Obama administration's landmark law is Section 2706, the Non-Discrimination in Health Care clause which states: “A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider's license or certification under applicable State law.”

The wording may be a little confusing but what this means essentially is that if a CAM practitioner is licensed within a state to perform certain procedures then insurance companies must give them the same consideration as they would a medical doctor.

So because of this clause, insurers could cover your visits to licensed CAM practitioners like acupuncturists, chiropractors, massage therapists, and naturopathic doctors. Now the question is, how will this change complementary and alternative medicine in the future?

There are a couple of different views regarding the future of CAM and the Care Act. Some believe that this will help promote integration among different practitioners that will improve the delivery of quality care to consumers. Others think it will lead to a more philosophical shift in health care moving the U.S. from focusing on just medical interventions to more health promotion and maintenance.

Allowing CAM practitioners to participate in the direct care of patients sits right in line with what the Consortium of Academic Health Centers for Integrative Medicine envisions: “a comprehensive and compassionate health care system offering seamless integration of effective complementary and conventional approaches to promote healing and health in every individual and community.”

However, changes might not be as significant as some people expect. Before a CAM procedure can be approved for coverage, it must be proven safe, effective, as well as cost-effective.

The situation might be a little harder if you are enrolled in Medicaid. Only medically necessary care that falls into the ten “essential health benefits” categories of the Care Act will be included for coverage under the government-sponsored program.

Still, the Non-Discrimination clause will be helpful to those who wish to seek options outside of conventional medicine. Some people would like to deal with pain through natural means and want to avoid unnecessary surgeries. Removing payment barriers can help doctors and other medical practitioners refer their patients to CAM practitioners without worrying too much about limited insurance coverage.

Admittedly the Affordable Care Act has a lot of work ahead of it with more than 45 million Americans currently without any form of health insurance. For public officials getting ready for the implementation of the health care law, wider access to CAM treatments is probably not a priority. But giving patients coverage for even limited access to nontraditional medicine is certainly a step toward the right direction toward solving America’s worsening health problems.

Michael Cahill is Editor of the Vista Health Solutions blog. He has a degree in Journalism from SUNY New Paltz and previously worked as a reporter for the Poughkeepsie Journal and an editor for the Rockland County Times. Follow him on Twitter at @VistaHealth and @ElectronicMike

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The Michael H. Cohen Law Group in Los Angeles, California provides healthcare regulatory, corporate, and litigation legal counsel. We do not offer healthcare insurance services, and express no opinion regarding the foregoing guest editorial.

For more information, contact the Michael H. Cohen Law Group.

Mediating HealthCare and Other Disputes: Mediation and Healing

Michael H. Cohen — Sun, 31 Mar 2013 12:48:36 -0500

Mediation uses many techniques from the healing arts, and can be even further enhanced by knowledge of energy healing.

Specifically, someone trained in techniques such as perceiving chakras, aligning intention, sending energy, and repairing energetic cords can add these abilities to traditional mediation techniques in order to heal broken relationships and help parties find their own creative solutions to difficult disputes.

Here is the article that originally appeared on mediate.com:

Mediation and Healing

by Michael Cohen

July 2004

Mediation is a healing path: it moves parties to reconcile their differences in an atmosphere that, ideally, improves their connectedness, bridges their separate objectives, and integrates rather than fragmenting through adversarial conduct. The parallels between mediation and energy work (also known by various names such as spiritual healing; energy healing; biofield healing) are beyond subtle: mediation aims to produce a “wise agreement” between the parties, according to Roger Fisher and Bill Ury in their classic book, Getting to Yes; similarly, energy work aims to produce a wise agreement within the individual, reconciling fragmented aspects of the self and facilitating a return to wholeness. Mediation builds community, while energy healing, when practiced responsibly, arguably builds communion with one’s self and others.

Thus, prior to entering into a negotiation and during the process, whatever emotions are swirling, one can fuel the exchange, through remembrance and the breath, to continually reset intention. For example, if the intention is to have a healing between the parties—a mutual understanding that repairs the cords between them and enhances relationship—hold that through the meeting. If the intention is to come up with creative, win-win solutions during brainstorming, holding that intention similarly should assist the process.

Of course, ethically (and spiritually), one should hold intentions that are sound, that produce satisfactory results for all sides; holding the intention to “defeat” the other in a win-lose, one-up/one-down dynamic facilitates neither wise agreement nor a better outcome. Similarly, holding a negative intention for the “adversary” as a means to wrestle advantage is neither wise nor advisable. On the other hand, understanding the interconnectedness of everyone in the room—including the mediators as well as the negotiators—can help set an intention that benefits everyone, and infuses the process with positive charge. There is much to be set about the application of techniques from energy to the world of mediation; understanding and wisely using intentionality is a good start.

Aside from these parallels, energy work may be used in mediation—or any negotiation—in a variety of ways. Whether one draws on techniques from Therapeutic Touch, Healing Touch, Polarity Therapy, the Barbara Brennan Healing Science methods that I learned, or even theories from acupuncture and traditional oriental medicine and/or the martial arts, a key to energy work is setting one’s intention. In the latter traditions, intentionality often is said to be rooted in the hara, a physical and energetic point in which one concentrates attention, awareness, focus, breath. By clarifying and then aligning intentionality in the hara, one can hope to produce a better result.

Michael H. Cohen, JD

Education: B.A., Columbia University, New York, 1983. J.D., Boalt Hall School of Law, University of California, Berkeley, 1986. M.B.A., Haas School of Management, University of California, Berkeley, 1988. M.F.A., Iowa Writers' Workshop, University of Iowa, 1990.

Member of the Bar: California (1999), Massachusetts (1988), New York (1988), Washington D.C. (2000).

Selected Legal Experience: Legislative Aide, New York City Councilman Henry J. Stern (1982). Assistant Investment Officer, Municipal Assistance Corporation for the City of New York (1983). Invited to Boston University Law Review (1984). Invited to California Law Review (1984). Member and Book Review Editor, California Law Review (1984-86). Law Clerk, Judge Thomas P. Griesa, United States District Court, Southern District of New York (1986-87). Associate, Davis Polk & Wardwell, New York (corporate department), New York (1990-93). Associate, Shereff, Friedman, Hoffman & Goodman (litigation department), New York (1993). Adjunct Instructor, Brooklyn Law School (1993; legal writing, moot court); Associate Professor, Widener University School of Law and Chapman University School of Law (1993-99; civil procedure, conflicts of laws, constitutional law, criminal law, health law, insurance law); Visiting Professor, Arizona State University (East Campus 1999-00). Associate, Burkhalter, Michaels & George, Orange County, California (2000; Of Counsel, 2001-02). Senior Lecturer, College of the Bahamas (UWI/LLB Program) (2005-; intellectual property, legal methods, law of international organizations, private international law). Principal, Law Offices of Michael H. Cohen (opened in 1999).

If you are interested in mediating a healthcare dispute or any other dispute (i.e., family law dispute, elder law dispute, trust & estate / probate dispute, business dispute, dispute in a litigated case, or other situation), contact the Michael H Cohen Law Group regarding our mediation practice.

The Michael H Cohen Law Group advises businesses in the healthcare, lifestyle, wellness, and other industries, and leads with expertise in issues such as: HIPAA compliance, telemedicine laws, anti-kickback (and Stark and fee-spliting) issues, medical spa legal issues, integrative medicine regulation, FDA compliance (including dietary supplements, cosmetics, OTC drugs, and medical devices), technology (e-commerce, mobile apps, mobile medicine, etc.), and other emerging areas. Contact our technology and healthcare attorneys today for a legal consultation.

A Friend of All Faiths: A Multidimensional Memoir - new review

Michael H. Cohen — Mon, 18 Mar 2013 21:06:31 -0500

"Your Friend of All Faiths book arrived on Friday in time for me to start reading it over the weekend.

Am about at the halfway point. I’m really enjoying your multi-dimensional quest, and your vivid characterizations of self and others. The “Universal Service” you invented is pretty amazing. What a great synthesis. You are also fortunate to have a wider opening in the reality-shield we all have wrapped around our psyches so that you have an access that mystics of all stripes would envy."

— Farida Fotouhi, President, Reality2 LLC

Reality2 is a marketing and advertising agency with over 25 years’ experience with clients ranging from major national brands to entrepreneurial start-ups. The Company applies a
reality-based approach to strategy, creative, production and media.

Cowboy Desert

Michael H. Cohen — Sun, 10 Mar 2013 13:00:38 -0500

Last night I dreamed that I wrote a bestseller called Cowboy Desert (TM), which was made a movie. I asked what this meant, and received this poem.

COWBOY DESERT

A spiritual cowboy

on the frontiers of consciousness

exploring the terrain of the self.

The arid desert,

perfect conditions for this exploration.

You are an experiment in consciousness.

It is part of the Grand Design.

Spirits wills it so.

There is no other way.

You must pass through the eye of the needle.

States expanding scope of practice for physician assistants, nurses, optometrists and phamarcists

Michael H. Cohen — Fri, 15 Feb 2013 21:16:30 -0500

States are looking to expand the scope of practice for physician assistants, nurse practitioners, optometrists, and pharmacists to meet the primary care shortage caused by Obamacare.

The Los Angeles times reports that:

About 350 laws altering what health professionals may do have been enacted nationwide in the last two years, according to the National Conference of State Legislatures. Since Jan. 1, more than 50 additional proposals have been launched in 24 states.

These proposals do not allow non-physicians to completely move into the MD's domain, which is full authorize to diagnose and treat disease. Nonetheless, the proposed legislation will allow non-physician practitioners (NPPs) to do more for patients with chronic diseases such as diabetes.

Such scope of practice expansion is opposed by medical groups--for example:

The California Medical Assn. says healthcare professionals should not exceed their training. Phinney, a pediatrician, said physician assistants and other mid-level professionals are best deployed in doctor-led teams. They can perform routine exams and prescribe medications in consultation with physicians on the premises or by teleconference.

The article did not discuss expanded scope of practice for chiropractors, acupuncturists, massage therapists, and other CAM (complementary and alternative medicine) providers, nor did it mention naturopathic physicians (NDs). Nor were providers such as nutririonists and dietitians mentioned.

The Michael H Cohen Law Group represents healthcare practitioners (such as physicians, nurses, dentists, psychologists, chiropractors, and other clinicians); healthcare facilities (such as hospitals, IDTFs, integrative medicine centers, medical groups, and psychotherapy practices); health-related business (such as manufacturers and distributors of cosmetics, dietary supplements, and medical devices; e-health and telemedicine providers; and medical spas); and entrepreneurs and start-ups on general business legal issues.

Contact our healthcare and FDA law attorneys for your healthcare and FDA legal needs, including licensing, scope of practice and disciplinary issues.

HIPAA Omnibus Rule creates changes in healthcare privacy and security practices

Michael H. Cohen — Sat, 02 Feb 2013 15:16:19 -0500

Health & Human Services released a monster HIPAA Omnibus rule with mega-changes to medical privacy and security law.

While physicians and other health care providers have some time comply, ultimately they will have to change their Notice of Privacy Practices and other documentation.

As well, there are significant penalties, and changes applicable to "business associates" and subcontractors.

We've posted more detailed pieces on our law firm website, in the following series:

HIPAA Omnibus Rule: Part 1 (Overview)

HIPAA Omnibus Rule: Part 2 (Business Associates & Subcontractors)

HIPAA Omnibus Rule: Part 3 (Enforcement & Penalties)

HIPAA Omnibus Rule: Part 4 (Security Rule Changes)

HIPAA Omnibus Rule: Part 5 (Privacy Rule Changes)

HIPAA Omnibus Rule: Part 6 (Business Associate Agreements)

HIPAA Omnibus Rule: Part 7 (Notice of Privacy Practices & Other Provisions)

HIPAA Omnibus Rule: Part 8 (Breach Analysis)

For HIPAA, HITECH, and medical privacy and security expertise, contact the Los Angeles, California-based Michael H Cohen Law Group.

Patient Protection and Affordable Health Care Act - Integrative Medicine Provisions

Michael H. Cohen — Sun, 27 Jan 2013 11:49:16 -0500

Healthcare reform law expands opportunities for integrative medicine, although implementing regulations will have to be developed to truly clear the brush.

In the Integrator Blog, John Weeks provides a useful summary of some key provisions, with commentary:

1. Inclusion of Licensed Practitioners Insurance Coverage

SEC. 2706. NON-DISCRIMINATION IN HEALTH CARE.

(a) Providers- A group health plan and a health insurance issuer offering group or individual health insurance coverage shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider's license or certification under applicable State law. This section shall not require that a group health plan or health insurance issuer contract with any health care provider willing to abide by the terms and conditions for participation established by the plan or issuer. Nothing in this section shall be construed as preventing a group health plan, a health insurance issuer, or the Secretary from establishing varying reimbursement rates based on quality or performance measures.

(b) Individuals- The provisions of section 1558 of the Patient Protection and Affordable Care Act (relating to non-discrimination) shall apply with respect to a group health plan or health insurance issuer offering group or individual health insurance coverage.

2. Inclusion of Licensed Complementary and Alternative Medicine Practitioners in Medical Homes

SEC. 3502. ESTABLISHING COMMUNITY HEALTH TEAMS TO SUPPORT THE PATIENT-CENTERED MEDICAL HOME.

(a) In General- The Secretary of Health and Human Services (referred to in this section as the `Secretary') shall establish a program to provide grants to or enter into contracts with eligible entities to establish community-based interdisciplinary, interprofessional teams (referred to in this section as `health teams') to support primary care practices, including obstetrics and gynecology practices, within the hospital service areas served by the eligible entities. Grants or contracts shall be used to--

(1) establish health teams to provide support services to primary care providers; and

(2) provide capitated payments to primary care providers as determined by the Secretary.

(b) Eligible Entities- To be eligible to receive a grant or contract under subsection (a), an entity shall--

(1)(A) be a State or State-designated entity; or

(B) be an Indian tribe or tribal organization, as defined in section 4 of the Indian Health Care Improvement Act;

(2) submit a plan for achieving long-term financial sustainability within 3 years;

(3) submit a plan for incorporating prevention initiatives and patient education and care management resources into the delivery of health care that is integrated with community-based prevention and treatment resources, where available;

(4) ensure that the health team established by the entity includes an interdisciplinary, interprofessional team of health care providers, as determined by the Secretary; such team may include medical specialists, nurses, pharmacists, nutritionists, dietitians, social workers, behavioral and mental health providers (including substance use disorder prevention and treatment providers), doctors of chiropractic, licensed complementary and alternative medicine practitioners, and physicians' assistants;

3. Integrative Health Care and Integrative Practitioners in Prevention Strategies

SEC. 4001. NATIONAL PREVENTION, HEALTH PROMOTION AND PUBLIC HEALTH COUNCIL.

(d) Purposes and Duties- The Council shall--

(1) provide coordination and leadership at the Federal level, and among all Federal departments and agencies, with respect to prevention, wellness and health promotion practices, the public health system, and integrative health care in the United States;

(2) after obtaining input from relevant stakeholders, develop a national prevention, health promotion, public health, and integrative health care strategy that incorporates the most effective and achievable means of improving the health status of Americans and reducing the incidence of preventable illness and disability in the United States;

(3) provide recommendations to the President and Congress concerning the most pressing health issues confronting the United States and changes in Federal policy to achieve national wellness, health promotion, and public health goals, including the reduction of tobacco use, sedentary behavior, and poor nutrition;

(4) consider and propose evidence-based models, policies, and innovative approaches for the promotion of transformative models of prevention, integrative health, and public health on individual and community levels across the United States;

(5) establish processes for continual public input, including input from State, regional, and local leadership communities and other relevant stakeholders, including Indian tribes and tribal organizations;

(6) submit the reports required under subsection (g); and

(7) carry out other activities determined appropriate by the President.

(f) Advisory Group-

(1) IN GENERAL- The President shall establish an Advisory Group to the Council to be known as the `Advisory Group on Prevention, Health Promotion, and Integrative and Public Health' (hereafter referred to in this section as the `Advisory Group'). The Advisory Group shall be within the Department of Health and Human Services and report to the Surgeon General.

(2) COMPOSITION-

(A) IN GENERAL- The Advisory Group shall be composed of not more than 25 non-Federal members to be appointed by the President.

(B) REPRESENTATION- In appointing members under subparagraph (A), the President shall ensure that the Advisory Group includes a diverse group of licensed health professionals, including integrative health practitioners who have expertise in--

(i) worksite health promotion;

(ii) community services, including community health centers;

(iii) preventive medicine;

(iv) health coaching;

(v) public health education;

(vi) geriatrics; and

(vii) rehabilitation medicine.

(3) PURPOSES AND DUTIES- The Advisory Group shall develop policy and program recommendations and advise the Council on lifestyle-based chronic disease prevention and management, integrative health care practices, and health promotion.

4. Dietary Supplements in Individualized Wellness Plans

SEC. 4206. DEMONSTRATION PROJECT CONCERNING INDIVIDUALIZED WELLNESS PLAN.

Section 330 of the Public Health Service Act (42 U.S.C. 245b) is amended by adding at the end the following:

`(s) Demonstration Program for Individualized Wellness Plans-

`(1) IN GENERAL- The Secretary shall establish a pilot program to test the impact of providing at-risk populations who utilize community health centers funded under this section an individualized wellness plan that is designed to reduce risk factors for preventable conditions as identified by a comprehensive risk-factor assessment.

`(2) AGREEMENTS- The Secretary shall enter into agreements with not more than 10 community health centers funded under this section to conduct activities under the pilot program under paragraph (1).

`(3) WELLNESS PLANS-

`(A) IN GENERAL- An individualized wellness plan prepared under the pilot program under this subsection may include one or more of the following as appropriate to the individual's identified risk factors:

`(i) Nutritional counseling.

`(ii) A physical activity plan.

`(iii) Alcohol and smoking cessation counseling and services.

`(iv) Stress management.

`(v) Dietary supplements that have health claims approved by the Secretary.

`(vi) Compliance assistance provided by a community health center employee.

`(B) RISK FACTORS- Wellness plan risk factors shall include--

`(i) weight;

`(ii) tobacco and alcohol use;

`(iii) exercise rates;

`(iv) nutritional status; and

`(v) blood pressure.

`(C) COMPARISONS- Individualized wellness plans shall make comparisons between the individual involved and a control group of individuals with respect to the risk factors described in subparagraph (B).

`(4) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out this subsection, such sums as may be necessary.'

5. Licensed Complementary and Alternative Providers and Integrative Practitioners in Workforce Planning

SEC. 5101. NATIONAL HEALTH CARE WORKFORCE COMMISSION.

(i) Definitions- In this section:

(1) HEALTH CARE WORKFORCE- The term 'health care workforce' includes all health care providers with direct patient care and support responsibilities, such as physicians, nurses, nurse practitioners, primary care providers, preventive medicine physicians, optometrists, ophthalmologists, physician assistants, pharmacists, dentists, dental hygienists, and other oral healthcare professionals, allied health professionals, doctors of chiropractic, community health workers, health care paraprofessionals, direct care workers, psychologists and other behavioral and mental health professionals (including substance abuse prevention and treatment providers), social workers, physical and occupational therapists, certified nurse midwives, podiatrists, the EMS workforce (including professional and volunteer ambulance personnel and firefighters who perform emergency medical services), licensed complementary and alternative medicine providers, integrative health practitioners, public health professionals, and any other health professional that the Comptroller General of the United States determines appropriate.

(2) HEALTH PROFESSIONALS- The term 'health professionals' includes--

(A) dentists, dental hygienists, primary care providers, specialty physicians, nurses, nurse practitioners, physician assistants, psychologists and other behavioral and mental health professionals (including substance abuse prevention and treatment providers), social workers, physical and occupational therapists, public health professionals, clinical pharmacists, allied health professionals, doctors of chiropractic, community health workers, school nurses, certified nurse midwives, podiatrists, licensed complementary and alternative medicine providers, the EMS workforce (including professional and volunteer ambulance personnel and firefighters who perform emergency medical services), and integrative health practitioners;

(B) national representatives of health professionals;
(C) representative of schools of medicine, osteopathy, nursing, dentistry, optometry, pharmacy, chiropractic, allied health, educational programs for public health professionals, behavioral and mental health professionals (as so defined), social workers, pharmacists, physical and occupational therapists,m oral health care industry dentistry and dental hygiene and physician assistant; ...

6. Experts in Integrative Health and State Licensed Integrative Health Practitioners in Comparative Effectiveness Research

SEC. 6301. PATIENT-CENTERED OUTCOMES RESEARCH.

Part D--Comparative Clinical Effectiveness Research
(d) Duties-[Under (4)

`(1) IDENTIFYING RESEARCH PRIORITIES AND ESTABLISHING RESEARCH PROJECT AGENDA-

`(A) IDENTIFYING RESEARCH PRIORITIES- The Institute shall identify national priorities for research, taking into account factors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice variations and health disparities in terms of delivery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, outcomes, and preferences, the relevance to patients and clinicians in making informed health decisions, and priorities in the National Strategy for quality care established under section 399H of the Public Health Service Act that are consistent with this section.

`(B) ESTABLISHING RESEARCH PROJECT AGENDA- The Institute shall establish and update a research project agenda for research to address the priorities identified under subparagraph (A), taking into consideration the types of research that might address each priority and the relative value (determined based on the cost of conducting research compared to the potential usefulness of the information produced by research) associated with the different types of research, and such other factors as the Institute determines appropriate.
...

`(4) APPOINTING EXPERT ADVISORY PANELS-

`(A) APPOINTMENT-

`(i) IN GENERAL- The Institute may appoint permanent or ad hoc expert advisory panels as determined appropriate to assist in identifying research priorities and establishing the research project agenda under paragraph (1) and for other purposes.

`(ii) EXPERT ADVISORY PANELS FOR CLINICAL TRIALS- The Institute shall appoint expert advisory panels in carrying out randomized clinical trials under the research project agenda under paragraph (2)(A)(ii). Such expert advisory panels shall advise the Institute and the agency, instrumentality, or entity conducting the research on the research question involved and the research design or protocol, including important patient subgroups and other parameters of the research. Such panels shall be available as a resource for technical questions that may arise during the conduct of such research.

`(iii) EXPERT ADVISORY PANEL FOR RARE DISEASE- In the case of a research study for rare disease, the Institute shall appoint an expert advisory panel for purposes of assisting in the design of the research study and determining the relative value and feasibility of conducting the research study.

`(B) COMPOSITION- An expert advisory panel appointed under subparagraph (A) shall include representatives of practicing and research clinicians, patients, and experts in scientific and health services research, health services delivery, and evidence-based medicine who have experience in the relevant topic, and as appropriate, experts in integrative health and primary prevention strategies. The Institute may include a technical expert of each manufacturer or each medical technology that is included under the relevant topic, project, or category for which the panel is established.

...
(f) Board of Governors-

`(1) IN GENERAL- The Institute shall have a Board of Governors, which shall consist of the following members:

`(A) The Director of Agency for Healthcare Research and Quality (or the Director's designee).

`(B) The Director of the National Institutes of Health (or the Director's designee).

`(C) Seventeen members appointed, not later than 6 months after the date of enactment of this section, by the Comptroller General of the United States as follows:

`(i) 3 members representing patients and health care consumers.

`(ii) 5 members representing physicians and providers, including at least 1 surgeon, nurse, State-licensed integrative health care practitioner, and representative of a hospital.

`(iii) 3 members representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits.

`(iv) 3 members representing pharmaceutical, device, and diagnostic manufacturers or developers.

`(v) 1 member representing quality improvement or independent health service researchers.
' (vi) 2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency.

7. Certified Professional (Direct-Entry) Midwives Covered in Birth Centers

SEC. 2301. COVERAGE FOR FREESTANDING BIRTH CENTER SERVICES.
(a) In General- Section 1905 of the Social Security Act (42 U.S.C. 1396d), is amended--

(1) in subsection (a)--

(A) in paragraph (27), by striking `and' at the end;

(B) by redesignating paragraph (28) as paragraph (29); and

(C) by inserting after paragraph (27) the following new paragraph:

`(28) freestanding birth center services (as defined in subsection (l)(3)(A)) and other ambulatory services that are offered by a freestanding birth center (as defined in subsection (l)(3)(B)) and that are otherwise included in the plan; and'; and

(2) in subsection (l), by adding at the end the following new paragraph:

`(3)(A) The term `freestanding birth center services' means services furnished to an individual at a freestanding birth center (as defined in subparagraph (B)) at such center.

`(B) The term `freestanding birth center' means a health facility--

`(i) that is not a hospital;

`(ii) where childbirth is planned to occur away from the pregnant woman's residence;

`(iii) that is licensed or otherwise approved by the State to provide prenatal labor and delivery or postpartum care and other ambulatory services that are included in the plan; and

`(iv) that complies with such other requirements relating to the health and safety of individuals furnished services by the facility as the State shall establish.

`(C) A State shall provide separate payments to providers administering prenatal labor and delivery or postpartum care in a freestanding birth center (as defined in subparagraph (B)), such as nurse midwives and other providers of services such as birth attendants recognized under State law, as determined appropriate by the Secretary. For purposes of the preceding sentence, the term `birth attendant' means an individual who is recognized or registered by the State involved to provide health care at childbirth and who provides such care within the scope of practice under which the individual is legally authorized to perform such care under State law (or the State regulatory mechanism provided by State law), regardless of whether the individual is under the supervision of, or associated with, a physician or other health care provider. Nothing in this subparagraph shall be construed as changing State law requirements applicable to a birth attendant.'...

This is a useful resource for those wanting a handy summary of integrative medicine provisions included, albeit in a preliminary way, in the legislation.

Unsupported Weight Loss Claims Continue to Trigger FTC Enforcement

Michael H. Cohen — Sun, 27 Jan 2013 11:36:40 -0500

Weight loss claims continue to trigger enforcement by FTC for false and deceptive advertising.

The FTC was active in 2012 against a variety of manufacturers making unsupported weight loss claims. This includes a diet plan marketer (Medifast Inc.) which was ordered to pay a $3.7 million penalty over claims for meal replacement products.

Medifast allegedly violated an earlier FTC settlement order. The FTC Press Release states:

Subsidiary of Diet Plan Marketer Medifast Inc. to Pay $3.7 Million to Settle FTC Charges
Jason Pharmaceuticals sells Medifast-brand low-calorie meal substitutes. Its most advertised plan is the Medifast “5 and 1” plan that consists of 800-1,000 calories per day. Filed on the FTC’s behalf by the Department of Justice, the complaint against Jason Pharmaceuticals alleges that the company made unsupported representations since at least November 2009 in radio, television, Internet, and print advertisements that consumers using Medifast programs and products would lose two to five pounds each week.
The company also represented that the experiences of consumer endorsers featured in the advertisements were typical, and that consumers would lose more than 30 pounds, according to the complaint.

One such ad stated:
“Why Medifast? Three great reasons.
Cynthia Lujan lost 73 lbs on Medifast! Cindy Daniels lost 43 lbs on Medifast!
Jennifer Lilley lost 70 lbs on Medifast!
You can lose up to 2 to 5 pounds per week on Medifast.”

Under the new settlement order announced today, Jason Pharmaceuticals is prohibited from misrepresenting that consumers who use any low-calorie meal replacement program, including the Medifast “5 and 1” plan, can expect to achieve the same results that an endorser does, or can lose a particular amount of weight or maintain the weight loss. Such representations must be non-misleading and backed by competent and reliable scientific evidence that consists of at least one adequate and well-controlled human clinical study of the low-calorie meal replacement program, or a study that follows a protocol detailed in the settlement order.

Under the settlement order, the company also is prohibited from making any other representation about the health benefits, safety, or side effects of any low-calorie meal replacement program, unless the representation is non-misleading and backed by competent and reliable scientific evidence that is generally accepted in the profession to yield accurate results.

The company also is prohibited from misrepresenting that any doctor, health professional, or endorser recommends a weight-loss product, program, service, drug, or dietary supplement.

Consumers should carefully evaluate advertising claims for weight loss. For more information, see the FTC’s consumer education piece: Who Cares: Weight Loss Promises.

The FTC cares about weight loss promises and is constantly scanning the Internet for violators. If your company has a weight loss product or claim, be sure to seek legal counsel regarding FDA and FTC legal and regulatory issues. Our FDA and FTC legal team can review your marketing copy, including Web copy, to counsel you on compliance issues. The Michael H Cohen Law Group has experience in FDA and FTC legal issues, including helping companies develop pro-active advertising and marketing campaigns, while understanding the legal boundaries that can lead to enforcement actions. Contact the Michael H Cohen Law Group for your healthcare legal and regulatory needs today.

Legal lines blur between coaching, hypnotherapy, and psychology (unlicensed practice)

Michael H. Cohen — Sun, 27 Jan 2013 11:03:36 -0500

Is hypnotherapy the unlicensed practice of medicine or psychology? Is life coaching legally safe?

A new case in Colorado suggests that hypnosis and hypnotherapy are not legally safe, and that practicing these modalities in the coaching setting can result in legal action.

A legal defense fund has been established by the International Research Institute, LLC for a life coach and hypnotherapist in Denver:

The Colorado Mental Health Board, which incorrectly believes that all hypnosis is either stage hypnosis or psychotherapy, issued a cease and desist order.

Deciding to fight this abusive action, Ms. Grant has incurred a tremendous financial burden just considering the over $13,000 in legal fees, which have already been billed to her and her husband. She did so not only to fight for her right to practice as a coach. She also realized that if she did not contest their action, all hypnotherapists, NLP practitioners, and coaches who may use any type of imagery or suggestion could have their right to practice curtailed. The case law that could result from a negative finding may be used as legal justification for action in any jurisdiction in the United States and may be cited in cases considered in courses around the world.

The hypnosis organization notes that in August 2011:

The Colorado Department of Regulatory Agencies at the request of the Colorado Mental Health Board, filed a cease and desist order against Zoilita Grant using as evidence an advertisement for her state licensed occupational school, Colorado Coaching and Hypnotherapy Training Institute.
At that time Zoilita sent a letter to Colorado Department of Regulatory Agencies (DORA) explaining that the advertisement was for her school and that she was a teaching approved trainings and that in her private practice she was a coach who specialized in working with small business owners. She referred DORA to both her school site and personal site www.ZoilitaGrant.net.

DORA then opened an investigation and Zoilita retained legal representation. DORA continued to allege that Zoilita Grant, a coach who operates out of the Denver area, was practicing psychotherapy without a license. Their claim was due to the fact that Ms. Grant, who was formerly licensed by the board while performing as a clinical hypnotherapist and hypnotherapy trainer, was practicing hypnotherapy in her activities as a coach. Ms. Grant regularly uses hypnosis as a training tool with her coaching clients.

The Board's allegation further stipulated that all hypnosis is either stage hypnosis or psychotherapy and therefore Ms. Grant was violating the law requiring psychotherapists to be licensed in the State of Colorado.

Laws involving hypnotherapy diverge across states. Some states explicitly mention hypnosis and/or hypnotherapy as a medical (or psychological) modality, and restrict lay use of these practices. Others are silent or ambiguous.

Medical and psychological licensing statutes define the scope of their licensed professions very broadly, so that unlicensed practitioners can easily run afoul of regulatory tripwires.

A number of states, such as California, Rhode Island, and Minnesota, have enacted statutes protecting non-licensed practitioners from prosecution for unlicensed medical practice, so long as they make a proper disclosure to their clients, and do not engage in medical diagnosis or treatment. These statutes, though, are relatively untested; and usually do not provide any explicit carve-out to the legal definition of psychology.

In any life coaching or hypnotherapy practice, be sure to check with an attorney experienced in legal issues involved alternative therapies, complementary medicine, and integrative medicine. Contact the Michael H Cohen Law Group if you have legal questions or concerns about your practice, whether it involves life coaching, hypnosis, naturopathy, natural medicine, dietary supplements, or other holistic health practices.

California proposes legislation regulating acupuncturist's use of title "doctor"

Michael H. Cohen — Fri, 11 Jan 2013 19:55:48 -0500

California recently proposed legislation further regulating an acupuncturist's use of the title, "doctor."

In general, a practitioner using the title "doctor" must be aware of state law restrictions. Simply having a degree such as PhD does not necessarily confer authority to use the title "doctor," and, in addition, using the title can be misleading and lead to legal consequences.

Here is the California legislation:

Senate Bill No. 628
CHAPTER 326
An act to add Section 4936 to the Business and Professions Code, relating
to acupuncture.
[Approved by Governor September 14, 2012. Filed with
Secretary of State September 14, 2012.]
legislative counsel’s digest
SB 628, Yee. Acupuncture: regulation.
Existing law, the Acupuncture Licensure Act, establishes the Acupuncture
Board and makes it responsible for enforcing and administering the act,
including licensing persons who meet specified licensure requirements.
Under the act, licensees are titled “acupuncturists,” and are authorized to
perform designated activities pursuant to their license. The unlawful practice
of acupuncture and any other violation of the act is a crime.
This bill would make it unprofessional conduct for an acupuncturist to
use the title of “Doctor” or use the abbreviation “Dr.” in connection with
the practice of acupuncture unless he or she holds a license authorizing that
use or a specified degree. This bill would also make it unprofessional conduct
for an acupuncturist to use the title “Doctor” or use the abbreviation “Dr.”
without indicating the type of license that entitles him or her to use that title.
The people of the State of California do enact as follows:
SECTION 1. Section 4936 is added to the Business and Professions
Code, to read:
4936. (a) It is unprofessional conduct for an acupuncturist to use the
title “Doctor” or the abbreviation “Dr.” in connection with the practice of
acupuncture unless he or she possesses a license that authorizes the use or
possesses an earned doctorate degree from an accredited, approved, or
authorized educational institution as set forth under Chapter 8 (commencing
with Section 94800) of Part 59 of Division 10 of Title 3 of the Education
Code, which is in acupuncture, oriental medicine, a biological science, or
is otherwise related to the authorized practice of an acupuncturist as set
forth in Sections 4927 and 4937.
(b) The use of the title “Doctor” or the abbreviation “Dr.” by an
acupuncturist as authorized in subdivision (a) without further indicating the
type of license or degree which authorizes that use shall constitute
unprofessional conduct.

If you are unsure about your use of a professional title such as "doctor" and the legal consequences, contact an experienced health care attorney who can counsel you.

The heart of healing is now

Michael H. Cohen — Fri, 21 Dec 2012 14:48:07 -0500

"The heart of healthcare reform is not about insurance and economics, but about bringing together all the dimensions of healing within our systems of care, and developing legal frameworks to support this integration."

A colleague of mine, a Taiwanese-born law student, reminded me of these words I wrote some years ago in one of my books.

He wrote:

Today, Dec 21, is a very special day which means human beings will step into a new area. It is also the day to remind old friend. More and more people will have the supernatural abilities because of the earth is moving into a new energy zone. More and more people will realize the truth of the world. Energy healing and holistic medicine will be the main stream in the not far future. We are still working together to make it reality.

Now I am busy preparing U.S. bar exam, hoping we can work together to promote alternative medicine in the future. I will recover social activities and will back to China after Aug 2013, to set up all kinds of connections related alternative medicine and health promotion. I will report you my progress.

To achieve your believe "the heart of healthcare reform is not about insurance and economics, but about bringing together all the dimensions of healing within our systems of care, and developing legal frameworks to support this integration." is not a easy thing, but it should be a trend.

It's important to be in the right place, at the right time, doing the right thing. As a lawyer representing physicians, chiropractors, acupuncturists, naturopathic medical doctors, sleep centers, clinical labs, substance abuse recovery centers, integrative medicine clinics, hospitals, medical groups, fitness and nutrition experts, online health and telemedicine businesses, and others in the holistic health and other healthcare spaces for their legal needs, is the right place.

Another friend today also reminded me of my writing - that seems to be a theme:

Examples of excellence:

"The choice of town must have had a purpose. Perhaps this city of alternate lifestyles, witches, warlocks and free-thinking mystical savants would have shocked those founding fathers, mothers, servants, infants, even with their ideals of tolerance and freedom. Yet again, I thought, perahps those same sober, pluralistic parents were reincarnated today as pink-haired, roller-blade teens, celebrants of personal expression, freed from the ravages of parental supervision to claim their deepest, internal heritage. Freedom was the attained end, here, and that ageless ideal bound all the town's inhabitants." (A Question of Time, page 12)

"Thus my mind whirred on, wrapped in its own reverie, forgetting, perhaps, the fact of its being encased in a body, within a metal body (the taxi), navigating artifical constructions on soil (buildings), while spinning around a home star (the sun)." (A Question of Time, page 15)

I am grateful to have been a positive transformational influence on friends and that my own integration of law, medicine and spirituality in my own being has helped others.

Attorney Michael H. Cohen is Principal of the Michael H. Cohen Law Group in Los Angeles, California.

He represents a broad range of healthcare providers, including medical and osteopathic doctors; psychologists, nurses, dentists and other allied health professionals; and complementary and alternative medicine practitioners such as chiropractors, acupuncturists, and massage therapists. His clients include clinical care facilities, dietary supplement companies, healthcare educational institutions, health insurance organizations, medical spas, medical device makers, telemedicine providers, and entrepreneurs in the health, wellness, and lifestyle industries.

Clients nationwide seek Mr. Cohen’s advice on business structure and entity formation; credentialing, licensing, and scope of practice concerns; professional disciplinary matters; employment contracts; informed consent and malpractice liability issues; HIPAA and other regulatory compliance; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and other FDA matters; website disclaimers and review of marketing materials; and other advice. Mr. Cohen is also highly sought after for special legal counsel by other attorneys and law firms in the areas of complementary/integrative medicine and aesthetic/cosmetic medicine.

End of the World as We Know It Raise Health, Healing & Law Opportunities

Michael H. Cohen — Thu, 13 Dec 2012 12:21:51 -0500

If it's the end of the world as we know it, then what does the new world bring in terms of opportunities for health, healing, prosperity, and fulfillment - and how can the law support this new ushering in?

That may seem like an odd preoccupation, but it's the subject of my book, Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation.

As early as 1995, I wrote:

The debate over health care reform has challenged pivotal assumptions about the way Americans care for themselves and their families. For example, the possibility of health care rationing has challenged the assumption that a patient receives all the care necessary to regain health. ¹ Similarly, advances in medical technology have challenged the assumption that nature sets the bounds of birth ² and death. ³ Many diseases lead to chronic or terminal hospitalization ⁴ and to a societal perception that technology alone cannot heal disease. ⁵

These challenges in foundational assumptions about health care have resulted in a paradigm shift--or at least a change in perspective or emphasis--from orthodox medicine ⁶ to more holistic approaches to healing. ⁷ The shift in part reflects a recognition that the patient, as a person, matters, that mind and emotions do affect health, and that orthodox medicine has limits, or at least can be complemented by alternative healing methods

Today we have integrative medicine, and the law around medicine and healing continues to evolve.

Yesterday was 12/12/12. Numerology, I learned, that adds up to 9, which signifies both the completion of old patterns and the initiation of the new. The bringing of the feminine nurturing, healing energy to the Earth and the end of warfare consciousness.

I was moved by a channeled message from Judy Sartori in which she proclaims the coming capital D Disclosure of contacts showing that we are not alone in the multiverse, that our species-centric perspective about to hit the Singularity.

Contrast that with these words from a healer - acupuncturist friend, not as optimistic but resonant in the way they capture the Old Earth patterns:

As for me Michael and 12/21 I am patiently waiting but and not excited or anticipating much. Maybe my way of not getting my hopes up. When I look around the world I can not see any sweeping uplifting of consciousness, just more stupid human suffering piled upon more human suffering, attaching and killing each other over pieces of dirt and scrapes of gold.

If we are to change it truly will take an invasion of our consciousness from the stars. I hope it happens for all our sake. Either next week, in our lifetime or down the road. Otherwise it will be countless years before we stop fighting over whose God should rule or what race of man is entitled to the most marbles.

For now we must endure, the speaker is saying.

I have also learned from this same person about the transformational potential in the human spirit, and about our ability to reach out and connect with energies and forces in the cosmos larger than our current rational mind. (See also A Tribute to John Mack).

What this means for me professionally is that working on legal issues governing the delivery of health and healing products and services, is "on mission" - in sync with the integration of head and heart, mind and breath, masculine and feminine, and the end and beginning of our notion of time.

Michael H. Cohen is a health care law and business law attorney providing corporate and regulatory advice to businesses and physicians, acupuncturists, naturopathic doctors, homeopaths and others in the holistic health, wellness, and green industries. He works with telemedicine, medical devices, FDA issues, and cutting-edge technologies, and gives clear legal advice to grow your business.

Complementary and integrative medicine - best cities

Michael H. Cohen — Tue, 11 Sep 2012 16:34:06 -0500

Best cities for complementary, and alternative / integrative medicine including San Francisco and Denver.

Oyher cities include: Seattle, Washington; Phoenix, Arizona; New York; San Diego and Los Angeles, California; Baltimore, Maryland; and Ft. Lauderdale, Florida.

For example:

Baltimore, Md.:

Maryland is another state that doesn’t seem like a prime candidate for being an alternative medicine hotspot, but you just might be surprised. There are numerous alternative health facilities in the city, ranging from acupuncturists to holistic healers. Additionally, head to the University of Maryland Medical Center to see CAM, from Reiki to acupuncture, being integrated into patient care. Johns Hopkins, one of the leading hospitals in the nation, also offers access to CAM and even boasts a Center for Complementary and Alternative Medicine, which does research into all areas of non-traditional treatment.

Remember that both non-licensed and licensed CAM practitioners offer services, and that licensure laws differ across states. For example, naturopathic medicine and acupuncture are not licensed in every state.

Practitioners must be careful not to intrude on the practice of medicine, psychology, nutrition, and so on, where licensure for these professions is mandatory.

For more information about licensing laws and limitations with respect to CAM practitioners, consult an attorney familiar with legal rules governing complementary, alternative, and integrative medicine.

Retail Clinics - Legal Issues Continue

Michael H. Cohen — Sat, 25 Aug 2012 20:19:56 -0500

Retail clinics with boutique (or concierge medicine) practices are on the rise, a study finds, but legal challenges continue.

Visits To Retail Clinics Grew Fourfold From 2007 To 2009, Although Their Share Of Overall Outpatient Visits Remains Low, is the name of the study by Ateev Mehrotra, a policy analyst at RAND Corp. and associate professor of medicine at the University of Pittsburgh School of Medicine, and Judith R. Lave, a professor of health economics at the University of Pittsburgh.

According to the article:

Visits to retail clinics increased from 1.48 million visits in 2007 to 5.97 million in 2009, representing roughly $460 million of healthcare spending in that year.
This represented a small share of overall outpatient care visits, which included 117 million trips to the emergency room and 577 million visits to physician offices.
Most of the visits for those 65 and older involved vaccinations for influenza, as opposed to care for chronic conditions.
Of total visits to retail clinics in 2007 -2009, 21.8% were for preventative care (including vaccinations) and 78.2% were for acute care (such as upper respiratory infections).
Only 1% of retail clinic visits during this period involved treatment for chronic disease.

The study did not draw any conclusions about the likely impact of the Affordable Care Act. This study adds to mounting data suggesting that primary care is changing and that trends are intensifying to move medicine out in communities, whether via telemedicine, concierge practices, or otherwise. Legal challenges relating to licensing, scope of practice, malpractice liability and standard of care will continue.

Medical spa laws toughened in California with greater penalties and enforcement

Michael H. Cohen — Sat, 28 Jul 2012 14:37:36 -0500

California has increased enforcement and penalties for unlicensed medical practice by medical spa owners and operators.

For our two posts, see:

California Steps Up Enforcement with New Law Targeting Medical Spa Treatments: Part 1 (Increased Enforcement, Penalties)

California Steps Up Enforcement with New Law Targeting Medical Spa Treatments: Part 2 (Corporate Practice of Medicine Issues; Legal Strategies)

Consult an experienced healthcare legal team that understands medical spa legal issues. Contact the Michael H. Cohen Law Group today.

Legal enforcement pressures increase for medical spas

Michael H. Cohen — Sat, 09 Jun 2012 11:31:11 -0500

Medical spas are facing greater regulatory enforcement and legal attention as authorities step up sweeps.

The California Medical Board just released a press release announcing one such action:

Medical Board investigation leads to criminal charges
against four suspects for practicing medicine without a license

SACRAMENTO — After being charged with the crimes of practicing medicine without a license and conspiring to aid and abet the unlicensed practice of medicine, four suspects have agreed to surrender pursuant to warrants issued for their arrest. The criminal charges against all four suspects stem from an investigation by investigators with the Medical Board of California’s Operation Safe Medicine. "The mission of the Medical Board is public protection, and this action reflects the Board's ongoing commitment to that mission," said Linda Whitney, executive director of the Medical Board.

Charged with felonies was Dana Elise Payinda, owner of Laser Solutions in Beverly Hills, CA for practicing medicine without a license. Debra Beth Luftman, M.D. was charged with aiding and abetting the unlicensed practice of medicine. Tracy Lynn Poire and Kimberly Benner, R.N. were also charged with practicing medicine.

The Medical Board received a complaint alleging that medical procedures were being conducted at Laser Solutions, and inappropriate medical services were being provided. Undercover operations confirmed that medical treatments were being rendered by non-physicians and prescription medications were being sold without a physician’s order or without the patient being seen by a doctor.

Investigators from the Board’s Operation Safe Medicine served a search warrant in December and seized evidence of illegal ownership and the illegal practice of medicine.

The public record documents in this case can be accessed on our Web site at www.mbc.ca.gov under the heading “Enforcement Public Documents.”

Consumers are urged to verify the medical license of any practitioner prior to receiving any medical services by contacting the Board, www.mbc.ca.gov or (800) 633-2322.

Notably, enforcement is going beyond the cease-and-desist letter and into criminal sanctions for unlicensed practice of medicine.

Medical spas can face a variety of medi-spa legal challenges, including:

unlicensed medical practice
aiding and abetting unlicensed practice of medicine, and corporate practice of medicine
investigation and discipline of physicians for letting laypersons "rent a license"
Board investigation of nurses, cosmetologists, and estheticians, and other health care providers
anti-kickback and fee-splitting scrutiny
legal challenges to integrative medicine practices
regulatory challenges involving supervision, scope of practice, and use of non-licensed health care providers

In order to properly address legal compliance, whether to mitigate risks and stave off enforcement action, or to handle an investigation, medical spa owners and clinicians should consult with experienced medi-spa legal counsel. Contact a skilled health care lawyer who understands the medical spa business and larger wellness industry, and who can provide appropriate legal guidance and counsel.

Lawsuit Challenges Board Investigation Re Non-Licensed Nutritional Advice

Michael H. Cohen — Thu, 31 May 2012 14:39:34 -0500

A blogger is suing the North Carolina Board of Dietetics/Nutrition for First Amendment violations of his free speech right, after he was investigated and charges with unlicensed practice of dietetics.

Unlicensed practice - whether of medicine, psychology, nutrition and dietetics, or massage therapy - is often considered criminal activity in most states.

Recently, our law firm has noticed an uptick in representation of clients who are under investigation for unlicensed practice of nutrition and dietetics. Enforcement authorities increasingly seem to be investigating non-licensed practitioners, and these practitioners frequently attend courses for integrative and holistic nutrition without being aware that their certificates will not protect them from government action.

Now, the Institute of Justice is filing a First Amendment claim on behalf of one such practitioner:

That's where Steve Cooksey, from Stanley, N.C., comes in. In February 2009, Cooksey was rushed to the hospital in a near diabetic coma. After years of sedentary living and poor diet, he had developed Type II diabetes. His doctors told him he would be dependent on drugs and insulin for the rest of his life.

While in the hospital, Cooksey spoke with a North Carolina-licensed dietitian who told him to eat a high-carbohydrate/low-fat diet, limit his caloric intake, monitor his blood sugar and inject insulin as needed. But as Cooksey began reading more about his condition in books and on the Internet, he became increasingly skeptical of the dietician's advice. Because diabetes is an inability to properly process sugar, he found himself attracted to theories by advocates of low-carbohydrate/high-fat diets. After much research, Cooksey eventually settled on a "Paleolithic" diet, which involves eating food similar to that eaten by our Stone Age ancestors, eschewing sugars, processed foods and starches in favor of fresh vegetables, fish, meats, eggs, fats and nuts.

After adopting a Paleolithic diet, Cooksey underwent a dramatic personal transformation. He lost 78 pounds and is now in excellent health; he freed himself of drugs and doctors, normalized his blood sugar and insulin, and considers himself fit and energized. Cooksey started a blog to share his experience and advice, becoming an advocate for the Paleolithic diet on his free Web site, Diabetes-Warrior.net.

As his Web site grew in popularity, Cooksey developed friendships with many of his readers, several of whom he began advising and counseling on how to overcome the challenges of adopting a Paleolithic diet. Eventually, he began offering a one-on-one coaching service, whereby for a fee he would provide this same sort of advice, counseling and encouragement in phone calls and e-mails to customers. Cooksey also started to receive questions from readers, which he would respond to in a free Dear Abby-style online advice column.

Unfortunately for Cooksey, his Web site caught the attention of authorities. On Jan. 13, Cooksey received a phone call from the North Carolina Board of Dietetics/Nutrition informing him that his advice about what to buy at the grocery store — even his uncompensated advice to friends — constituted the unlicensed and, hence, criminal practice of dietetics. The board sent him a 19-page print-up of his Web site, which its members had gone through with a red pen, informing him that his private, uncompensated advice to friends is illegal "assessing," that the published advice in his Dear Abby-style column is illegal "counseling/advising," and that his coaching service is illegal, too. The red-pen review struck out various statements the board members claimed he could not legally make unless he became a licensed dietician, a process that takes years and costs thousands of dollars. The penalties for violating the dietetics-licensure statute range from fines to jail time.

In Complementary & Alternative Medicine: Legal Boundaries & Regulatory Perspectives, I described case law in which courts held that the 10th Amendment - the police power (or power to regulate health, safety, welfare, and morals) trumps 1st Amendment free speech.

The current lawsuit attempts to strike a blow for the First Amendment against occupational licensing laws. Writing for the Institute for Justice, a nonprofit, public interest law firm, the attorney who filed the case describes nutritional board investigations as "a lucrative, status-enhancing monopoly over the provision of dietary advice."

This may be a landmark case defining the rights of non-licensed providers. In the meanwhile, practitioners who offer nutritional advice should consult with experienced health law attorneys to assess whether they are within the legally scope of practice of a licensed profession, or, compliant with laws in their state governing nutritional advice.

Contact the Michael H. Cohen Law Group if you are practicing nutrition and are under investigation or simply need legal advice to determine your level of risk and regulatory compliance.

Mobile medicine apps are the future: legal issues remain

Michael H. Cohen — Tue, 27 Mar 2012 20:40:16 -0500

Mobile medicine apps are the future, as we move increasingly into digital, virtual communication; yet FDA medical device and other legal issues remain.

Recently it was reported that everything in medicine in going mobile:

Cardiologist Eric J. Topol, MD, was on a cross-country flight when an attendant made an announcement asking if there was a doctor on board.

Dr. Topol, chief academic officer for Scripps Health, responded and was brought to a man who was in obvious trouble. Only a year or two ago, Dr. Topol would have had to make an educated guess and hope he could take care of the patient until the plane landed.

This time, though, he pulled out his iPhone, and with an app that produces an electrocardiogram, he determined that the patient was having a heart attack. The plane made an emergency landing while paramedics waited on the ground to take the patient directly to surgery to open the blocked arteries causing the attack.

Though the story is an extreme example, it illustrates why mobile technology was such a big focus of the 2012 annual meeting of the Healthcare Information and Management Systems Society, where Dr. Topol shared the story. With each passing day, mobile technology is giving physicians more opportunities to practice medicine from anywhere, at any time....

Mobile technology is bringing the patient’s bedside to the physician’s smartphone or tablet computer.....

Just a few years ago, physicians with patients in hospitals either had to be at the patient’s bedside to get a complete view of what was going on or rely on a floor nurse’s interpretation of what the patient’s monitoring devices showed.

Mobile technology has made it possible to bring the patient’s bedside to the physician’s smartphone or tablet.

Applications can send a physician real-time updates on a patient’s condition regardless of where the physician is. A doctor can monitor the wave-forms of cardiac monitors, contraction and fetal monitors, ventilators, and a host of other bedside monitors. A dashboard displays a patient’s vitals and lab values, and all the information from the patient’s electronic health record can be accessed from a device small enough to fit in a pants pocket.

If you are fan of Ray Kurzweil, who wrote The Age of Spiritual Machines and The Singularity Is Near, you'll recognize this scenario: from Web to mobile to implants in our bodies - tiny nano robots that monitor our health and give us instantaneous boosts and repair. The emphasis on mobile medical technology is a way-station to that reality.

FDA and other legal and regulatory issues, however loom.

Recently, for example, the FDA announced that when cellphones are used as medical devices, they are subject to legal rules and regulation governing medical devices. Smart phone? Smart FDA.

Telemedicine and legal rules governing corporate practice of medicine and unlicensed medical practice also may apply. For example, see:

Intellectual property concerns, including copyright, trademark, and patent, also will be important.

If you are developing a mobile medical application (app) or a device for e-health, be sure to consult with an attorney familiar with Food and Drug Administration laws governing medical devices, Federal Trade Commission rules governing advertising, state medical licensing and telemedicine rules, and other areas of law and regulation.

Is my product a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated?

Fri, 23 Mar 2012 17:16:41 -0500

Many entrepreneurs want to know whether their invention is a medical device, a drug, a cosmetic, a biologic, or otherwise FDA-regulated.

Cosmetics v. Drugs

Let's start with some basic definitions:

The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the federal Food and Drug Administration (FDA) define products by their intended use.

Cosmetics are "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. According to the FDA, among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

The FDA states:

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

According to the FDA, intended use can be shown by:

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials.
Consumer perception, which may be established through the product's reputation.
Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use.

Thus, certain claims "may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic....Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells."

An example where ingredients cause the product to be considered a drug, is fluoride in toothpaste.

The FDA has different labeling requirements for drugs and cosmetics.

Approval requirements for drugs vs. cosmetics: there is no premarket approval system for cosmetic products or ingredients (with the exception of color additives).
Drugs usually must receive premarket approval by the FDA or conform to final regulations that specify conditions where they are generally recognized as safe and effective,but not misbranded. (There are separate rules for over-the-counter (OTC) drugs).
Good manufacturing practices (GMPs) are different: there are strict GMP requirements for drugs and none for cosmetics (other than ensuring that the products are neither adulterated nor misbranded. However, no regulations set forth specific GMP requirements for cosmetics.
FDA maintains the Voluntary Cosmetic Registration Program⁷, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].
Labeling requirements are different. The FDA has a Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients."

The FDA has a webpage that serves as a portal for regulatory information regarding FDA regulation of drugs.

Included is information about drug applications for over-the-counter (OTC) drugs. The FDA states:

Because there are over 300,000 marketed OTC drug products, FDA reviews the active ingredients and the labeling of over 80 therapeutic classes of drugs, for example analgesics or antacids, instead of individual drug products. For each category, an OTC drug monograph is developed and published in the Federal Register. OTC drug monographs are a kind of "recipe book" covering acceptable ingredients, doses, formulations, and labeling. Many of these monographs are found in section 300 of the Code of Federal Regulations¹. Once a final monograph is implemented, companies can make and market an OTC product without the need for FDA pre-approval. New prescription drugs, on the other hand, require pre-approval before they can go on the market. These monographs define the safety, effectiveness, and labeling of all marketing OTC active ingredients. New products that conform to a final monograph may be marketed without further FDA review. Those that do not conform must be reviewed by the New Drug Application² process. A drug company may also petition to change a final monograph to include additional ingredients or to modify labeling.

According to the FDA, 6 out of 10 drugs are OTC drugs.

Medical Devices

The first thing is to determine if you have a medical device. The FDA notes that the definition of medical devices is very broad:

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products³ with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration as a medical device and is subject to premarketing and postmarketing regulatory controls.

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

The FDA has a wealth of information to consider before marketing a medical device on its FDA webpage dedicated to medical device regulation.

Medical Device v. Drug

The FDA notes that the difference between a medical device is its intended use: if the intended use is through chemical action or being metabolized by the body, the product is usually a drug.

Note that the FDA regulates drugs through its Center for Drug Evaluation and Research (CDER), but regulates biological products and blood banking equipment through its Center for Biologics Evaluation and Research, and veterinary products through its Center fo Veterinary Medicine (CVM).

If you have a medical device, the next thing is to determine its device classification (i.e., whether it is Class I, Class II or Class III), and whether your device is "substantially equivalent" (SE) to an already legally marketed medical device that is not subject to premarket approval (PMA). You determine this by filing a 510(k) submission to the the FDA to demonstrate substantial equivalence.

There are two powerful ways to begin to research substantial equivalence, in preparation for the 510(k) submission:

Search the 510(k) Medical Device Classification Database

Search the Device Classification Panels in the Code of Federal Regulations (CFR)

Devices are organized in 21 CFR, Parts 862-892 into 16 medical specialty panels, such as anesthesiology, cardiovascular, chemistry, dental, ear nose and throat, gastroenterology and urology, general and plastic surgery, immunology, microbiology, and so on.

For Class I devices exempt from [510(k)] the submission of a [510(k)] and marketing clearance from FDA is not required. If your Class I (or certain class II) device is exempt, subject to the limitations on exemptions, from the 510(k) process, this will be stated in the classification regulation. However, other General Controls such as registration and listing, labeling, and good manufacturing practices apply. If you have a Class III device requiring premarket approval (PMA) the FDA has guidance on obtaining a PMA.

Dietary Supplements

The term "dietary supplement" was defined in the Dietary Supplement Health and Education Act (DSHEA) of 1994. The FDA states the definition for consumers as follows:

A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement.

The FDA provides several guidance documents for industry professionals seeking assistance with labeling, claims, substantiation, and other regulatory issues.

If you have a product and are unsure whether it might be regulated by the FDA as a cosmetic, drug, medical device, dietary supplement (or food), biological, or otherwise, the FDA website is a good place to start. You should also contact an experience FDA attorney to help you create legally compliant labeling, advertising, and marketing materials for your product. Our law firm has FDA expertise and can help provide legal guidance for you from concept to market.

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Michael H. Cohen — Tue, 20 Mar 2012 17:29:52 -0500

A federal judge recently held that the disclaimer required by the FDA for a qualified health claim about green tea and the risk of cancer is so strongly worded that it “effectively negates” the manufacturer’s claim.

Note that the case involves a qualified health claim (QHC) and not the typical structure / function claim that people at Whole Foods or other health food stores typically see on the dietary supplement label. The QHC is different in that:

QHCs enable companies to make a health claim about a substance in relation to a disease or condition when the supporting science fails to meet the FDA’s “significant scientific agreement” standard, so long as that health claim is “qualified” in such a way as to not mislead consumers....

In practice, however, FDA rarely approves QHCs: the agency approved only twelve QHCs between 1999 and September 2010—and when they did, they usually created disclaimers that completely reversed the meaning of the claim. It was because of this that ANH-USA sued the FDA over its treatment of the QHC for selenium and cancer. And we were successful in creating a precedent that restricts FDA’s ability to infringe on the right to free speech, a right that is at least in part provided by QHCs.

Fleminger, Inc., sells green tea at TeaForHealth.com and discusses the science of antioxidants and the research on green tea’s anti-cancer properties. Fleminger first submitted a health claim petition to FDA in 2004. A year later, the FDA proposed two disclaimers that stated, in part, “FDA concludes that it is highly unlikely that green tea reduces the risk” of breast cancer or prostate cancer. Fleminger petitioned for an administrative review but it was denied.

In 2010, FDA sent a warning letter to Fleminger threatening to seize its products and insisting it use the exact language set forth in its qualified health claims. Shortly thereafter, however, FDA proposed a revised claim: “Green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.” This prompted Fleminger’s suit in the US District Court, asserting that FDA was making Fleminger “choose between speaking exactly as [FDA] wishes, remaining silent, or risking adverse action for its own commercial speech in violation of the First Amendment.”

Judge Bryant agreed with Fleminger: The FDA’s language “effectively negates the substance–disease relationship claim altogether….There are less burdensome ways in which the FDA could indicate in a short, succinct and accurate disclaimer that it has not approved the claim without nullifying the claim altogether.”

According to a U.S. GAO document entitled Food Labeling: FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims -

FDA is responsible for ensuring the proper labeling of food, and the use of structure/function claims is subject to the general statutory requirement that labeling not be false or misleading. However, FDA has not given companies guidance on the scientific support needed to prevent false or misleading information in a structure/function claim for food. FDA has guidance for the dietary supplements industry on the scientific support needed to prevent false or misleading information for a structure/function claim for dietary supplements...

The GAO compares FDA and FTC authority to the regulatory system used in the European Union:

Unlike FTC, which may require companies to provide the evidence to support their advertising claims, FDA bears the burden of proving that a structure/function claim is false or misleading without having the authority to compel companies at the investigation stage to produce the evidence that the companies assert as support for their advertising claims. According to senior attorneys in FDA’s Office of the Chief Counsel, FDA’s efforts to meet that burden are hampered by the lack of access to the evidence that a company relies on to make such a claim. In particular, while FDA may ask a company to provide its evidence, FDA does not have express legal authority to compel the company to provide information. To support an action, FDA may need to review the scientific literature to determine whether the literature supports a claim—an effort that may be time consuming and labor intensive. FDA may also need to establish through research how consumers perceive the claim. If the structure/function claim, or any claim for that matter, is one for which there is little publicly available information, it can be difficult for FDA to develop the evidence needed to support an enforcement action. It also can be difficult to evaluate the support for a structure/function claim when the functions, such as “immunity” or “attention,” do not have generally established measures for the claimed benefit. For example, it is not necessarily clear what outcome measures would be a valid means of assessing whether a food “improves vitality.”

Furthermore, in contrast to the United States, the EU follows a different course: EU Commission officials told us the responsible EU food agency must preapprove the type of food claims that FDA calls structure/function claims before they can be used. EU Commission officials also stated that their scientific review agency rejected 85 percent of structure/function claims companies have submitted because of the lack of scientific support. Canada is also reviewing structure/function claims food companies have submitted by developing a list of approved claims; it too has rejected most claims, including some found on labels in the United States, according to a Canadian official. To protect the public from false or misleading claims, the Canadian food labeling agency is working with the Canadian agency that regulates advertising to develop a framework for regulating structure/function claims.

The above is positive in terms of pushback against the FDA from a free speech perspective, though again, it deals with qualified health claims and not structure/function claims.

Qualified health claims are health claims that characterize the relationship of a food component to a disease or health-related condition, as modified with a disclaimer or otherwise qualified by FDA to characterize the strengths and limitations of the scientific support to address the claim’s potentially misleading nature. For example, the following is a qualified health claim allowed by FDA characterizing the relationship between the consumption of tomatoes and the risk of gastric cancer:1 “Four studies did not show that tomato intake reduces the risk of gastric cancer, but three studies suggest that tomato intake may reduce this risk. Based on these studies, FDA concludes that it is unlikely that tomatoes reduce the risk of gastric cancer.” Qualified health claims for food are not provided for in statute. Instead, they came about as a consequence of FDA’s decisions following a 1999 federal appeals court ruling (Pearson v. Shalala). The court held that the First Amendment does not permit FDA to prohibit a potentially misleading health claim on a dietary supplement label unless FDA considers whether qualifying language on the label could negate the potentially misleading nature of the claim. (Dietary supplements are products that contain certain dietary ingredients such as vitamins, minerals, or herbs, intended to supplement the diet, and are labeled as dietary supplements.)

Notes one commentator:

The FDA still has authority to regulate structure / function claims and may treat them as disease claims if they reference an underlying disease or condition (such as obesity or diabetes, for example). Note that there are also FDA and FTC substantiation requirements with regard to structure / function claims, even though not as strict as for QHCs.

If you are involved in manufacturing or distributing dietary supplements or other natural products, be sure to contact an experienced health care lawyer who is familiar with the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) review of dietary supplement claims and labels.

Contact our legal team today.

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