1. Make copies of these forms for future use.
  2. When you encounter a barrier to filling your prescriptions, first acquire the name of the responsible medical professional who is blocking access.
  3. Put your name, insurance identification number and name of the drug on a copy of the “Certificate of Medical Necessity” form, and send it directly to the medical professional who is blocking assess.
  4. If your prescription is still rejected, then submit the second form “Notice of Failure to Access Medically Necessary Medication” form and the “Certificate of Accountability” form.
  5. If it is still rejected, submit the third form “Final Notice of Failure to Access Medically Necessary Medication and Formal Notice of Appeal” form. At any point in the process, you may elect to include a letter describing how the medication has helped you and/or a note with your diagnostic code. However, be advised this personal information may be entered into a computerized data base that could be accessed by others in the future.
  6. If it is still rejected refer to “Patient Response to the Final Notice of Failure to Access Medically Necessary Medication” form
  7. Record all communications on the “Communication Log” for future reference.















I am a licensed physician who has personally examined the above captioned patient and assumed clinical responsibility: I have training, experience, knowledge, licensing and an awareness of the medical literature relevant to this patient's presenting complaints.

In considering all the relevant evidence available, it is my professional opinion that it is medically necessary for this patient to receive the treatment and/or medication(s) in the manner (dose, brand, quantity, and schedule) prescribed as part of a treatment plan towards a goal to achieve full and sustained recovery from their condition. Individualized assessment and sound clinical judgment are the primary considerations in all treatment decisions. There is a broad range of pathophysiology, clinical presentations and coexisting interactive comorbid full syndrome and sub-syndromal conditions that are seen in any diagnostic category. The APA DSM-IV states--“The limitations of the categorical classification system must be recognized. In DSM-IV, there is no assumption that each category of a mental disorder is a completely discrete entity with absolute boundaries dividing it from other mental disorders or from no mental disorder. There is also no assumption that all individuals described as having the same mental disorder are alike in all important ways. The clinician using DSM-IV should therefore consider that individuals sharing a diagnosis are likely to be heterogeneous even in regard to the defining features of the diagnosis and that boundary cases will be difficult to diagnose in any but a problematic fashion… A dimensional system classifies clinical presentations based on quantification of attributes rather than the assignment to categories works best in describing phenomena that are distributed continuously and that do not have clear boundaries… It is important that DSM-IV not be applied mechanically by untrained individuals. The specific diagnostic criteria included in DSM-IV are meant to serve as guidelines to be informed by clinical judgment and are not meant to be used in a cookbook fashion.” In addition, evidence based medicine demonstrates there is also a very broad range of responses to different treatments within these diagnostic categories as well. Therefore, it is prudent to treat a patient and it is reckless to create or approve a treatment plan based only upon a DSM diagnosis. Although everyone appreciates the value of cost containment, is must be done in a manner that does not increase total health care costs, is responsible, accountable, medically sound, ethical, in compliance with laws and guidelines and protects confidentiality. The AMA has formally warned that "some actions by pharmacy benefit managers and others may constitute the practice of medicine without a license."


Since my prescription was written in New Jersey, your action must comply with New Jersey State law, as well as Federal and ethical guidelines and medical standards of care. Be advised in accordance with NJ State Law #Senate 1631 (Title 17B of the NJ Statutes), and the Adopted Rules NJAC 89:38-18 and Adopted Amendment NJAC 8:38-1.2 (which became operative on 7/1/01), it is illegal if an insurance company with a pharmaceutical benefit program fails to honor reimbursement for this prescription. If this is not a
so-called "preferred drug," i.e.; one where a "pre-authorization" barrier is created, based upon Amendment NJAC 8:38-1.2 the drug must be covered and the most this patient may be penalized is 30% above the co-pay of the "preferred drug."


Since implementation of the new HIPAA regulations, there has been a decline of medical confidentiality after records are released from a doctor’s office and entered into an unknown chain of computerized databases. As a result, a higher level of scrutiny is now needed before releasing any confidential medical information. It is specifically noted the requested confidential medical information cannot be released with only your request for a number of reasons which include, but are not limited to the findings of the General Accounting Office (GAO), the current challenge that HIPAA regulations violate the Constitution, the position of the American Psychiatric Association, the Country Doctor Exception, the advise of the Surgeon General, pending antitrust litigation against PBMs and the confidentiality requirement of the Hippocratic Oath.


The GAO surveyed 25 federal agencies, reviewed 2400 systems of records and through a forum for federal privacy officers, the GAO found a significant lack of compliance with the federal Privacy Act of 1974. It concluded “the government cannot adequately assume the public that all legislated individual privacy rights are being protected.” It noted by the GAO that the Office of Management and Budget, the agency responsible for enforcing the Privacy Act, has a lack of leadership, oversight and guidance. The recently enacted HIPAA regulations violate the First Amendment of the United States Constitution (the right to not speak publicly) and the Fifth Amendment by depriving individuals of the power to exercise their privacy rights with respect to their health care information by granting “regulatory permission” for third parties to use and disclose that information against the individuals’ wishes; and it is currently being challenged in the Eastern District Court of Pennsylvania by the American Psychoanalytic Association et. al. [1] The American Psychiatric Association notes HIPAA sets a floor, not a ceiling on medical confidentiality and advises a number of guidelines for the release of information. You are notified that I may qualify for the Country Doctor Exception to HIPAA and I therefore require the consent of my patient before the release of any medical information to you. It is also necessary to comply with restrictions on disclosure to payers enacted by the Surgeon General in his Report on Mental Health of Dec 1999, and these guidelines are based upon protocols for disclosure mandated by New Jersey and Washington, DC. In addition, it is recognized the two largest PBMs, Medco and AdvancePCS, are currently being sued in Federal District Court in Philadelphia for having abused their roles as prescription-benefit managers for many large health plans by unfairly steering customers toward mail-order services, which are more profitable for prescription managers while compromising access and quality of care for patients.


In addition, formularies must include more than one medication per therapeutic class, if available. Therefore, if the prescribed drug is in a unique therapeutic category and there is no "therapeutic equivalent," the drug must be covered. An emergency supply of medication must be provided until this issue is resolved. If failure to access this medication results in a decline of this patient's functional abilities, please be advised that anyone in your decision making chain may be liable for any damages sustained by the patient or any other parties (i.e. accidents, auto accidents, assaults, homicides, etc.) as a result your failure.

Please be advised that all correspondences regarding this matter shall be in writing, and a copy of all communications shall be included in the patient’s chart for future reference. You are NOT given authorization to enter any confidential information about this patient or physician into any information data bank.

[1] Hausman, Ken. HIPAA Privacy-Rule Opponents Get Their Day in Court; Psychiatric News January 16, 2004, Volume 39 Number 2, 2004; American Psychiatric Association
p. 2
Robert C Bransfield, M.D., F.A.P.A.
225 Hwy # 35 Red Bank, NJ 07701
Fax 732-741-5308
































I am in receipt of your additional request to provide information on the above captioned individual for your internal review process. Please be advised I have may have no contractual arrangement with your company that would conflict with my responsibility to my patient. The patient has supplied your company with a Certificate of Medical Necessity and possibly an Addendum to Certificate of Medical Necessity). Your receipt of this documentation, refusal to comply, creating a barrier for this patient to access medically necessary care and your failure to provide information to justify an extraordinary and potentially discriminatory review process is noted and documented in the medical record. It is a standard of care to personally examine, exercise individualized clinical judgment and treat patients: it is medically unsound to justify a medication treatment based only upon a diagnosis or to base clinical decisions upon “goals,” “criteria” or “guidelines” that are created by opaque administrative procedures and lack total accountability. “Fail-first” policies are noted to be a “prescription for disaster” and to not save costs when all health care costs are considered. [1]

 Please be advised I personally examined the above captioned patient. As a result of a thorough and individualized assessment of this patient, while exercising in depth clinical judgment, the patient has been given prescription(s) to assist in a treatment plan which is
individualized for his/her specific needs. This includes decisions regarding the type of medication, whether brand name or generic, the number of days dispensed at one time and whether or not a mail order pharmacy is medically appropriate and these decisions are based upon evidence-based practice. Evidence-based practice is defined by the Institute of Medicine as “the integration of best-researched evidence and clinical expertise with patient values.”[2] Please be advised the medication(s) prescribed has/have significant clinically meaningful therapeutic advantage in terms of safety, tolerability and/or efficacy for this patient; is/are compatible with current medical literature and research findings; is FDA approved; is not contraindicated by the FDA for the specific treatment for which the drug has been provided and not labeled “Caution-Limited by Federal Law to Investigational Use.” The medication may or may not be FDA approved for the manner in which it is used in this patient. Please note “The FDA does not regulate the practice of medicine and physicians may use a drug in ways other than indicated on the labeling when, in their professional judgment, it is warranted in a particular case.” [3] The FDA defines off-label use as indications, dosage, form, dose regimen, population or other use parameter not mentioned in the approved labeling; and the FDA recognizes that off-label use of drugs by prescribes is often appropriate and may represent the standard of practice. Some of these off-label uses are recommended by subspecialty societies, CDC, etc. Many pediatric uses are not on label. This is a result of the historical slowness of FDA review, liability, and lack of incentive for off patent drugs.[4] “Limited access, whether to drugs or mental health specialists was associated with higher total health care costs,” [5] increased costs of health care services [6] and increased costs to state-funded programs.[7] “Restricted access to health care services and medication is associated with overall higher utilization and higher health care costs…Results showed that cost-containment strategies employed by various health maintenance organizations were associated with poor treatment outcomes for patients and in fact increased total health care costs.”[8] “Data show that very few drug cost-containment policies can selectively reduce unneeded care while maintaining essential care.” Drug containment policies among the elderly and mentally ill are associated with “increased hospital and nursing home admissions, partial hospitalizations, distribution of psychoactive medications by community mental health centers, and use of emergency mental health services. Vulnerable populations are most likely to experience adverse effects from hastily-applied drug cost-containment policies, and resulting compensatory measures may create more expense than the policy removes.”[9] “Creating a formulary for drugs used to treat mental illness is not likely to save money for health plans as readily as formularies for other types of drugs, according to an analysis by Haiden A. Huskamp, Ph.D., of the department of health economics at Harvard Medical School, Boston…For one thing, ‘there is substantial biological heterogeneity within most mental disorders,; making it more difficult to predict which drug will work best for which patient, she said.”[10] Even Medco “recognizes that only treating physicians can make prescribing decisions. [11]

As stated previously, your actions must comply with various state and federal laws that regulate prescription benefits and good faith insurance practices, including the May 5, 2003 Department of Health and Human Services Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers Federal Pharmaceutical Guidelines, which also apply to pharmaceutical benefit management. These guidelines and the Sept 30, 2002 announcement preceding their release state that "many practices commonly used in the marketing and sale of prescription drugs could run afoul of federal fraud and abuse laws,” notably "'switching arrangements,' under which drug companies offer
financial incentives to shift patients from one drug to another, are suspect under the anti-kickback statute." Similar arrangements, under which companies pay drugstores or pharmacy benefit managers to contact patients or doctors to encourage them to change from one drug to another, are also suspect, according to the guidelines. It warned companies that they would run afoul of the law if they rewarded pharmacies and pharmacy benefit managers for "moving market share" from one product to another. Licensed health care professionals who obstruct access to medically necessary medication and whose incomes, bonuses and employment status are dependent upon obstructing patient’s access to treatment are in violation of medical ethics and are subject to sanctions by professional licensing boards. Failures to comply with these or other regulatory, legal and ethical guidelines are subject to regulatory, legal and other actions. The patient shall be informed of their options if you fail to comply.


In addition, PBM’s have been and are being challenged in a number of legal actions. Below are a few examples, but not a comprehensive list of some of the recent legal issues involving PBMs:

1)      Nation's Largest Prescription Benefit Managers Violate Anti-Trust Laws,
Lawsuits Allege Alexandria, Virginia - August 15, 2003
Suits Against Medco, AdvancePCS Come Days Before Merck Spin-Off of Medco
The nation's two largest prescription benefit managers (PBMs) - companies
that administer prescription drug benefit plans for plan sponsors such as
insurance companies, HMOs and employers - are violating the antitrust laws
to the detriment of some 140 million Americans and at the expense of retail
pharmacies across the nation, according to two separate lawsuits filed today
in federal court in Philadelphia. The defendants, each named in one of the suits, are Medco Health Solutions, Inc., a subsidiary of Merck & Co., Inc., and AdvancePCS. Medco administers prescription benefit plans covering over 63 million Americans and is the largest PBM in terms of net revenues. AdvancePCS administers plans covering over 75 million Americans and is the largest PBM in terms of the number of people covered. The suit against Medco also includes Merck as a defendant on the grounds that Medco is merely the alter ego for Merck in promoting its brand name drugs. The lawsuits allege that each of the defendant PBMs has illegally reduced or eliminated competition on price, service and consumer choice that would otherwise thrive among the plan sponsors that each PBM represents. Each PBM allegedly does so by acting as a common agent for the plan sponsors in their dealings with retail pharmacies including negotiating and fixing reimbursement levels and rates, restricting the level of service offered to customers, and arbitrarily limiting the ability of retail pharmacies to compete on a level playing field with the PBM's mail order pharmacy.
"It would be blatantly illegal for insurance companies or employers to agree
on the rates they pay to pharmacies and the restrictions they place on
consumers," said Michael Freed of the Chicago law firm of Much Shelist Freed
Denenberg Ament & Rubenstein, a spokesman for the plaintiffs. "Medco and
AdvancePCS have abused their role as PBMs for many major insurance
companies, Blue Cross plans, HMOs and large employers to accomplish the same
result. And, it is just as illegal." The class action lawsuits were brought on behalf of pharmacies across the nation. The Pharmacy Freedom Fund, a coalition of several thousand independent pharmacy owners, and the National Community Pharmacists Association, representing the owners of 24,000 pharmacies across the
country, joined in the suits. Specifically, the lawsuits allege that, acting as the common agent for plan sponsors, the PBMs limit competition by:
Setting reimbursement rates for pharmacies far below the rates that would
apply in a competitive market;
Fixing and artificially depressing the prices to be paid to pharmacies for
generic drugs;
Prohibiting retail pharmacies from providing more than a 30-day supply of
drugs while the PBMs' own mail order pharmacies routinely provide a 90-day
Requiring retail pharmacies to charge an effectively higher co-pay than the
co-pay that the PBMs' own mail order pharmacies charge; and
Imposing one-sided contracts and added costs and inefficiencies on retail
Medco and AdvancePCS profit directly from this anticompetitive conduct in
several ways. First, they have pushed reimbursement rates so far below a
competitive level in recent years that they have created a "spread" between
what they bill the Plan Sponsor and what they pay the pharmacy. According to
the Pharmacy Benefit Management Institute, the average fee that PBMs pay to
community retail pharmacies for dispensing a brand name drug was $2.21 in
2001, down from $2.50 in 1995, a decline of 11.6% in nominal terms and 24%
when adjusted for inflation.
Second, they operate mail order pharmacy operations that compete with retail
pharmacies (and other mail order pharmacies) for refill and follow-on
prescriptions. By precluding retail pharmacies from offering a 90-day supply
of drugs or lower co-pays, the PBMs place artificial limits on consumer
choice in order to divert business from community pharmacies to the PBMs
mail order pharmacies. "The mail order pharmacies of Medco or AdvancePCS
refuse to compete fairly with community pharmacies on cost and service for
consumers," said John Rector, Senior VP of NCPA. "Why not allow consumers to
choose and permit community pharmacies to compete?"
The suit comes days before Merck plans to spin-off Medco as a separate unit.
Both Medco and Advance PCS have come under governmental and consumer
pressure in recent years for, among other things, refusing to reveal their
financial arrangements with drug companies from whom they get rebates. This
conflict of interest was also cited in today's lawsuit against Medco. The
suit alleges that Merck has exerted control over the core of Medco's PBM
operations, as reflected by Medco's admitted preference for Merck products.
That control will continue for at least four more years because, under an
agreement signed last year, Merck required Medco to give Merck's patented
products preferential treatment for five years or face potentially huge
liquidated damages.

2)      July 15, 2002, MERCK-MEDCO UNIT FACES DRUG CLASSIFICATION LAWSUIT Merck-Medco Managed Care, the pharmacy benefit management division of Merck, admitted in a recent filing with the Securities and Exchange Commission that it had been sued in June for allegedly improperly classifying the drug tamoxifen as a brand name drug instead of a generic one. [12]

3)      Lawsuit against Merck's Medco unit joined by US Justice Dept - report AFX News Limited -- June 24, 2003 LONDON (AFX) - The US Justice Department is joining a lawsuit that alleges Merck & Co Inc's Medco Health Solutions Inc pharmacy benefits manager (PBM) unit adopted an "aggressive profits-before-patients policy" which resulted in a potentially dangerous lack of oversight in filling prescriptions and increased pharmaceutical costs for the federal government, the Wall Street Journal Europe reported. The complaint alleges that after Merck purchased Medco in 1993, the company began to make systemic changes in its mail-order prescription-filling system -- disregarding safety and instead promoting higher profits per prescription, the Journal said. The suit was brought by two former Medco pharmacists. The government intends to file its own complaint within 90 days. The two former Medco pharmacists make detailed charges that enormous pressure was placed on employees to falsify orders to meet goals and to disregard complaints by patients and doctors about drug switching or pill shortages, the paper said. [13]

4)      Merck-Medco Policy on Switching to Costlier Drugs Faces Scrutiny by Barbara Martinez, Staff reporter of The Wall Street Journal [14]

5)      Lawsuit Documents Detail Drug Makers Paying Big Bucks to Sway Sales by Milt Freudenheim: Merck-Medco Managed Care, one of the largest prescription drug plan managers, was paid more than $3 billion in rebates in the late 1990s from drug makers seeking to promote sales of certain drugs, according to documents filed in a long-running class action lawsuit. The documents, which open a window on the secret deals that drug plan managers have with pharmaceutical companies, say that Medco received the rebates as incentives to promote some of the world's most expensive drugs. Medco, a unit of Merck & Co., then persuaded doctors to prescribe those drugs to patients at the expense of similar medicines that often cost less, according to the documents, which were filed by plaintiffs in the case. [15]

6)      West Virginia Sues Merck-Medco Over Rebates News Source: The Miami Herald Published Date: November 14, 2002 Editor's Summary: CHARLESTON, W. VA -- West Virginia authorities on Wednesday filed a lawsuit against Merck-Medco, a subsidiary of drug giant Merck, accusing it of pocketing more than $6 million. State Attorney General Darrell McGraw said the suit alleges fraud, breach of contract, and unjust enrichment. According to the suit, Merck-Medco cost the state millions more by steering people covered by the Public Employees Insurance Agency to expensive, Merck-made drugs. [16]

7)      “Physician sues Massachusetts over prior authorization rule. As states struggle to control Medicaid prescription drug costs, doctors voice concern about patient access to medically necessary treatments…Patients are put at great risk to decompensate, lose stability and ultimately require hospitalization.”[17]

8)      Drug Manager Sued Over Rebates, Prices, ALICIA CHANG: Associated Press ALBANY, N.Y. - Two New York labor groups are suing Express Scripts
Inc., accusing the nation's third-largest manager of prescription drug plans
of allegedly pocketing rebates and inflating drug prices, driving up health
care costs in the state.
The lawsuit was filed Dec. 31 in state Supreme Court in New York City
and announced Sunday by the Organization of New York State Management
Confidential Employees and United University Professions, which represent
more than 30,000 state workers.
Pharmacy benefit managers are essentially the middlemen that negotiate
on behalf of their clients for discounts from drug manufacturers. The suit
accuses St. Louis-based Express Scripts of deceptive practices, such as
keeping rebates paid by drug makers instead of passing those savings along
to health plans.
Express Scripts also received kickbacks from drug manufacturers to
recommend higher-priced drugs rather than more affordable alternatives, the
suit said.
"Our members are being shortchanged, and the taxpayers of New York
State are being shortchanged," William Scheuerman, president of United
Professions, said in a statement.
Express Scripts spokesman Steve Littlejohn declined to comment Sunday
on pending litigation. But he said the company has complied with the terms
of its contract of providing lower-cost prescription drugs to its members.
"We align our interests to those of our clients and our members,"
Littlejohn said. "That's how we do business."
The New York suit is the latest in a series of criticisms of
for-profit pharmacy benefit management companies. Several states are
investigating whether the companies' practices violated antitrust laws.
The lawsuit seeks undisclosed monetary and punitive damages. Express
Scripts provides pharmacy benefit management for 1.1 million current and
retired state workers under a contract that expires at the end of 2005. [18]

9)      Missouri-based coal company Peabody Energy has filed a lawsuit alleging that Medco, which managed a prescription drug benefit for the firm, favored products made by Merck, which until August 2003 was the PBM's parent company, the St. Louis Post-Dispatch reports. Peabody in 1999 hired Medco to manage a drug benefit for about 31,000 employees, retirees and dependents. In the lawsuit, filed Dec. 23 in U.S. District Court in St. Louis, Peabody seeks $35 million in compensatory damages and alleges that Merck directed Medco to ensure that Merck's patented drugs were included on the employees' preferred drug list; required Medco to provide drugs made by Merck to patients at rates that exceeded Merck's general market share nationwide; and directed Medco to encourage patients to use Merck's cholesterol drug Zocor instead of Pfizer's rival treatment Lipitor, even though Zocor is "significantly more expensive and cost Peabody more," according to the suit. The value of the contract was not available, and a
spokesperson for Merck declined to comment on the case, the Post-Dispatch
reports. Medco spokesperson Jennifer Leone declined to comment on the suit
but said that Medco "fulfilled all of our contractual obligations to Peabody." The lawsuit represents "the latest in a series of similar allegations" against the companies, according to the Post-Dispatch. However, Glenn Garmont, an analyst for New York-based First Albany, said that it might be difficult for the plaintiffs to prove that they were not aware of the connection between Medco and Merck. "The relationship between Merck and Medco is one that is fairly well-known and publicized," Garmont said.[19]

10)  Pharmacy Benefit Managers' Price Disparities Driving Up Drug Costs,
Study Says: 01/16/2004. The disparity between the amounts that pharmacy benefit managers charge clients and reimburse pharmacies is "contributing to the rapid rise in health care costs," according to a pilot study in the Journal of the
American Pharmacists Association, the Newark Star-Ledger reports. To conduct
the study, researchers analyzed 129 prescriptions filled at drug stores in
six states and found that PBMs earned an average of $12.29 per prescription.
PBMs charged clients about $4.65 more than they reimbursed pharmacies for
brand-name drugs and about $23.45 more for generic drugs, according to the
study. Robert Garis, co-author of the study and a pharmacy professor at
Creighton University, said, "This indicates an unnecessary markup. A lot of
increases in out-of-pocket costs are due to this spread. The losers are the
clients and consumers." The Star-Ledger reports that almost 24 states are
investigating PBMs' pricing practices [20]


Many of the inherent problems associated with managed formularies and the treatment of mental illness is summarized in a special edition of Drug Benefit Trends (Managing Mental Illness: The Hidden Costs of Restricting Access to Medications) that objectively investigates the costs of restricting access to psychiatric medications. [21] It this edition, it is demonstrated that “cost-containment measures that limit access to medications can result in increased expenditures on visits to doctors and hospitalizations that exceed any savings in drug costs;” [22] “3 studies provide strong evidence that restricting access to medications used to treat mental illness is associated with higher total costs related to increasing the number of visits to doctors; offices, emergency department visits, and hospitalizations.;” [23] “doctors need the flexibility to tailor treatment to individualized patients and their needs, free of bureaucratic roadblocks that limit access to medications;” [24] “the time and effort involved in fighting medication restrictions discourages psychiatrists from taking on additional difficult-to-treat psychotic patients,” [25] “restricting access to medications hurts patients, their families, and their communities; and can trigger a downward spiral that ends in homelessness or incarceration.” [26] As a result of these findings, the Kaiser Commission on Medicaid and the Uninsured recommended it its Model Prescription Drug Prior Authorization Process for State Medicaid Programs that no restrictions be placed on psychotherapeutic drugs. [27, 28]

The physician’s ethical obligation is “to prescribe only the most appropriate medication for the patient, without regard to restrictions imposed by managed care formularies.” [29] A strongly enforced standard in medicine is that “authority shall be commensurate with responsibility,” [30] and any intentional obstruction of access by inappropriate denial, deterrence, delay and selection [27] shall not be tolerated.

Since I have personally examined this patient, and because of my expertise and credentials, it is not possible that any physician on your staff has greater expertise in determining a more appropriate treatment plan for this patient. I am available to educate your staff regarding proper psychopharmacology to assist in your internal review process. However, before your staff has any input into clinical decisions with this case, it is mandatory for you to meet the following requirements and to complete and return the Accountability Statement, which is included.


[1] New York State Assembly Committee on Health Care, Jan 1, 2003.

[2] Institute of Medicine Committee on Quality of Health Care in America (2001). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academies Press.

[3] FDA website

[4] FDA website

[5] Horn SD. Outcomes and Expenditures: Lessons From a New Research Paradigm; Drug Benefit Trends, Vol 14, Suppl E, Dec 2002; p5-8.

[6] Bartels SJ, Horn S, Sharkey P, Levine K. Treatment of Depression in Older Primary Care Patients in Health Maintenance Organizations. Int J Psychiatry Med. 1997;27:215-231

[7] Nelson D. Limiting Access to Medications: Not a Cost-Effective Public Policy; Drug Benefit Trends, Vol 14, Suppl E, Dec 2002; p 19-23.

[8] Horn SD; Limiting Access to Psychiatric Services Can Increase Total Health Care Costs; J Clin Psychiatry 2003;64 (supp 17)

[9] Soumerai S; Unintended Outcomes of Medicaid Drug Cost-Containment Policies on the Chronically Mentally Ill; J Clin Psychiatry 2003;64 (supp17)

[10] Huskamp HA; Health Affairs 22[5]:84-96,2003

[11] Frieden J; Psychiatric Formularies Not Likely to Save Money; Clinical Psychiatry News; Dec, 2003, p.64

[12] Letter from Kevin Hall, MD, Vice President, CPP and Sumit Dutta, MD, Senior Director CPP to Robert Bransfield, MD; 3/12/2003.





[17] Albert T; Physician sues Massachusetts over prior authorization rule; AMNews; Oct 27, 2003 p.5

[18] CHANG, ALICIA. Associated Press; posted 1-11-2004

[19] Shinkle, St. Louis Post-Dispatch, 1/15.

[20] Silverman E, Newark Star-Ledger, 1/16.

[21] Drug Benefit Trends; Vol.15;Suppl.1;Dec 2003

[22] Ingoglia CS; Caring for Persons With Mental Illness: Making Policy Decisions That Are Truly Cost-Effective; Drug Benefit Trends; Vol.15;Suppl.1;Dec 2003; p5

[23] Horn SD; Limiting Access to Psychiatric Services Can Increase Total Health Care Costs; Drug Benefit Trends; Vol.15;Suppl.1;Dec 2003; p12

[24] Bailey RK; Psychotropic Medications: One Size Does Not Fit All; Drug Benefit Trends; Vol.15;Suppl.1;Dec 2003; p19

[25] Pomerantz JM; Making a Hard Job Harder; Drug Benefit Trends; Vol.15;Suppl.1;Dec 2003; p25

[26] Miller JE; Restricting Access to Medications Hurts Patients, Their Families, and Their Communities; Drug Benefit Trends; Vol.15;Suppl.1;Dec 2003; p30

[27] Somers S, Perkins J; National Health Law Program Inc. Model Prescription Drug Prior Authorization Process for State Medicaid Programs. Washington, DC: The Henry J. Kaiser Family Foundation: 2003:22.

[28] Tennison C; Responding to Restrictive Formularies. Psychiatric Annals; 34:2;Feb 2004; p139-148.

[29] American Academy of Child and Adolescent Psychiatry. Policy Statement: Restrictions on the Prescribing Practices of Child and Adolescent Psychiatrists by Managed Care Formularies. Washington, DC; American Academy of Child and Adolescent Psychiatry; 1997.

[30] American Psychiatric Association. NMHA Speaks Out Against Restricted Formularies. Psychiatric News. 1998;33(11):42.



Robert C Bransfield, M.D., F.A.P.A.
225 Hwy # 35 Red Bank, NJ 07701
Fax 732-741-5308











































1)   The name, title, addresses & license number of the individual(s)
determining "medical necessity" who intend to share clinical responsibility.


2)   The name and title of all, including managers or executives who are
not themselves licensed health care professionals, but who supervise
licensed healthcare professionals.


3)   The name, title address & license number of all individuals on the
Pharmacy and Therapeutics Committee who intend to share clinical


4)   The name, title, address & license number of any other individual or
group who contributed to the decision to require pre-certification of this
drug and/or the development of the relevant guidelines.




5)   The name of the HIPAA security officer (Attach a copy of the OIG Compliance “written standards of conduct, policies procedures and protocols that verbalize the company’s commitment to compliance”).


6)   What is the evidence for requiring pre-certification of this medication in this
patient and the reason for exclusion if denied?


7)   Do you, or your company, receive a financial incentive to deny this
treatment or substitute an alternative drug or kickbacks (rebates) or bundling arrangements from pharmaceutical companies that market competing products? If so, explain the details of the financial incentives?




8)   If you propose a "therapeutic equivalent," what is the evidence this treatment is equivalent in this patient?




9)   If you propose a "generic equivalent," what is the proof the potency is equivalent, the proof the patient will not react adversely to the different “inert ingredients,” and the evidence this treatment will be equivalent in this patient?

10)   Disclose all possible conflicts of interest.


11)  Do you personally guarantee ethical accountability and privacy of
this information?

12)  I shall submit a signed informed consent from the patient, noting this
information shall not be placed into any database.

13)  The treating physician shall be reimbursed their customary and usual professional fee per hour for the time needed to assist in the pharmaceutical benefit review process.

FRAUD NOTICE: Any person who knowingly processes a claim in a false or misleading manner is subject to criminal and civil penalties.

The above statements are true to the best of my knowledge and belief.
I acknowledge I am an authorized agent of the organization requesting the information. I have not altered this form in any manner. I, and my organization, assume full responsibility for any adverse impact upon the patient's treatment as a result of our determinations. We acknowledge that liability for any adverse effects of our determinations is not pre-empted by ERISA.

Signed: ________________________________

Name: (Printed) _________________________

Title: __________________________________

Address: _______________________________



Date: _________________________________










Please be advised the patient has access to medically necessary medication through you organization. They presented a valid prescription and a Certificate of Medical Necessity and in some circumstance an Addendum to Certificate of Medical Necessity. You were then sent a Notice of Failure to Access Medically Necessary Medication and an Accountability Statement. Although all the information you needed was in the patient’s prescription and the Certificates of Medical Necessity, you persisted in denying access to medically necessary medication. I offered to provide you the clinical information you requested and educate your staff after completion of the Accountability Statement, but you failed to provide the information which the patient has a legal right to access, and you failed to defend or justify why you discriminated against this treatment in this patient. If your activities are medically and ethically well founded, I am sure you would have been willing to disclose the names and roles of all individuals in your decision making process and the basis for your position. Conversely, your failure to disclose this information may be viewed as current recognition of impropriety when evaluated in subsequent proceedings. The names of the responsible parties in this decision shall be acquired through various databases.

According to the AMA, the American Psychiatric Association, and the Texas Medical association in the Calad and Davila cases before the US Supreme Court, once you seek a diagnosis, that person is a patient. Therefore, your request for a diagnosis creates full ethical and legal liability for your actions as a health care provider.

If you persist in denying access to medically necessary treatment, the patient shall be sent a Patient Response to the Final Notice of Failure to Access Medically Necessary Medication, and further regulatory or other actions may be initiated.


[1] Albert T; Both Sides Ready for ERISA Case; American Medical News; Feb. 16, 2004.






Robert C Bransfield, M.D., F.A.P.A.
225 Hwy # 35 Red Bank, NJ 07701
Fax 732-741-5308







Please refer to the included records. As you can see, your pharmacy plan has denied access to medically necessary medication. You have a number of options at this point. The option you chose depends upon the details of your particular circumstances. Your options include, but may not be limited to the following:


1)      Contact the company yourself and ask for assistance. Record all communications and the names and credentials of everyone you communicate with.

2)      Pay for the medication outside your pharmacy plan.

3)      Attempt to access the medication through any plan the pharmaceutical company may have. (Please note not all medications are available to everyone and financial requirements may apply.)

4)      You have a right to send a letter of appeal to the pharmacy appeals unit of your insurance company and/or the pharmacy benefit management (PBM) company affiliated with your insurance company.

5)      Contact your insurance agent or the benefit manager who purchased the insurance policy for your company and ask for assistance.

6)      Contact a patient advocate (I.e. ) and/or an attorney for assistance.

7)      Contact the American Psychiatric Association Managed Care Helpline (1-800-343-4671, fax 1-703-907-1089, and email

8)      Various advocacy organizations may be available to provide assistance. Some may be found by performing a search on the Internet.

9)      If the names of the responsible parties are concealed, the names can be acquired by accessing the company’s site on the Internet or by calling the company and asking for the names of the higher level executives, such as the CEO, the Medical Director, the National Pharmacy Director, the Director of Pharmacy Practice, etc.

10)  You may release or authorize a release of your clinical information to the PBM, but be fully aware of the risks involved in releasing confidential information to third parties and be aware that release of this information may not result in approval or payment for the prescription.

11)  If you are a New Jersey resident, report this problem to Gail Simon at the Department of Insurance and Banking (609-292-0844 x50333)

12)  In some instances, NJ residents may consider contacting the New Jersey Attorney General’s Office, which has an insurance fraud division.

13)  Contact the state board of pharmacy. All pharmacy boards have websites on the Internet.

14)  On a Federal level, you are protected by the US Constitution, the RICO Law, the False Claims Act and the Department of Health and Human Services Office of Inspector General Compliance Program Guidelines for Pharmaceutical Manufacturers (which also applies to PBM’s and other pharmaceutical distributors), the PhARMA Code and a number of other Federal laws and guidelines. The False Claims Act (31 U.S.C. 3729-33) prohibits knowingly presenting (or causing to be presented) to the federal government a false or fraudulent claim for payment or approval. If you report a violation of the False Claims Act and it results in penalties, you are entitled to a percentage of the penalties collected. Included in the False Claims Act is the anti-kickback statute that prohibits in the health care industry some practices that are common in other business sectors. The anti-kickback statute is a criminal prohibition against payments (in any form, whether the payments are direct or indirect) made purposefully to induce or reward the referral or generation of federal health care business. In assessing whether there is a violation of the False Claims Act, relevant questions include: Does the arrangement or practice have a potential to interfere with, or skew, clinical decision-making? Does the arrangement or practice have the potential to increase costs to the federal health care programs? (I.e. Social Security Disability, Medicaid, Medicare, etc.) Does the arrangement or practice have a potential to increase the risk of over utilization or inappropriate utilization? Does the arrangement or practice raise patient safety or quality of care concerns? Switching arrangements as noted in the OIG’s 1994 Special Fraud Alert (59 FR 65372; December 19, 1994) are suspect under the anti-kickback statute. When a formulary is established it is unlikely to raise significant issues under the anti-kickback statue only so long as the determination of clinical efficacy and appropriateness of formulary drugs by the formulary committee proceeds, and is paramount to, the consideration of costs. Any rebates or other payments to PBM’s that are based on or otherwise related to the PBM’s customers’ purchases potentially implicate the anti-kickback statute. If there is credible evidence of misconduct from any source and, after a reasonable inquiry, there is belief that the misconduct may violate criminal, civil, or administrative law, there should be a prompt reporting of the existence of misconduct to the appropriate federal and state authorities within a reasonable period, but not more than 60 days after determining there is credible evidence of violation. Appropriate federal and state authorities include the OIG, the Criminal and Civil Divisions of the Department of Justice, the US Attorney in relevant districts, the Food and Drug Administration, the Federal Trade Commission, the Drug Enforcement Administration and the Federal Bureau of Investigation, and the other investigative arms for the agencies administrating the affected federal or state health care programs, such as the state Medicaid Fraud Control Unit, the Defense Criminal Investigative Service, the Department of Veteran Affairs, HRSA, and the Office of Personnel Management (which administers the Federal Employees Health Benefit Program). Some violations may be so serious that they warrant immediate notification to governmental authorities.[1]

15)  If state Medicaid and prescription plans receive federal funds to provide health care and fail to fulfill this responsibility, there may be some circumstances where this is a violation of the False Claims Act.

16)  If you feel members of the Pharmacy and Therapeutics Committee, the Medical Director or reviewing professional deviated from ethical conduct, there may be grounds for a complaint to the state board that licensed that professional in that state.

17)  If you cannot acquire the names of the responsible individuals within the PBM, you may be able to access this information by purchasing one share of stock. As an owner, you would have more rights to access information about the company.

18)  You may be eligible to be included in one of several class action suits against PBM companies. Some of these companies have been accused of committing fraud by inflating the price of drugs and manipulation of average wholesale price (AWP). In one suit Medco is accused of receiving $3.56 billion in payments from drug companies and a judge has given preliminary approval to a $42.5 million settlement of class-action lawsuits claiming that Medco overcharged clients trough questionable business practices. Current defendants in suits include, but are not limited to, Advanced PCS, Express Scripts, Medco and Caremark Rx. More information is available at:

19)  You may chose to contact local, state and federal politicians for assistance.

20)  Different media outlets may be able to provide assistance.

21)  There may be class action suits that may apply to your situation.

22)  Buy one share of stock in the PBM and/or the insurance company. As an owner, now you have the right to access a greater amount of information about the operations of the company and the names of the responsible individuals.

23)  Remember, you are the patient with the ultimate authority and power to advocate for you health care. Be prepared to advocate to access quality health care.


[1] Department of Human Health and Human Services Officer of Inspector General Compliance Program Guidelines for Pharmaceutical Manufacturers. Federal Registry/Vol.68, No.68/Monday, May 5, 2003/Notices






Robert C Bransfield, M.D., F.A.P.A.
225 Hwy # 35 Red Bank, NJ 07701
Fax 732-741-5308














Communication Log






Date of prescription:


Receipt of barrier to access:




Responsible professional:


Date Certificate of Medical Necessity and Addendum

 to Certificate of Medical Necessity sent:


Date of approval:


Date further barrier to access:


Date Notice of Failure to Access Medically Necessary

 Medication & Accountability Statement sent:


Date of approval:


Date further barrier to access:


Date Final Notice of Failure to Access Medically Necessary

 Medication & Formal Notice of Appeal sent:


Date of approval:


Date further barrier to access:


Date Patient Response to the Final Notice of Failure

 to Access Medically Necessary Medication sent:


Date of approval:

Date further barrier to access:


Date and final actions:


Other notes: