Starting September 30, 2014, applicable manufactures and applicable group purchasing organizations must report payments to “covered recipients”.
Who is a “covered recipient”?
- A Physician or Teaching Hospital
What is Reported?
- Applicable manufacturer or GPO’s name
- Covered Recipient’s
- Amount of payment or other transfer of value
- Date of payment or other transfer of value
- Form of payment or other transfer of value
Nature of payment
- The name of the related drug, device, biological or supply
- Eligibility for delayed publication (research payments)
- Name of entity that received the payment or other transfer of value, if not provided to the covered recipient directly (indirect payments)
- Payments or transfers of value to physician owners or investors
Payments for Research
(i) Name of the research institution, individual or entity receiving the payment or other transfer of value.
A. If paid directly to a physician covered recipient, all of the following must be provided:
(1) The physician’s name as listed in the NPPES (if applicable)
(2) National Provider Identifier
(3) State professional license number(s) (for at least one State where the physician maintains a license) and State(s) in which the license is held
(5) Primary business address of the physician(s).
B. If paid directly to a teaching hospital covered recipient, list the name and primary business address of teaching hospital.
C. If paid to a non-covered recipient (such as a non-teaching hospital or clinic), list the name and primary business address of the entity.
(ii) Total amount of the research payment, including all research-related costs for activities outlined in a written agreement, research protocol, or both.
(iii) Name of the research study.
(iv) Name(s) of any related covered drugs, devices, biologicals, or medical supplies (subject to the requirements specified in paragraph (c)(8) of this section) and for drugs and biologicals, the relevant National Drug Code(s), if any.
(v) Information about each physician covered recipient principal investigator (if applicable) set forth in paragraph (f)(1)(i)(A) of this section.
(vi) Contextual information for research (optional).
(vii) ClinicalTrials.gov identifier (optional)
Payments for Preclinical Research
For preclinical studies, applicable manufacturers only have to report:
(i) Research entity name
(ii) Total amount of payment
(iii) Principal investigator(s) including
- State professional license number(s)
- Business address
Special rules for payments or other transfers of value related to continuing education programs.
Payments or other transfers of value provided as compensation for speaking at a continuing education program are not required to be reported, if all of the following conditions are met:
Excluded from Reporting
- Existing personal relationships
- Payments or other transfers of value less than $10, except when the total annual value of payments or other transfers of value provided to a covered recipient exceeds $100
- Educational Materials that Directly Benefit Patients or are Intended For Patient Use
- Discounts, including rebates
- In-Kind items for the provision of charity care
- Product samples (coupons and vouchers)
- Short term loan of covered device (no more than 90 days)
- Contractual warranty
- Covered recipient acting as a patient
- Provision of healthcare
- Non medical professional
- A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security or mutual fund
- Civil or criminal action or administrative proceeding
- Indirect Payments or Other Transfers of Value where applicable manufacturer is unaware of the identity of the covered recipient
- Drug Samples
Specifics regarding Tamara A. Miller, MD. –
Dr. Miller has worked for more than 20 years distinguishing herself as an expert in Multiple Sclerosis. As an expert, Dr. Miller is offered the opportunity to participate in research of newly developing medicines for Multiple Sclerosis. It is important to note that all monies listed in the “Research Category” are gross funds – not net. A great deal of money is spent on expensive research items such as MRI’s and laboratory testing for the patients enrolled in the research trials. These expenses are not considered in the gross amount reported for the research trial. Doctor Miller’s time spent conducting research is time not spent in daily care of non-study patients. There will not be new and emerging medications in a time when our society needs them most without the research cooperation of private physicians in research studies.
All monies are deposited into company accounts to pay bills and overhead so that we can remain independent. Remaining independent allows excellent patient care without pressure to conform to large organization groupthink. This allows our community to have choices when it comes to their healthcare.
In addition, Dr. Miller travels the country to educate physicians and patients on newly developed Multiple Sclerosis FDA approved medications. Dr. Miller strongly believes that patient education and education of her peers promotes better choices for both the patient and the physician when it comes to treatment options.
Dr. Miller is an active speaker for multiple pharmaceutical companies – many of which have multiple sclerosis disease modifying medicines. Most of these pharmaceutical companies are competitors in the Multiple Sclerosis markets. Dr. Miller speaks for these competing companies because she firmly believes there is not one “right or correct” drug for all patients. There is, however, a best choice of a medicine for a specific patient if the provider and patient understand all the risks/benefits of every medication available. No one manufacturer has the perfect drug for all MS patients.
Without patient and peer education, there is a significant risk to our society that less efficacious medicines will be prescribed due to ignorance of the physician and the push for lower cost / lower efficacy medicines by healthcare organizations.
Every patient’s well being and quality of life are first on Dr. Miller’s agenda.
It is important to note that time traveling to provide patient/peer education seminars is time spent away from the physician’s office. That time spent away results in the physician not seeing their patients or generating revenue to pay overhead including employee’s salaries.
All monies are deposited into company accounts to pay bills, pay overhead, and our employee salaries so that we can remain independent. Remaining independent allows us to provide excellent patient care and allow our community to have choices when it comes to their healthcare.
You can still see a doctor at our clinic.
Dr. Miller would encourage any of our patients to discuss with her any concerns about her research or speaking arrangements to contact her for further information.
Dr. Miller has been a speaker and/or consultant for Allergan, Bayer, Biogen Idec, Genzyme, Sanofi-Aventis, Novartis, Acorda, Questcor, Forest, and TEVA.
Dr. Miller receives research support from Allergan, Biogen Idec, Genzyme, Novartis, Ono, Sanofi-Aventis, Roche-Genentech, EMD Serono, Ipsen, Elan, ONO Pharmaceuticals, Sun Pharma, and Teva Neuroscience.