Topics Covered on This Page
General Prescription Requirements
Tamper resistant prescriptions
- Schedule II
- Schedules III-IV
- DEA Registration
- DEA Rule on Electronic Prescriptions for Controlled Substances
- Mid-Level Practitioners
Prescribing Controlled Substances – DEA Registration
Prescribing Controlled Substances – Mid-Level Practitioners
Vermont Prescription Monitoring System (VPMS)
Drug Diversion: Patient Fraud
Medicare Part D
Medicaid Preferred Drug List
Prescribing For Self And Family
Free Drug Samples
Gift Ban and Disclosure of Allowable Expenditures by Manufacturers of Drugs, Devices and Biologics
About the Author
By Madeleine Mongan, Esq.
Vermont Medical Society
What are the basic requirements for prescribing and dispensing drugs in Vermont?
A prescription drug order must be communicated directly to a pharmacist in a licensed pharmacy. The Vermont Board of Pharmacy licenses non-resident mail-order and internet pharmacies that agree to its requirements. Written prescriptions may be used for all drugs.
Prescriptions for all drugs except controlled substances listed in Schedule II may be communicated orally. In certain limited situations, described below, prescriptions for drugs in Schedule II may also be communicated orally.
Prescriptions may be transmitted electronically.
Recently promulgated federal DEA rules include very specific requirements for electronic prescriptions for controlled substances, however. See the discussion of the new rules below. Prescriptions for controlled substances in Schedules II through V may also be prepared electronically, printed and signed manually. The printed prescription must be presented prior to dispensing, or be faxed with a manual signature.
What are the Vermont Board of Pharmacy requirements for electronic transmission (fax and e-mail) of prescriptions?
· All electronic prescriptions should be transmitted directly to a pharmacist in a licensed pharmacy of the patient’s choice;
The prescription should include the prescriber’s phone number for verbal confirmation, the time and date of transmission and the identity of the pharmacy intended to receive the transmission; and
The prescription must be transmitted by an authorized practitioner or his or her designated agent.
Electronic transmission may be used for prescriptions for controlled substances consistent with federal law.
Can a prescriber authorize an employee to send or call in a prescription orally or electronically to a pharmacist?
Yes, the prescribing practitioner may authorize an agent or employee to call in, fax or e-mail a prescription to a pharmacist.
How long are most prescriptions valid?
One year. No prescription may be filled or refilled more than one year after the prescription was written. See section below on refills for controlled substances.
Are tamper-resistant prescriptions required?
Yes, as of Jan. 1, 2010 the Vermont Baord of Pharmacy has required tamper resistant prescriptions for all prescriptions. The Office of Vermont Health Access has required tamper resistant prescriptions since 2008.
What does the Vermont Board of Pharmacy rule require for a tamper resistant prescription?
Written and electronic prescriptions must:
- Prevent unauthorized copying of a completed or blank prescription form;
- Prevent erasure or modification of information written on the prescription by the prescriber; and
- Prevent the use of counterfeit prescription forms.
- Handwritten prescriptions must be written on a tamper resistant pad.
- Computer generated printed prescriptions must be printed on tamper resistant paper or other tamper proof methods as defined by the Centers for Medicaid and Medicare Services, including micro-printing and/or printing a "void" pantograph accompanied by a reverse "Rx," which causes a word such as "Void," "Illegal," or “Copy" to appear when the prescription is photocopied.
- Pescriptions written which comply with Medicaid rules will satisfy this rule.
Where can I find more information about the requirement for tamper resistant prescriptions?
The OVHA website has information about these prescriptions and a list of vendors. Section 9.5 of Board of Pharmacy Rules describes the requirements for tamper resistant prescriptions.
Office of Vermont Health Access provider website -- information about tamper resistant prescription pads: http://ovha.vermont.gov/for-providers/tamper-resistant-drug-pads
List of tamper-resistant prescription pad vendors from OVHA website:
Maine Care information about tamper resistant prescriptions and vendors: http://www.mainecarepdl.org/index.pl/home/tamper-resistant-prescription-pads
Pharmacy Board Rules: http://vtprofessionals.org/opr1/pharmacists/rules/Pharmacy%20Rules%20Effective
(See, Section 9.5 for tamper resistant prescription requirements.)
What types of drugs are on the controlled substances schedules I through V and how were the schedules created?
The original list of controlled substances was included in Section 812 of the federal Controlled Substances Act, when it was enacted in 1970. Since then a number of substances have been added, removed, or transferred from one schedule to another. The current list of controlled substances on schedules II through V may be found on the DEA website at: http://www.deadiversion.usdoj.gov/schedules/schedules.htm
Schedule I includes illegal drugs with no identified medical benefit, such as LSD, mescaline, PCP, ecstasy, marijuana and others.
Schedule II includes amphetamines, morphine, fentanyl, Ritalin, methadone, dilaudid and other drugs.
Schedule III includes Buprenorphine, Marinol, steroids, Vicodin, some codeine combinations, paregoric, testosterone and other drugs.
Schedule IV includes Xanax, Valium, Phenobarbital, Halcion, Ambien and other drugs.
Schedule V includes Robitussin, Lomatil and other drugs.
Controlled Substances: Schedule II
Can a prescription for a Schedule II controlled substance be communicated by facsimile to a pharmacy?
Only the following types of prescriptions for Schedule II controlled substances may be communicated by a manually signed fax without delivering a written original prescription to the pharmacy prior to dispensing:
- Schedule II drugs compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion; or
- Schedule II drugs for a resident of a long-term care facility; and
- Schedule II drugs for a patient under a Medicare hospice program’s care or for a patient enrolled in a state hospice program.
Note: for these types of prescriptions, the hard copy of the faxed prescription serves as the original written order and must be filed in the patient’s medical record.
Other prescriptions for Schedule II controlled substances may be communicated by the prescriber by fax only if the original written, signed prescription is presented to the pharmacist prior to dispensing.
In an emergency, are oral or electronic prescriptions for Schedule II controlled substances permitted?
In an emergency, a prescription drug order for a Schedule II controlled substance may be communicated by the practitioner orally provided that:
- The quantity prescribed is limited to the amount adequate to treat the patient during the emergency period;
- The oral prescription is immediately reduced to writing by the pharmacist, or an electronic prescription to a hard copy;
- If the prescribing practitioner is not known to the pharmacist, the pharmacist makes a reasonable effort to determine that the oral authorization came from a licensed and registered practitioner; and
- Within 7 days after authorizing an emergency oral prescription drug order, the practitioner delivers a written prescription to the dispensing pharmacist.
The prescription must have written on its face “Authorization for Emergency Dispensing,” and the date of the oral or electronic prescription. Pharmacists are required to notify the U.S. Drug Enforcement Administration (DEA) if the prescribing practitioner fails to deliver a written prescription.
May prescriptions for Schedule II controlled substances be refilled?
No. Refilling a prescription for a controlled substance listed in Schedule II is prohibited by federal law.
May prescriptions for Schedule II controlled substances be postdated?
No. Postdating Schedule II prescriptions is prohibited by federal law.
May I prepare multiple prescriptions for a Schedule II drug to be filled by my patient on different dates?
Yes, you may write multiple prescriptions with multiple fill dates for Schedule II drugs that may be filled sequentially and will enable the patient to receive over time, up to a 90-day supply of the drug.
What are the requirements for the issuance of multiple prescriptions for schedule II controlled substances?
The prescriber must include written instructions on each separate prescription indicating the earliest date on which a pharmacy may fill each prescription. Each prescription must be dated as of the date it is written. Each prescription must be issued for a legitimate medical purpose by a prescriber acting in the usual course of his/her professional practice. The rule does not specify the number of separate prescriptions that may be issued for the 90-day supply. For example, a practitioner may issue three 30-day prescriptions or nine 10-day prescriptions, having the combined effect of a 90-day supply.
Note: Multiple prescriptions are not considered refills because separate prescriptions are required for each fill date. They are not considered to be back-dated because each prescription includes both the date the prescription was issued and the date for filling the prescription.
Am I required to see my patient in person every time I prescribe a Schedule II drug?
No, you can mail a prescription for a Schedule II drug to a patient or to a pharmacy. You may also fax a prescription, but the pharmacist may not dispense the drug until an original prescription is received. You should keep in mind that under federal law, prescriptions for Schedule II drugs may only be written for a legitimate medical purpose, consistent with sound medical practice considering the nature of the drug being prescribed and the risk of diversion. The medical record should reflect your assessment that the patient does not need to be seen in person, and that you have taken into account the risk of diversion.
Note: the Vermont Board of Medical Practice’s Policy on the Use of Controlled Substances for the Treatment of Pain states that “patients should be seen at least quarterly and as frequently as warranted by the clinical circumstances.”
How long are prescriptions for controlled substances on Schedules II valid?
In Vermont, prescriptions for Schedule II drugs, written without multiple fill dates, are only valid for 30 days. Prescriptions written for multiple fill dates are valid for up to 90 days. If a prescription for a Schedule II drug without multiple fill dates is not filled within 30 days after it is written, a new original prescription must be written.
Is there a limit on the number of Schedule II dosage units a practitioner can prescribe for a patient?
No, the Controlled Substances Act and the DEA Rules do not limit the number of dosage units a practitioner can legitimately prescribe. However, if a practitioner issues multiple schedule II prescriptions, he/she is limited to the combined effect of allowing a patient to receive, over time, up to a 90-day supply.
Under federal law, prescriptions for Schedule II drugs may only be written for a legitimate medical purpose, consistent with sound medical practice considering the nature of the drug being prescribed and the risk of diversion. The medical record should reflect your assessment that amount of the drug prescribed and the duration of the prescription are medically appropriate for the patient, and that you have taken into account the risk of diversion.
Controlled Substances Schedules III-V
Are there limits on refilling prescriptions for drugs on Schedule III, IV or V?
Prescriptions for controlled substances listed in schedule III or IV cannot be refilled more than six months after the date the prescription was initially issued, and may be refilled no more than five times during that six-month period.
Prescriptions for Schedule V may be refilled as authorized by the prescriber, consistent with Vermont law, which limits refills to a one-year period.
Is postdating of prescriptions for controlled substances permitted?
No, prescriptions for controlled substances must be dated and signed on the day they are issued.
How long are prescriptions for controlled substances on Schedules III – V valid?
Prescriptions for drugs on Schedules III and IV are valid for six months. Prescriptions for drugs on Schedule V are valid for one year.
How frequently may prescriptions for Schedule III and IV drugs be refilled?
Five (5) times in the 6-month period.
How long are prescriptions for other drugs, not controlled substances, valid in Vermont?
Prescriptions for non-controlled drugs are valid for one year. Prescriptions for non-controlled drugs may not be filled or refilled more than one year after the prescription was originally written.
DEA Rule on Electronic Prescriptions for Controlled Substances
What is DEA’s rule “Electronic Prescriptions for Controlled Substances?”
DEA’s rule, “Electronic Prescriptions for Controlled Substances” revises DEA’s regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. The rule was published in the Federal Register Wednesday, March 31, 2010 and became effective on June 1, 2010.
Is the use of electronic prescriptions for controlled substances mandatory?
No, the new regulations do not mandate that practitioners prescribe controlled substances using only electronic prescriptions. Nor do they require pharmacies to accept electronic prescriptions for controlled substances for dispensing. Whether a practitioner or pharmacy uses electronic prescriptions for controlled substances is voluntary from DEA’s perspective. Prescribing practitioners are still able to write, and manually sign, prescriptions for schedule II, III, IV, and V controlled substances and pharmacies are still able to dispense controlled substances based on those written prescriptions. Oral prescriptions remain valid for schedule III, IV, and V controlled substances. Electronic prescriptions for controlled substances are only permissible if the electronic prescription and the pharmacy application meet DEA’s requirements. In addition, electronic prescriptions for controlled substances may be subject to state laws and regulations. If state requirements are more stringent than DEA’s regulations, the state requirements would supersede any less stringent DEA provision.
When can a practitioner start issuing electronic prescriptions for controlled substances?
A practitioner will be able to issue electronic controlled substance prescriptions only when the electronic prescription or electronic health record (EHR) application the practitioner is using complies with the requirements in the interim final rule.
How will a practitioner be able to determine that an application complies with DEA’s rule?
The application provider must either hire a qualified third party to audit the application or have the application reviewed and certified by an approved certification body. The auditor or certification body will issue a report that states whether the application complies with DEA’s requirements and whether there are any limitations on its use for controlled substance prescriptions. (A limited set of prescriptions require information that may need revision of the basic prescription standard before they can be reliably accommodated, such as hospital prescriptions issued to staff members with an identifying suffix.) The application provider must provide a copy of the report to practitioners who use or are considering use of the electronic prescription application to allow them to determine whether the application is compliant with DEA’s requirements.
Until a practitioner has received an audit/certification report from the application provider indicating that the application meets DEA's requirements, how can the electronic prescription application or electronic health record application be used to write controlled substances prescriptions?
Nothing in this rule prevents a practitioner or a practitioner's agent from using an existing electronic prescription or EHR application that does not comply with the interim final rule to prepare and print a controlled substance prescription, so that EHR and other electronic prescribing functionality may be used. Until the application is compliant with the final rule, however, the practitioner will have to print the prescription for manual signature. Such prescriptions are paper prescriptions and subject to the existing requirements
Where can I find more information about the DEA’s rule on Electronic Prescriptions for Controlled Substances?
The DEA has posted a questions and answers document for prescribing practioners on its website at: http://www.deadiversion.usdoj.gov/ecomm/e_rx/faq/practitioners.htm
A pdf version of the rule itself is available at: http://www.deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331.pdf
Is DEA registration required to prescribe controlled substances?
Yes, the Controlled Substances Act and its regulations require a practitioner to obtain and maintain a current Drug Enforcement Administration (DEA) registration in order to purchase, possess, distribute, and prescribe controlled substances.
The intent of the DEA registration number is to identify and validate those individuals who have been authorized by the federal DEA to prescribe controlled substances in the course of their professional practice.
Is a separate DEA Registration required for separate practice locations?
If the practitioner only prescribes controlled substances from the second location (and does not administer, dispense or store controlled substances there) a separate registration is not required if the practice location is in the same state. If the separate practice location is in another state, a separate DEA Registration is required.
Is a DEA Registration required to prescribe medications other than controlled substances?
No. DEA registration is only legally required to certify transactions involving controlled substances.
How can a prescriber register with the DEA?
Forms and on-line registration are available on the DEA website. http://www.deadiversion.usdoj.gov/online_forms.htm
Does Vermont require state registration to prescribe regulated drugs or controlled substances?
No, but Vermont licensing Boards require licensed prescribers to have DEA numbers if they prescribe controlled substances.
May nurse practitioners and physician assistants prescribe controlled substances to treat pain?
Yes, if their practice guidelines or scope of practice document permits prescription of controlled substances.
Advance practice registered nurses (APRN) must develop practice guidelines with a collaborating physician, that are reviewed annually, and filed in the workplace. APRNs may prescribe the medications that are covered in their practice guidelines, including controlled substances. Practice guidelines for APRNs must be approved by the nursing board; and the pharmacy board must be informed of the prescription authority of the nurse practitioner.
Note: The Board of Nursing is revising the APRN rules.
Physician assistants may prescribe drugs if the drugs are prescribed by their supervising physician and if the drugs are permitted by their scope of practice document. The physician assistant’s scope of practice document must be approved by Vermont Board of Medical Practice and provided to pharmacists on request.
Note: The Board of Medical Practice Rules (effective 2-16-2001) are being revised because of changes to the Vermont Statutes
May nurse practitioners and physician assistants prescribe controlled substances such as methadone or Buprenorphine to treat drug addiction or dependence?
No, although nurse practitioners and physician assistants may prescribe controlled substances for pain and other symptom control, midlevel clinicians may not prescribe or administer methadone or Buprenorphine for treatment of drug abuse, dependence or addiction.
Are Nurse Practitioners and Physician Assistants required to have DEA numbers?
Physician assistants who prescribe drugs from Schedules II through V are required by the Rules of the Vermont Board of Medical Practice to obtain DEA numbers.
The Administrative Rules of the State Board of Nursing require nurse practitioners to have a DEA number if they prescribe controlled substances, and to demonstrate that they have a DEA registration number at the time of renewal.
What is the Vermont Prescription Monitoring System?
The Vermont Prescription Monitoring System (VPMS) tracks prescribing and dispensing of controlled substances on Schedules II, III and IV in an electronic database operated by the Vermont Department of Health. All pharmacists and dispensers licensed by the Vermont Board of Pharmacy are be required to send information about the prescriptions for Schedule II, III and IV drugs that they fill to the Department of Health, including names of patients, prescribers, drugs, and the amount, dosage, days supply of the drug dispensed. Information from the VPMS database, including a complete history of their patient’s prescriptions for controlled substances, is available to physicians to help them effectively manage their patients’’ treatment with controlled substances. The system can alert physicians to possible abuse of controlled substances or addiction.
Who will be able to access the information from the controlled substances monitoring database?
The information in the database is confidential and the Department of Health is authorized only to disclose information from the database as follows:
- Patients may request information about themselves
- Physicians, other prescribers and pharmacists may request information about patients that is needed for treatment purposes
- The Commissioner of Health may inform physicians or patients when data raises questions about the type of drugs or dosages prescribed.
- Licensing boards, such as the Board of Pharmacy or the Vermont Board of Medical Practice that are investigating specific individual licensees or applicants may request information needed for the specific investigation.
- The Commissioner of Health may inform the Commissioner of Public Safety, after consultation with the patient’s health care practitioner, when disclosure is necessary to avert a serious or imminent threat to a person or the public.
How can a prescriber access the VPMS database?
A prescriber may register with the Department of Health. The registration form, which must be notarized, is available at: http://healthvermont.gov/adap/documents/VPMS_RegistrationForm.pdf
A training guide that explains how to use the database is available at: http://healthvermont.gov/adap/documents/VT_RxSentry_TrainingGuide_
Once a physician has registered, data relating to “bona fide current patients” is available through the VPMS website at: http://healthvermont.gov/adap/VPMS.aspx
Quarterly reports are automatically generated by VPMS on patients who exceed certain thresholds related to the number of providers or pharmacies used. These “Patient Threshold Reports” are mailed to the prescribers who wrote the prescriptions to insure that they have a complete picture of the patient’s prescribed controlled VPMS substance use.
How can I use information about my patients from the VPMS database?
The Department of Health has a Frequently Asked Questions sectionfor prescribers and pharmacists who are using the database, that explains how the information may be used.
What should I keep in mind with respect to prescribing controlled substances to treat pain?
The Board of Medical Practice has a Policy on the Use of Controlled Substances for the Treatment of Pain, adopted in January of 2006 and based on a national model policy. The express purpose of the policy is to alleviate physician uncertainty and encourage better pain management. The policy recognizes the need for patient access to appropriate and effective pain relief and identifies inappropriate treatment as including non-treatment, under-treatment, over-treatment, continued use of ineffective treatment, and treatment that is not evaluated or assessed.
The VBMP policy includes detailed guidelines addressing:
- Treatment plan;
- Informed consent;
- Agreements for treatment;
- Periodic review of treatment;
- Medical records;
- Prescription medication abuse and diversion; and
- Compliance with controlled substances laws.
The policy indicates that the board will not apply the guidelines in the policy rigidly stating that, “The board will not take disciplinary action against a physician for deviating from the policy when contemporaneous medical records document reasonable cause for deviation. The physician’s conduct will be evaluated to a great extent by his or her documentation of the management and outcome of pain treatment.”
The policy includes as attachments two sample contracts that physicians may use as tools, a Contract for Long-Term Narcotic Therapy for Non-Cancer Pain and an Agreement for Controlled Substances for Chronic Pain. Use of one of these two specific policies is not mandated or even endorsed by the VBMP, however.
The policy is available on the Vermont Department of Health, Board of Medical Practice Website.
Are there pain assessment tools recommended by the Department of Health?
Yes. Many clinicians have found Responsible Opioid Prescribing, by Scott M. Fishman, M.D., to be a useful guide for addressing pain. This book was distributed to all licensees by the Vermont Board of Medical Practice.
The following list of Pain and Function Assessment Tools is from Responsible Opioid Prescribing:
- Initial Pain Assessment Tool
- Brief Pain Inventory
- McGill Pain Questionnaire
- Visual Analog Scale
- Wong-Baker FACES Pain Rating Scale
What can I do if my patient needs addiction treatment?
A list of addiction treatment resources in Vermont can be found on the Division of Alcohol and Drug Abuse Programs’ website: http://healthvermont.gov/adap/treatment/treatment_county.aspx
Are there any specific requirements concerning pain treatment for patients in hospitals or nursing homes or other settings?
The Vermont Hospital and Nursing Home Patients’ Bill of Rights and the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) provide that patients have the right to receive “professional assessment of pain and professional pain management.”
There is also a Patients’ Bill of Rights for Palliative Care and Pain Management that applies to patients in all settings. It states that patients suffering from pain have the right to request or reject the use of any or all treatments in order to relieve pain.
Vermont Board of Medical Practice:
Policy for the Use of Controlled Substances for the Treatment of Chronic Pain
Policy on Termination of the Physician-Patient Relationship
Hospital Patients’ Bill of Rights: 18 V.S.A. § 1852 (a)(16)
Nursing Home Patients’ Bill of Rights: 33 V.S.A. § 7301 (2)(T)
Patients’ Bill of Rights for Palliative Care and Pain Management: 18 V.S.A. § 1871
What steps can I take to reduce drug diversion and protect against drug fraud?
You can develop an office or institutional policy on prescribing controlled substances for treatment of chronic conditions and apply it consistently. The policy could address the following components:
- Use of an informed consent form for treatment with controlled substances;
- Use of agreements for long-term controlled substances therapy;
- Individualized treatment plans;
- Objectives for evaluation of treatment;
- Periodic review of treatment;
- Consultation with pain or addiction specialist;
- Numbered and watermarked prescription pads;
- Copies of prescriptions kept in the chart;
- Collaboration with pharmacists, hospitals and other physicians treating the same patient; and
- Requiring a photo id and maintaining a copy in the chart.
Are sample opiate treatment contracts and opiate treatment consent forms for pain and addiction treatment available?
The Board of Medical Practice’s Policy for the Use of Controlled Substances for the Treatment of Chronic Pain includes two optional sample opiate treatment contract forms: http://healthvermont.gov/hc/med_board/documents/pain_policy.pdf
The American Academy of Pain Medicine has a sample agreement and consent form on its website, for long-term treatment of chronic pain: http://www.painmed.org/pdf/opioid_consent_form.pdf
Appendix H of the SAMHSA/CSAT Treatment Improvement Protocols is a Sample Addiction (Buprenorphine) Treatment Agreement/Contract http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat5.section.73127
How can I know if a patient is taking the controlled substances I prescribe?
If you have concerns, you can ask the patient to agree to substance monitoring to verify that they are taking the type and amount of narcotic that you are prescribing.
From a liability perspective, what is the most important step a clinician can take when prescribing controlled substances, particularly to patients who have a history of drug abuse, or you consider at risk for diversion?
Document evaluation, treatment and rationale carefully in the medical record.
How can I be sure that my patient is only obtaining controlled drugs from one physician and one pharmacy?
Physicians may register with the Vermont Prescription Monitoring System (VPMS) and check the VPMS database on-line to determine if their patients are obtaining controlled substances from other physicians or more than one pharmacy.
Prescribers can also request that patients who are Medicaid Beneficiaries be “locked-in” to one pharmacy or prescriber for controlled substances. To request that a Medicaid, VHAP or Dr. Dynasaur patient be “locked-into” a single pharmacy or physician, a prescriber can contact the Office of Vermont Health Access (OVHA) Clinical Division. The clinical division can provide prescribers with “Beneficiary Lock-In Request” forms and can answer any questions regarding the lock-in procedure and process. Because the physician lock-in procedure requires patients to obtain all drugs from one prescriber, some physicians prefer to use only the pharmacy lock-in.
Prescribers may also check with other insurers or their pharmacy benefit managers (PBMs ) to determine if they have this type of information available.
May I disclose drug fraud to law enforcement?
HIPAA permits disclosure to law enforcement in limited situations. Disclosure is permitted when it is required by state law, such as disclosure of gun shot wounds. Disclosure is permitted when, consistent with applicable law and ethical standards, the disclosure is designed to prevent or lessen a serious and imminent threat to the health or safety of an individual or the public, such as the public health threat represented by the diversion of drugs. Finally, a health care professional may disclose evidence of criminal conduct on the premises (45 CFR 164.512(j)(1)). Whether a particular situation meets one of these exemptions is dependent on the specific facts of the situation. We recommend that practitioners consult with an attorney, their medical malpractice carrier or risk manager in making a determination of whether one of these exceptions apply.
Vermont law has an exception to the patient privilege for drug fraud. It states that information communicated to a physician in an effort to unlawfully procure a regulated drug will not be considered a privileged physician - patient communication. 18 V.S.A. § 4223. Misrepresentation, forgery, alteration of prescriptions, concealment of a material fact, or use of a false name or address are all examples of fraud that would be covered under this law. To report information about patients to law enforcement, a HIPAA exception, (see above) is required, in addition to the Vermont law’s waiver of the patient privilege. Once again, we encourage practitioners to consult with risk management, malpractice carriers or an attorney.
Under both HIPAA and Vermont law, disclosure must be limited to the minimum amount of information needed to enable law enforcement to investigate the drug fraud, or prevent the harm from occurring. Detailed information about the patient’s medical condition or treatment should not be disclosed.
Finally, AMA Ethical Opinion E-5.05 on Confidentiality provides that the obligation to safeguard patient confidences is subject to certain exceptions which are ethically and legally justified because of overriding social considerations. Where a patient threatens to inflict serious bodily harm to another person and there is a reasonable probability that the patient may carry out the threat, the physician should take reasonable precautions for the protection of the intended victim, including notification of law enforcement authorities.
May I disclose suspected diversion or drug abuse to law enforcement if I work in a program that treats patients for drug abuse or addiction?
Programs that provide alcohol or drug abuse diagnosis, treatment or referral for treatment are subject to the federal regulation governing confidentiality of alcohol and drug abuse patient records. 42 CFR Part 2. These rules provide strict protection for patient confidentiality and include specific consent forms that must be used to disclose information about drug treatment.
Under 42 CFR Part 2, you may disclose if the patient has consented in writing and the consent form meets the specific requirements of the federal regulation. The patient may revoke the consent at any point, however.
Under 42 CFR Part 2, you may also disclose certain crimes or threats to commit crimes without patient consent. These include crimes committed on the premises of your office or program, crimes against staff or threats to commit crimes on your premises or against your staff. In these limited circumstances, regardless of patient consent, you may disclose to law enforcement, the patient’s name, address, whereabouts, the circumstances of the incident and the patient status of the patient who committed or threatened to commit a crime.
The Confidentiality of Alcohol and Drug Abuse Patient Records Regulation and the HIPAA Privacy Rule: Implications for Alcohol and Substance Abuse programs: http://www.hipaa.samhsa.gov/download2/SAMHSA'sPart2-HIPAAComparisonClearedWordVersion.doc
42 CFR Part 2: http://www.access.gpo.gov/nara/cfr/waisidx_02/42cfr2_02.html
What steps can I take if I believe a patient whom I am treating for drug abuse, dependence or addiction is diverting drugs?
You can request that the patient sign a written treatment agreement, specifying that if the patient fails to comply with the contract, you will no longer prescribe controlled substances for the patient. You can also require the patient to agree to urine monitoring as a condition of continuing to receive treatment with controlled substances from your practice. Finally, you can discharge the patient from your practice provided the requirements of the VBMP policy on Termination of the Physician-Patient Relationship are met.
- Policy on Termination of the Physician-Patient Relationship
What is Medicare Part D?
Since January of 2006, Medicare has offered insurance coverage through commercial prescription drug plans. There are a number of companies offering multiple drug plans to Medicare beneficiaries in Vermont. Low-income beneficiaries are only eligible for premium subsidies for plans with lower premiums.
Medicare plans cover generic and brand-name drugs. Plans have formularies that may include rules about quantity limits and tiered cost-sharing. Plans must notify beneficiaries 60 days before drugs they use are removed from the formulary or placed on a higher cost-sharing tier to enable them time to request a formulary exception.
How does the Medicare Part D exceptions and appeal process work?
CMS requires Part D plans to have exceptions and appeals processes.
Exceptions may be requested when:
- A patient is using a drug on a plan formulary that is removed during the plan year;
- A patient is using a drug that has been moved from a preferred to a non-preferred co-payment tier during the plan year; or
- A physician has prescribed a non-formulary drug or a drug on a higher co-payment tier that is medically necessary for a patient and drugs on the formulary or at lower co-payment tiers are medically inappropriate for the patient.
Plans are required to approve exceptions if they agree that formulary or lower co-payment tier drugs would not be as effective as the requested drug, or would have an adverse effect on the patient or both. Plans generally have up to 72 hours to make exception decisions, but must decide within 24 hours when the patient’s health condition warrants an earlier expedited decision.
After a plan makes an unfavorable coverage determination or denies an exception request, the patient or physician may appeal the plan’s decision. There are several levels of appeal.
How do I contact a Medicare Part D Prescription Drug Plan (PDP) about coverage decisions or appeals?
The links below include information on contacting plans operating in Vermont in 2009.
http://ovha.vermont.gov/for-providers/2009-pdp-pharmcy-contact-sheet-verified.pdf (Contact information for Part D plan operating in Vermont )
http://ovha.vermont.gov/for-providers/2009-mapd-pharmacy-contact-sheet-verified.pdf (Contact information for Part C plans with drug coverage)
Are Part D plans required to accept the following model Medicare Part D Coverage Determination Request Form and the model Part D Exception and Prior Authorization Request Form?
Yes, the Part D Regulations require plans to accept any written instrument that is used by an enrollee, an enrollee’s representative or a prescribing physician to request a coverage determination. While plans may have their own forms, they must also accept the model forms at the link below.
My patient has coverage from one of the state pharmacy programs and is also eligible for Part D. Where can I find more information about what is covered by the Office of Vermont Health Access’ (OVHA) pharmacy plans that wrap Medicare Part D coverage?
OVHA Pharmacy programs:
OVHA programs that wrap Part D:
OVHA OTC drug coverage:
How can I find what drugs are covered by Medicare Part D Prescription Drug Plans that my patient signed up for?
Plan formularies are available on the plan websites and are also available free to use online or download to a PDA through Epocrates®.
Who manages the Medicaid Preferred Drug List (PDL)?
The Office of Vermont Health Access (OVHA) contracts with a pharmacy benefit management company, MedMetrics, to administer the Preferred Drug List (PDL). The Drug Utilization Review Board, which consists of approximately eight physicians and four pharmacists, reviews proposals from the Office of Vermont Health Access (OVHA) and makes decisions on whether to add and remove drugs from the PDL. The DUR Board also reviews the clinical criteria for drugs on the PDL.
Where can I find a current list of drugs on the Medicaid Preferred Drug List (PDL) and the clinical criteria for approving use of the drugs?
Both a PDL quick list and a comprehensive list with clinical criteria are posted on the OVHA website. OVHA and MedMetrics update the lists annually, and interim changes are also posted on the website. The lists are also available electronically at no charge from Epocrates for installation on a computer or personal digital assistant.
Clinical Criteria Manual for PDL http://ovha.vermont.gov/for-providers/09-06-vt-clinical-criteria-june-1-2009-final.pdf
NOTE: These documents are updated frequently; check the OVHA website for updates.
Is the PDL available electronically to use on my PDA or computer?
The ePocrates™ database of drugs on OVHA’s PDL is available electronically and is updated quarterly by MedMetrics, OVHA’s pharmacy benefit manager. ePocrates™ offers a free product, ePocrates Rx™, which also provides the formularies of several other payers. Visit www.epocrates.com to register, to download an update to your computer or PDA, to get help with the selection of a PDA for product discounts and technical support.
How does the PDL work?
If a drug is not on the PDL or if clinical criteria for prescribing the drug are not met, Medicaid coverage will be denied at the pharmacy, unless prior authorization is obtained from MedMetrics of OVHA. Prior authorization may be obtained by faxing or phoning MedMetrics. If MedMetrics denies authorization of coverage, physicians may appeal to a clinical pharmacist at MedMetrics or to the OVHA Medical Director.
Prior Authorization (PA) Requests and Initial Reconsiderations of Denials
MedMetrics Clinical Call Center
- Toll free phone: 1-800-918-7549;
- Toll free fax: 1-866-767-2649
Second Reconsideration of a Denial or to Discuss Cases
- OVHA Medical Director -- Office: 879-5906; Fax: 879-5963
How can I request that a drug be added to or removed from the PDL?
You can request that the DUR Board add a drug to the Preferred Drug List or remove a drug from the list. Make the request in writing to the Chair of the DUR Board and copy OVHA and MedMetrics. It is advisable to attach clinical information about the effectiveness of the drug as compared to other drugs, when this information is available. You should also ask that your request be included on the agenda of a DUR Board meeting. All DUR board meetings are public meetings, so you may attend the DUR Board meeting and present the case for adding the drug to the PDL in person.
18 V.S.A. Sections 1997 – 2001 Medicaid Pharmacy Best Practices and Cost Control Program:
§ 1997 Definitions
§ 1998 Pharmacy best practices and cost control program established
§ 1999 Consumer protection rules; prior authorization
§ 2000 Pharmacy benefit management
§ 2001 Legislative oversight
Information about the DUR Board: (current list of physician and pharmacist members; meeting dates, agendas, minutes): http://ovha.vermont.gov/advisory-boards/advisory-boards
Preferred Drug List and Clinical Criteria:
Clinical Criteria Manual for PDL http://ovha.vermont.gov/for-providers/09-06-vt-clinical-criteria-june-1-2009-final.pdf
Prior Authorization Process:
Is generic substitution required in Vermont?
Yes, when a pharmacist receives a prescription for a drug that is listed in the U.S. Department of Health and Human Services publication Approved Drug Products With Therapeutic Equivalence Evaluations (the “Orange Book”), the pharmacist is required to select the lowest priced drug which in his or her professional judgment is chemically and therapeutically equivalent.
Note: When a pharmacist refills a prescription, he or she must obtain permission from the prescriber to dispense a drug that is different from the drug dispensed when the prescription was originally filled.
What can I do if my patient needs a brand drug and generic substitution is not appropriate?
If the prescriber does not wish substitution to take place, he or she must write "brand necessary" or "no substitution" in his or her own handwriting on the prescription blank, together with a written statement that the generic equivalent has not been effective, or with reasonable certainty is not expected to be effective, in treating the patient's medical condition or causes or is reasonably expected to cause adverse or harmful reactions in the patient.
In the case of an unwritten prescription, there shall be no substitution if the prescriber expressly indicates to the pharmacist that the brand name drug is necessary and substitution is not allowed because the generic equivalent has not been effective, or with reasonable certainty is not expected to be effective, in treating the patient's medical condition or causes or is reasonably expected to cause adverse or harmful reactions in the patient.
Can a patient obtain a brand name drug from a pharmacy instead of a generic?
Pharmacists may dispense brand drugs to patients on request, if patients agree to pay the full cost of the drug, or any additional cost in excess of the amount allowed by their health insurance plan.
18 V.S.A. Chapter 91 Generic Drugs http://www.leg.state.vt.us/statutes/fullchapter.cfm?Title=18&Chapter=091
Can I prescribe drugs for myself and for my family members?
It is unacceptable medical practice and unprofessional conduct for a physician to prescribe controlled substances listed in DEA Schedules II, III, and IV for his or her own use, according to the rules of the Vermont Board of Medical Practice.
It also is unacceptable medical practice and unprofessional conduct for a licensee to prescribe Schedule II, III, and IV controlled substances to a member of his or her immediate family, except in a bona fide emergency, of short-term and unforeseeable character. "Immediate family", as referred to above, includes the following: a spouse (or spousal equivalent), parent, grandparent, child, sibling, parent-in-law, son/daughter-in-law, brother/sister-in-law, step-parent, step-child, step-sibling, or any other person who is permanently residing in the same residence as the licensee.
AMA Ethical Opinion E-8.19 also advises physicians generally not to treat themselves or family members. Exceptions for prescription of drugs other than controlled substances, include emergency settings or isolated settings where another physician is not available.
Note: The Board of Medical Practice Rules have not been revised to include extensive changes made in 2002 by Act 132, the law that attached the Board to the Department of Health.
AMA Ethical Opinion E-8.19 Self-Treatment or Treatment of Immediate Family Members.
Does Vermont law regulate free samples of drugs?
Vermont law imposes a fine on individuals or businesses that leave free samples accessible to children.
“A person, firm or corporation that distributes or causes to be distributed a free or trial sample of a medicine, drug, chemical or chemical compound, by leaving the same exposed upon the ground, sidewalks, porch, doorway, letter box or in any other manner, that children may become possessed of the same, shall be fined not more than $300.00 nor less than $100.00.”
Does the AMA have a policy on sample medications?
Yes, H-120.991supports the continued availability of drug samples, with appropriate safeguards to prevent diversion. The policy supports practices such as ensuring proper storage to ensure potency and security; maintaining records of all samples that are distributed, destroyed or returned; and reporting losses or thefts of prescription drug samples. Samples should not be sold.
May physicians accept drug samples or other free pharmaceuticals for personal use or use by family members?
The AMA Council on Ethical and Judicial Affairs’ guidelines permit personal or family use of free pharmaceuticals (i) in emergencies and other cases where the immediate use of a drug is indicated, (ii) on a trial basis to assess tolerance and (iii) for the treatment of acute conditions requiring short courses of inexpensive therapy, as permitted by Opinion E-8.19: Self-Treatment or Treatment of Immediate Family Members. It would not be acceptable for physicians to accept free pharmaceuticals for the long-term treatment of chronic conditions. The use of drug samples for personal or family use should not interfere with patient access to drug samples. Finally, it would not be acceptable for non-retired physicians to request free pharmaceuticals for personal use or use by family members.
18 V.S.A. § 1504 – Distribution of samples of medicine
AMA Ethical Opinion - E-8.061 Gifts to Physicians from Industry
AMA Ethical Opinion - E-8.19 Self-Treatment of Treatment of Immediate Family Members
AMA House of Delegates Policy - H-120.991 Sample Medications
Who must comply with the law?
Manufacturers of pharmaceuticals, biological products, and medical devices must comply with the gift ban and must report allowable expenditures to the Vermont Attorney General.
What gifts are banned?
The ban covers anything of value given to a health care provider for free, including food, entertainment, travel, subscriptions, advances, or anything else of value, unless it is explicitly allowed or the health care provider reimburses the cost at fair market value. Examples of banned expenditures in a Frequently Asked Questions document prepared by the Attorney General’s Office include lunch provided for a doctor’s office; coffee and donuts for non-prescribing staff, dinner provided in New Hampshire to a physician whose primary office is in Vermont or driving a Vermont physician to an event in New York.
What type of expenditures are allowable (not banned) but must be disclosed by the manufacturer to the Attorney General’s office and included in the Attorney General’s annual report?
The following expenditures are not banned as long as certain requirements are met, but the allowable expenditures must be disclosed by the drug, biologic or device manufacturer to the Vermont Attorney General’s office:
- Articles or journals or other educational items, if they are peer-reviewed academic, scientific or clinical articles or journals, or serve an educational purpose and are for the benefit of patients (examples include brochures for patients, medical books for physicians, models of human anatomy or other visual aids to use with patients;
- Loan of a medical device for a short-term trial period up to 90-days;
- Medical device demonstration or evaluation units used for patient education purposes;
- Scholarships or other support for medical students, residents and fellows to attend seminars or conferences;
- Gifts to academic institutions and professional, educational or patient organizations;
- Conference sponsorship provided payment is not made to health care providers and program content is free from industry control;
- Honoraria and payment of expenses provided there is a contract with deliverables that do not include marketing activities, and content is determined by the health care professional;
- Technical training on medical devices;
- Bona fide clinical trials;
- Research projects;
- Samples; and
- Other payments at fair market value such as payment to a physician to present information to other physicians, even without CME accreditation, if no food is provided.
Where can I find more information about the requirements for, and limitations on, activities that are not banned, but must be disclosed?
The Attorney General’s office has created a Guide to Vermont’s Prescribed Products Law for FY 2010 and 2011 Disclosures, which was published by the Vermont Office of the Attorney General on the office’s website at:
Guide for FY2011
What is considered to be a sample?
A unit of a prescription drug, biological product or medical device that is not intended to be sold and is intended to promote the sale of the drug, product or device. The term “sample” includes starter packs, coupons or other vouchers.
What activities do not require disclosure and are not included in the gift ban?
- Rebates and discount; and
- Royalties and licensing fees.
Are manufacturers’ contributions to continuing medical education (CME) programs sponsored by educational institutions or professional associations exempt from disclosure?
No. Manufacturers must disclose unrestricted grants for CME but disclosure is limited to the value, nature and purpose of the grant and the name of the institutional or professional association grantee. The names of the individual participants in such a program need not be disclosed.
The costs of maintaining a table at a conference or seminar which is not limited to Vermont prescribers or institutions need not be reported.
What must be disclosed?
The value, nature, and purpose and recipient information, of permitted gifts or allowable expenditures (except those that are exempt from disclosure) to any active Vermont prescriber or Vermont institution.
What information is the manufacturer required to disclose about recipients?
The recipient’s name, address, institutional affiliation, and state license number, and the drug, biologic or device that is being marketed.
Public disclosure of reported information
What happens to disclosed information?
The Vermont Office of the Attorney General must file an annual report with the Vermont legislature and the Governor by April 1, 2012. After the report is issued, the Attorney General will make all disclosed data other than the recipients of free samples publically available and searchable on an internet website.
What happens to information that is disclosed about free samples?
Data relating to distribution of free samples may be released by the Attorney General to academic researchers for analysis and aggregated public reporting as long as the data sent to the researchers does not include the names or license numbers of individual recipients. Any public reporting of the distribution of free samples will not allow for the identification of individual recipients.
May a company designate any of this information as “trade secret”?
After July 1, 2009, manufacturers may no longer designate any of the disclosed information as “trade secret.” Consequently, although information designated in previous years’ disclosures as trade secret will be kept confidential, data received for FY10, covering expenditures made between July 1, 2009, and June 30, 2010, will be released to the public after the FY10 report is issued.
Law: 33 V.S.A. § 2005. PHARMACEUTICAL MARKETERS; Act 59: http://www.leg.state.vt.us/docs/2010/Acts/ACT059.pdf
Attorney General’s website on Pharmaceutical Marketing:
Includes links to forms, guidelines and public annual reports on manufacturer spending on marketing prescribed drugs, devices and biologics: http://www.atg.state.vt.us/issues/pharmaceutical-manufacturer-payment-disclosure.php
AG’s Guide to Vermont’s prescribed products disclosure law for FY 2011 Disclosures: http://www.atg.state.vt.us/assets/files/Guide%20To%20Vermonts%20
Attorney General’s Answers to Manufacturers’ Questions:
AMA Ethical Opinion E-8.061: Gifts to Physicians from Industry: http://www.ama-assn.org/ad-com/polfind/Hlth-Ethics.pdf
Is there a Vermont program that patients can use to import lower cost brand drugs from Canada, UK and Ireland?
Yes, I-SaveRx is a mail order pharmacy program that was originally developed by the state of Illinois to provide mail order access to lower cost brand prescription drugs from Canada, the United Kingdom and Ireland. Vermont joined the program in 2005. Vermont residents can participate in this program as an interim solution to the escalating cost of prescription drugs.
What does the I-SaveRX program do?
- It provides Vermonters with an option to order affordable brand prescription drugs from Canada, the United Kingdom and Ireland
- It processes prescription drug refills only
- It provides a three-month supply of prescription drugs
What doesn’t the I-SaveRX program do?
- It does not enable patients to order narcotics, controlled substances or medications requiring refrigeration
- It does not fill first time prescriptions. Patients must fill a new prescription for the first 30 days at a pharmacy.
- It does not fill all prescriptions. Only a selected group of brand drugs are available. Generic drugs, narcotics, and medications requiring refrigeration are not available through this program.
- It does not accept or bill insurance. Patients pay by check or credit card. If they have prescription drug coverage, they should check with their insurance company for reimbursement information.
Where can patients get more information about I-Save Rx?
As a prescriber, what legal considerations should I be aware of, with respect to reimportation of drugs?
The import provisions of the Federal, Food, Drug, and Cosmetic Act, include the following compliance requirements:
- Pharmacies and or dispensers selling imported drugs must ensure that drugs sold in the US are FDA approved;
- Drugs manufactured in the U.S. may only be imported back into the U.S. by the manufacturer; and
- Drugs must meet all U.S. labeling requirements and be dispensed by a pharmacist pursuant to a valid prescription.
What are some potential risks to physicians with respect to drug importation?
Physicians who dispense drugs from their office, should be cautious about importing or reimporting the drugs they dispense. They could be subject to patient lawsuits if the drugs they dispense are adulterated or misbranded. They could also be the subject of federal enforcement actions.
Madeleine Mongan is deputy executive vice president for the Vermont Medical Society, representing the interests of the physicians who practice in Vermont. She works with the Vermont Legislature, state agencies and insurers on health care policy and provides education and technical assistance to Vermont physicians on legal issues. Her practice addresses a range of health law issues including confidentiality, licensing, managed care, public health, contracting, and fraud and abuse. She represents Vermont physicians on the Area Health Education Centers Statewide Advisory Board. She is a member of the American Health Lawyers Association and the Vermont Bar Association where she is past chair of the Health Law Committee. She received her B.A. from the University of Delaware, M.A. from Stanford University and J.D. from the University of California at Davis.