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Pharmaceutical
Issues
Topics Covered on This Page
General Prescription Requirements
Prescription Of Regulated Drugs
(Controlled Substances)
Prescribing Controlled Substances – DEA
Registration And State Regulation
Prescribing Controlled Substances – Mid-Level
Practitioners
Drug Diversion: Patient Fraud
Prescription Monitoring Program
Pain
Prescribing
Medicare Part D
Medicaid Preferred Drug List
Generic Substitution
Prescribing For Self And Family
Free Drug
Samples
Disclosure Of Pharmaceutical Manufacturer And
Detailer Gifts To Prescribers
Reimportation
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. In
addition, prescriptions for all drugs except controlled substances
listed in Schedule II may be communicated orally, or by electronic
transmission. In certain situations, described below, prescriptions for
drugs in Schedule II may also be communicated orally or electronically.
Does the definition of “electronic transmission”
include transmission by e-mail and facsimile?
Yes.
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 identify 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. The prescription must be
transmitted by an authorized practitioner or his or her designated
agent.
Can a prescriber authorize an employee 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, provided that the
identity of the agent or employee is included in the prescription.
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
regulated drugs and controlled substances.
Resources:
http://vtprofessionals.org/opr1/p_therapists/forms/ptrule.pdf
What drugs are on 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.
Can a
prescription for a Schedule II controlled substance be communicated
electronically to a pharmacy?
Only prescriptions for the following types of Schedule II controlled
substances may be communicated electronically 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.
Note: for these types of prescriptions, the hard copy of the
electronic transmission serves as the original written order and must be
filed in the patient’s record.
Other prescriptions for Schedule II controlled substances may be
communicated by the prescriber electronically 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 or by way of
electronic transmission, 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 72 hours 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.
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.
May I
prepare multiple prescriptions for a Schedule II drug to be filled by my
patient on different dates?
No, that would be considered comparable
to issuing a refill for a Schedule II drug, which is prohibited by
federal law.
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.
How long are
prescriptions for controlled substances on Schedules II – V valid?
In Vermont prescriptions for Schedule II drugs are only valid for 10
days. If a prescription for a Schedule II drug is not filled within 10
days after it is written, a new original prescription must be written.
Prescriptions for drugs on Schedules III and IV are only valid for six
months. Prescriptions for drugs on Schedule V are valid for one year.
How long are
prescriptions for non-controlled drugs 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.
Is there a limit on the number of days worth of a Schedule II drug
that may be prescribed?
No, The Controlled Substances Act and the DEA do not limit the
number of days’ supply that may be prescribed. 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 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.
Resources:
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 DEA registration required to prescribe
medications other than controlled substances?
No. DEA registration is only legally required to certify
transactions involving controlled substances. Some pharmacy benefit
managers and insurance companies, however, require DEA numbers for all
prescriptions.
How can a prescriber register with the DEA?
Does Vermont
regulate drugs?
Yes, the Vermont Board of Health is authorized to designate regulated
drugs. The Vermont Regulated Drugs rules include lists of three classes
of drugs:
-
depressant and stimulant drugs;
-
narcotics and narcotic drugs; and
-
hallucinogenic drugs.
The rule also includes recommended individual therapeutic dosages.
The rule is available on the Department of Health website at:
http://healthvermont.gov/regs/reg_drug_rule.pdf
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.
Prescribing Controlled Substances
– Mid - Level Practitioners
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.
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 the Vermont Board of Medical Practice and provided to
pharmacists on request.
Note: 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.
Resources
Drug
Diversion: Patient Fraud
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 a 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;
-
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 American Academy of Pain Medicine has a sample agreement and
consent form on its website, for long-term treatment of chronic pain.
Go to:
http://www.painmed.org/productpub/statements/pdfs/controlled_substances_
sample_agrmt.pdfhttp://www.painmed.org/productpub/statements/pdfs/
opioid_consent_form.pdf
Appendix H of the SAMHSA/CSAT
Treatment Improvement Protocols is a sample addiction (buprenorphine)
treatment agreement/contract
Go to:
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 require a patient to agree to
monitoring to verify that he or she is 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 everything carefully in the medical record:
-
History and physical examination;
-
Diagnostic and laboratory results;
-
Evaluations and consultations;
-
Treatment objectives;
-
Discussion of risks and benefits;
-
Informed consent;
-
Treatment, medications;
-
Instructions and agreements;
-
Periodic reviews;
-
Discussions with and about patients. For example,
questions and responses; calls for medications and explanations; calls
to verify treatment by another practitioner.
How can I be sure that my
patient is only obtaining controlled drugs from one physician and one
pharmacy?
1. Medicaid Beneficiary Lock-in
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.
2. BC/BS Restat
The BC/BS Restat
system blocks payment for multiple
opiate prescriptions for the same time period and for attempts
to fill opiate prescriptions at
several pharmacies.
May I disclose drug
fraud to law enforcement?
HIPAA permits disclosure to law enforcement in three situations. First,
disclosure is permitted when it is required by state law. Next,
it 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)]
Vermont law has created 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 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 may be reported to law enforcement, under this law.
Vermont case law requires mental health
professionals who have determined that a patient poses serious risk of
danger to another, to take steps that are reasonably necessary to
protect foreseeable victims. Failure to warn identified victims was held
to constitute a breach of duty in Peck v. Counseling Service of
Addison County, 146 VT 61 (1985). Selling or illegally providing
controlled substances to another person creates a serious and imminent
threat to public health and has the potential to cause serious bodily
harm to individuals. It is likely that Vermont courts would extend this
ruling to other types of health care professionals.
Note:
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. 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.
For more information, go to:
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
Are all physicians who
prescribe buprenorphine for substance abuse or addiction treatment
considered to be drug abuse treatment programs for purposes of 42 CFR
Part 2?
Probably not. Unless an individual physician practice specializes in or
holds itself out or promotes itself to the community as providing drug
abuse treatment services, the practice would probably not be considered
a drug abuse treatment program for purposes of 42 CFR Part 2.
42 CFR Part 2 was promulgated long
before buprenorphine waivers were developed and does not specifically
address this situation, however. The rule carves out emergency room
practitioners who provide drug treatment or diagnosis unless their
primary function is the provision of alcohol and drug abuse treatment or
unless they identify themselves or promote themselves as providing drug
and alcohol treatment services. By analogy, a similar carve out should
apply to physicians who treat their patients’ drug addiction with
buprenorphine.
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 not be able to 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.
For more information, go to:
http://healthvermont.gov/hc/med_board/010699terminationadvisory.pdf
What is the Prescription Monitoring Program?
Act 205, effective on July 1, 2006 authorized the Department of Health
to create an electronic database and reporting system for Schedule II,
III and IV controlled substances. All dispensers licensed by the Vermont
Board of Pharmacy will be required to forward information about
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, and days’ supply of the drug dispensed.
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.
When will the database
be available?
The Department of Health is in the process of establishing an advisory
committee for the program, promulgating rules and hiring staff and a
contractor to create the database. Once the contractor is hired and
rules are promulgated, the program will be able to begin to collect data
from pharmacies. It is expected to take several years before the data
will be available online in real-time, but some data may be available
sooner, probably by phone.
Is there a risk of being disciplined for
prescribing opiates for pain treatment?
A study of disciplinary actions taken by medical boards across the
country showed that the risk of being disciplined by a state medical
board for treating a real patient with opiates is virtually
non-existent. Physicians who were disciplined had multiple violations in
addition to prescribing opiates such as prescribing for themselves,
family or non-patients; prescribing for patients with addictions
without addressing the addiction; inadequate records; no indication for
opiates; sexual activity with patients; or other types of professional
incompetence.
For more information, see:
-
Risk of Disciplinary Action against Physicians
Prescribing Opiates, Jack Richard, MD; Marcus Reibenburg, MD
-
Journal of Medical Licensure and Discipline, Vol.
91, Number 2, 2005, Page 14
What should I keep in mind
with respect to prescribing controlled substances to treat pain?
The Board of Medical Practice has a new Policy on the Use of
Controlled Substances for the Treatment of Pain, adopted in January of
2006 and based on a model policy developed by the Federation of State
Medical Boards. 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:
- Evaluation;
- Treatment plan;
- Informed consent;
- Agreements for treatment;
- Periodic review of
treatment;
- Consultation;
- Medical records;
- Prescription medication
abuse and diversion; and
- Compliance with controlled
substances laws.
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:
http://healthvermont.gov/hc/med_board/pain_policy.pdf
Are there any
requirements concerning pain treatment for patients in hospitals or
nursing homes?
The Vermont Hospital and Nursing Home Patients’ Bill of Rights and the
Joint Commission on the Accreditation of Health Care Organizations
(JCAHO) also provide that patients have the right to receive
“professional assessment of pain and professional pain management.”
Resources:
http://healthvermont.gov/hc/med_board/pain_policy.pdf
http://healthvermont.gov/hc/med_board/010699terminationadvisory.pdf
http://www.leg.state.vt.us/statutes/fullchapter.cfm?Title=18&Chapter=042
http://www.leg.state.vt.us/statutes/fullchapter.cfm?Title=33&Chapter=073
What is Medicare Part D?
Since January of 2006, Medicare has offered insurance coverage through
commercial prescription drug plans. In 2006 there are 17 companies
offering about 40 different drug plans to Medicare beneficiaries in
Vermont, but this number of plans is expected to decrease in 2007.
Low-income beneficiaries are only eligible for premium subsidies for 11
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;
- 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 five
levels of appeal:
- Redetermination by the Part
D Plan;
- Reconsideration by an
Independent Review Entity;
- Administrative Law Judge,
- Medicare Appeals Council;
and
- Federal District Court.
A plan has seven days to make
a redetermination decision, and up to 72 hours for an expedited
decision. If the redetermination decision is unfavorable for the
patient, the patient may proceed to an independent review. The
Independent Review Entity has up to seven days to make its decision, or
72 hours for an expedited appeal. Patients or physicians filing higher
level appeals may need to meet additional requirements such as an
“amount in controversy requirement,” and there are no time limits
specific to Part D appeals for these procedures.
How do I contact a Medicare Part D
Prescription Drug Plan (PDP) about coverage decisions or appeals?
The link below includes information on contacting plans operating in
Vermont in 2006.
http://www.ovha.state.vt.us/docs/2006-03-03-Mailing_PDP_Contacts.pdf
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
links below.
http://www.cms.hhs.gov/MLNProducts/Downloads/Form_Exceptions_
final.pdf
http://www.cms.hhs.gov/PrescriptionDrugCovGenIn/Downloads/
ModelCoverageDeterminationRequestForm.pdf
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, including VPharm 1,2 and 3?
Go to:
http://www.ovha.state.vt.us/docs/2006-03-03-Pharmacy_Programs_Grid_Revised.pdf
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. These can be
accessed by going to:
http://www.vtmd.org/advocacy&education/Medicare/Medicare%20
Vermont%20Plan%20Formularies.html
Plan formularies are also available
free to use online or download to a PDA through Epocrates®. OVHA has
developed a fact sheet explaining how to register for and use Epocrates®.
http://www.ovha.state.vt.us/docs/2006-03-03-Epocrates_Use.pdf
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
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.
Is the PDL available
electronically to use on my personal digital assistant (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 for 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.
Resources:
18 V.S.A. Sections 1996 – 2001
Medicaid Pharmacy Benefit Management Program:
-
§ 1996 Vermont prescription
drug pricing and consumer protection 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
http://www.leg.state.vt.us/statutes/sections.cfm?Title=33&Chapter=019
Is generic
substitution required in Vermont?
Yes, when a pharmacist receives a prescription for a drug which 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. In the case of an oral prescription,
substitution is not permitted if the prescriber expressly indicates to
the pharmacist that the brand name drug is necessary and substitution is
not authorized.
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.
Resources:
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
licensee to prescribe controlled substances listed in DEA Schedules II,
III, and IV for his or her own use. [See Rules, 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 include emergency settings or isolated settings
where another physician is not available.
Resources:
VBMP Rules:
The Board of Medical Practice Rules are being revised to reflect
extensive changes made in 2002 by Act 132, the law that transferred the
Board to the Department of Health. Because the Rules currently conflict
with the law in many details, they are not available on the Board’s web
site. For a paper copy of the Rules (understanding that wherever they
differ from the Statutes, the Statutes take precedence), you can send
your name, postal address, and request to
medicalboard@vdh.state.vt.us.
AMA Ethical Opinion E-8.19
Self-Treatment or Treatment of Immediate Family Members
http://www.ama-assn.org/apps/pf_new/pf_online
Does Vermont law regulate
free samples of drugs?
Vermont law imposes a fine on individuals or businesses that leave free
samples accessible to children.
The law says that “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-120.991 supports 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:
- in emergencies and other
cases where the immediate use of a drug is indicated;
- on a trial basis to assess
tolerance; and
- 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.
Resources:
-
18 V.S.A. § 1504 –
Distribution of samples of medicine
-
AMA Ethical Opinion -
E-8.061 Gifts to Physicians from Industry
-
AMA Ethical Opintion -
E-8.19 Self-Treatment of Treatment of Immediate Family Members
-
AMA House of Delegates
Policy - H-120.991 Sample Medications
What must be disclosed?
The value, nature, and purpose of any gift, fee, payment, subsidy, or
other economic benefit provided in connection with detailing,
promotional, or other marketing activities by the company, directly or
through its pharmaceutical marketers, to any physician, hospital,
nursing home, pharmacist, health benefit plan administrator, or any
other person in Vermont authorized to prescribe, dispense, or purchase
prescription drugs in this state. Disclosure shall include the name
of the recipient [(33 V.S.A. § 2005(a)(1)]
What is required in
reporting the “value, nature and purpose and recipient” of an economic
benefit?
The Office of the Attorney General defines the four reporting criteria
as follows:
- Value - The fair market
value of the economic benefit, rounded to the nearest dollar.
- Nature - A description of
the economic benefit given, whether it is cash, dinner, plane tickets,
etc.
- Purpose - A short
description of the detailing, promotional or other marketing
activities, such as advertising, charity function, seminar, etc.
- Recipient –
This disclosure requires the names and type of recipients, which
includes institutions, physicians, hospitals, pharmacists, etc. The
disclosure law was amended in 2004 to require the disclosure of the
names of the recipients.
Will recipients of gifts
from pharmaceutical companies be identified by name in the reporting
process?
Companies are required to report the names of recipients of gifts to the
Office of the Attorney General. The Office of the Attorney General does
not include identifying information in the annual reports it publishes,
but the identity of recipients may be obtained from the Office of the
Attorney General by a member of the public or the media on request.
Are non-prescribing office staff covered by
the law?
The Office of the Attorney General will treat gifts to an office or
office staff as gifts to the prescriber. For example, if the gift is a
$60 luncheon for an office of two physicians and three non-prescribing
office staff, the gift amount is allocated per prescriber, or $30 each
and is reportable, because it exceeds the $25 threshhold. The gift may
not be divided by five and considered as five separate and unreportable
$12 gifts.
What is exempt from disclosure?
The following are exempt from disclosure:
- Free
samples of prescription drugs intended to be distributed to patients;
-
Payment of reasonable compensation and reimbursement of expenses in
connection with an approved bona fide clinical trial;
- Any
gift, fee, payment, subsidy or other economic benefit the value of
which is less than $25.00;
-
Scholarship or other support for medical students, residents and
fellows to attend a significant educational, scientific, or
policy-making conference of a national, regional, or specialty medical
or other professional association if the recipient of the scholarship
or other support is selected by the association;
-
Unrestricted grants for continuing medical education programs; and
-
Prescription drug rebates and discounts [33 V.S.A. § 2005(a)(4)].
What is an “approved” clinical trial?
An “approved clinical trial” means a clinical trial that has
been approved by the U.S. Food and Drug Administration (FDA) or has been
approved by a duly constituted Institutional Review Board (IRB) after
reviewing and evaluating it in accordance with the human subject
protection standards set forth at 21 C.F.R. Part 50, 45 C.F.R. Part 46,
or an equivalent set of standards of another federal agency [33 V.S.A. §
2005(c)(1)].
What happens to disclosed information?
The Vermont Office of the Attorney General collects and stores the
information on the disclosure forms in electronic format and requires
the companies to send in a hard copy of the responsible individual’s
signature. Disclosed information, including the identify of recipients,
is available to the public, with the exception of trade secrets.
The Vermont Office of the
Attorney General must file an annual disclosure report with the
Legislature and the governor [33 V.S.A. § 2005(a)(1)]. The disclosure
report does not include names of recipients, but as noted above, this
information is available to the public, including media representatives,
on request from the Attorney General’s Office.
Resources:
Is there a
Vermont program that patients can use to import lower cost brand drugs
from Canada, the United Kingdom 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 and 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.
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 US may only
be imported back into the US by the manufacturer; and
-
Drugs must meet all US 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.
Resources:
Return to Guide
Home Page
About the
Author
Madeleine
Mongan
is counsel and vice president for policy for the Vermont Medical
Society,
representing the interests of the physicians who live and 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 steering committee of the Vermont Bar Association Drug
Policy Committee, the Area Health Education Centers Advisory Board, and
the Vermont Health Resource Allocation Plan Board. She is a member of
the American Health Lawyers Association and the Vermont Bar Association
where she co-chairs 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.
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