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196 Cards in this Set

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Medicare, who does it cover?

Provides federal health insurance for:
–Those 65 years and older
–Permanent disability
–End-stage renal disease (ESRD)
–Exposed to environmental health hazards
Where branch of the government does the Center for Medicare & Medicaid Services (CMS) fall under?
Health and human services
Medicare part A
What does it cover?
Hospitalization insurance – no premium
Medicare part B
What does it cover?
Optional plan for Outpatient medical services
•Diagnostic services – x-rays, lab tests
•Physical and speech therapy
•Colostomy supplies
•Small number of outpatient drugs, that cannot be self-administered
•DME, certain vaccines, diabetic supplies
How does one pay for the medicare part B benefits?
Costs around 30 dollars per month and is deducted from their monthly social security benefits.
Medicare part C
What does it cover?
Combination of A&B in a managed care plan
Medicare part D
What does it cover?
Prescription Drug Benefit
Part D enrollment period?
•Beginning 3 months prior to month turning 65, extending 3 months after month of turning 65.
•If don’t enroll within this window, then late fees
–1% per month
•Open enrollment period each year to move from one plan to another
–Usually during Fall (October 1 generally)
Part D Beneficiary Cost
•Range $15-$132/month, average $30/month
Part D Beneficiary Cost
What are the three phases?
•I: Annual deductible of $325 + 25% co-insurance, from $325 to $2970
•II: Doughnut hole: $2970 to $6733.75
•III: Catastrophic coverage 5% co-pay or $2.65 generic or $6.60 brand
–Under ACA, doughnut hole will be gradually reduced
What drugs are covered under Medicare Part D?
–Covers Rx drugs for medically accepted indications and also biologics, insulin and medical supplies for insulin admin
What drugs are excluded under Medicare Part D?
•Weight loss / weight gain drugs
•Fertility drugs
•Erectile dysfunction drugs
•Cosmetic or hair growth drugs
•Cough and cold drugs used to treat symptoms
•Vitamins and minerals
•Outpatient drugs which mfg requires testing or monitoring
What are the requirements for Medicare drug formularies?
–Plans may use drug formularies that include drug tiers
•Formulary must include all therapeutic categories and classes of drugs determined by USP
•Formulary needs to include 2 agents from each class
What are the exceptions for Medicare Part D formularies (all drugs in class must be covered)
–Antidepressants
–Antipsychotics
–Anticonvulsants
–Antiretrovirals
–Antineoplastics
–immunosuppressants
Medicare Part D Pharmacy access
How to ensure that patients have access to pharmacies?
–Plans must ensure that beneficiaries have access to network of pharmacies
•Urban – within 2 miles of participating pharmacy
•Suburban – within 5 miles partic. pharmacy
•Rural – within 15 miles partic. Pharmacy
How many day supply can a mail order pharmacy and community pharmacy dispense?
90 day supply
How are Reimbursement to pharmacies set for medicare part D?
set by the Part D plan, not by CMS
Who negotiates dispensing fees in regards to medicare Part D?
Dispensing fees are negotiated between plan and networked pharmacies
How long do plans have to reimburse pharmacies regarding medicare part D?
within 14 days of electronic claims and within 30 days for non-electronic claims
How often must plans for Medicare part D update drug cost database?
Weekly
How are claims not covered to medicare part D handled?
–Plan must transmit instructions to the pharmacy to provide to the beneficiary for each claim not covered
–Notice must also instruct beneficiary how to request a coverage determination
Is MTM services covered under medicare part D?
Yes.
–Plans required to provide coverage for MTM
Can pharmacists receive fees for MTM services?
Yes.
What area is prone to fraud and abuse?
DME – Durable Medical Equipment
How do providers achieve of DME get credentials?
Providers must achieve DMEPOS (DME, Prosthetics, Orthotics, Supplies) credential and be accredited by an independent org.
Are many DMEPOS items covered by Medicare?
No.
•Must give Pt. Advance Beneficiary Notice (ABN)
Who does Medicaid cover?
–Blind
–Disabled
–Aged
–Members of families with dependent children
How is medicaid eligibility determined?
by income & assets
With duel eligibility patients, who do you bill first?
First bill medicare. It is fraud to bill medicaid when a patient is covered by medicare.
How much does medicare fund of Medicaid in each state?
about 90%
Does medicaid have a prescription plan?
Yes. Optional plan.
What is the MAC program?
Are multiple source drugs covered in this manner?
Federal program.
It established a maximum allowable cost for drugs.
No. Multiple source drugs are covered under FUL
What was the FUL reimbursement program established?
–FUL reimbursement scheme was devised in response to pharmacist complaints about MAC
•Some of the reimbursement prices were so low that pharmacies could not even purchase the drugs for the reimbursement
•FUL drugs reimbursement costs are 150% of published price AWP (Average wholesale price)
•Many rounds of litigation over these prices
•Right now looking at 175% of AMP (average manufacturer price)
What is the 2007 – US Troop Readiness, Veterans’ Care, Katrina Recovery and Iraq Accountability Appropriations Act
•Tamper Resistant Prescription Pads
•Also included provision that written Rxs must be on a tamper resistant pad
•Tamper resistant pad to prevent:
–Unauthorized copying of a completed or blank pad
–Erasure or modification of information written on the bad
–Use of counterfeit rx pads
•Emergency fills permitted, as long as provider submits Rx w/in 72 hours
What is the difference between a skilled nursing facility and a intermediate nursing facility?
SNF: Provides a higher level of acuity in regards to services. Patients are eligible for medicaid and medicare reimbursement

INF: medicare reimbursement only.
Self-administration of drugs in a long term care facility?
–For each LTCF resident a comprehensive care plan must be developed
•Individual residents may self-administer meds if plan has determined this is safe
•Plan must identify medication storage location
What are unnecessary drugs in regards to federal long term health care?
•Excessive dose or duration
•Inadequate monitoring
•Inadequate indications
•Adverse consequences
Dispensing cycle and federal long term health cycle.
Length?
Reasoning?
Exceptions?
14 day supply dispensing cycle
–ACA mandates CMS to regulate on dispensing strategies for LTCF to reduce waste
–Exceptions:
–Antimicrobials
–Agents required to be dispensed in original mfg package
–Agents with packaging that improves compliance
Pharmacy services and federal long term health care?
Required?
Duties?
Yes, required.
–Can be employed staff member or consultant contractor
•Pharmacy services to be in a timely manner
–Consultant pharmacist to keep pharmacy records on all LTCF patients
–Drug Regimen Review for each LTCF resident at least once per month
•Any irregularities reported to MD and DoN
•Report must be acted upon
What is the Sherman Antitrust Act and whom does it protect?
Makes unlawful every contract, combination or conspiracy that restrains trade
–Protects competition, not competitors
–Thus, facilitates a competitive market, but does nothing for a business failing under intense competition
What are the factors of the Sherman Antitrust Act?
•Concerted activity: agreement between TWO companies to reduce trade and thus harm consumer's welfare
•Market power: analyze market power of alleged violator.
Mergers: will it created a monopoly?
Tying arrangements: certain drugs are only shipped to pharmacy that can monitor blood pressure
Robinson-Patman Act what is it?
•Unlawful for sellers to discriminate price between multiple purchasers unless costs can be justified
–“volume purchases”
•Common in pharmaceutical purchases were there is differential pricing
–Manufacturers and wholesalers must have reasonable basis for the differentials
What are the three major areas of the Omnibus Budget Recon. Act (OBRA) 1990
–Rebates
–Demonstration Projects
–DUR
Rebates and OBRA 90
–Requires mfgs to provide pharmaceuticals to state Medicaid programs at their “best price”
–The mfg must pay a rebate back to Medicaid that compensates them for what they were billed by the pharmacy upon the dispensing of the medication
–Medicaid pays the higher amount at point of care, but then is reimbursed by the mfg
Demonstration Projects and OBRA 90?
Goal?
How Accomplished?
–Goal: to determine through scientific means whether the outcomes of patient care improve and costs decrease when pharmacists are paid to provide DUR
–Demonstration projects are accomplished in many different ways
•Computerized records
•Consultations
Drug use review.
Focus?
–Focused on health care outcomes
Drug use review.
3 parts?
•Retrospective DUR
•Educational Programs
•Prospective DUR
Drug use review.
Purpose?
continuous quality improvement
OBRA 90 and retrospective review?
–Medicaid programs to have DUR board
•Pharmacists and physicians
•Reviews data collected by Medicaid claims databases
•Looks for trends
•If areas need improvement, then recommends educational programs
OBRA 90 and educational programs?
–Can be face-to-face (peer-to-peer) about certain professional habits
–Can be in a group, symposium format
–Goal is to improve the way the medications are being used
OBRA 90 and prospective review?
Purpose?
AKA-prior authrization
–Try to capture trends right at point of dispensing and initiate best practices to avoid future problems
Components of the OBRA 90 prospective review?
•Screen prescription prior to dispensing
•Patient counseling
•Documentation of relevant information
Counseling standards and OBRA 90
–“offer to discuss” with each patient
•Name & description of medication
•Dosage, form, route, duration
•Specific directions for use
•Common severe side effects, interactions, contraindications and ways to prevent them,
•Techniques for self-monitoring
•Proper storage
•Prescription refill information
•Action in the event of a missed dose
–Patients can “waive” counseling
What is anti-kickback statute (AKS) state?
Whoever knowingly and willfully offers or pays any remuneration (including any kickback, bribe, or rebate) directly or indirectly, overtly or covertly, in cash or in in kind to any person to induce such person..
To refer an individual to a person for the furnishing or arranging for the furnishing of any item or service for which payment may be made in whole or in part under a Federal health care program; or
To purchase, lease, order or arrange for or recommend purchasing, leasing, or ordering any good, facility, service, or item for which payment may be made in whole or in part under a Federal health care program. (42 U.S.C. Section 1320a-7b(b)(2).
How does intent play into the AKS?
PPACA clarified that actual knowledge that violating AKS or specific intent is not required.

One Purpose Test: Statute violated if one purpose of remuneration is to obtain money for or induce referrals
What is a renumeration?
Kickback
Bribe
Rebate
In cash or in kind
Anything of value
What is the definition of a federal health care program?
Plan or program that provides health benefits, whether directly, through insurance, or otherwise, which is funded directly, in whole or in part, by the United States Government; or any State health care program

Federal Employee Health Benefit Program (FEHBP) is not a federal health care program (statutory exception) – Odd exception!
Statutory penalties of the AKS.
Felony
Maximum $25,000 penalty
Maximum 5 years imprisonment
Fraud and abuse statutes are what type of statutes?
Criminal statutes
What type of statute is the false claims act?
Civil statute
What type of law has developed regarding false claims liability act?
Case law had developed regarding False Claims Act liability premised on violation of AKS
What is the basis for violation of false claims liability act?
PPACA clarified as a matter of statute that a violation of AKS would be a basis for False Claims Act liability
What is the false claims act intent standard?
Actual knowledge, deliberate ignorance, reckless disregard
What is the monetary penalty regarding the false claims act?
Treble damages plus penalties
AKS and Civil Monetary Penalty Law
$50,000 penalty for each violation
Damage of up to 3 times total amount of remuneration offered, paid, solicited, or received, regardless of whether part of remuneration was for lawful purpose
Same intent standards as False Claims Act
Exclusion
Separate CMP authority for patient inducements and for Stark violations
What are the exceptions to the AKS and Civil Monetary Penalty Law (CMPL)?
Discount Exception
Employee Exception
Group Purchasing Organization
Discount exception and the CMPL?
Properly disclosed and appropriately reflected in costs claimed or charges made by the provider or entity under Medicare or a State health care program.

Legal dispute about scope – OIG takes position that exception does not stand on its own (must be in safe harbor to be protected)
Employee exception and the CMPL?
Protects payments from an employer to an employee
Bona fide employment relationship
Provision of covered items or services
Group Purchasing Exception and the CMPL?
Vendor must have a written agreement (for fair market value) with purchasing agent
Fixed payment amount or fixed percentage of the value of purchased under the group purchasing agreement
Purchasing agent must disclose to provider entities and HHS (upon request) the amounts received from each vendor with respects to the provider entities’ purchases
WHAT HIPAA DID FOR FRAUD AND ABUSE
Provided safe harbor provisions
Required HHS to give advisory options regarding specific proposals. These opinions are binding on the parties involved but not on others. Case by case determination of what is legal.
The law establishes a formalized process of accountability in the development of additional safe harbors. HHS is required to solicit proposals for new safe harbors or revisions of existing ones. If the government does not accept a recommendation, it is obliged to explain its rationale in an annual report to Congress.
Regulatory Safe Harbors
Categories listed?
Likely less than 10 used in practice
Investment Interests
Space Rental
Equipment Rental
Sale of Practice
Warranties
Discounts
Employees
Group Purchasing Organizations
Waiver of beneficiary coinsurance and deductible amounts
Increased coverage, reduced cost-sharing amounts, or reduced premium amounts offered by health plans
Space Rental Safe Harbor
Conditions?
Lease in writing and signed by parties.
Lease covers all premises lease between parties and specifies leased premises
If lease is periodic, rather than full-time, exact schedule, precise length, and exact rent must be specified
Term not less than 1 year
Aggregate lease payment is set in advance, FMV, and does not take into account volume or value of referrals
Aggregate space does not exceed space reasonably necessary to accomplish business purpose
Discount Safe Harbor
What they do not include?
Cash or cash equivalents (except rebates)
Supplying one good or service without charge or at a reduced charge to induce purchase or a different good or service, unless:
Reimbursed by FHCP using same methodology
Reduced charge is fully disclosed and accurately reflected
Reduction in price applicable to one payor but not Medicare or a State health care program
Routine reduction or waiver of any coinsurance or deductible amount
Warranties
Services provided in accordance with personal services or management services contract
Other remuneration not specifically described in safe harbor.
Discount must generally be made at time of sale
Electronic Health Records Safe Harbor
Conditions?
Nonmonetary remuneration (interoperable software, IT, training services)
Necessary or used predominantly for HER
Eligibility or amount of assistance cannot take directly into account volume or value of referrals
Written signed agreement
Recipient pays 15% of donor’s costs
Transfer occurs and conditions met before 12/31/2013
Other conditions –
EXPIRES
By its Terms The False Claims Act Provides any person who....
(1) knowingly presents, or causes to be presented, to (the Government) a false or fraudulent claim for payment or approval;
(2) knowingly makes, uses or causes to be made or used, a false record or statement to get a false or fraudulent claim paid or approved by the Government;
(3) conspires to defraud the Government by getting a false or fraudulent claim allowed or paid.
Is liable to the United States Government for a civil penalty for not less than $5,000.00 and not more than $10,000.00 plus three times the amount of damages which the Government sanctions because of the act of that person
Qui Tam Actions Civil Actions for False Claims
(b) Actions by private persons. (1) a person may bring a civil action for a violation of (the False Claims Act) for the person and for the United States Government. The action shall be brought in the name of the Government. The action may be dismissed only if the court and the Attorney General give written consent to the dismissal and their reasons for consenting.
Qui Tam Actions
Private Party Civil Fraud Suits
“Relators (whistleblowers)
Government Intervention (optional)
Awards
15-25% of proceeds (government)
25-30% plus Attorney’s Fees (private)
Statutory Bar: Public/Government Info
CONCERNS WITH THE FRAUD AND ABUSE STATUTES
Broad interpretation hinders evolution of health care marketplace in response to growing costs and competition
Barrier to market oriented attempts to rationalize the medical care marketplace
Discourage vertical integration essential for econ efficiency and consumer welfare
Made to address over-utilization of government programs (not a problem with HMO and managed care)
PPS-Prosepective payment system. Fixed fees according to specific diagnosis related groups. Hospitals discharge patients sooner.
What specific services does stark I and II refer to?
Stark I-Lab services

Stark II-“Designated Health Services” List
Stark I and II
What does it state?
Prohibits:
Physicians with a “financial interest” with a provider from making
Referrals of Medicare/Medicaid patients to the provider for
Designated Health Services
To receive payment
Stark exceptions
Prepaid Health Plans
Group Practice
Ancillary Services
Employment
Personal Services
Space/equipment rental
One Time Transaction
Stark law legality and exceptions?
There is no requirement that the conduct involve the knowing and willful receipt of a kickback: if no exception applies the law has been violated
Stark anti-referral law is an example of what type of bill?
“exceptions bill”-It sweepingly prohibits self-referrals but then legitimizes a large number of specific arrangements.
Name the three types of stark exemptions?
(1) those applicable to ownership or investment financial relationships;
(2) those applicable to compensation arrangements;
(3) generic exceptions that apply to all financial arrangements
Self-referrals and state laws
(1) the “federal model” approach free standing statutes tracking with some variation either the Medicare fraud and abuse or Stark legislation
(2) disclosure statutes that do not prohibit physician ownership interests in facilities to which they refer, but require that the referring provider reveal such interests to her patients.
Others prohibit ownership and investment interests, and, and do not reach compensation arrangements, However, laws prohibiting “bribes” and “kickbacks” may reach such activities.
What agency is primarily responsible for enforcement of federal drug laws?
DEA
DEA falls under what department?
Department of justice
Mission of the DEA?
•Prevent diversion and abuse of CS
•Ensure adequate & uninterrupted supply of CS to meet legitimate medical, scientific & research needs
Controlled substance act is designed as a...
closed system
Congressional Intent is to....(regarding controlled substance act)
prevent diversion of CS into illegal channels
Controlled substance def.
a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter.

•The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.
Who has authority to place a drug on a schedule?
Attorney general
In consultation with HHS.
CI
high potential for abuse.
no currently accepted medical use in treatment in the US.
lack of accepted safety for use of the drug
CII
high potential for abuse.
has a currently accepted medical use in treatment with severe restrictions
may lead to severe psychological or physical dependence.
CIII
abuse less than the drugs or other substances in schedules I and II.
currently accepted medical use
moderate or low physical dependence or high psychological dependence
What drug is being considered for a CII?
How initiated?
Hydrocodone.
Was initiated by a citizen's petition.
CIV
low potential for abuse relative to the drugs or other substances in schedule III.
currently accepted medical use
limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III
CV
low potential for abuse relative to the drugs or other substances in schedule IV.
currently accepted medical use
limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.
Generally cough or diarrhea medicine.
Scheduled Listed Chemical Product (SLCP)
Product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be distributed lawfully in the US as a Non-prescription drug
–List I chemicals
•Important in the mfg of CS
•Includes ephedrine and pseudoephedrine
•phenylpropanolamine (now only for vet use, by Rx only)
–List II chemicals
•Used in mfg of CS
Registration Requirements
•Manufacturers and Distributors
Register annually
Registration Requirements
•Dispensers
–Prescribers and Pharmacies
–Registration duration determined by AG
•Between 1-3 years (3 years)
Exemptions from registration
Criteria?
–Agent (employee) of registered manufacturer, distributor, or dispenser, if acting in usual course of business
–Common or contract carrier of warehouse
–Ultimate user who lawfully possesses
Attorney general can waive registration to whom?
–Public Health Service Practitioners
–Bureau of Prisons Practitioners
–Military Service Practitioners
•Use Service ID number
•DEA may issue “placebo”# for off-base Rxs
–Waiver does not apply to non-exempted activities (“moonlighting”)
Attorney general can deny registration with these factors?
(1) maintenance of effective control against diversion of particular controlled substances into other than legitimate medical, scientific, and industrial channels;
(2) compliance with applicable State and local law;
(3) prior conviction record of applicant under Federal or State laws relating to the manufacture, distribution, or dispensing of such substances;
(4) past experience in the distribution of controlled substances; and
(5) such other factors as may be relevant to and consistent with the public health and safety
DEA Form 224
What is it used for?
New Pharmacy Registration Form
What situations require a new registration number with the DEA?
Use form 224
•Change of Address
–Physical change or postal address change requires new registration
•Transfer of business
–Must notify DEA 14 days prior to transfer
•Name, Address, DEA# of old business and new business
•Where business activities will occur
•Date on which CS inventory will be transferred
•Take inventory on transfer day, both keep copy
–Transfer facilitated if affidavit submitted which verifies pharmacy has been licensed with the state
Methods of CS “Disposal”
•Issuance and dispensing upon a Rx
•Transfer to another Registrant
•Surrender to DEA/Law Enforcement (DEA from 41)
•Destruction
•Unintentional “disposal” - theft
Transfer CS to another Registrant
How long must the records be kept?
Federally- 2 years
Utah state laws-5 years
Transfer CS to another Registrant
Form used and who supplies it?
Receiving Registrant must issue DEA Form 222 to the Supplying Registrant
How is a dispenser classified as a distributor in regards to Transfering CS to another Registrant
If ≥ 5% of all CS dispensed per year to other dispensers, must also register as “distributor
Transfer CS to another Registrant
Misc. examples
–Transfer to a manufacturer
–Transfer to a reverse distributor
Reverse Distributor (RD)
Registration?
CII and Forms?
CII-V documentation
–Can get list of authorized RD from DEA
•Many distributors are also RDs
•Requires separate registration
•Typically requires prior authorization of RD
–If CII, RD must issue DEA Form 222 to the pharmacy
–If CIII-V, record the “reverse” distribution
•Log of drug name, form, strength, quantity, date
•Include name and DEA # of RD
Inventory of Drugs Surrendered for Disposal
Form used
DEA form 41
DEA Form 41
•Applies to all CS schedules
•Complete form (on-line) and submit to DEA
–Hold CS to be destroyed until receiving instructions from DEA
•Form not needed if destruction witnessed by DEA Agent or state law enforcement agency – record for your records
–“Blanket Authorization” for Destruction
Usually used in hospital/clinic setting for disposal of injectable controlled substances; DEA rarely gives
Breakage/spillage
Form used?
any recoverable amount of CS, must be reported with DEA Form 41
Requirements for electronic alarm system according to the DEA.
Recommends, but does not require alarm system.
–DEA expects that pharmacies will take reasonable efforts to secure CS
Utah state laws require an alarm system.
Storage requirements for CII-V
DEA requires pharmacies to keep CII-CV in a locked cabinet or dispersed through the non-controlled stock to deter theft
Storage requirements for CI
–CI agents must be kept in securely locked, substantially constructed cabinet
Class V drugs required to be locked up?
carfentanil, etorphine HCl & diprenorphine must be in a safe or steel cabinet
registrant shall not employ, as an agent or employee with access to controlled substances, any person who has:
been convicted of a felony offense relating to controlled substances or who, at any time,
–had an application for registration with the DEA denied,
–had a DEA registration revoked or has surrendered a DEA registration for cause.
What does "for cause" mean?
means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual's handling of controlled substances.
Reporting Theft or Significant Loss
•Notify DEA and Local Police
–Must notify within 1 business day of discovery of “theft” or “significant loss”
–record Case # from local police
•Complete DEA Form 106
–Send original to DEA Field Office, keep copy
–Applies to all CS schedules
•Shipping losses (“in-transit” loss)
–If signed for (“custody”), pharmacist must report loss using Form 106, otherwise, shipper reports
What must be included on DEA form 106
–Name and address of registrant (pharmacy)
–DEA registration number
–Date of theft or significant loss
–Name and telephone number of local police dept notified
–Type of theft (e.g., night burglary, robbery, etc)
–Listing of symbols or cost code used by pharmacy in marking containers
–Listing of controlled substances missing from theft or significant loss
FBI investigation of CS robberies/burglaries required when?
•If replacement cost of goods stolen > $500
•Interstate/foreign commerce involved in crime
•Person killed or suffered SBI (significant bodily injury) during crime
Violators of CS robberies/burglaries are subject to?
•$25,000 fine, 20 years prison
•If gun used, $35,000 fine, 25 years prison
•If death, $50,000 fine, life imprisonment
Inspections of pharmacies
•May be made in reasonable manner during business hours
•Inspection by consent
–does not require warrant
–must be informed
–consent may be withdrawn
–Notice of Inspection provided to pharmacy
•contains specific info on inspection
Inspection by administrative warrant
–same effect as regular search warrant
–required showing of probable cause is lower than regular warrant
–“in public interest” is valid prob. cause
–Judge issues to inspector
–no prior consent required
–non-cooperation may subject to arrest
–warrant must contain specific info
Range of criminal penalties for violating CSA
–misdemeanor --> felony
–jail time (misdemeanor) prison (felony)
•can be months to life-imprisonment
–substantial criminal fines
–intended for non-registrants, but can apply to registrants also
–fines for negligent failure recordkeeping
–fines/imprisonment for intentional failed record keeping
Recordkeeping Requirements for control substances?
•All records concerning CS must be kept for at least two (2) years
•Records and inventories for CII must be kept separate from all other records
•Records must be “readily retrievable”
Recordkeeping Requirements
Paper Prescription copy records (two options)
Option one-three separate files
•A file for Schedule II drugs dispensed,
•A file for Schedule III, IV and V drugs dispensed
•A file for prescription orders for all noncontrolled drugs dispensed

Option 2-two separate files
•A file for all Schedule II drugs dispensed,
•A file for all other drugs dispensed (noncontrolled and those in Schedule III, IV and V).
–If this method is used, a prescription for a Schedule III, IV and V drug must be made readily retrievable by use of a red “C” stamp not less than one inch high.
Recordkeeping Requirements
Electronic Prescription Records:
–Electronic records must be maintained electronically for two years from the date of their creation or receipt.

–Records regarding controlled substances must be readily retrievable from all other records. Electronic records must be easily readable or easily rendered into a format that a person can read
Inventory Requirements
When done and how often and documentation?
•Initial Inventory
•Recommended by DEA: Name, address, DEA# of registrant, signature
•every 2 years following initial inventory
–Must be within the 2 year period
–Do Not need to submit to DEA
–Keep with CS records
Inventory requirements: CII
–Actual physical Count
Inventory requirements: CIII-CV
–Estimated count may be made
–Actual physical count required if container holds more than 1000 units and has been opened
Inventory requirements: Newly scheduled
–Inventory on day schedule takes effect
DEA form 222a
Order additional forms for ordering of CS
How many blank 222a forms can you have in your pharmacy?
–Each “book” contains seven (7) forms
–May have total of six (6) books
What does the pharmacist complete on a 222 form?
–Name and address of Supplier
–Date of completing the form
–Number packages, Size of package, Name of item
–Number of last line completed
–Must be signed by person authorized to execute the form
•Signer of DEA registration for Pharmacy
•Anyone included in a valid Power of Attorney (POA)
Order of events on a 222 form after a pharmacist fills out their section?

How long is records maintained?
•Copy 1 and Copy 2 to supplier
•“Requestor” retains Copy 3 with CII records: valid for 60 days
•Supplier: Keeps Copy 1; forwards Copy 2 to DEA
•Upon receipt of CII from supplier: records on copy 3 the number of containers furnished and date received.
Keep completed copy 3 for 2 years or more.
Can a supplier substitute bottle size on a CS 222 form order?
Yes.
Supplier is able to substitute for identical product on 222 form, that may differ in package size or qty, if same CS, and qty received does not exceed amount ordered
Errors/Omissions in DEA Form 222
–Minor misspellings in Registrants name or address allowed
–Minor misspellings in Drug name allowed
–Supplier allowed to fill in issue date.
–Size of package: only if 1 allowed commercial package size
–Strength: only allowed if 2 allowed commercial strength
–Last line completed: supplier NOT allowed to fill in.
Power of Attorney documentation
–Form must be similar to or exactly like the form provided by the DEA: signed by person who signed the most recent DEA registration and the person being given POA
–Does NOT need to be filed with the DEA
–Must be kept with CII records (222 forms)
–May be revoked at any time
–Two (2) witnesses on each form
Ordering CIII-CV
–No special form is required
–Must maintain receipt record for 2 years: readily retrievable
–Invoice or packing slip will suffice
CS Ordering System (CSOS)
•CSOS will ultimately completely replace 222 forms
•Can be used to order CI-CV CS
•Individual “persons” must register for a digital certificate: Person who signed the DEA registration (224/223) or Person granted Power of Attorney (POA)
To be legally valid, CS Rx:
–must be issued by: Practitioner authorized to prescribe CS in their jurisdiction; and Practitioner Registered with DEA (or meeting a registration exemption)

–Purpose of Issue: Issued for legitimate medical purpose and within their scope of practice.
Controlled substances and verbal vs written Rx:
•CII must be written with ink or indelible pencil or typewritten, except in an oral emergency or electronically

•CIII-CV may be written (including facsimile) or verbal
All Rxs for CS must contain:
–Full name and address of patient
–Date Rx issued and signed
–Drug name, dosage form and strength
–Quantity of drug prescribed
–Directions for use
–Number of refills authorized (if any)
–Name, address and DEA # of practitioner
–Manual signature of the practitioner (unless emergency oral Rx, or e-Rx)
•e-Rx must have digital signature
CII
Tender and Refills allowed
–Tender: Expiration not specified in Federal Law, Utah says 30 days
–Refills: Not refillable
CII-IV
Tender and Refills allowed
–Tender: Expires six (6) months from issue
–Refills: No more than five (5) refills

Utah state laws follow this
CV
Tender and Refills allowed
–Tender: Expires twelve (12) months from issue
–Refills: If prescriber indicates, can be refilled PRN
How to handle a Oral Emergency Rx for CII (“Emergency Dispensing”)
–Must be immediately reduced to writing by pharmacist
–Must include all info req’d on a written Rx (except signature)
–All three (3) of the following factors:
1-Immediate admin is necessary and proper
2-No appropriate alternative available
3-Not reasonably possible to provide written Rx
–Qty limited to that req’d for emergency (72 hours)
–Written Rx must be received by pharmacy w/in 7 days and include “Authorization for Emergency Dispensing”. If not report to DEA
Facsimile Transmission
May serve as original for what controlled substances?
–May serve as the “original” paper Rx for CIII-CV: must have all requirements of Rx
–May serve as the “original” paper Rx for CII, if:
•CII narcotic compounded for direct admin to pt.
•CII for resident in LTCF
•CII for pt. Enrolled in hospice certified by Medicare or licensed by the state: Dr. must make note of this
Can you issue multiple Rx for CII's?
Conditions?
Yes. Up to 90 days.
•Legitimate medical purpose
•Does not pose undue risk of diversion/abuse
•Instructions on each Rx indicating earliest date on which Rx can be filled
–Date of Issue/Date of Earliest Filling
•Permissible under state laws
•Complies with all other laws/requirements
E-prescribing and controlled substances
CII-CV
•Involves third-party “application providers”
•Prescriber must “identity proof” with application provider. Will be issued two-factor authentication credential: Something you know, you have, you are (will need to use two of three factors)
•Pharmacies also undergo identity verification
Label requirements:
–Pharmacy name and address
–Serial (prescription) number
–Date of initial dispensing
–Name of the patient
–Name of prescribing practitioner
–Directions for use and precautionary statements, if any
–Warning statement:
“CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient to whom it was prescribed.”
Partial Dispensing requirements
CII
allowed if RPh “unable to supply” full amount
•Must note on front of Rx amount dispensed
•If remaining portion cannot be disp w/in 72 hrs, then RPh must notify prescriber and no further disp allowed (needs new Rx)
Partial Dispensing requirements
CIII-CV
may partially disp if qty noted disp and initials back of Rx
May not exceed the total amount authorized on the Rx
•May not be filled after six months from issue
Partial fills and LTCF
–Patients in LTCF or documented “Terminal Illness” may receive partial fillings
–Pharmacist must record on Rx either, “LTCF patient” or “terminal illness”
–Rx shall be valid for up to 60 days from issuance
Can you ship a CII-CV outside the country for a patient?
No.

–Must register with DEA as an “exporter”
–Must obtain an export permit
OTC Dispensing CV
Dispensing requirements
–Must be allowed by state law
–Dispensed only by pharmacist
–Must ensure medical necessity of the need
–Not more than 240 mL or 48 dosage units of opium containing product
–Not more than 120 mL or 24 dosage units of any other CS product
–Same purchaser ≥ 48 hr period
–Purchaser must be at least 18 years old
–ID/proof of age required, if RPh does not know
OTC Dispensing CV
Logbook requirements
•Name and address of purchaser
•Name and quantity of CS purchased
•Date of each sale
•Initials of Dispensing Pharmacist
•Must be kept for two (2) years from date of last transaction in book
Steps to handle CIII-CV transfer between pharmacies.
One-time basis
–Transferring pharmacist
•Write Void on transferred Rx
•Name, address, DEA# of pharmacy transferred to
•Name of Pharmacist receiving transfer
•Date of transfer
–Receiving pharmacist
•Write Transfer on face of Rx
•Original Rx number from transferring pharmacy
•Date of original issuance and original dispensing
•Original # refills authorized
•# refills remaining
•Original pharmacy name, address, DEA#
•Name of transferring pharmacist
•USPS Requirements for Mailing CS
–Inner container marked/sealed according to CSA and placed in plain outer wrapper
–If prescription, then labeled according to CSA
–Outside wrapper is free of markings that would indicate nature of contents
Ryan Haight Act
Online Pharmacy Consumer Protection Act 2008
–Online pharmacies must be registered with DEA
–Formal definitions of online pharmacies
–Registration procedures
–Website requirements (must include)
•Contact info
•Name of PIC & telephone no.
•States in which licensed
•Statement of compliances
–Reporting requirement - monthly
•Narcotic Addiction Treatment Act 1974
–Addiction Treatment Programs that use CS agents in treatment must register with DEA
–Also requires approval from Center for Substance Abuse Treatment (CSAT)
•Drug Addiction Treatment Act 2000 (DATA)
–Individual Practitioners that want to use CIII-V approved for addiction treatment must request a waiver from Center for Substance Abuse Treatment (CSAT)
Drug Addiction Treatment Act (DATA)
–Allows individual physicians to treat drug dependence, without registering as NTP
–Apply to DHHS for waiver
–Can treat 30 pts at a time with CIII-V
–Currently only Suboxone or Subutex (Buprenorphine) are eligible for this program
–Can apply to increase to 100 pts
–DEA number will begin with an “X”
Five Percent Rule and CS
Pharmacy may distribute controlled substances to prescribers or other pharmacies without being registered as distributor, provided:
–Only between DEA registrants
–Records of transfers kept by both registrants
–Must DEA Form 222 for CII
–Total number of dosage units of all CS distributed by pharmacy may not exceed five percent (5%) of all CS dispensed by the pharmacy during a calendar year
Combat Meth Epidemic Act (CMEA)
•Ephedrine, phenylpropanolamine (PPA), and pseudoephedrine (PSE)
–Pharmacies w/ DEA# do not need separate List I Chemical registration
–3.6 gm/day threshold
–9 gm/month threshold
–Must maintain log book
•Products by name
•Quantity sold
•Name and address of purchaser (positive ID req’d)
•Date and time of sales
What CAN be changed on a CII Rx?
•RPh may add or change patient’s address and date of birth
•May change or add dosage form, drug strength, quantity, or directions for use
–ONLY after authorization of prescriber
–Must be written on the Rx/medical records
What CANNOT be changed on a CII Rx?
•Never change the patient’s name
•Never change the name of CS
–Except for generic substitution, as permitted by state law
•Never change the prescriber’s signature
•Never add or change the issue date
•Three fundamental tenets to a valid CS prescription
–Issued for a legitimate medical purpose
–Prescriber acting in usual course of professional practice
–Pharmacist has corresponding responsibility for Rx validity
CII for Chronic Pain?
Yes. After all other options have been tried.
CII for Detoxification?
Can you dispense it?
Yes. Need, but must have a separate registration with the DEA as a narcotic treatment program (NTP).
CII for Chronic Pain/Recovering Addict?
May use CII CS to treat pain (acute or chronic) in a patient who is also recovering from narcotic addiction
Difference between license and certification?
Certification means you have some degree of skills, but other people can practice without a certification. It is a professional designation.

License is generally issued by a government authority. It gives us authority to practice within the the state.
Reasons to Regulate Professions
–People without specific training cannot distinguish between qualified and non-qualified
–People who need health care must be protected from non-qualified providers
Objectives of licensure
–Increase quality of care
–Reduce cost of care
–Inhibit criminal abuse of drugs
State Board of Pharmacy

Purpose and who do they protect?
•Purpose: protect public health, safety, & welfare
–Boards are designed to protect the “public” not the “profession
State board of pharmacy

What is the makeup of the board?
–Comprised of practicing professionals and usually at least one member of public
–Appointment is political, usually direct appt or confirmation by Governor
What is the most important role of state pharmacy boards?
–Most important role is professional licensing
•Validates competency of individual professionals
•Validates suitability of facilities conducting pharmacy operations
What are the general requirements to become a pharmacist?
•Graduation from pharmacy school
•Completion of specified internship requirement
•Attainment of specified age
•Passing score on licensing examination(s)
–NAPLEX and MPJE
•Demonstration of good moral character
–Additionally
•Some states may require practical demonstration of ability (“wet lab”)
•May also have a required oral interview with Board
Responsibilities of the state board of pharmacy?
Licensing
Disciplinary Actions Against a License
Help develop standards of practice
Qualifications of ancillary pharmacy personnel
–Continuing education
–Collaborative practice agreements
–Regulation of PBM & Third-party programs
–Impaired Pharmacist Programs / Diversion Programs
DOPL Duties & Responsibilities
(a) prescribing, adopting and enforcing rules;
(b) investigating the activities of licensed persons
(c) subpoenaing witnesses, taking evidence, for hearings on administrative matters
(d) taking administrative and judicial action against persons in violation of the laws
(e) seeking injunctions and temporary restraining orders to restrain unauthorized activity;
(h) issuing licenses, or refusing to issue, revoking, suspending, renewing, refusing to renew, otherwise acting on licenses
(i) preparing and submitting annual report
(k) administration of examinations
DOPL Board membership
How many?
How long is their term?
How appointed?
5 members, 4 licensees & 1 public
Serve 4-year term, no more than 2 consecutive terms
Appointed by Executive Director with Confirmation/Rejection by Gov
DOPL Boards-Duties
(a) recommending appropriate rules;
(b) recommending policy and budget
(c) establishing a passing score for examinations;
(d) screening applicants and recommending licensing, actions to the director in writing;
(e) establishing standards of supervision for students or persons in training
(f) acting as presiding officer in conducting hearings
How to get a pharmacy license.
Two types of applications?
Apply through written application
License by endorsement-switch states, must prove skills and equal education/training
Change of information?
Must notify the division within 10 business days of moving
Temporary License
When can you get one?
While waiting for pass board exams after graduation (can apply and take test three times)

Emergency in another state.
Restricted license
When does this occur?
may be issued to individual who meets license qualifications but has engaged in unprofessional or unlawful conduct AND
•Division determines there is a need to observe the applicant in a monitored or supervised practice
When is the renewing period for a license?
•Pharmacy - Renew Sept 30 - odd years
•Pharmacist - Renew Sept 30 - odd years
•Technician - Renew Sept 30 - odd years
License Reinstatement
What to do when you are late?
–submit a completed renewal form as furnished by the division demonstrating compliance with requirements and/or conditions of license renewal
–pay the established license renewal fee and a late fee

Fees go up after you are 31 days past your renewal date to 2 years afterwards.
Reasons for License Denial
•unprofessional conduct
•unlawful conduct
•determined mentally incompetent
•unable to practice with reasonable skill and safety due to:
–mental or physical condition prevents practice
–excessive use of intoxicating substances
Minimum Suspension Time of pharmacy license
90 days
Not Unlawful or Unprofessional Conduct to:
Partners and STD's
–Write Rx for “partner of _______”
–Dispense Rx for “partner of _____”
–Partner’s identifying information can be omitted from Rx and Rx label
–Must otherwise counsel person picking-up prescription about the medications