25_Policy, Practice and Regulatory Issues
Terms in this set (42)
Which entity defines practice of pharmacy; provides template/wording for state BOP ; and provides stats on pharm practice?
Which entity would you refer to when deciding the level of practice you would be allowed to practice at, when expanding your clinical services
Your state BOP
How often are beneficiaries targeted for MTM
Every 3 mos ( 4 x /yr)
What are the targeted patients for MTM
Several dx states; Multiple covered Part D meds; Cost of part D meds > 3507 per year
Can a nurse or physician provide MTM?
What is a MAP?
Medication Action Plan - focus is on the patient. Items on the plan are meant for the patient to implement (not provider recommendations)
What are the elements of the CMM?
(Comprehensive medication management)
Core principles of patient centered home: Assessment; Care plan (for each medication problem and assessment of where they are at in terms of resolution; Follow up. In collaboration with care provider.
Qualifications for CMM
High cost meds and multiple meds; difficult to reach goals; adr; high risk/monitor drugs; readmissions
Who can provide CMM
Nurse; physician; pharmacist (pharmd or equiv; cdtm or granted athority to provide cmm, certified or eligible to be)
For MTM - the CMR must be done within how many days after enrollment?
If a patient declines to complete a TMR - does it still need to be completed?
Can a CMM be completed by written communication?
No - communication must be bidirectional. This can includ e visit and phone or face to face
How often must a Collaborative drug therapy management plan be reviewed?
Do all 50 states allow pharmacists to administer vaccines?
Which vaccines are covered by Medicare part B?
Influenza; pneumococcal; Hep B; Any vaccine necessary to treat an injury
What vaccines can mass immunizers bill for?
influenza and pneumococcal only
What is roster billing?
Mass immunizers submit 1 form and list of pts
What is centralized billing?
Allows mass immunizers at 3+ sites to submit vaccine claims to one medicare admin contractor
How often do you need to enroll with CMS prior to influenza season for roster billing?
Once before first influenza season
Are there any part B deductibles or copayments associated with vaccines?
What is the CPT code associated with vaccines?
Which vaccines are payable under D?
Any vaccine not covered by part B, including Zoster
Which entity collects lab user fees and conducts inspections?
What are the criteria for CLIA waived tests?
Approved by FDA for home use; Use methods simple, accurate and liklihood of error is minor; pose no reasonable risk if test is performed incorrectly. Regulations list specific tests; manufacturers can apply for waiver; FDA Tests approved for home use (e.g. ua; ovulation; prengx; hb; bgl home test)
Are professional use versions for home tests automatically waived?
With a CLIA waiver is granted, when does a clinic need to notify the state agency?
When there is any change in ownership, name, address, or director with 30 day or if adding tests
What is an error of commission
Doing something wrong
What is an error of ommission
Failing to do the right thing
What is an AE
An event resulting in unintended harm to the patient by an acti of commission or omission rather than the udnerlying disease or condition of the pt
What is the external voluntary reporting system for vaccines?
VAERS (vaccine adverse event reporting system)
What tool would you use to proactively identify and address issues that could occur for your clinic?
FMEA (failure modes and effects analysis)
Can a pharmacy be a recognized 340b provider?
No - but they can contract with facilty that is
Which patients are eligible for 340b pricing?
Under the care of the 340b entity; RX is written when the pt is being cared for at the 340b entity; pt does not have a Medicare/Medicaid managed care plan (duplicate discount)
What is the best way to identify med errors?
Use Global trigger Tool
Which is more serious a Class I or Class II drug recall?
Class I (resonable probability exposure will cause serious adverse health consequence or death). III is not likely to cause adverse health consequences ; II may cause temporary or reversible or prob of serious adverse effects is remote
What is the NCC MERP category tool?
Taxonomy (level or harm) for med errors A has the capability to cause erro to I Error may have caused death.
Which formulary tier has the lowest cost? I, II or III? Or specialty tier?
Is having one med per drug class an acceptable formulary decision?
Usually not - too restrictive
What is TROOP?
True out of pocket cost; cost of meds before deductible kicks in; copayments; payments made during the gap (donut hole) time
Are OTCs included in TROOP?
What is the coverage gap?
Time between when initial maximum insurance coverage for the year has been exceeded and the TROOP threshold is met and then catastrophic coverage will start.
Do products covered by part B count for TROOP?
No - includes self administered oral chemo, ESRD meds; clotting factors for hemophilia; EPO - ESRD; enteral nutrition; IV drugs require a pump