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44 Cards in this Set

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Are pharmacists allowed to administer vaccines?
State permitted
Not all states require a Rx for medicare billing - VA does require a Rx though

Pharmacists permitted to administer vaccines and receive payment for the vaccine and service under Medicare

Pharmacists must be permitted by state law to administer vaccines

VA permits pharmacists to administer vaccines only to adults - not pediatrics (18 and over)

approves nurse practitioners & LPNs to administer vaccines

vaccines considered VI must have a Rx - even if Medicare allows it w/o Rx
Who develops protocol for vaccine administration?
Control of Board of Nursing

Vaccines considered SVI must be prescribed

Board of nursing administers protocol

Established by prescriber and practitioners
What are the 3 "S's" regarding HIPAA?
Simplification of health care transactions

Standardization of health care transactions - similar computer interfaces (transfer of billing/payment/eligibility info)

Pharmacies were the 1st to adopt standardization - long before HIPAA began (does not apply to paper claims - don't have to be standardized)

Security - most difficult to maintain
What are the transaction standards for pharmacies regarding HIPAA?
X12N interface used for most functions
- Insurance enrollment/ disenrollment
- Transmission of durable medical equipment (DME)
- Professional service claims
--Physicians and other providers
--Pharmacists professional claims
--this is the standard for billing professional codes - CPT codes - 3 for pharmacists (time involved for med. review, level of med. review, specifiticy of follow-up) - X12N standard is used to bill these codes
NCPDP v. 5.1 for retail pharmacy claims
- Includes nursing home pharmacy claims
- Does NOT include PHYSICIAN-billed claims
- Does NOT include claims for DME transmitted with retail pharmacy claims

National coordinating for prescription drug claims
- every line of data in transaction is approved by NCPDP (keeper of transaction standards)
currently on viersion 6-7
Physicians bill electronically via X12N interface
What are the security standards regarding HIPAA?
Prior to HIPAA, no existing guidelines and standards ensuring reasonable security of individuals health information

Consumers lobbied Congress steps to ensure security = SECURITY SAFEGUARDS

Consumers promoted procedures to integrate security safeguards --> initiated HIPAA
- **Administrative procedures
- Physical safeguards
- Technical security services
- Technical security mechanisms
45 CFR Part 142 (Status of Security Standards) states:
“The rule proposes standards for the security of individual health information and electronic signature used by health plans, health care clearinghouses and health care providers …”

“In order for health entities to administer their programs, they must ensure their customers that the confidentiality and privacy of health care information they electronically collect, maintain, use or transmit is SECURE…”

Proposed rule released on August 12, 1998

Final regulation released in February 2003

stressed electronic record security
What proactive measures were created to protect/ secure health information?
Information “security” officer
- manages data/info - i.e. IT department in SU

Define employee access - who can get what, when (passwords)

Protection of electronic mechanisms of communication
- Computer passwords
- Firewalls
- Fax machines
- Telephonic capabilities

Protected Access Areas
- Keypads
- Locked medical records

Education and training programs, and

Establish reasonable sanctions for non-compliance
Define health care privacy
Individually Identifiable Health Information (IIHI)
- Detailed information that points to a specific person’s health status - ID's a specific pt
--Diagnosis
--Treatment protocol
--Prescription information
--Therapy
--Labs

Protected Health Information (PHI)
-IIHI transmitted or maintained by a covered entity
-Includes written, electronic and oral
--research protocols
Define TPO
Protects health information with 3 functions:

Treatment
- Provision, Consultation, Referrals, Prescriptions
--issue w/ consultant pharmacists - falls under operations b/c review process is required by law
--pharmacist consultation is directly involved w/ treatment at that particular time (note difference)

Payment
- Billing, Claims management, Collection activities, Insurance review by insurance companies, audits by 3rd parties

Operations
- Quality assessment, Drug utilization review, Medical review (MRR), planning and development - determining whether a pt should go to an ER or not; determining formularies
Define Covered Entity
Covered Entity (give each pt a broad notice of privacy practices - then can do what they want with the information they have - except selling data w/o permission, certain types of research, etc.)
- Group Health Plans – Insurance, Medicaid, Medicare, HMOs (access to Xrays, prescription drugs, etc.)
- Providers – Those Health Care Professionals Who Transmit PHI for TPO
- Clearinghouses –Facilitate the Process of Transmitting PHI from One Entity to Another (typically utilizes transforming format of information)
- physicians' officies may hire an entity to transmits claims for them
covered entity = pharmacist/ pharmacy (but consultant pharmacists are NOT covered entities b/c not transmitting info to 3rd party for payment - get paid by pharmacy they are contracted with - only goal/ purpose is to review medication records)
What are the requirements for covered entities?
Transmit information under an electronic transaction standard
- Even one covered transaction applies

Qualifies as a “health care provider”
- Receives or maintains health information, billing information on behalf of individual parties
- Pharmacists, pharmacies, nurses, physicians
Define business associates (BA) regarding privacy standards
Contracted entity that provide services on behalf of a covered entity if the serrvices would normally be provided by the covered entity (i.e. need for DUR as required by OBRA 90 - if pharmacist is contracted somewhere else (like a central fill) - then is considered a business associate
- Billing
- Data analysis
- Quality review

Contract sets out terms of relationship and requirements for maintaining health information
Would drives be required to have business associate agreements?
No, according to HHS, drivers transport, but do not regularly access PHI (protected health information)

What about contract nurses who work in a covered nursing home?
- May be considered part of the facility’s workforce depending on control over work activities
(they are not considered consultant pharmacists)
Define Use vs. Disclosure
Use:
The employment, application, utilization, examination, or analysis of IIHI within an entity that maintains that information
Relates to TPO

Disclosure
The release of, transfer of, divulging of, or providing access to information to an outside entity
Research purposes
In some cases, information provided to patient’s family members
Define notice vs. authorization
Notice Pertains to Use of Information

Must make reasonable efforts to provide patients with notice of privacy practices
- Must provide a complete notice to patient
- Abbreviated version OK if given with longer version

Authorization Pertains to Disclosure of Information

Requirements Under Authorization are Far More Strict
- Must Be in Writing
- Must Identify Specific Information to Be Disclosed
- Must Be In Every Instance
- Can Be Revoked
Define minimum necessary
Reasonable Safeguards
Privacy Assessment
Access your organization’s operations to determine how patient information flows through your pharmacy/facility/practice setting
Where Does the Information Go? Who Uses and Discloses It? For what reasons?
Assign Categories of Type of Information that Should be Assessed by an individual
Reasonable Safeguards (I.e. hallway discussion)
Document Procedures to Limit PHI Disclosures
What is not included in de-identified information regarding research?
- Names
- Any Geographic Reference Smaller than a State, except for first three digits in a zip-code if range contains more than 20,000 people
- Telephone Numbers
- Fax Numbers
- Email Address
- Medical Record Numbers

All elements, except for year, related to:
- Birth date
- Admission date
- Discharge date
- Date of Death

- Social Security Numbers
- License Numbers
- Those 90 and over must be pulled into aggregate category of 90+ (b/c more easily identified for some reason)
Define terminology regarding pharmacy pricing systems
Relate to how drus are paid and contracted for
- Average wholesale price (AWP)= list price - medicare assumes this price is already inflated so reduces it by 15% (+ dispensing fee for pharmacies)
- Average manufacturers price (AMP)- usu. much lower than AWP
- Widely available manufacturers price (WAMP)
- Average sales price (ASP)- Medicare part B uses this
- Estimated acquisition cost (EAC)
- Wholesale acquisition cost (WAC)
- Actual acquisition cost (AAC)
- Federal upper limit (FUL)
- Also known as maximum allowable costs (MAC) - for generics with 3 or more manufacturers
- Competitive acquisition program (CAP)
Explain dispensing fees
Paid for under AWP reimbursement and WAC

Generally paid once every 30 days

Supposed to compensate for services provided by pharmacists
Explain private payment under PBMs
Largest amount of payments for drugs in US

Generally reimbursement is based on AWP rates plus a dispensing fee

Typically reimbursement drops, not increases each year

In some cases, payers have begun to pay under ASP
Describe the Medicaid program
Established in 1965 in conjunction with Medicare program

Designed to provide health care for poor people

Mostly focuses on women, families and children

Seniors who have spent down assets also paid for under Medicaid
What are the benefits of the Medicaid program?
Nursing home care

Prescription drugs for women, family, and children
-Before January 1, 2006, also included seniors

Pays for hospitalization of children and women
-Seniors’ hospitalization is paid for by Medicare program
(even if qualify for Medicaid)

Generally co-payments are capped to no more than $5 for any services
- Recently, these amounts have been increased for some services

children <18yo don't have copayments for Rx drugs under Medicaid programs - seinors do

if person can't pay copay on drug - provider CANNOT pressure the pt to pay!
Who contributes to funding of the Medicaid program?
Federal government contributes majority of fundings to progam - but states also contribute
- based on a state-specific formula establish by fed. gov
fed = 75% of dollars, state = 25%

very policitally established formulation

Rural areas get more than urban even though cost of living is higher - but healthcare is more difficult to obtain in rural areas - ongoing battle for funds
Explain the Medicaid Program expenditure problems
Very high expenditure of federal government expenditures

Expected to reach $3.6 trillion in 2014

Growing at annual rate of 7.1 during 2003-2014

Total expenditures will reach 18.7 of gross domestic product by 2014
What reimbursements are allowed in the Medicaid Pharmacy Program?
Individual state legislatures set reimbursement rates for Medicaid pharmacy
- can only get reimbursed for a max of 3 generic manufacturers
Federal government sets minimum payment amounts for reimbursement

Federal rules indicate that reimbursement is based on the pharmacy’s estimated acquisition price
- Usually interpreted to mean AWP minus a discounted rate or WAC plus a percentage
- Multi-source generic products reimbursement based on FUL set by the federal government
Explain the Medicaid Pharmacy Program Reform
In 2005, Medicaid program considered for reform

Target was at pharmacy and pharmacists - though the manufacturers are actually responsible for prices

Considered several proposals to completely revamp the system to establish a new system

- looked at pharmacy dollars for generics vs. brand drugs - (profit margin)

quote from member of congress: "Well, it's not immoral to make sure that prescription drug pharmacists don't overcharge the system."

Changes enacted in 2005:
- Reimbursement for generics to 250% of AMP set by the federal government
- Changes supposed to be enacted January 2007
- State legislatures were expected to enact changes
- Potential for big problems for pharmacies
--Report by federal government shows that pharmacies will lose money on a majority of generic scripts dispensed under AMP
- More changes could occur!
Explain the Medicare Part B Program
Medicare Part B is considered a supplementary program to the Medicare program

Intended to cover payment for doctors’ visits and other supplementary services, including rehabilitation therapy --> hospitalizations

Also covers some drug therapy for cancer, transplant meds (high risk disease states)

Medigap policies may be purchased to make up for what medicare doesn't cover
Medicare Part B Program

not tested on this
Medicare-eligible individuals pay monthly premium for Part B
- Optional benefit
- Premium is now “means tested” based upon individual’s income
- New for 2007
- Minimum is $93.50 per month for individuals who make $80K or less per year or $160K per couple
- Maximum premium is $161.50 for individuals who make $200K or more or $400K per couple
- Must pay 20% co-insurance for all services under Medicare Part B, including drugs
- For individuals eligible for low-income assistance Medicaid programs pay some or all of the costs
What drug therapy is covered under the Medicare Part B Program?
Payment based on statutory implementation

Payments for medications administered by physicians

Payments for inhalation and infusion products
Medicare Part B Program

not tested on this either
Drugs based on statutory designation
- Immunosuppressive medications post transplant
- Covered by Medicare Part B indefinitely IF individual received transplant when covered by Medicare in a Medicare-eligible transplant center
- Covered by Medicare Part B as secondary to private insurance or Medicaid for 36 months
- Oral anti-cancer agents and anti-emetics for use within 48 hours of chemotherapy
- Payment is based on ASP since 2005
- Prior to ASP reimbursement, based on AWP
- Pharmacies receive a supplying fee instead of a dispensing fee
- Supplying fee is $50 for the first rx post transplant
- Then, fee is $24 each month for first rx then $16 for each prescription filled
What is the supplying fee for the Medicare Part B Program?
Pharmacies receive a supplying fee instead of a dispensing fee

Supplying fee is $50 for the first rx post transplant

Then, fee is $24 each month for first rx then $16 for each prescription filled
Medicare Part B Program

not tested on this
Drugs for infusion therapy and chemotherapy
- Administered by a physician in physician’s office
- In some cases, might be self-administered at home but that would be paid for by Medicare Part D

Reimbursed under ASP
- Reimbursement prior to ASP considered subject of fraud and abuse investigations/allegations
- Many drugs were reimbursed at rates 9000% above AAC

Physicians do not receive supplying fee but are paid an additional fee for the services rendered in conjunction with administration
Competitive acquisition protram for Medicare Part B Program

not tested on tis
Competitive acquisition program (CAP)
- Alternative to traditional Medicare Part B program
Designed for vendors that bid on the program
- Vendors must have wholesale license and pharmacy license
- Vendors encouraged to bid products very low
- Physicians must select to enroll and participate in program as alternative to Medicare “buy and bill” program
Payment for inhalation products under Medicare Part B Program (do need to know this)
Payment under Part B if administered by a device considered durable medical equipment also paid for by Part B

Medicare program encourages use of MDIs rather than inhalation devices

Reimbursement is based on AWP but substantially reduced since 2005

Pharmacies receive a dispensing fee for dispensing these products
- Not considered a supply fee
Explain the Medicare Part D/ Medicare Advantage
Product of nearly 40 years of debate

Medicare program established in 1965 did not include payment for prescription drugs
- Included payments for hospitals, doctors, and nursing care but never for outpatient drug therapy

Past 10 years as prescription drug costs increased significantly and many seniors not covered by prescription drugs

Passed in December 2003 after a year of contentious debate

Included the implementation of the Medicare prescription drug programs, changes to Medicare Part B and other substantial changes

Most significant health care legislation in 40 years
What are the components of the Medicare Part D Program?
Voluntary program, don’t have to join (unless Medicaid)
- Focuses on an employer-type rx benefits
- Requires the establishment of prescription drug plans (PDPs) including an insurance company that contracts with a PBM or other prescription drug benefits administrator to bid on provision of services
- Medicare subsidizes program but does not directly pay or negotiate with PDPs and pharmacies
- Requires PDPs to allow access to community pharmacies and not simply mail-order pharmacies
Requires PDPs to have access to long-term care pharmacies
Community pharmacies can dispense a 90 day supply but might have to pay more for drugs
- Folds the dually eligible Medicare and Medicaid beneficiaries under Medicare Part D program
- Provides low-income beneficiaries with additional assistance
- Requires medication therapy management (through PDPs, not pharmacies) offerings for individuals whose drug spending exceeds $4000 and who have multiple chronic diseases
- Only approximately 5% of all beneficiaries anticipated to meet this threshold
- Programs offered to residents of nursing facilities can be different
What are the basic coverage parameters for the Medicare Part D/ Medicare Advantage program?
Beneficiaries must pay 20% of total costs until total out-of-pocket spending reaches $2250
- Must reach a $250 deductible

Then, beneficiaries pay 100% of costs between $2250 and $3600 in out-of-pocket costs

Government subsidizes costs for amounts above $3600 in out-of-pocket spending
- Beneficiaries pay $5 for generics or 5% of total drug spending

Low-income beneficiaries and dually eligibles have capitated spending
Describe the Medicare Part D regional/nationaly plans
- 34 Part D regions
- Entire states covered by region
- Plans offer regional and national plans
- Many PBMs administer plans for regional and national plans

Plans must submit bids to federal government to provide services
- Must establish in advance the amount of $ anticipated to spend
Describe formularies pertaining to the Medicare Part D/ Medicare Advantage program
Infrastructure developed by USP

Must offer 2 drugs in each category and class of medications

Excludes certain drugs from coverage under Part D including
- Benzodiazepines
- Barbiturates
- Over the counter agents

Must cover “most drugs” of psychotherapeutic agents, immunosuppressives, cancer drugs, etc
Explain coverage of vaccines under the Medicare Part D/ Medicare Advantage program
Vaccines covered by both Part B and Part D

Determination depends on the following
- Previously covered by Medicare Part B continue coverage (Flu, pneumoccocal)
- Treatment of condition: Part B
- Prevention of condition: Part D (For example: hepatitis, tetanus)
- Pharmacists receive payment for both vaccine and a service fee (always under Medicare Part B)

if covered by part B, then is covered by part D (flu & pneumonia)
What problems existed for implementation of Medicare Part D/ Medicare Advantage?
Dual eligible individuals autoenrolled did not have proper information

Plans not staffed properly to answer number of questions

Medicare Part D/B billing problems and distinguishing how to fill

Too many plans
What is the government's role in administering the drug benefit?
Awards contracts to PDPs and MA plans

Sets general parameters and rules

Cannot negotiate prices or interfere with price negotiation

Does not set prices for drugs or the manner of payment for drugs

(currently in legistlation)
What can pharmacists do to help enroll people into Medicare Part D programs?
Pharmacists can provide an overview of available plans and prices

Pharmacists may not accept applications from an individual

Pharmacists may not help complete an application for an individual

Pharmacists may not steer beneficiaries into a certain plan

Where can individuals go for further assistance?

www.medicare.gov or call 800-MEDICARE
Explain Medicare payment for drugs in hospitals
Inpatient hospitals receive payment under Medicare Part A for all services and care provided
- System of payment is called the diagnosis related groups (DRGs)
- Government establishes a single price and daily reimbursement rate to pay for all services
- Services grouped according to procedure or reason for admittance into hospital
- Drugs included under the single daily rate
- Does not change under the Medicare Part D program
- Medicare Part A pays for all hospitalization costs of Medicare eligible individuals
--Medicaid only pays for hospitalizations for those who do not qualify for Medicare and qualifies for Medicaid only