116th Annual Convention - NCPA · Like signing a blank check! 3. ... pharmacist must have both of...

116th Annual Convention

Date: Tuesday, October 21, 2014 Time: 8:30 am – 10:00 am Location: Austin Convention Center, Room 18AB, Level 4 Title: How Not to be An Audit Target in 2015

ACPE # 207-000-14-229-L04-P 0.15 CEUs ACPE # 207-000-14-229-L04-T Activity Type: Application-based Speaker: Mark Jacobs, RPh, Director of PAAS Services, PAAS National Pharmacist and Pharmacy Technician Learning Objectives: Upon completion of this activity, participants will be able to: 1. Discuss the most common audit triggers. 2. Create staff training measures that will decrease your audit recovery risks. 3. Summarize the process of disputing an audit. Disclosures: Mark Jacobs is the Vice President of Operations with PAAS National and is receiving an honorarium for this program. The conflict of interest was resolved by peer review of the slide content. NCPA’s education staff declares no conflicts of interest or financial interest in any product or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.

NCPA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is accredited by NCPA for 0.15 CEUs (1.5 contact hours) of continuing education credit.

NCPA Disclosure Statement The National Community Pharmacists Association (NCPA) Office of Continuing Education makes every effort to develop continuing education activities that are scientifically based, accurate, current, and objectively presented. In accordance with the Accreditation Council for Pharmacy Education Standards for Commercial Support NCPA has implemented a mechanism requiring everyone in a position to control the content of an educational activity to disclose any relevant financial relationships with any proprietary entities producing health care goods or services and mange/resolve any conflicts of interest prior to the activity. Individuals must disclose to participants the existence or non-existence of financial relationships. NCPA does not view the existence of interests or relationships with commercial entities as implying bias or decreasing the value of a presentation. It is up to the participants to determine whether the interest or relationships influence the presenter with regard to exposition or conclusions. If at any time during this activity you feel that there has been commercial or promotional bias, please inform us by reflecting the information on the session evaluation form.

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How Not to be an Audit TargetIn 2015

Mark Jacobs RPh

DisclosuresDisclosures

Mark Jacobs is the vice president of operations with PAAS National and is receiving an honorarium for this program. The conflict of interest was resolved by peer review of the slide content.

Learning ObjectivesLearning Objectives

1. Describe four areas of focus associated with Plan Compliance

2. Identify at least five strategies for fighting back against PBM Claw-backs in 2015

3. Define which element of the NPI# Registry can trip up pharmacy providers despite having used the correct Type 1 NPI#

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Plan Compliance

Plan Requirements:• Waste: DS, OBQ, IDS, • Abuse: Overrides, Rx NPU, UAR, DID, • Fraud: Misbranding, duplicate billing or billing for fake prescriptions• Partial fill CS Audits• DID audits• CS Requirements• POC concerns and dilemmas • Compound restrictions grow tighter • LTC Orders and the difficulties they pose – Solutions• Compliance Audits are on the rise• Audit Prevention Newsletter• Invoice Audits!• And More…

Plan Compliance

Increased stakes

1. Pharmacy Audits

2. FWA Compliance Audits

3. HIPAA Compliance Audits

4. CMS Star Ratings and Medication Adherence

Pay to Play and Penalties

Increased stakes

1. Some contracts requiring fees

2. Some (additional types of) fees are hidden

3. Some re-credentialing plans require fees

4. Some audits have financial penalties in addition to their normal recoupment amounts

5. Forgot to attest to FWAC last year? That could be yet another fee!

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Decreased Reimbursement

1. Contracts fail to inform pharmacies what they will pay them for generics

2. Like signing a blank check!

3. PBMs taking business and directing to mail order

4. Specialty pharmacy fastest growing segment and they are looking to take that too!

Time to fight back?!

Can we successfully fight back?

The Medical Equipment Suppliers Association (MESA) reports that a RAC auditor has admitted that they pay hospitals up to $25 per audit to offset costs of providing copies of records to respond to audits.

• Subsequently, MESA wrote CMS Administrator Marilyn Tavenner in July 2014 recommending that DMEPOS suppliers be reimbursed in the same way hospitals do.

• MESA received a response from Melanie Combs-Dyer, Acting Director of the Provider Compliance Group at CMS.

• Although the initial response was not favorable for DMEPOS providers, Ms. Combs-Dyer has directed her staff to conduct research on the issue and exploring the possibility of revising future RAC contracts.

Stay tuned!

Other ways to fight back

• Stay on top of all plan requirements

• Have clean records

• Remember all prescription data elements

• Engage entire staff to look for potential audit losses

• If in doubt, verify the prescription with the prescriber

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All Prescription Data Elements:

• Patient First and Last Name• Full Date• Drug• Strength• Dosage Form• Quantity to Dispense• Mathematically useful directions for use• Refill information• Submit Correct Day Supply• Submit Correct NDC#• Submit Correct Prescriber and Type 1 NPI#


For Telephone Orders:

• Document “Phone-In” or “T/O”

• Date

• RPh Initials

• Name of person calling in prescription

Hydrocodone‐Containing Products Go to C‐II

1. What will happen with Hydrocodone?

2. Lots of unanswered questions

3. Federal law allows refills issued prior to October 6, 2014 to be refilled through April 8, 2015

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Hydrocodone Goes to C‐IIWhat does this mean for pharmacy?

The Rule states “Any prescriptions for HCPs that are issued before October 6, 2014, and authorized for refilling, may be dispensed.”

• Does this mean an original date of fill for a HCP prescription, pre‐October 6th dated, that has refills can occur after October 6th and the refills are valid?

• Does this mean that a patient could hang onto a HCP prescription with refills dated prior to October 6, 2014 and wait to get it filled it later and still be eligible to obtain the refills?

Hydrocodone Goes to C‐IIWhat does this mean for pharmacy?

• Should a HCP prescription written with refills prior to October 6th, but filled after October 6th, be filled as Schedule C‐III or Schedule C‐II?

• Will physicians backdate prescriptions they write to circumvent the “no‐refill” rule for C‐IIs?

• Will transfers of prescription copies from one pharmacy to another of HCPs be valid after October 6, 2014, with refills remaining?

Today’s Prescription is Tomorrow’s Audit!

1. What about state law?

2. Can pharmacy’s software accommodate allowing existing refills issued prior to October 6th to be filled once HCPs are a C-II?

3. Safest move may be to require a new prescription on or after October 6, 2014

4. Ripe for take-back 12-18 months from now if you do it wrong

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Other Controlled Substance Audit Issues from 2014

CMS Partial Fill Audits:

• C III-V Rxs with more than 5 refills Often valid if documentation that patient requested

lesser quantity

• C II Rxs with more than 1 fill Often valid if written for nursing home or hospice patients

These may continue to be an audit issue in 2015

To be valid, a partially filled C‐II must contain…

1. The pharmacist must record on the prescription whether the patient is "terminally ill" or a "LTCF patient.

2. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the• date of the partial filling• quantity dispensed, • remaining quantity authorized to be dispensed, and

the

• identification of the dispensing pharmacist.

To be valid a partially filled C‐II must contain…

CONTROLLED SUBSTANCES LISTED IN SCHEDULE II

§1306.13 Partial filling of prescriptions. • For each partial filling, the dispensing pharmacist shall record on the

back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist.

• The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication.

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To be valid a partially filled C III‐V must contain…

The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:

(a) Each partial filling is recorded in the same manner as a refilling,

(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and

(c) No dispensing occurs after 6 months after the date on which the prescription was issued.

To be valid a partially filled C III‐V must contain…

CONTROLLED SUBSTANCES LISTED IN SCHEDULE III, IV and V

§1306.23 Partial filling of prescriptions. • The partial filling of a prescription for a controlled

substance listed in Schedule III, IV, or V is permissible, provided that:

• (a) Each partial filling is recorded in the same manner as a refilling,

• (b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and

• (c) No dispensing occurs after 6 months after the date on which the prescription was issued.

All controlled substance prescriptions must meet 21 CFR 1306.05

Manner of issuance of prescriptions(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.

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Prescriber Registration Number

Suboxone™

Effective July 25, 2005, physicians must include their DATA 2000 waiver ID number on prescriptions for opioid addiction treatment medications. The practitioner's DEA registration number and the unique identification number (DATA 2000 waiver ID number or "X" number) must be on the prescription 21 CFR 1306.05(a). The identification number is not in lieu of the DEA registration number, it is an addition. If the prescription is telephoned to the pharmacy, the pharmacist must have both of these numbers on the prescription record so the physician can provide the numbers or the pharmacist may have them on file.

The SAMHSA Buprenorphine Physician Locator Web site lists the physicians in each State who have DATA 2000 waivers. A physician listed on the site can be considered to have a valid DATA 2000 waiver. Note, however, that the site does not list every physician with a valid waiver, only those who have agreed to be listed on the site. Physicians with valid waivers may choose not to be listed on the site.

A pharmacist desiring to verify that a physician who is not listed on the site has a valid DATA 2000 waiver can contact SAMHSA by phone at 1-866-BUP-CSAT (1-866-287-2728) or by e-mail at [email protected]. Pharmacists should convey their DEA registration number with these requests.

Suboxone™ Rx

Suboxone Film 8mg#30Dissolve one q8HNo refill

Prescriber NPI Number

CMS published a final rule that requires prescribers who are not covered entities themselves to obtain an individual (Entity Type 1) National Provider Identifier (NPI) and disclose it when needed for a pharmacy claim.

Covered organization health care providers must direct prescribers to obtain an individual NPI by May 6, 2013. This means that virtually all prescribers must now obtain an individual NPI (Entity Type 1).

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Prescriber NPI Number

Some NPI# Audits due to Invalid Taxonomy Code

• Examples include: Counselor Mental health

• Public Health and Welfare

“Prescriber” Taxonomy Code must come from the Health Care Provider Taxonomy Code Set

Prescriber NPI Taxonomy Code

A list of taxonomy codes can be found at http://www.wpc-edi.com/reference and click on “Health Care Provider Taxonomy Code Set”.

• In general, physicians should list a primary taxonomy code from the (+) Allopathic and Osteopathic Physicians link.

• Nurse Practitioners and Physicians Assistants should select from (+) Physician Assistants & Advanced Practice Nursing Providers and

• Not the (+) Nursing Service (Related) Provider lists.

Be Audit Ready for 2015

• Complete all FWA Attestations requested prior to year end

• Last year, one PBM charged $100 for failing to attest

• This year, that same PBM charged $500

• What will they charge next year if you forget?

• Or… Will you lose your provider contract instead?

Tip #1: Keep a Worksheet and log of your attestations

Tip #2: Print your on-line confirmation

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Formulary changes require contact with the prescriber

Remember…

• Proventil™ HFA, Ventolin™ HFA and Pro-Air™ HFA are NOT interchangeable

• Humalog™ and Humulin™ are NOT interchangeable with Novolog™ and Novolin™


Do You Have Adequate Proof of Copay Collection?

• Computer Record of Transaction

• Linked to point-of-sale system?

Routinely waiving copays may result in contract termination

Setting up a first party charge system that you do not collect on is the same as waiving or reducing copays


Do You Have Adequate Proof of Purchases?

• More and more pharmacies are failing invoice audits

• Are you purchasing all drugs from verified licensed U.S. Pharmaceutical Wholesalers?

• You can find out by going to NABP

http://www.nabp.net/programs/accreditation/vawd/vawd-accredited-facilities

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Do You Have Adequate Proof of Purchases?

• Do you keep your invoices?

• Avoid trading stock as much as possible

• Trading stock may be illegal in some cases

• Dangerous adulterated drugs are entering the U.S. drug chain

• Don’t be lured by specials and discounts from gray or black market wholesalers

Risks include:

Patient Harm

Violation of state and federal laws

HIPAA/HITECH – Are you ready for Phase Two Audits in 2015?

Phase Two OCR Audits Begin October 2014 and run through June 2015

Remember…

• A random selection of 550-800 covered entities will be chosen

• Phase 1 audits uncovered that the smaller the covered entity (think pharmacies), generally, the more compliance issues it had with all three HIPAA standards: privacy, security and electronic transactions

• Plus, many covered entities from phase one audits failed the HITECH provisions!

HIPAA/HITECH – Are you ready for Phase Two Audits in 2015?

The OCR will narrow the focus of Phase 2 audits to:

• Security risk analysis and management;• Breach content and effectiveness of notifications;• Privacy notices and access to records; and**• Proper safeguards and adequate training

**Privacy Rule requirements include: (1) notice of privacy practices for PHI, (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures.

Once the covered entities are selected, they will receive audit requests and have just two weeks to respond!

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Part B DME Audits – 97% Error Rate!

Claims for Glucose Test Strips to CGS from July 1, 2013 to September 30, 2013 resulted in a 97% denial rate.

Reasons Include:• Detailed Written Order – missing required elements (such as

beneficiary name, specific items to be dispensed, specific frequency of testing)

• Medical Records – not provided, lacked a current (< 6 months) test log (which must now be in the physician record, not the pharmacy’s) or physician record documenting frequency of actual testing OR did not provide a specific reason for overutilization

• Refill Request – not provided or missing required elements (such as description of item requested or quantity of each item still on hand)

• Proof of Delivery – not provided or was incomplete• Date of Service – did not match pickup date

Other DME Error Rates Are Also High!

Ways to Reduce DME Payment Recovery for 2015

Ways to reduce DME claims errors:• Follow the Detailed Written Order Requirements• Follow “Proof of Delivery” Requirements• Follow Other LCD Requirements• Supply Physician’s with LCD and Policy Statement Information• Obtain copy of Medical Records prior to dispensing – It is a legal requirement for

them to supply you with this• Social Security Act, the law governing Medicare. Section 1842(p)(4) of the Act

https://www.noridianmedicare.com/dme/news/docs/2008/03_mar/physician_letter.html

In case of an item or service…ordered by a physician or a practitioner…but furnished by another entity, if the Secretary (or fiscal agent of the Secretary) requires the entity furnishing the item or service to provide diagnostic or other medical information in order for payment to be made to the entity, the physician or practitioner shall provide that information to the entity at the time that the item or service is ordered by the physician or practitioner.

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The Refill Too Soon Discrepancy and How to Avoid it in 2015

• Patient beings you a prescription for a 60 day supply

• Pharmacy transmits the prescription as 60DS and receives EPL rejection

• Plan limits to 30DS and pharmacy has permission to transmit same prescription as 30DS

What should you do?

Pharmacy staff makes note on Rx and on computer file, “Pt may not refill prescription for 48 days.”


• Patient receives a new prescription for Drug A 10mg #30 Sig: 1qDay

• Three days later, patient brings you a new prescription for Drug A 20mg #30 Sig: 1qDay

What should you do?

Fill the new Rx for 20mg and tell the patient to discard the 10mg?

Fill the new Rx for 20mg and tell the patient to finish the 10mg tablets by taking two daily?

Instruct patient to take two 10mg tablets and return in 7 days


• Patient beings you a prescription for a medication to be refilled today (October 21) because they are leaving for vacation on Saturday

• Insurance rejects prescription as “refill too soon”, may not fill until October 23

What should you do? Fill prescription using a vacation override? Give the patient a two day supply at no charge? Inform the patient to return on Thursday and you will have their

prescription ready for them

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• Patient calls you for a refill of their medication because they can’t find the bottle they picked up yesterday

• Insurance rejects prescription as “refill too soon”, may not fill until November 12, 2014

What should you do? Fill prescription using a vacation override? Tell them too bad – Go home and look for it? Call the help desk to see if they are eligible for a “lost or

spilled medication” override? Fill it for cash?


Circumstances:

• Did directions change?

• Check refill history

• Justifiable?

• Think of cost control and any potential medical reasons when making your decision

• Is override or other intervention appropriate?


Overrides:

• Does intervention require help desk?

What codes are available?

• High Dose

• Vacation

• Lost or spilled?

• Dosage Change

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Decision Time

• You receive a prescription for Eye drops Qty# 10ml Sig: Use 1 GttOU BID X 3 days

• Drug is available in 5ml, 10ml and 15ml

Do you…

Fill the Rx as written?

Dispense 5ml with one refill?

Dispense 5ml with zero refills?

Decision Time

• A Nurse Practitioner writes a prescription for Lantus™ Insulin Disp#5 Vials Sig: Inject 150 units qHS

• The pharmacy technician inputs the prescription as a 30DS and you are checking the order

Do you…

Initial and approve the order?

Send it back to re-enter the DS as 28DS because Lantus™ will expire in 28 days not 30?

Send it back and inform the pharmacy technician to re-process the prescription for 4 vials as a 30DS?

None of the above

Decision Time

• A prescriber phones in a prescription and you forget to write that she authorized 4 refills on the prescription, but your Rx label comes out correct.

What do you do?

Initial by the 4 refills on the label and by the date?

Re-process the prescription with zero refills?

Enter the four refills as authorized by the prescriber?

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Decision Time

• You receive a prescription for a non-controlled substance, where the prescriber has crossed out the quantity of 30 and written for quantity of 60 with directions – Take 1 tablet twice a day

What should you do?

Enter #60 as a 30DS?

Fill the prescription for #30 as a 15DS?

Call the prescriber to confirm the quantity change?

Reversing Prescriptions

• You notice a prescription in the will-call bin that was filled on October 1st.

• You know the patient comes in at the end of every month to pick up their prescriptions

What should you do?

Reverse the prescription on-line?

Mail it to them?

Call the patient to pick up their medication?

Reverse and rebill it for today’s date?

Pharmacy Records

• You are going through some old boxes and find invoice purchases from five years ago.

• State law only requires that you maintain all records for four years

Do you?

Toss them?

Shred them?

Save them for another five years?

All books, records and accounts of transactions, data, prescription files, drug purchase invoices, prescriptions, signature logs, and documentation related to the provision of covered services

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Prescription Origin Codes

• You receive a written prescription for a C-IV substance.

• You have to call the prescriber to verify something on the prescription

Do you fill the prescription using origin code

One – Written?

Two – Phone?

Five – Any reason to give it a new number?

E‐Prescription Snafu

Other E‐Rx Issues

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Preventing Audit Chargebacks on Sig Logs in 2015

Work directly with the auditor in 2015

Sig Log Example

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LAWF

What Rx elements are missing?

PA‐C Prescribing of C‐II

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Pt Name and DOB have been removedWhat else is missing from this Rx?

Remedies for LTC Order Deficiencies

• POS or chart orders with policies right on them

• State Law defining policies for Institutional or LTC orders

• Policy and procedures manual

• Others?

In addition to quantity and refill information, what else is sometimes missing from Chart Orders?

• Physician Signature

• Date of Signature

• What happens if the order is dated later?

• FBW!!!

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OK?

Caremark Network UpdateMay 30, 2014

The Latest Compounding IssuesMust collect copays

• Collection of Copay Amounts

• Provider must collect patient pay amount, unless:

1. Otherwise directed by Caremark

2. Otherwise permitted under applicable law


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The Latest Compounding IssuesClinical Efficacy and Therapeutic Value• Disclose All ingredients

• Submit the actual NDC# of each covered and non-covered ingredient

• Two scientific studies in peer reviewed journals

• Clinical Efficacy


The Latest Compounding IssuesStability of each Ingredient

• Clinical and Therapeutic Value, and

• Stability of each ingredient

• If compound claim rejects due to pricing edits, provider shall not alter the quantity or identity of the individual components to inappropriately enable reimbursement


Other Compound Issues:

Compound Priced Below Plan Threshold• If submitted correctly, this claim or series of claims

would have rejected and required prior authorization review

Not including All Ingredients used in Compound• The pharmacy submitted the compound without all

ingredients used. Please submit all ingredients using 08 clarification code

Prime Therapeutics – Pharmacy Audit Recovery Guidelines (January 2014)

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What Does This Mean????

Topicals

Day Supply is becoming a larger audit risk

Reasons:

Increased Cost

Over-dispensing/Exceeds plan limits

Previously little or no controls

Waste or Abuse?

Topicals and Day Supply

Due Diligence/Reasonable Efforts expected to estimate day supply

Ways to perform expectations of the plan:

Assess patient/treatment area

Monitor past and future utilization

Request mathematically useful directions from prescriber

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Ask Your Software Vendor for Help

• Software vendors may be able to turn-on or activate certain features on the computer Rx fill sticker to help you avoid audit problems.

Examples:• DS• Rx OC• DAW• LF• NPI#• DEA#• Others?

Don’t be An Audit target in 2015!

Phone orders

Key Elements:

• Phone-In or T/O

• Date with RPh Initials

• Called in By:

• DEA# for CS


Prescription Transfers

Key Elements depending on your state may include:

• Original Rx#• Date transferred• Date of original Rx• Date last filled• Name of transferring pharmacy• Transferring pharmacy’s address and phone number

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Prescription Transfers

Key Elements depending on your state may include:

• Name of the transferring pharmacist• Name of the pharmacist receiving the prescription• Original number of refills authorized• Number of refills remaining (Be sure if 6 refills remain, that all

staff fill the Rx with 1 + 5 refills and use the correct original date and expiration date for the prescription.)

• Remember to also check out the standard Rx requirements including DEA# for controlled substances.


Pharmacy audits require a team effort.

• Intake Window Personnel • Data Input Technicians• Filling Technicians• RPh Checking the Medication Therapy• Packaging Technician• Cashier


Waiving Copays can be a problem • Federal Law requires collection of the full copay• Some exceptions• State Medicaid may also have exceptions• Generally not acceptable to waive copays for most

plans

Audits: • Some audits now verify copay collection• Best process is to have POS system link to software

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So… You’ve been notified of an Audit!

Yipee!

If When you are an Audit Target in 2015!

Written Notice: • Should allow time to schedule and

accommodate• Date or Week of the Audit• Time or Time Estimate• Prescription Date range, Rx number range• Masked List of Rx Numbers

If When you are an Audit Target in 2015!

Preparation:

• Schedule to accommodate

• Call for Exact Date and Time

• Time or Time Estimate – How long will it take?

• Prescription Date range, Rx number range

• Masked List of Rx Numbers

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If When you are an Audit Target in 2015

Due Diligence:

• Realize you were not randomly selected!

• Network

• Learn as much about the audit company and auditor as possible

• Familiarize yourself with the Plan Manual

• Know and understand exactly what you agreed upon


Pre-Audit Logistics:

• BIN Numbers

• Claims History

• Locate records

• System for Filing Rxs

• E-Prescriptions – Many still want paper copy

• Don’t forget Sig Logs


Audit-Day Logistics:

• Where?

• Requirements

• Should I video tape the audit?

• HIPAA – PTO: Payment Treatment Operations, minimum necessary Prescriptions

Sig Logs

Computer Screens

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On‐Site Compliance Audits

Post-Audit Pharmacy Compliance Examination:

• FWA Training

• FWA Policies

• Code of Conduct

• Quality Assurance & Error Reporting

• Exclusion List Monitoring

• Expect HIPAA…

On‐Site Compliance Audits

FWA Policies

Exclusion List Monitoring

Code of Conduct and Conflict of Interest

Statements

Training

Quality Assurance and Error Reporting

Expect HIPAA!

HIPAA Risk Analysis

Disaster Recovery Plan

Privacy Rule

Security Rule

Breach Notification

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HIPAA Audits

Phase Two Audits will begin October 2014 and run through June 2015: • A random selection of 550-800 covered entities will be chosen

• Phase 1 audits uncovered that the smaller the covered entity (think pharmacies), generally, the more compliance issues it had with all three HIPAA standards: privacy, security and electronic transactions

• Plus, many covered entities from phase one audits failed the HITECH provisions!

HIPAA Audits

The OCR will narrow the focus of Phase Two Audits: • Security risk analysis and management;• Breach content and effectiveness of notifications;• Privacy notices and access to records; and**• Proper safeguards and adequate training

• **Privacy Rule requirements include: (1) notice of privacy practices for PHI, (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures.

• Once the covered entities are selected, they will receive audit requests and have just two weeks to respond!

Desk Audits

Written Notice:

• Should allow time to gather documents

• Provide Copies of all requested documents

• Review for legibility, completeness and plan compliance

• Sig Logs – Make sure you have the correct date

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Desk Audits

Written Notice:

• Organize, write Rx number on each page

• Submit before deadline

• Pay attention to carrier requirements

• Any documents that are sent by fax – confirm receipt of those documents

Phone Audits

Written Notice?

• Probably Not

• Can be seen as a courtesy call to help with plan compliance

• Need to have policies and procedures in place to verify who you are speaking with (PHI)

• Document thoroughly Who Called?

What did they say?

What did you do?

Who are you?

Invoice Audits are on the Rise!

Who is your wholesaler?• Are they NABP – VAWD?• NABP working with FDA to draft pedigree

requirements of DQSA later in 2014• Dangerous drugs are entering the supply chain• Purchasing or reselling unapproved drugs is mis-

branding!• Mis-branding carries extreme penalties• Don’t be lured by specials from gray or black market

wholesalers – If it sounds too good to be true?

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Why Invoice Audit?

• Verify pharmacy purchased product

• Verify correct NDC# is billed

• Ensure product is not mis-branded

• Pharmacy is required to keep records

• Biggest risk is inventory trades or purchases

What’s Wrong with Inventory Trades?

• Occasional infrequent trades may be acceptable with your Board of Pharmacy

• Many states limit to no more than 5% of inventory be sold or distributed – Caution: Not a license to distribute or trade!

• Also, Class of Trade Issues – Hospitals and LTC Pharmacies may contract at lower prices

• Trading with them could result in unfair competition and also be a violation

• Violating anticompetitive laws could result in civil or criminal penalties including fines and jail time.

Learning Objective #1

Describe four areas of focus associated with Plan Compliance

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Describe four areas of focus associated with Plan Compliance

Answer:

1. Pharmacy Audits

2. FWA Compliance Audits

3. HIPAA Compliance Audits

4. CMS Star Ratings and Medication Adherence


Identify at least five strategies for fighting back against PBM Claw-backs in 2015


Identify at least five strategies for fighting back against PBM Claw-backs in 2015

Answer:• Stay on top of all plan requirements• Have clean records• Remember all prescription data elements• Engage entire staff to look for potential audit losses• If in doubt, verify the prescription with the prescriber

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Define which element of the NPI# Registry can trip up pharmacy providers despite having used the correct Type 1 NPI#


Define which element of the NPI# Registry can trip up pharmacy providers despite having used the correct Type 1 NPI#

Answer:

• Examples Include: Counselor Mental Health

• Public Health and Welfare

116th Annual Convention - NCPA · Like signing a blank check! 3. ... pharmacist must have both of...

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