cms changes impacting pharmacy: seize the initiative · •discuss the necessity of working with...

Pharmacy Track

CMS Changes Impacting Pharmacy: Seize the Initiative

Bonnie Kirschenbaum, MS, FASHP, FCSHP

Free lance consultant, columnist

Boulder/Breckenridge, CO

Learning Objectives

• Discuss the necessity of working with Revenue Cycle Teams in cross functional programs.

• Describe the role of pharmacy leaders in educating their health systems on the impact of OPPS changes including bundled payments, waste billing, Observation Stay changes, etc.

• Provide a basis for new practitioners and clinicians to understand the financial aspect of healthcare, a topic not often covered during their formative training.

The P&T Committee

The MD writing orders

Everyone has a fiduciary responsibility!!

The patient taking responsibility

Revenue Cycle: the Billing Dept

IT

Pharmacy working across all care sites

Nursing

Social ServicesPatient Navigator

3

Technology

Helping or hindering?

Process

Need fixes?

People

The Revenue Cycle

So Many Moving Parts!! Nursing

CDM

HCPCSPayor Rules

Med ordered

Documentation

5

Payor

info

shared

Document

Prior auth

in EHR

LCD/NCD

requirements

met

Accurate

CDM

CDM–

PDM

match

Document

+ Bill IV

drug

admin

Waste

billing

Zero-

priced

drug

billing

Bundled

items

billed

Codeable

documentation

Living up to your reimbursement potential

Focus Areas Identified

Payment +

collection

can no

longer be

confined to

the

financial

silo.

Clinical

input is

critical!

NCDs, LCDs, PAs and ICD10 : The Vital Links

• understand these?

• positioned your clinical and technical staff to practice in a cross-functional manner along with Patient Navigators to ensure compliance to the use of these components of Specialty Drug use and reimbursement?

• EHR documentation

• ICD10 supports requirements

• Payment

Appropriate Med Ordered

PA, NCD or LCD applies

• No awareness, no follow-up

• No documentation to support use requirements

• No payment due to lack of medical necessity

Appropriate Med Ordered

PA, NCD or LCD applies

$

0

Who’s responsible? Everyone including Pharmacy Clinicians!

Prior Approval vs. NCDs and LCDsPrior Approval (Payor) NCDs and LCDs

Applies to: 3rd party carriers (possibly Medicaid)

Medicare (possibly Medicaid)

Need Patient’s payorstatus?

yes yes

Drug tagged in CPOE/PDM? yes yes

Link to actual rule needed? yes yes

Rule Requirements: Ask permission first before drug administration

Understand & follow requirements, document completely and thoroughly.Code correctly and as required

Payment: Only if permission is given first

Determined after the fact and may be denied if not all rules followed

BonnieKirschenbaum 4.2016 8

What’s Covered and What’s Not

• The fact that a drug, device, procedure, or service has a Healthcare Common Procedure Coding System (HCPCS) code and a payment rate under OPPS does not imply coverage by Medicare

• Indicates only how the product, procedure, or service may be paid if covered by the program

• FI’s/MACs determine if all program requirements for coverage are met, e.g. that it’s reasonable and necessary to treat the beneficiary’s condition and whether it’s excluded from payment


LCDs, NCDs & Prior Authorizations

• Essential that all concerned

– understand which drugs have these requirements

– have set a procedure for how to handle them

– ensure the required documentation is in the medical record BEFORE the drug order is written and ESSENTIAL before the drug is actually prepared and administered

– Can't be remedied after the fact

• If this step not taken or documentation missing, no payment made

• Get LCDs and NCDs from your MAC's website and the prior authorization list from your payors. Pay attention to the ICD-10 codes that apply

• Work out a plan with infusion centers as to responsibility for who's doing what, who's documenting what, how’s this info going to be transmitted to pharmacy

• Equally important is ensuring that it remains a permanent part of the record in real time sequence for auditing purposes

BonnieKirschenbaum 4.201612

Off Label Indications

• Dilemma often arises when the literature supports and a patient is

treated for an off-label indication

• Fact that it is off-label may be sufficient grounds for FI to deny payment

• Patient and billing assistance programs offered by several

pharmaceutical companies may be helpful in providing support when

attempting to have denials overturned

• Officially Accepted Compendia can be used to support the off-label

decision. Be aware of what they are!

• http://www.cms.gov/Medicare/Coverage/CoverageGenInfo/compendia

.html


NCD/LCD References

• NCDs on the CMS Website http://www.cms.gov/medicare-coveragedatabase/indexes/ncd-alphabeticalindex.aspx?bc=BAAAAAAAAAAA

• NCD IOM Pub. 100-03 https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Internet-Only-Manuals-IOMsItems/CMS014961.html

• IOM Pub. 100-08, Chapter 13 http://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/pim83c13.pdf

• Each MAC publishes their own LCDs– Novitas JL Medical Policy Center

http://www.novitassolutions.com/webcenter/portal/MedicalPolicy_JL/MedicalPolicy

– Novitas JH Medical Policy Center http://www.novitassolutions.com/webcenter/portal/MedicalPolicy_JH/Medical+Policy


• How do you remind clinicians which drugs have these requirements?

• How do you document that requirements met? Authorization given?

• Anyone check on this before dispensing/administering the drug?

• Routinely follow-up on denied payment for “lack of medical necessity” ?

Just how many kinds of bundles could there be? Lots!!

Drugs costing <$110/day

Entire episode of care(e.g. breast cancer)

Defined episode of care(e.g. Hip replacement, cardiac care, observation status stay)

IV drug admin

CMS Policy-Packaged DrugsBiologicals & Radiopharmaceuticals

Essentials

• All drugs & biologicals must be ordered, documented as given and billed for even if they are not separately payable

• Why is this crucial?– Billing does 2 things: ask for reimbursement + get data into the

claim

– Missing drug data = assumption none was given

– Treatment misrepresented if missing drug data

– Actual costs of treating the bundle misrepresented

– No IV drug admin fees paid if no drug billed

Proposed OPPS 2017 Drug Administration Rates

• How many are proposed to increase? 86%

• By how much? 0.4% to 95%

• Are any decreasing? Yes, a few from -18% to -43%

Off to find out if we document completely, use the correct codes and capture Drug Admin revenue for all applicable outpatient drugs (even Patient Assistance Products and those pesky White Bag products)

• Is this an issue at your facility?

• Stumbling blocks?

• Who needs to be involved?

• What are you going to do?

• How is bundled payment divided/allocated to cost centers including pharmacy?

• Anything else?

I’ve heard you can bill for drug waste …

how does this work?

20

Answer these 4 questions

• Is the drug being used for a Medicare patient being treated in an outpatient area?

• Are you using a single dose vial/pkg of the drug?

• Does the product have a HCPCS code?

• Does the dose fall into the pass-through or separately payable category and not the <$110/day bundle or any other packaged or bundled payment category?

• If yes, proceed to waste billing

• If no, then there’s nothing to do

21

Correctly billing for expensive outpatient drug

waste has blown up into such a huge issue that

CMS actually delayed implementation by 6 months

to Jan 1, 2017 to allow facilities to get their act

together.

The change they are trying to implement seems

simple (and would be if everyone was actually

doing what they were supposed to) but few

facilities were even abiding by current rules and now there is a lot of scrambling going on.

Steps to Take

• Review the MAC requirements for your geography

• Determine which drugs are going to be waste candidates

• Create a CDM # for each one

– Drug A CDM #123456

– Drug A waste CDM# 123457

• Convert the dose administered into billing units, round up to the next whole billing unit as needed

• Document the dose administered in the medical record

• Determine the number of billing units wasted

– The # in the vial (use the NDC ASP CMS Qtrly update) minus the number of billing units used for the dose

• Document the amount wasted & the reason why in the medical record

• On the same day, Bill for the dose administered using billing units + Bill for the amount wasted using billing units

23

Reducing Reimbursement Loss or Compliance Errors

Billing for waste is not mandatory but if trying to recoup those $, then…..

• Know the rules your contractor requires you to follow

• Using the JW modifier is mandatory

• Decide which products your outpatient departments will apply this to

• e.g. may decide to only apply this to a handful of expensive agents in the infusion clinic or specialty outpatient clinics

• Develop a P&P and orient your staff

• Make use of IT but do frequent compliance checks

• Ensure that required documentation is actually happening and in the manner specified by the MAC/FI

24

Background

The “Medicare Claims Processing Manual,” Chapter 17, Section 40 provides policy detailing the use of the JW modifier for discarded Part B drugs and biologicals. Current policy allows MACs the discretion to determine whether to require the JW modifier for any claims with discarded drugs or biologicals, and the specific details regarding how the discarded drug or biological information should be documented. Be aware in order to more effectively identify and monitor billing and payment for discarded drugs and biologicals, CMS is revising this policy to require the uniform use of the JW modifier for all claims with discarded Part B drugs and biologicals.

Additional InformationThe official instruction, CR9603, issued to MACs regarding this change is available at

https://www.cms.gov/Regulations-and-guidance/Guidance/Transmittals/Downloads/R3538CP.pdf Questions? Contact your MAC at their toll -free number available at • http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-

MLN/MLNMattersArticles/index.html under - How Does It Work.

http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/index.html

• https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html

• ASP crosswalks (NDC to HCPCS)– maintained by the Division of Ambulatory Services to support ASP-based

Medicare Part B payments only. – are intended to help understand which drug products (identified by NDCs)

are assigned to which HCPCS billing codes. – are not intended to be a comprehensive list of all drugs/NDCs available in

the United States. – also include information on the NDC package size and the number of

billable units (as defined by the HCPCS code descriptor).

NDC to HCPCS

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice/2016ASPFiles.html

Field Descriptions/Example

• HCPCS Code: Jxxxx• Short Descriptor: Short descriptor of the HCPCS code• Code Dosage Descriptor: The dosage descriptor assigned to the HCPCS code (ex., 5 mcg.)• Labeler Name: Manufacturer Name• 11-Digit National Drug Code (NDC) or Alternate ID: typically xxxxx-xxxx-xx (dashes are included); alternate IDs

vary in formatting• Drug Name: ProductName (brand or generic name may appear)• Package Size: amount in one item. (ex., For a product that is 100mcg/0.5 ml in one vial, the • package size would be 0.5.) • Package Quantity: number of items in the NDC (ex., For an NDC that is 4 vials in a shelf pack, • the package quantity would be 4.)

• Billable Units Per Package: the number of billable units per package (ex., 100 mcg in a • package divided by 5 mcg in the dosage descriptor = 20 billable units per package.)• Billable Units Per 11-Digit NDC: the number of billable units per NDC (ex., 20 billable units in each item

multiplied by 4 vials in the NDC shelf pack (aka the package quantity) = 80 billable units per NDC.)

Drug Waste Considerations

1. Narcotic waste (Joint Commission Med Mgmt revisions)

2. Getting correct 340B Accumulator totals

3. Medicare waste billing4. Private payor waste billing?

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• Are you ready?

• Built your drug files at HCPCS billing unit level?

• Consistent policy throughout the facility?

• Done the math? Gains? Losses?

• Advice for others?

• Anything else?

340B Proposed Mega-Guidance• Ready for change?

• Involved in the orderly process (hopefully!) in your institution to be ready for transitions?

• What role are you playing in planning for the possible contingencies related to denied or delayed claims that affect your drug budget? Or the loss of 340B pricing for orphan drugs?

Is this you?

White House Office of Management and Budget started its review Sept. 1 of the final guidance document (RIN:0906-AB08 ), according to the OMB's reginfo.gov website

http://www.reginfo.gov/public/do/eoDetails?rrid=126711

HRSA Releases Proposed 340B Mega-Guidance 8.25.15• Program eligibility and registration• Eligibility of drugs for purchase under 340B• Patient eligibility to receive 340B drugs• Requirements for covered entities• Arrangements for contract pharmacies• Manufacturer responsibilities• Rebate options for AIDS drug assistance programs• Program integrityUnknown: unclear if this mega-guidance will replace existing, limited guidance documents or how it will be treated in terms of HRSA audits.Known: all covered entities will be affected at some level. For some this means substantial programming and process changes to ensure compliance.


Significant Impacts: Determining Patient Eligibility

• .


Current Guidance: 3 steps Proposed Mega-Guidance 6 steps

Services must be provided at a facility that’s registered for the 340B program and listed on the public 340B database

Covered entity must have an established relationship with the individual, maintaining records of the individual’s healthcare

Covered entity has access to the individual’s patient records, which show that covered entity is responsible for care

Individual must receive healthcare services from providers either are employed by covered entity or maintain contractual/other arrangements (eg consult referral) such that covered entity responsible for care provided

Services must come from a provider who is either employed by a covered entity or is an independent contractor for the covered entity, which may bill for services on behalf of the provider

Drug individual receives must be ordered or prescribed by the covered entity provider as a result of the service already described

Significant Impacts: Determining Patient Eligibility


Current Guidance: 3 steps Proposed Mega-Guidance 6 steps

Healthcare services individual receives from covered entity are consistent with services for which entity received grant funding or federally qualified health center look-alike status. Disproportionate share hospitals exempt from requirement

The individual’s healthcare is consistent with the scope of the federal grant, project, designation, or contract.

Note: individual not considered a patient of covered entity if only healthcare service individual receives from covered entity is dispensing of a drug or drugs for self-administration or administration at home

The drug is ordered or prescribed based on a healthcare service classified as outpatient.

Significant Impacts: More Requirements

• Discharge prescriptions from an inpatient stay no longer will qualify; only drugs billed as part of an outpatient visit will be eligible, (may require more complex eligibility processes in contract pharmacy settings)

• Referring providers must meet stricter requirements that will limit eligibility

• Medicaid managed care organizations (MCOs)

– Covered entities will have an obligation to prevent duplicates

– Contract pharmacies must exclude Medicaid MCOs in the same fashion that they currently carve out Medicaid fee-for-service providers from their 340B purchases

• Bundled Medicaid drugs will not be 340B eligible

• Contract pharmacies will be required to undergo quarterly reviews by the covered entity with which they are contracted


Key Issues in PlayNot all are covered by the MegaRule

• Orphan Drugs– Addressed in a previous HRSA guidance– Ruled against in a court decision

• CMS covered outpatient Drug Rule• Final Average Manufacturer Price (AMP) Rule released impacting

Medicaid Billing and Reimbursement• Medicaid Rebate Rule• Limited distribution drugs, specialty drugs• Material breach requiring corrective action and repayment• The furor over drug pricing

– Congressional hearings regarding drug pricing– Medicare reimbursement and 340B– POS codes


340B Requires

• Eligible Facility

• Eligible Physician

• Eligible Patient

• Eligible Drug


Got all 4?There’s no such thing as Presumptive Eligibility !!

Billing for Pharmacy Services

A Multitude of Initiatives: New Opportunities for Pharmacy

A review of CMS initiatives that involve drug therapy.

39|

40

Ambulatory Care Patient

Sleeps @ home

Part D Meds

MD office visit: PFS

Yes under MTM and PFS &

Transitions of Care & CMS

chronic care rules when

coordinated with the

physician

Outpatient

Sleeps @ home except*

OPPS, Part B Drugs

Clinic visit, ER visit

Ambulatory Surgery

Observation Patient*

Procedural Areas

Yes under MTM and PFS

& CMS chronic care

rules when coordinated

with the physician

Inpatient

Sleeps @

hospital

IPPS

Not currently

Payment for pharmacy services in any of these areas?

Medication Therapy Management: a federally mandated component of services that must be provided to Targeted Medicare beneficiaries under Part D

41

Multiple Diseases

Multiple Drugs

Annual $ exceed a

cost threshold

>$4000

Target Patient

Pharmacy Billing for E&M codes in Part B

• "incident to" codes used to help support pharmacist services fall under E&M services codes

• Understanding E&M services and billing codes under CMS rules for documentation is essential when "incident to" billing codes are used to support pharmacist services

• https://www.cms.gov/outreach-and-education/medicare-learning-network-MLN/MLNedwebguide/emdoc.html

Work with pharmacy staff to ensure they know how to proceed with getting paid for these services

9/20/2016 42

https://www.cms.gov/outreach-and-education/medicare-learning-network-MLN/MLNedwebguide/emdoc.html

Outpatient Chronic Care Management (CCM)

• CY 2015: CMS adopts separate payment codes for CCM services – non-face-to-face care management services for Medicare patients with multiple (2 or more) significant, chronic conditions

• Could include

– regular development and maintenance of a plan of care

– communication with other treating health professionals

– medication management

• Hospitals requested clarification of their role in furnishing CCM services and in defining the scope of service elements for the hospital outpatient setting that are analogous to the scope of service elements finalized as requirements to bill for CCM services in the CY 2015 Medicare Physician Fee Schedule final rule with comment period (see page 39290)

9/20/2016 43

CCM by Pharmacy in hospital based OP Clinics

• OPPS 2015: CCM Payment begins, includes pharmacists

• OPPS 2016: additional requirements• Federal Register link http://www.gpo.gov/fdsys/pkg/FR-2015-07-08/pdf/2015-16577.pdf pg

39289

• CMS FAQ link https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Payment-Chronic-Care-Management-Services-FAQs.pdf

– Work with Pharmacy staff to ensure they understand requirements for this payment

– Payment is inclusive of all providers (physician, pharmacist, etc)

– Who’s coordinating this at your facility??

9/20/2016 44

http://www.gpo.gov/fdsys/pkg/FR-2015-07-08/pdf/2015-16577.pdf

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/Payment-Chronic-Care-Management-Services-FAQs.pdf


Putting $ into Perspective

Rituximab billing errorHCPCS code: J9310Billing unit 100mg

July 2016 ASP $791.40Case Description

Billing unit 10 fold errorEach 1000mg dose billed as 1 billing unit

instead of 10 billing unitsGot $791.40 but lost $7122.60 for each pt

Assume 1000 patients/yrLost revenue = $7,122,600

Chronic Care Management Opportunity Available $

$60/month/eligible patient for 20 minutes

documented service

Would need to manage 9892 patients for 20

minutes each month for 1 year to earn $7,122,600

Key Takeaways

Key Takeaway #1• Move out of your silo, Recognize implications of your

decisions & actions and remember, it’s not about you, it’s about the patient !!

Key Takeaway #2• The 3 Elements to Leadership are vision, understanding the

situation and having the courage to act while remembering that It’s not a popularity contest!!

Key Takeaway #3• Pharmacy is part of the healthcare ecosystem, every part of

which has to step up their efforts to contribute to affordability. What are you going to start doing? Stop doing? Keep Doing?

Submitting Presentation

Once complete, please email your presentation to Lisa [email protected]

All Presentations due to Lisa by

April 10th, 2015

mailto:[email protected]

cms changes impacting pharmacy: seize the initiative · •discuss the necessity of working with...

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