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HCCA CLINICAL

PRACTICE COMPLIANCE

CONFERENCE

CMS Open Payments Formerly Known as the Sunshine Act

October 13, 2014Philadelphia, Pennsylvania

PRESENTATION OBJECTIVES

Open Payment RegulationsReporting Requirements – who, what, when Exclusions

Payment ReconciliationsProcessTimingDisputes

Focus on physicians – not manufacturers or teaching hospitals – most common situations

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IT LOOKS WORSE THAN IT IS

Today we’re only reviewing the basics of the Open Payments regulations – not everything on all the slides – they’re a resource for future questions!

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DISCUSSION QUESTIONS

Do you have conflict of interest policies?

Did you receive/provide any Open Payments education? From or to whom?

Did you check your data before it became public? Any surprises? Any frustrations?

What type of payment records do you keep?Did you use the Open Payments app?

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DISCUSSION QUESTIONS

Did you understand what would and would not be reported?

Have you looked at your public data?Any surprises?

Do you routinely disclose relationships to patients? How?

Have you gotten questions from patients?5

BACKGROUND - ASSOCIATION OFAMERICAN MEDICAL COLLEGESJune 2010 – Report of the Task Force on Financial Conflicts of Interest in Clinical Care *

Having conflict of interest policies and procedures is good medicine.

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AAMC FINDINGS *

Utilization increases with ownership

Gifts affect decision making

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AAMC FINDINGS

How institutions act is also an influence, like faculty and resident physicians, on students.

Especially for those serving in direct leadership roles for faculty physicians (division chiefs and department chairs), addressing conflicts of interest is critically necessary.

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AAMC FINDINGS

It’s imperative for transparency in relationships among academic medicine, physicians, and industry...with respect to public Web sites …the accuracy, freedom from inconsistency, and ease of understanding of the information disclosed will determine whether this format for achieving transparency has any real value.

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manufacturer manufacturer manufacturer

ADDRESSING TRANSPARENCY

Primary Methods -Websites Hospital websites Physicians Manufacturers Consumer organization websites

Brochures, letters to patientsPosted notices: check-in, offices,

exam rooms10

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WEBSITES AREN’T NEW

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FEELING BETTER?

No? Maybe you need a little sunshine… 12

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OPEN PAYMENTSPREVIOUSLY - SUNSHINE ACT

Physician Payment Provision of the Patient Protection and Affordable Care Act of 2009

Became law on March 23, 2010; public comments closed February 17, 2012.

Initially reporting of payments made in 2012 -implementation delayed until August 2013

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OPEN PAYMENTS - PURPOSE

Promote transparency into the financial relationships physicians and teaching hospitals have with drug and device manufacturers No assumptions or conclusions about the payments –

just data

“CMS will simply make the program available to the public to create transparency and allow interested stakeholders to analyze, monitor, and use the data.” *

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PURPOSE

“… transparency will shed light on the nature and extent of the relationships that exist and hopefully discourage development of inappropriate relationships.” *

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DISCUSSION

Do you have conflict of interest policies? Are policies the same for physicians and

non-physicians?

Did you receive/provide education?

To/From Whom?

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HOW OPEN ARE THE PAYMENTS: WHO, WHAT AND WHEN

Who Reports: Drug, biological and medical supply and device manufacturers to report

What’s Reported: All payments, transfers of value, ownership interests

Payments to Whom: Physicians and teaching hospitals

When: Payments made between January 1 and December 31

When: Reports are due by March 31 17

WHO REPORTS PAYMENTS

Reports Payments and Transfers of Ownership - Manufacturers of drugs, devices,

biological or medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP)

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WHO

Group Purchasing Organizations (GPOs)Operate in the United States, or in a territory,

possession or commonwealth of the USPurchases, arranges for or negotiates the purchase of a

covered drug, device, biological or medical supply, for a group of individuals or entities and not solely for use by itself Includes GPOs that -

Negotiate contracts for their members, Entities that purchase covered drugs, devices,

biologicals, and medical supplies for resale or distribution to groups of individuals or entities

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WHAT’S REPORTED

Cash and cash equivalentsStockStock optionsPartnership sharesLimited liability company

membership(s)LoansBondsOther financial instruments

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PAYMENTS TO WHOM

Physicians and their immediate family members

SpouseNatural or adoptive parent, child or siblingStepparent, stepchild, stepbrother stepsisterFather-, mother-, daughter-, son-, sister-in-lawGrandparent or grandchildSpouse of grandparent or grandchild

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WHO’S A PHYSICIAN?Doctor of Medicine Osteopathy Dentistry Dental Surgery Podiatry Optometry Chiropractic Medicine Fellows

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PAYMENTS NOT REPORTED

Excludes – Physicians employed by the reporting

manufacturer Physicians employed by a teaching

hospital – when teaching hospital is recipient of payment

Residents Nurse Practitioners Physician Assistants

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DETAILS REPORTED

Manufacturers report physician’s Name First, last middle initial

Business addressPrimary practice address

NPIIndividual – not group

Specialty Date of payment Type of payment (not required)

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WHAT ELSE IS REPORTED?

Related drug, device, biological or medical supplyIf payment is for education, marketing or researchName under which product is marketed

Form and nature of payment

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FORM OF PAYMENT

Categories Cash or cash equivalent In-kind items or services Stock, stock option or other ownership

interest, dividend, profit or other return on investment

Any other form of payment or other transfer of value

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NATURE OF PAYMENT

Categories Consulting Fees Compensation for services other

than consulting Honoraria Gift Entertainment Food and beverage Travel and lodging

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NATURE OF PAYMENT

Categories continued Education Research Charitable contribution Royalty or license Current or prospective ownership or

investment interest

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NATURE OF PAYMENT

Categories continued Compensation for serving as faculty or

as a speaker for an unaccredited and non-certified continuing education program.

Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program

Grant Space rental or facility fees (primarily

teaching hospitals)29

WHEN MANUFACTURERS REPORT

Calendar year – and due by March 31of the following year First year only - payments made between

August 1 and December 31, 2013 needed to be reported by March 31, 2014

Information should be publicly available by June 30 Year 1 Only - September 30, 2014

Physicians have NO reporting requirements!

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Specifics Related to Certain Payments

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CHARITABLE CONTRIBUTIONS

Paid directly to charity, not for services provided Example: Donation to a non-profit hospital

Payments for physician services, redirected by the physician to a charity, are NOT charitable contributions. The nature of the payment would not change. Example: Payments for consulting services redirected

to a charity are reported as consulting.

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FOOD AND BEVERAGE

Group setting – divide the value of the meal by the number of participants; report if the per person cost exceeds $10 threshold Includes non-physicians Excludes physicians who don’t eat/drink

Meals dropped off – reported If don’t want meals will need to make it clear to

manufacturer

Conferences –not included if it’s impossible to determine who partook Example: buffet meal, coffee, snacks

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MEAL CALCULATION EXAMPLES

Example 1: Educational Dinner Cost: $3,000 Participants: 50 (30 physicians, 20 non-physicians) Cost per Participant: $60 – reportable for 30

physicians

Example 2: Educational Dinner Cost: $3,000 Participants: 350 (200 physicians, 150 non-

physicians) Cost per participant: $8.57 – not reportable

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COMPENSATION FOR MEDICAL EDUCATIONFACULTY OR SPEAKER

Accredited and certified continuing education payments Nature of Payment: Compensation for serving as

faculty or as a speaker for an accredited or certified continuing education event. Excludes subsidies (reduced tuition) by CME (non-

manufacturer) organizer

All other compensation as a speaker or faculty Nature of Payment: Compensation for serving as a

faculty or as a speaker for an unaccredited and non-certified education event

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ENTERTAINMENT & GIFTS

EntertainmentAttendance at Recreational Cultural Sporting Other events

GiftsItems that don’t fit into another category Does not include

tickets to events – that’s entertainment –even if the ticket was a gift

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RESEARCH

Definition *: “a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social sciences research. This term encompasses basic and applied research and product development.” Includes

Pre-clinical research and FDA Phases I-IV research Investigator-initiated investigations Written agreement OR contract OR protocol

If payments don’t meet above requirements –then report under a different category

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EXCLUSIONS – NOT REPORTED

Existing personal relationshipsPayments or transfers of value less

than $10 Unless total annual value exceeds $100 Threshold will increase annually based

on CPI Small incidental items under $10

provided at conferences – don’t need to be tracked

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EXCLUSIONSEducational materials that directly

benefit patients or are intended for patient use Examples: anatomical parts to use for patient

education, brochures, flash drives with data Textbooks to physicians are reportable. Must be educational –not marketing or promotional

Discounts and rebatesSamples for use by patients

Includes drugs, supplies, devices Items or coupons for items Physician and manufacturer agree, in writing, the

products will be provided to the patient39

EXCLUSIONS

In-kind items for the provision of charity care Items provided for patients who cannot pay;

there’s no expectation of payment If item is given to all patients, including those

who can pay, it is reportable Physician and manufacturer agree, in writing,

that items will be used only for charity care

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EXCLUSIONS

Short term loans of devices, multiple and single use, and related supplies Loan of no more than 90 days for the entire year

Consecutive days or sporadically

More than 90 days – excess is reportable

Items and services provided under a contractual warranty, contractual maintenance agreement, or product recall

Physician participating as a subject (patient) in a research study

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EXCLUSIONS

Provision of healthcare to employees Includes employees and their families

Manufacturer has on-site healthcare

Physicians involved in civil or criminal action or administrative proceedings for a manufacturer

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EXCLUSIONS

Indirect payments – manufacturer makes payment to third party; third party makes payment to physician. Manufacturer does not direct the payment or know

identity of the recipient – use is unrestricted Example 1: manufacturer pays consulting firm;

consulting firm employs and pays physician Example 2 (reportable): physician requests payment

to go to a third party – third party provides payment to physician – payment is reported under recipient’s name

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INDIRECT PAYMENTS

Example 3 (reportable/not reportable): manufacturer gives funds to a professional organization to specifically award grants to physicians (use is restricted).Excluded – manufacturer doesn’t know name of

recipient by June 30 of next calendar yearReported – manufacturer learns name of recipient

before second quarter of following yearReported – manufacturer directs organization to

provide grants to top X physicians – manufacturer may not know names but should be able to determine

Incumbent on third parties to track payments and report back to manufacturers

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INDIRECT PAYMENTS FOR CME Payments made to a third party are not reported

if all the following are met:Program meets accreditation/certification standards of

ACCMA, AOA, AMA, AAFP or ADA CERP

Manufacturer doesn’t direct selection of speaker in any way (including suggesting list of speakers)

Manufacturer doesn’t directly pay the physician/speaker

Example: vendor makes payment to AMA to compensate speakers at an accredited conference Suggests possible speakers – reportable No involvement with speaker selection – not reportable

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REPORTING: MANUFACTURERS

AND GPOS

May voluntarily provide physicians with data before submitting it to CMS

Required to be electronically submitted to CMS by the 90th day of each calendar year March 31 for the previous calendar year

Transactions are reported at the individual payment, transfer of value, ownership or investment interest level

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DISCUSSION

Types of payments received?

Checked data before it became public? Any surprises? Frustrations?

What payment records kept? Open Payments App?

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DATA REVIEW

Period of at least 45 days View own data only – 2 years System was down a fair amount of time

this year – because of corrupt data (physician was able to see different physician’s data – same name)

Review period extended to September 10, 2014*

* CMS extended the review period August 28, 2014

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DATA REVIEW

CMS will announce the review and correction period – with specific review instructions - via: Email list serves Online postings: CMS website and Federal

Register Directly, likely by email, to CMS registered

physiciansCMS registration isn’t required but

physician must be registered to review data

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DATA REVIEW

Register on CMS’ and Open Payments’ websites Both Apple and Google have apps to track your

payments!

Additional 15 days after 45 day review period to correct data Earlier the dispute identified more likely it is to be

corrected

Available data - all data submitted Payments or other transfers of value Ownership or investment interest

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AGREE? DISAGREE?

Physician is responsible for reviewing and initiating any dispute Done electronically Detail the disputeInclude proposed resolution

System flags transaction and notifies manufacturer

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RESOLUTIONS AFTER 15 DAY

REVIEW PERIOD

If not resolved it’s marked disputed Manufacturer’s data are published Transactions are available throughout

the year to review or disputeResolutions reflected on public website after next data update (not after resolution)

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PAYMENTS PUBLICALLYAVAILABLE

First Year: September 30, 2014 Data from August 1 – December 31,

2014

Future Years: June 30 Data from previous January 1 –

December 31

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DATA ELEMENTS – PAYMENTSSEARCHABLE & DOWNLOADABLE *

Manufacturer’s name Covered recipient’s

(physician’s) Name Specialty Practice location

Amount of payment Date of payment Form of payment Nature of payment

Name of related drugs, devices, biologicals or medical supplies

NDCs of related drugs or biologicals

Name of entity that received the payment if not the physician

Statement of additional context - optional

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DATA ELEMENTS – RESEARCHSEARCHABLE & DOWNLOADABLE

Name of entity receiving payment

Total amount of research payment

Name of study Name of related

covered drugs, biologicals, devices or medical supplies

NCDs of related covered drugs and biologicals

Principal investigator Name Specialty Primary address

Context of research ClinicalTrials.gov

identifier (optional)

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DATA ELEMENTS –OWNERSHIP & INVESTMENT INTERESTSEARCHABLE & DOWNLOADABLE

Manufacturer’s name Covered recipient’s

(physician’s) Name, specialty, location

Ownership/investment interest by physician or family

Dollar amount invested Value and terms of each

ownership/investment interest

Any payment provided to physician Amount, date, form, nature Names of covered DBDM

NCD of drugs/biologicals Name of entity that

received payment –if not physician

Voluntary statement of context

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GOING FORWARD –PLANNING FOR 2015Keep documentation; get the app

Calendars Meals, entertainment, events, gifts

Copies of payments Copies of program agendas Receipts for reimbursed travel Entertainment ticket stubs

Return unwanted items Keep return mailing receipts Save emails requesting no gifts 57

GOING FORWARD

Register to review data!!

Dispute items as soon as identified.

Notify patients in advance Letter Brochure Website

Determine how you’ll answer questions

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DISCUSSION

Did you understand what would/would not be reported?

Have you looked at your public data? Any surprises?

Do you routinely disclose relationship interests to patients? How?

Have you gotten any questions from patients? Or anyone?

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Questions? Comments? Thoughts?

Before CMS Screen Shots

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SPEAKER INFORMATION

Jodie R. CaplanCarilion ClinicRoanoke, VA

540-224-5755jrcaplan@carilionclinic.org

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Registration & Open Payments Review Screen Shots

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Start here – set up user id and password

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Access to Open Payments

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Publicly Available Datahttp://www.cms.gov/openpayments/index.html

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The End

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