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February 13, 2013

Physician Payments Sunshine Act Final Rule: Quick Reference Guide

Sunrise 2
We posted several stories analyzing the various aspects of the Final Rule to implement the Physician Payments Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA).  In light of the significant complexity the rule presents to many stakeholders, we decided to provide a condensed chart or quick reference guide for readers to know many of the key details for reporting. 

                                                             42 CFR Part 403

   

Start Date for Collecting/Tracking

August 1, 2013

Must Report to CMS by

March 31, 2014 (aggregate data)

Publication of Reports

September 30, 2014 and June 30th in future years

Who Reports

Applicable Manufacturers & Applicable Group Purchasing Organizations (GPO) (click here for definitions and here for limitations on applicable manufacturer reporting) must report payments made to “covered recipients”

Covered Recipient

  • Physician; 
    • Includes doctors of medicine and osteopathy, dentists, podiatrists, optometrists, and chiropractors, who are legally authorized to practice by the State in which they practice
    • Applies regardless of whether physician enrolled in Medicare
    • Applies as long as physician has a current license to practice
    • Does not include medical residents
  • Teaching hospital;
    • CMS will publish a list of teaching hospitals annually

What is Reported?

  • Applicable manufacturer or GPO’s name;
  • Covered Recipient’s
    • Name (as listed in NPPES) including middle initial
    • Specialty (physician only)
    • Primary business street address (practice location)
    • National Provider Identifier (NPI) #
    • State Professional License Number(s)
  • Amount of payment or other transfer of value;
  • Date of payment or other transfer of value;
  • Form of payment or other transfer of value:
    • Cash or cash equivalent
    • In-kind items or services
    • Stock, stock option, or any other ownership interest
    • Dividend, profit or other return on investment
  • Nature of payment (see below and click here for more detail);
  • The name of the related drug, device, biological or supply:
    • National Drug Code (NDC) of related covered drug/biological, if any
    • For devices/med supply
      • name under which its marketed; or
      • therapeutic area or product category
    • “non-covered” product
    • “none”
    • combination
  • Eligibility for delayed publication (research payments)
  • Name of entity that received the payment or other transfer of value, if not provided to the covered recipient directly (indirect payments)
    • Payment to 3rd party at request of; or
    • Designated on behalf of covered recipient
  • Payments or transfers of value to physician owners or investors;
  • Statement providing additional context for the payment or other transfer of value (optional)

Nature of Payment

  • Consulting fee
  • Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program.
  • Honoraria;
  • Gift;
  • Food and beverage;
  • Entertainment;
  • Travel and lodging (including the specified destinations)
    • City, State, and Contry
  • Education;
  • Research (see here for more info and below for what to report)
  • Charitable Contribution;
  • Royalty or license;
  • Current or prospective ownership or investment interest;
  • 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 (teaching hospital only).
  • Ownership or investment interest;

Payments for Research

(i)    Name of the research institution, individual or entity receiving the payment or other transfer of value.

A.  If paid directly to a physician covered recipient, all of the following must be provided:

(1)  The physician's name as listed in the NPPES (if applicable).

(2)  National Provider Identifier.

(3)  State professional license number(s) (for at least one State where the physician maintains a license) and State(s) in which the license is held.

(4)  Specialty.

(5)  Primary business address of the physician(s).

B.  If paid directly to a teaching hospital covered recipient, list the name and primary business address of teaching hospital.

C. If paid to a non-covered recipient (such as a non-teaching hospital or clinic), list the name and primary business address of the entity.

(ii)  Total amount of the research payment, including all research-related costs for activities outlined in a written agreement, research protocol, or both.

(iii) Name of the research study.

(iv) Name(s) of any related covered drugs, devices, biologicals, or medical supplies (subject to the requirements specified in paragraph (c)(8) of this section) and for drugs and biologicals, the relevant National Drug Code(s), if any.

(v)  Information about each physician covered recipient principal investigator (if applicable) set forth in paragraph (f)(1)(i)(A) of this section.

(vi) Contextual information for research (optional).

(vii)  ClinicalTrials.gov identifier (optional).

Payments for Pre-Clinical Research

For pre-clinical studies, applicable manufacturers only have to report: (i)    Research entity name (as required in paragraph (f)(1)(i) of this section).

(ii)  Total amount of payment (as required in paragraph (f)(1)(ii) of this section).

(iii) Principal investigator(s) (as required in paragraph (f)(1)(v) of this section), including

  1. name
  2. NPI
  3. State professional license number(s)
  4. Specialty
  5. Business address

No requirement to report an “associated product, or study name.”

Special rules for payments or other transfers of value related to continuing education programs.

Payments or other transfers of value provided as compensation

for speaking at a continuing education program are not required to be reported, if all of the following conditions are met: 

i. The event at which the covered recipient is speaking meets the accreditation or certification requirements and standards for continuing education of one of the following: 

  1. The Accreditation Council for Continuing Medical Education (ACCME).
  2. The American Academy of Family Physicians.
  3. The American Dental Association's Continuing Education Recognition Program.
  4. The American Medical Association.
  5. The American Osteopathic Association. 

ii. The applicable manufacturer does not pay the covered recipient speaker directly. 

iii.The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program. 

Excluded from Reporting

  • Existing personal relationships
  • Payments or other transfers of value less than $10, except when the total annual value of payments or other transfers of value provided to a covered recipient exceeds $100.
  • Educational Materials that Directly Benefit Patients or are Intended For Patient Use
  • Discounts, including rebates
  • In-Kind items for the provision of charity care
  • Product samples (coupons and vouchers)
  • Short term loan of covered device (no more than 90 days)
  • Contractual warranty
  • Covered recipient acting as a patient
  • Provision of healthcare
  • Nonmedical professional
  • A dividend or other profit distribution from, or ownership or investment interest in, a publicly traded security or mutual fund
  • Civil or criminal action or administrative proceeding
  • Indirect Payments or Other Transfers of Value where applicable manufacturer is unaware of the identity of the covered recipient
  • Drug Samples

Penalties

(click here for more information)

A civil money penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported.  The total amount of civil money penalties will not exceed $150,000.  

Knowingly failing to submit payment information will result in a civil money penalty of not less than $10,000, but not more than $100,000, for each payment.  The penalty will not exceed $1,000,000. 

Combined, penalties may not exceed $1,150,000.

Reports

  • Annual Reports to Congress April 1, 2015
  • Annual Reports to States

Pre-emption

“State and local entities may require reporting of nonrequired of information for payments or other transfers of value reported to CMS, which are not required under Federal law.  This includes payment categories excluded by the Federal law, with the exception of those that do not meet the minimum dollar threshold ($10).  “States and localities may require reporting of payments or other transfers of value not required to be reported at all under the Federal law.  For example, they may require the reporting of payments to non-covered recipients or by non-applicable manufacturers. 

Links to Additional Policy & Medicine’s Stories on Final Sunshine Act Regulations 

Top 50 Things to Know About the Final Sunshine Act Regulations 

Final Sunshine Rule and Continuing Medical Education (CME)

Payments Related to Research and Delayed Publication 

Reporting Requirements 

45-Day Review Period and Penalties 

Cost and Regulatory Impact Analysis 

Nature of Payment Categories 

Final Sunshine Act Regulations: Definitions 

 

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Comments

Feed You can follow this conversation by subscribing to the comment feed for this post.

Drugs samples are excluded from the reporting requirement.

We receive sample medications from drug reps as part of our sampling program for patients. Do the medications received through the sampling program require reporting with a value?

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