Life Science Compliance Update

« Previous article | Home| Next article »

March 22, 2010

Physician Payment Sunshine Provisions: Patient Protection Affordable Care Act Passed the House

Congress
Tonight the House of Representatives passed the senate bill the Patient Protection Affordable Care Act and a Reconciliation package.  Within the Act is the Physician Payment Sunshine Provision  (pp 1542 – 1563).   

 Below is a summary of that provision:

Provision

Patient Protection Affordable Care Act – Passed House and Senate

Start Date for Recording

January 1, 2012

Start Date for Reporting

March 31, 2013

Publication of Reports

September 30, 2013 and June 30th in future years

Definition of Entity (Who Reports)

Applicable group purchasing organization’ means a group purchasing organization (as defined by the Secretary) that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.

The term ‘applicable manufacturer’ means a manufacturer of a covered drug, device, biological, or medical supply which is operating in the United States, or in a territory, possession, or commonwealth of the United States.

The term ‘manufacturer of a covered drug, device, biological, or medical supply’ means any entity which is engaged in the production, preparation, propagation, compounding, or conversion of a covered drug, device, biological, or medical supply (or any entity under common ownership with such entity which provides assistance or support to such entity with respect to the production, preparation, propagation, compounding, conversion, marketing, promotion, sale, or distribution of a covered drug, device, biological, or medical supply).

Report on self-referral

a requirement that the referring physician inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred from a person other than a person described in subparagraph (A)(i) and provide such individual with a written list of suppliers (as defined in section 1861(d)) who furnish such services in the area in which such individual resides.’’.

Form of Reporting

  • Electronic
  • Searchable
  • Easily Downloaded

Included in Disclosure

  • Name;
  • Business address;
  • Physician specialty; 
  • National provider identifier;
  • The value of the payment or transfer of value;
  • The name of the related drug, device, or supply, if available; to the level of specificity available;
  • A description of the form of payment;  
    • Cash or cash equivalent
    • In-kind items of services
  • Drug samples, the name, number, date, and dosage units of the sample.

Definition of Payment

  • Gift;
  • Food;
  • Entertainment;
  • Travel or trip;
  • Honoraria;
  • Research funding or grant;
  • Education;
  • Research;
  • Charitable Contribution;
  • Direct Compensation for Serving as Faculty or Speaker for Medical Education Program;
  • Consulting fees;
  • Ownership or investment interest;
  • Royalties;  
  • license fee;
  • speaking fees;
  • dividends;
  • profit distribution;
  • stock or stock option grant;
  • Any categories of information the secretary determines appropriate;

Covered Recipient

  • Physician; 
  • Teaching hospital;

Excluded from Reporting

A transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100.

  • Product Samples (separate provision)
  • Educational Materials
  • Loan of a device for short term trial period (90 Days)
  • Warranties
  • Received as a Patient
  • Discounts
  • In-Kind used for provisions of charity care
  • Dividends from stock ownership in publically traded companies
  • Self Insurance Payments from Manufacturer for Employees
  • Non Medical Professional Services
  • Legal Services

Product Development

Payments under a product development agreement must be reported for services furnished in connection with the development of a new drug, device, biological, or medical supply, and must also be reported with the following information:  

The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration; and

Payments made four calendar years after this date

Clinical Investigations

Confidential until either:

  • Date of FDA approval or clearance;
  • Payments made four calendar years after this date;

Penalties

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.

Third Party Payments

Reported if they are requested by or designated on behalf of a physician

Reports

  • Annual Reports to Congress
  • Annual Reports to States

Pre-emption

Pre-Empts State Laws that are similar or weaker than this provision

Does not pre-empt more restrictive laws (lower limits of payments, gift bans….)

Other Transparency Sections

In addition to payments from manufactures, there are several other transparency measures addressed law include:

Insurance Companies 

· To ensure transparency and accountability, health plans would be required to report the proportion of premium dollars that are spent on items other than medical care.

Hospitals

· Hospitals will be required to list standard charges for all services and Medicare DRGs.

Drug Samples

· Submit to the Secretary of HHS rather than make available (as the current law requires) data on drug samples including recipient, amount, theft and losses.

Nursing Homes

· Discloser of Ownership

· Staffing Data

· Results of State Facility Surveys

· Enforcement Actions

· Expenditures on Staffing Expenditures for Direct Patient Care


Imaging Services

For Imaging Services the referring physician must inform the individual at the time of the referral that:

· The individual may obtain the services from a person other than the referring physician; a physician who is a member of the same group practice as the referring physician; or an individual who is directly supervised by the physician or by another physician in the group practice.

· The individual must be provided with a written list of suppliers who furnish services in the area in which the individual resides.

Summary

Passage of this law will bring about a systemic shift in the health care industry, with government taking a larger roll in care of patients.    For CME,  grants will be reported if they are requested on behalf of a specific physician and/or are given to a teaching hospital.

  

Physician Payment Sunshine Provision

« Previous article | Home| Next article »

TrackBack

TrackBack URL for this entry:
http://www.typepad.com/services/trackback/6a00e5520572bb88340120a9613ec0970b

Listed below are links to weblogs that reference Physician Payment Sunshine Provisions: Patient Protection Affordable Care Act Passed the House:

Comments

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

More control I can't believe that the people whom we elect have the time or
even the peace of mind to put toghter a law that they cannot ever follow themselves...

The comments to this entry are closed.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
July 2015
Sun Mon Tue Wed Thu Fri Sat
1 2 3 4
5 6 7 8 9 10 11
12 13 14 15 16 17 18
19 20 21 22 23 24 25
26 27 28 29 30 31