In July 2009, the U.S. House of Representatives released its health care reform bill (which revises the draft discussion released by the House on June 19, 2009). Significantly, the bill includes a new version of Federal Physician Payment Sunshine legislation that is stricter and more expansive than the version proposed earlier this year in the Senate.

This latest version of the House bill contains the following distinctions:

applies to distributors as well as manufacturers;

removes language that manufacturers and distributors report payments made "directly, indirectly, or through an agent, subsidiary, or other third party" to covered recipients.  Now, language narrowed to only apply to payments/transfers of value made by manufacturers and distributors;

requires conflict-of-interest disclosures for each hospital or other health care entity (not including a Medicare Advantage organization) that bills Medicare under part A or part B for each physician who, directly or indirectly, owns an interest in the entity; 

greatly expands the list of covered recipients for which payments and other transfers of value must be reported (including group purchasing organizations);

lowers the Senate’s $100 reporting threshold to $5;

includes delayed reporting requirements for product development agreements and clinical investigations (which mirrors the Senate version).  The original House draft discussion only had delayed reporting for product development agreements;

heightens confidentiality of product development agreements and clinical investigations;

expands definition of "clinical investigations" to include experiments involving materials derived from human subjects;

contains specific reporting requirements and confidentiality provisions for drug samples;

excludes discounts and rebates from reporting;

increases potential penalty limit on knowing failure to submit information to 0.1 % of total annual revenues (if that percentage is greater than $1,000,000); and

allows state Attorneys General to enforce the federal sunshine requirements.

Click here to download the House Health Care Reform Bill in its entirety (or scroll down to Title IV, Subtitle D to view the "sunshine" provision).  R-Squared will be monitoring Sunshine Act developments closely and will post periodic updates and alerts to the website.

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