The healthcare reform bill that passed the House on March 21 with a 219-212 majority aims to change not only healthcare delivery in the United States, but also the reporting requirements for payments between pharmaceutical and medical-device companies and physicians. Included in the healthcare reform bill, called the Patient Protection and Affordable Care Act, are Physician Payment Sunshine Provisions that would affect both pharmaceutical company meetings for healthcare providers and continuing medical education.
The provisions, which largely are based on language agreed to by the Senate Finance Committee after investigation by the offices of U.S. Sens. Chuck Grassley, R-Iowa, and Herb Kohl, D-Wis., say that, as of January 1, 2012, companies would be required to begin tracking the names of physicians they provide payments to, along with addresses, specialties, national provider identifiers, name of the drug or device involved, and whether the payment was cash or in-kind services. The pharma and medical device companies providing payments to HCPs would need to begin reporting this information on March 31, 2013. The reporting, which would have to be electronic, searchable, and easy to download, would be made public on September 30, 2013, and on June 30 in subsequent years.
The bill defines “payment” as including gifts, food, entertainment, travel, honoraria, research funding, education, consulting fees, and speaker fees for medical education programs, among other items. Payees would consist of physicians and teaching hospitals, as well as third parties that are “requested by or designated on behalf of a physician.” Anything valued at less than $10 would be exempted, unless the total paid to a physician in one year exceeds $100. The bill specifically exempts educational materials, samples, and other select items.
The Sunshine Provisions would kick in for states with weaker reporting laws, while states that have stricter reporting requirements in place—lower payment caps or gift bans—would not be affected by it.
Impact on CME
Thomas Sullivan, president and founder of Rockpointe Corp., a medical education company headquartered in Columbia, Md., said on his Policy and Medicine blog that, for CME, these provisions mean that “grants will be reported if they are requested on behalf of a specific physician and/or are given to a teaching hospital.”
However, Sullivan thinks the bill in general “is a good start. Overall, I think this is going to create a greater need for continuing medical education.” Specifically, he says, it will affect CME for physician assistants and nurse practitioners. Because some provisions of the bill, such as one that calls for an increase in reimbursement for Medicaid patients to the level of reimbursements given for Medicare patient care, will theoretically call for an increase in primary care. But because of the shortage of primary care physicians coming out of medical school and residency programs, there won’t be enough physicians available to provide that care in a reasonable time frame; PAs and NAs will likely be asked to increase their primary-care roles, which in turn will entail more continuing medical education, he says.
In addition, the increasing need for comparative effectiveness trials that determine which tests and courses of treatment provide the best results also should also necessitate more CME, says Sullivan—“How else would you let healthcare providers know the results of those trials?”
Provision’s Pharma Effects
On the pharma meetings side, “The inclusion of these provisions reflects the requirement for greater transparency over the pharma industry’spractices,” says Tijana Ignjatovic, strategic healthcare analyst at ‘independent market analyst, Datamonitor, which provides business data, analysis, and opinion to industries, including pharmaceutical and healthcare. However, says Ignjatovic, because several states already have legislation in place that requires disclosure of such relationships, “this aspect of reform legislation would not have a considerable impact on pharma beyond that which is already happening in the market.” As examples, Ignjatovic points out that Pfizer and Merck & Co. already have pledged to disclose their financial relationships with physicians in an attempt to boost industry transparency.
In addition, says Ignjatovic, while many companies are already reassessing their relationships with physicians and CME organizations, these provisions also would make financial relationships with other healthcare organizations, such as pharmacies and pharmacy-benefit managers, less desirable, too, because PBMs and health insurance plans are included among the organizations covered by the Sunshine provisions.
“We’re entering a new era of transparency,” says Kim Slocum, who is president of KDS Consulting LLC, a healthcare consulting firm in West Chester, Pa., “As a result, I think it will be incumbent on meeting planners to pay a lot more attention to the ‘how much did we spend on this doctor’ question. If it hasn’t happened already, I wouldn’t be at all surprised to see most major biopharmas get very serious about applications developed in their finance systems to track this sort of thing across all the potential touch points—sales/marketing, marketing research, clinical trials, etc. Someone in legal or regulatory functions is going to be tasked to get this answer.”
He adds that meeting planners should be proactive in finding out exactly who in their (or their client’s) organization is in charge of compliance, and they should be having a discussion now about what’s needed and what’s possible. “An ounce of prevention now will be worth many pounds of cure (and potential corporate embarrassment) down the road,” he says. “Early outreach means a chance to influence what gets counted and how. That can make all the difference between a system that’s ‘meeting friendly’ and one that isn’t.”
While a spokeswoman from the Pharmaceutical Research and Manufacturers of America declined to discuss specific provisions of the bill at this time, a statement released shortly after the bill’s passage indicated that the pharmaceutical and biotech advocacy organization generally was in favor of the bill’s passage, though it also said, “Our commitment to help pay for health care reform will require all of our companies to make some difficult choices moving forward—on top of already losing more than 150,000 jobs since 2007 because of the recession and other economic factors.”
The House also passed the Reconciliation Act of 2010 by a 220-to-211 vote, a package of amendments to the healthcare reform bill. That reconciliation package now goes to the Senate for a vote; the Patient Protection and Affordable Care Act will become law when President Obama signs it on March 23, regardless of the ultimate fate of the reconciliation package.