Introduction

The goal of the Physician Payments Sunshine Act (PPSA) is to increase the transparency of financial relationships between physicians and manufacturers of drugs, biologics, medical devices, or medical supplies. The Act requires manufacturers of these products to submit information to a publically accessible website about payments or other items valued at $10 or greater given to physicians. By increasing the transparency of physician-manufacturer relationships, the PPSA increases the public’s awareness of the possibility of bias in a physician’s prescribing patterns that may result from these relationships. But are physicians the only healthcare providers with prescribing authority who receive such payments or other items of value from manufacturers? And are they the only healthcare providers who are potentially influenced by these items?

Background

Physician Payments Sunshine Act

The PPSA was originally sponsored by Senators Chuck Grassley and Herbert Kohl in 2007. The content of the PPSA became incorporated as section 6002 (Transparency Reports and Reporting of Physician Ownership or Investment Interests) into the Patient Protection and Affordable Care Act, which was signed into law in March 2010. The Center for Medicare and Medicaid Services (CMS) is responsible for establishing the methods by which the PPSA provisions will be implemented. In December 2011, the CMS published a “Proposed Rule” outlining its implementation plans, but a “Final Rule” outlining the ultimate implementation plans has not yet been published. The exact content and dates for implementing the PPSA provisions are therefore not known. However, the CMS announced on its blog in May 2012 that it would not require manufacturers to start collecting information regarding payments to physicians before January 1, 2013, thus indicating that implementation of the Act will begin on this date, at the earliest.

Physician and non-physician healthcare providers

For the PPSA, a physician is defined as a medical doctor, doctor of osteopathy, dentist, podiatrist, optometrist, or chiropractor. Mid-level healthcare providers, such as nurse practitioners, physician assistants, or midwives are not included in the PPSA regulations. Nurse practitioners are registered nurses with additional training at the master’s or doctoral level, who function as primary care providers in many circumstances. Physician assistants are individuals with an average of 27 months of comprehensive medical training after at least two years of undergraduate university courses, who work under the supervision of a physician. Midwives are classified as certified nurse midwives, certified midwives, or certified professional midwives. Certified nurse midwives are registered nurses with a bachelor’s degree who receive training at the master’s or doctoral level in women’s healthcare issues from adolescence through menopause, plus the care of newborns. Certified midwives undergo similar training, but are not nurses. Certified professional midwives are not nurses, do not require a bachelor’s degree, and do not receive a degree during their training. Their training is limited to the care of pregnant women and newborns.

Issue

Should PPSA regulations apply to other healthcare providers in addition to physicians?

Rule

The PPSA regulations should apply to other healthcare providers in addition to physicians if the following conditions are met:

1. the non-physician healthcare providers are authorized to prescribe drugs, biologics, medical devices, or medical supplies,

2. the non-physician healthcare providers described are likely to receive payments or other items valued at $10 or greater from pharmaceutical companies or other manufacturers listed in the PPSA, and

3. the prescribing patterns of non-physician healthcare providers described are potentially influenced by receiving payments or other items from pharmaceutical companies or other manufacturers listed in the PPSA.

Analysis

Non-physician healthcare providers are authorized to prescribe drugs, biologics, medical devices, or medical supplies.

Physicians are not the only healthcare providers who prescribe drugs, biologics, devices, or medical supplies. Nurse practitioners, physician assistants, and certified nurse midwives are authorized to prescribe drugs in all 50 states, although several states place restrictions on their ability to prescribe controlled substances. Certified midwives are authorized to prescribe drugs only in the state of New York, whereas certified professional midwives are not authorized to prescribe drugs in any state.

Nurse practitioners and physician assistants are the largest groups of mid-level healthcare providers. In 2010, there were approximately 106,000 practicing nurse practitioners and 70,000 practicing physician assistants in the United States; together, the number of these healthcare providers was not far below the number of practicing primary care physicians (approximately 209,0000). It has been estimated that as a group, nurse practitioners in the United States write millions of prescriptions per year. Thus, certain healthcare providers in addition to physicians are authorized to prescribe drugs, biologics, medical devices, or medical supplies.

Non-physician healthcare providers who are authorized to prescribe drugs, biologics, medical devices, or medical supplies are likely to receive payments or other items valued at $10 or greater from pharmaceutical companies or other manufacturers listed in the PPSA.

A study by Elissa Ladd, PhD, RN, FNP-BC, and colleagues published in 2010 examined the interactions of 263 nurse practitioners with promotional activities by the pharmaceutical industry. The results indicated that 49% attended one to five pharmaceutical industry-sponsored lunches in the previous six months and 64% attended one to five pharmaceutical industry-sponsored dinners in the previous six months. Similarly, a study by Nancy Crigger, MA PhD FNP-C, and colleagues published in 2008 of 84 family nurse practitioners reported that 85% “sometimes,” “frequently,” or “always” accepted free office supplies and 77% accepted free equipment. The cost of these gifts was not mentioned, but it is likely that they exceeded $10 in most instances. Therefore, many nurse practitioners do appear to receive payments or other items valued at $10 or greater from pharmaceutical companies or other manufacturers covered under the PPSA. Although there are no similar studies examining the relationships between physician assistants or certified nurse midwives and manufacturers, it is reasonable to assume that these other mid-level healthcare providers are also likely to receive payments or other items valued at $10 or greater from pharmaceutical companies or other manufacturers listed in the PPSA.

The prescribing patterns of non-physician healthcare providers are potentially influenced by receiving payments or other items from pharmaceutical companies or other manufacturers listed in the PPSA.

In the Ladd study of 263 nurse practitioners discussed above, 48% of nurse practitioners admitted that they were more likely to prescribe a drug after attending an industry-sponsored lunch or dinner discussing the drug. By contrast, only 7% thought that gifts obtained from pharmaceutical industry sales representatives affected whether they prescribed the representatives’ drug. It can be questioned, however, whether the 93% of nurse practitioners who thought that gifts did not influence their prescribing patterns were correct. When discussing the results of the study of 84 nurse practitioners mentioned above, Dr. Crigger noted that the nurse practitioners exhibited a “low awareness of how marketing by pharmaceutical companies affects clinical decisions.” In the Crigger study, 48% of nurse practitioners thought that gifts influenced their prescribing patterns “rarely,” “sometimes,” or “frequently.” Thus, the prescribing patterns of nurse practitioners, and presumably other non-physician healthcare providers, are potentially influenced by receiving payments or other items from pharmaceutical companies or other manufacturers listed in the PPSA.

Conclusion

The PPSA regulations should be applicable to other healthcare providers who are authorized to prescribe drugs, biologics, medical devices, or medical supplies because they are likely to receive payments or other items valued at $10 or greater from pharmaceutical companies or other manufacturers listed in the PPSA, and the prescribing patterns of these non-physician healthcare providers are potentially influenced by receiving these payments or other items.

For more information about this issue, contact the Kulkarni Law Firm.