The lazy, hazy days of summer 2014 masked a tumult of changes behind the scenes affecting the regulation of health care. As fall approaches, be on guard for a storm cloud ahead: a new level of scrutiny for health care providers is quickly approaching Have these programs resulted in too much bureaucracy? Let’s take a close look at what’s ahead.

The Sunshine Act—What is It?
The Physician Payment Sunshine Act aims to enhance patient safety by requiring disclosure of certain financial relationships between pharmaceutical manufacturers and health care providers. Most notably, the Act requires manufacturers of drugs, devices, and biological and medical supplies to track and report all financial relationships with physicians and teaching hospitals.  

Recent headlines would lead us to believe the Sunshine Act is a new development. Actually, it has been around for some time. Passed in 1976, it is one of the Freedom of Information Acts, designed to increase transparency of financial relationships between health care providers and pharmaceutical manufacturers, thereby ideally enhancing patient safety.1,2 Although originally introduced as an independent piece of legislation in 2007 by Senator Chuck Grassley (R-IO), the law in its current form was included in an amendment to the Patient Protection and Affordable Care Act. 

You may not yet be aware of many of the changes coming from the Sunshine Act. Pharmaceutical and medical device companies recently began tracking their interactions with physicians and reporting to the Centers for Medicaid and Medicare Services (CMS) any financial payments made; CMS will display all the information reported on its public database, planned to go live in September 2014.2 

Doctors can dispute 2013 data until Dec. 31, 2014 by logging onto and review/correct any reporting of personal financial transactions with industry. Unfortunately, it will not be corrected in the public database until 2015.1 Please review your postings. The website has had its problems, crashing on occasion. Sound familiar?

Meaningful Use/EHR Incentive Programs
Another area of potential for added scrutiny is CMS’s “meaningful use” program. As part of the American Recovery and Reinvestment Act of 2009, meaningful use is defined by CMS as “using electronic health records (EHR) technology for improved care coordination, to maintain privacy, engage patients, and improve quality, efficiency and reduce health care errors.”3 The objectives have evolved and are being rolled out in three separate stages: MU1—data capture and sharing; MU2—advance clinical processes; MU3—improved outcomes.3 

Our practice started MU2 upgrades this summer. Just when we were beginning to feel comfortable with MU1 EHR hierarchy, an added level of MU2 complexity has hit us hard.1 These additional measures assure a slower patient flow (we are asking many more questions), additional staff time and expense, more time at the computer and less time with the patient. One of our docs recently bemoaned that he spends 90% of his time on the computer and 10% examining his patients. Although the goal is to improve patient care, I’m not sure how the current circumstances will yield such an outcome. 

CMS will likely glean additional patient and practice information with a full range of potential ramifications and, yes, more scrutiny of our practices. Specifically, I expect the abundance of clinical data collected will lead CMS to wonder:

(1) Are we asking the “right” questions in their opinion, based on their goals?
(2) Exactly how much time are we spending with each patient?
(3) Does all the above justify the level of coding charged?

I suppose more scrutiny on all fronts is the new norm. I welcome closer scrutiny in areas where better patient care is the end result or when services are enhanced, but I do not enjoy the added level of surveillance that makes us feel like we are under the microscope, and determines how we should practice on a day-to-day basis. 

Stay tuned for the weather report on the Sunshine Act and MU2 as it unfolds in daily practice. Stormy or sunny—who knows?