If you don't mind criticism and can handle the pressure of constantly being between a rock and a hard place, you might be suitable for a career at the Centers for Medicare and Medicaid Services (CMS). Unlike those in the spotlight who have earned fame and adulation for their work, those at CMS are lightning rods for what many would call controversy, especially for those working in healthcare.
The point is that no matter what CMS seems to do, it’s constantly under fire, possibly for good reason, depending on your personal experience and perhaps even your political point of view. Organizations are constantly taking aim at the federal arm. Case in point: Thirteen healthcare organizations recently sent a letter to CMS urging, pleading with the Office of the National Coordinator for Health information Technology (ONC) to issue a proposed rule clarifying the meaning of information blocking and how enforcement will be applied.
Under the 21st Century Cures Act, signed in December, vendors and providers are prohibited from blocking information and face penalties of up to $1 million per violation for noncompliance. According to the letter, leaders from organizations including the American Academy of Family Physicians, the American Academy of Ophthalmology, athenahealth, DirectTrust, IBM, McKesson and Oracle, among others, “this business practice barrier to interoperability does not just thwart federal and private efforts to more fully share clinical information, it may pose significant risk to patient safety. Information blocking impedes provider access to the most current, accurate or complete information on their patients.”
These leaders point to the 21st Century Cures Act: “The law, if implemented correctly, can facilitate the sharing of information to both enhance personalized care, as well as strengthen the growing population health model of coordinated high-quality care.
They claim the best first step for the administration in implementing these provisions is to gain broad stakeholder input, making the recommendation HHS issue a proposed rule that answers the following important questions to provide clarity around the provision. In so doing, they want the ONC to clarify several points:
1. What is information blocking and what is not?
2. What constitutes “special effort” in eliminating blocking and promoting interoperability?
3. How ought "should have known" be defined?
4. How should patient access be measured?
5. How does the law interact with existing laws like HIPAA and medical malpractice?
Additionally, they want the ONC to enhance the proposed rule by addressing the following points:
1. What is standard vs. non-standard implementation?
2. What “reasonable” business practices do not constitute information blocking?
3. The statute institutes penalties on vendors up to $1 million per violation. How should "per violation" be defined?
4. How should active information blocking be differentiated from business conduct such as contract terms?
5. What constitutes a "complete record"?
6. How should the ONC Certification Program be updated to reflect the new requirements?
7. Should there be a mitigation pathway before claims are subjected to OIG investigation and penalties?
8. What data, outside of what is in law, should be collected from the public for reports of info blocking?
9. What flexibilities should be built into a system that can keep up with technology but is sufficiently specific?
10. What are unintended consequences that regulations should avoid?
11. Should there be a reporting mechanism for government information blocking?
12. What, if any, safe harbors will need to be instituted? How will you ensure that if instituted, they do not prevent the enforcement of information blocking prohibitions or deter the benefits of future technology to facilitate information exchange?
They want clarity and they, like many organizations in their situation, have taken their points to the public in an exercise in transparency. Touché.