As providers are all too well aware, their payments from Medicare are affected by their score in the Merit-based Incentive Payment System (MIPS). MIPS imposes a number of requirements; if these are not met, payments may be reduced or denied.
The MIPS requirements apply to all Medicare claims, even those whose performance is not necessarily affected by a MIPS constraint. Among these universal requirements is the meaningful use of electronic health records (EHRs). Within the EHR requirements, we have the promotion of interoperability with other EHR systems, and within that, we have the security requirements. Among the security requirements is an annual security risk assessment.
In the Federal Register of July 27, 2018, the Centers for Medicare and Medicaid Services (CMS) proposes that the current security risk assessment requirement in MIPS be replaced. The suggested replacement will be an attestation to the activities included in the security risk assessment standard that has been performed in the past MIPS year.
This essentially switches the scoring of the security risk requirement from the equivalent of a numeric grade to a pass/fail scoring system. A practice or institution passes if it has done the assessment; how well it has done on the assessment falls by the wayside. The requirements are stated in a bare-bones fashion in the Code of Federal Regulations at 45 CFR 164.308.
CMS states that their rationale is, in part, a result of the realization that a risk assessment is done well, or not at all.
The thinking behind this can be found in the Office of Civil Rights (OCR) newsletter for April 2018. This newsletter distinguishes a gap analysis (“find the holes”) from a security risk assessment (“make sure there are no holes”). It is a highly useful guide to discerning the scope and the level of effort required for a serious risk assessment.
An article on the HHS website goes into greater detail explaining what is subject to the security rules and why:
All e-PHI created, received, maintained or transmitted by an organization is subject to the Security Rule. The Security Rule requires entities to evaluate risks and vulnerabilities in their environments and to implement reasonable and appropriate security measures to protect against reasonably anticipated threats or hazards to the security or integrity of e-PHI. Risk analysis is the first step in that process.
The guidance issues from OCR noted that the CFR requirements are divided into two categories: required and addressable.
The addressable requirements are not optional. Rather, if the approach specified in an addressable requirement is not feasible, the provider organization must develop an effective alternative to approach to achieve the same end and document this. The tendency to document-but-not-implement should be firmly resisted.
Experts suggest that OCR has significantly underestimated the time required to do a serious risk assessment. Obviously, you have to look at hardware-associated risks. Are the BIOS files in your desktops and laptops updated? Has router firmware been updated?
You must take a hard look at software-associated risks as well. Are operating systems patched? You must strategically assess administrative risks: are you enforcing complex password requirements? Are you using biometric identifiers? Is data access truly on a need-to-know basis?
The reader may protest that those concerns are nowhere to be found in the guidance. True. The point is that an adequate risk assessment will have revealed these as questions that need to be asked on a day-to-day operational basis. A risk assessment that is not dynamic misses all the critical points of vulnerability.
A risk assessment should point out any unnecessary risks and then offer a solid plan to eliminate them. It’s good to remember that the whole point of the endeavor is to make sure that the government (and all organizations) move toward the better Internet and network security. With cyber breaches occurring on almost a daily basis, there’s every need to be more cautious about how we handle, store, and transmit Big Data.
The current cost of a data breach has reached between $1.3 million and $3.5 million. The number one most sought-after data that hackers are vying for is healthcare information. On the Dark Web, 30,000 up-to-date healthcare records will fetch a pretty price.
Under this proposed rule change, you will no longer be given a percent of compliance score on your risk assessment. You will simply be in or out of compliance. The upside is less administrative hassle; all you have to do is carry out the activities and attest that you did this. The downside is that this may lead to a relaxation of vigilance at a time when threats are constantly increasing.
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