Regulations

Article – MU No More…Meet MACRA, MIPS and APMs

dondennison Policy , , , , , , ,

The death of Meaningful Use (MU) will not be mourned by many physicians.

While the overall program drove adoption of electronic medical record (EMR) systems, which is necessary for information accessibility, the measures required to be reported upon were viewed by many as misguided and not a reflection of the actual practice of medicine.

Also, many of the EMR systems implemented were criticized as being hard to use with limited capabilities to allow information interoperability with other systems.

Regardless of one’s views of MU, CMS is moving on.

With a keen focus on patient outcomes, CMS is looking to new models for reimbursement, such as the Medicare Access and CHIP Reauthorization Act (MACRA) legislation, introduced last year.

CMS is also intent on addressing the lack of interoperable patient record information.

“We’re deadly serious about interoperability. Technology companies that look for ways to practice data blocking in opposition to new regulations will find that it will not be tolerated.”

Andy Slavitt, acting administrator of the Centers for Medicare & Medicaid Services

The MACRA site provides an overview of Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APMs), which are sure to be popular acronyms to fill the void created by the decline of the use of MU in discussions.

Here is another article on Slavitt’s comments. And another article by HIMSS.

My previous posts on healthcare payment reform are here, here and here.

ACR: CMS Delays Clinical Decision Support (CDS) Implementation Requirement

dondennison Policy , ,

ACR post (30-Oct-2015) is here.

Highlight…

…CMS states that they anticipate including further discussion and adopting policies regarding claims-based reporting requirements in the CY 2017 and CY 2018 rulemaking cycles. Therefore, they do not intend to require that ordering professionals meet this requirement by January 1, 2017

Meaningful Use Stage 3 Rule and Imaging

dondennison Policy , , , , ,

At 3 pm ET on March 20, 2015, CMS released the Meaningful Use Stage 3 proposed rule to “specify the meaningful use criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and Medicaid electronic health record (EHR) incentive payments and avoid downward payment adjustments under Medicare for Stage 3 of the EHR Incentive Programs.”

Here is a useful overview of MU Stage 3 (not just about imaging). And here is another MU Stage 3 overview. And here is an infographic.

A quick search for any mention of “imaging” (there are no instances of the word “images” in the 301 page PDF document; I checked), and here are the main excerpts.

Page 78

In alignment with the HHS National Quality Strategy goals, providers are encouraged to implement CDS related to quality measurement and improvement goals on the following areas:
…
Appropriateness of diagnostic orders or procedures such as labs, diagnostic imaging, genetic testing, pharmacogenetic and pharmacogenomic test result support or other diagnostic testing.

Page 81

Objective 4: Computerized Provider Order Entry
…
Proposed Objective: Use computerized provider order entry (CPOE) for medication, laboratory, and diagnostic imaging orders directly entered by any licensed healthcare professional, credentialed medical assistant, or a medical staff member credentialed to and performing the equivalent duties of a credentialed medical assistant; who can enter orders into the medical record per state, local, and professional guidelines.

Page 82

We propose to continue our policy from the Stage 2 final rule that the orders to be included in this objective are medication, laboratory, and radiology orders as such orders are commonly included in CPOE implementation and offer opportunity to maximize efficiencies for providers. However, for Stage 3, we are proposing to expand the objective to include diagnostic imaging, which is a broader category including other imaging tests such as ultrasound, magnetic resonance, and computed tomography in addition to traditional radiology. This change addresses the needs of specialists and allows for a wider variety of clinical orders relevant to particular specialists to be included for purposes of measurement.

Page 85

We also propose to maintain for Stage 3 the Stage 2 description of “radiologic services” as any imaging service that uses electronic product radiation (77 FR 53986). Even though we are proposing to expand the CPOE objective from radiology orders to all diagnostic imaging orders, this description would still apply for radiology services within the expanded objective.
…
Proposed Measures: An EP, eligible hospital or CAH must meet all three measures.

Proposed Measure 1: More than 80 percent of medication orders created by the EP or authorized providers of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using computerized provider order entry;

Proposed Measure 2: More than 60 percent of laboratory orders created by the EP or authorized providers of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using computerized provider order entry; and

Proposed Measure 3: More than 60 percent of diagnostic imaging orders created by the EP or authorized providers of the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period are recorded using computerized provider order entry.

Page 86

Based on our review of attestation data from Stages 1 and 2 demonstrating provider performance on the CPOE measures, we propose to increase the threshold for medication orders to 80 percent and to increase the threshold for diagnostic imaging orders and laboratory orders to 60 percent. Median performance for Stage 1 on medication orders is 95 percent for EPs and 93 percent for eligible hospitals and CAHs. Stage 2 median performance on laboratory and radiology orders is 80 percent and 83 percent for eligible hospitals and CAHs and 100 percent for EPs for both measures. We believe it is reasonable to expect the actual use of CPOE for medication orders to increase from 60 percent in Stage 2 to 80 percent in Stage 3 and the actual use of CPOE for diagnostic imaging and laboratory orders to increase from 30 percent in Stage 2 to 60 percent in Stage 3. We note that despite the expansion of the category for radiology orders to diagnostic imaging orders, we do not anticipate a negative impact on the ability of providers to meet the higher threshold as the adoption of the expanded functionality does not require additional workflow implementation and allows for inclusion of a wider range of orders already being captured by many providers. Therefore, for medication orders we propose the threshold at 80 percent and for diagnostic imaging and laboratory orders we propose the threshold at 60 percent for Stage 3.

Page 88

Proposed Measure 3

To calculate the percentage, CMS and ONC have worked together to define the following for this measure :

Denominator: Number of diagnostic imaging orders created by the EP or authorized providers in the eligible hospital’s or CAH’s inpatient or emergency department (POS 21 or 23) during the EHR reporting period.

Numerator: The number of orders in the denominator recorded using CPOE.
Threshold: The resulting percentage must be more than 60 percent in order for an EP, eligible hospital, or CAH to meet this measure.

Exclusion: Any EP who writes fewer than 100 diagnostic imaging orders during the EHR reporting period.

Page 221

A table lists the estimated time burden to attest for the CPOE rule (Measure 3 for Imaging), as 10 minutes for an EP and also 10 minutes for a hospital.

Revenue Revolution in Radiology

dondennison Financials , , , , , , , ,

I have been reading a lot recently about trends in healthcare and imaging around costs and revenues. There seems to be a perfect storm of changes in the market that will have a fundamental impact on diagnostic imaging service providers. I find this topic interesting because, unless you understand how the money is moving, you won’t understand why things are happening. Here is a summary of what I have discovered.

Medicare Reimbursement Cuts

This one is obvious. If you lower the amount of money paid for something, your revenues will go down (unless volume goes up proportionally). Here is an infographic from MITA on the cuts made since 2006.

Fewer Medical Imaging Exams being Ordered

Here is an article from MITA on the decline of the total number of CT exams being done in the U.S. Here is another one citing data published by the American College of Radiology (ACR). It states: “…physicians are calling for less, not more, imaging tests.” This shows a measurable reduction in the volume of exams performed in the U.S. And here is an article indicating a steady decrease in imaging studies being ordered for patients in the ED, following a steady increase up to 2007.

Image Sharing

The sharing of patients’ clinical records across facilities is a key part of Accountable Care, and is generally a good thing for patient care. So is sharing imaging records. With reliable options now available on the market, sites within a local referral area are rapidly launching or signing up to services to share images. The clinical benefits of comparing new imaging exams with priors are well understood, but this practice will often result in avoiding the need to perform a repeat exam. This benefits the patient (less radiation and anxiety and delay), and the operations of the receiving organization (less schedule disruption, less costs due to CD importation). The other impact, of course, is that the receiving organization loses some revenue from that avoided repeat exam. This will result in a reduction in volume of exams performed.

Adoption of Clinical Decision Support

Starting on January 1, 2017, imaging exams will require the use of Clinical Decision Support (CDS) to ensure that physicians are following Appropriate Use Criteria (AUC). In addition to clinical evidence, factors such as relative radiation level and cost of the exam are used to determine what is appropriate. All things being equal, the lower cost exam is likely to be recommended. The adoption of CDS may result in a reduction in volume of exams performed, or a recommendation to a lower cost (profit) exam.

Preauthorization Requirements

In some insurance plans, preauthorization is required before certain exam types can be ordered (even when CDS is used, in some cases). This may require a consultation with a radiologist or Radiology Benefits Management (RBM) company. Here is an article from 2011 on the use of preauthorization and CDS. The larger the burden on the ordering physician, the less likely they are to order the exam, which may result in a reduction in volume of exams performed, or a recommendation to a lower cost (profit) exam.

Patient Steerage

Last year, I did a blog post on an article on the trend of “patient steerage”. The original article is here. Essentially, patient steerage is when a payer incents a patient to use a provider that offers the imaging service at a lower cost. If a service provider is not price competitive, this will result in a reduction in volume of exams performed.

The Castlight Effect

This company received a lot of attention because of the size of its IPO, but it is also notable for what they actually do. As this article explains, they provide healthcare provider cost information for a range of healthcare services to employee health plans. The intent being that, given the choice, consumers will choose lower cost options. This is very likely to happen when the patient has a significant co-pay (e.g. 20%) and they will personally benefit from lower cost options. If a service provider is not price competitive, this will result in a reduction in volume of exams performed.

Wait, but what about Quality?

With all the talk about the shift of reimbursement from volume of procedures to quality or outcomes, I found this tweet on Castlight interesting… Castlight Tweet If we shift away from volume incentives/payment, reduce the prices paid (through policy or competition), but don’t recognize quality, the service of diagnostic imaging has been commoditized, and I don’t think that this will benefit patients, in the end.

Consolidation

I have heard a couple of opinions that believe that the strong trend of consolidation among healthcare providers will allow the largest of providers to dictate terms and pricing to payers. As it was explained to me, it works like this: The big, well-known healthcare provider, which has bought up many of the facilities in the area, tells the insurance payers, ‘If you don’t give me preferential pricing for my services, I won’t accept your insurance plan at my facilities’. If the healthcare provider is big enough and well respected, the insurance provider will have a tough time selling insurance plans to companies and individuals when the buyer learns that they can’t go to the big provider. This is called leverage. If this is true (and I think that it is), this will result in isolated areas of reimbursement stabilization or even increases. Here is an article talking about what the impact of provider consolidation means to private payers. It cites a steady increase in the number of physicians becoming employees of hospitals (vs. independent private practices)…

“…the number of doctors employed by hospitals increased to over 120,000 from 80,000 between 2003 and 2011. About 13 percent of all doctors are now employed directly by hospitals.”

A Necessary Change in Revenue Cycle Management Systems

Here is an article on the need for an overhaul of Revenue Cycle Management (RCM) systems in the U.S. It includes some stats on administration costs per transaction (compared to financial services transactions) and consolidation trends, as well as the value of analytics. Some excerpts…

“…the number of hospitals per integrated delivery system took a big jump last year from 6.4 to 7.1…”

“…the physicians who go into practice do not want to be entrepreneurs as much as they used to. When 52 or 53 percent of residents today become employees of integrated delivery systems, it tells you that the whole market has changed.”

Using Analytics to Maximize Revenues

Here is an article on using analytics and their reports to optimize financial operations.

So, what do you think?

P.S. Here is an interview that goes into the details of payer vs. provider, along with a case for more bundled payments. And here is a blog post that goes into more detail on bundled payments, including the shift from retrospective to prospective bundles.

P.P.S. Here is an article explaining the difference between charges and costs.

P.P.P.S. Here is a notice of rule changes proposed by CMS on the method by how physicians fees will be determined. “…we are updating our practice expense inputs for x-ray services to reflect that x-rays are currently done digitally rather than with analog film.”

P.P.P.P.S. Here is an article on a study on the disparity of costs for a Mammogram in the L.A. area. $60 to $254 for self-pay, with a bill of $694 to the insurance company for the same procedure elsewhere. 30% of Mammograms in the study were self-pay.

P.P.P.P.P.S Here is an article, with a nice infographic, on 5 common medical practice denials and remedies. Spoiler alert: Radiology made the Top 5 list of unexpected denials.

P.P.P.P.P.P.S Here is an infographic on the declining employment demand and income of Radiologists by a medical recruitment firm.

Article – Forecasting a New Reality for Radiology — An Investment Banker’s Thoughts on How Imaging Will Evolve

dondennison Radiology , , , ,

A lot has been written on consolidation of Radiology practices in the U.S.. This article in Radiology Today reiterates the economic and regulatory forces behind this trend, but also includes some points on the emotional aspects felt by those that built Radiology practices and are faced with selling.

One point not raised in the article is the operational efficiencies that can be found in IT consolidation. An effective IT organization using a modern image and management platform, backed with skilled staff can enable Radiologists to focus their efforts on quality of service delivery, and not on IT installation, configuration, upgrades, etc.

Article – New HIPAA rule could change BAA talks

dondennison Policy , , , , , , ,

As this article explains, the rules of accountability need to apply to all parts of the delivery chain, from the healthcare provider to the infrastructure vendor.

It is my experience that the readiness of the vendor to provide the necessary security controls (technical, policy, etc.) is usually not the issue. It is often the healthcare provider staff that lacks the knowledge of appropriate and effective controls that prevents proper security from being in place.

For example, even when proper single sign-on (SSO) methods are available in systems, rather than taking the time to implement this between systems (which often requires some learning), staff will often default back to wanting to simply pass a user ID and password (often a generic one) from one system to the next, because that was all they could do 10 years ago to avoid having the user log into multiple systems.

FDA and New Cybersecurity Regulations

dondennison Healthcare IT , , , ,

A friend forwarded this post to me.

Links worth checking out…

Here are my thoughts…

  • Frankly, security in healthcare devices ranges from embarrassing to terrifying—especially at the interface point between devices/systems. As more devices become network enabled, the level of risk is exponentially increased. Too often, software in medical devices are built by clinically focused developers, or hardware engineers tasked also with the software layer. Developing for security (and performance) is a specific skill set within software development, and it is not commonly found in the average developer. I have found that developers with experience in Web-based consumer applications (that manage personal data) and those with banking application experience generally “get it” more than others, but that’s just my experience. Also, product managers need to get a lot smarter about security and make it a priority in the product scope.
  • Regulations are brought in when industry fails to protect the public interest, and that is what is happening here. If the medical device industry was better at doing proper risk-based design and validation—which security and protection of data would certainly be an area of focus—and including risk mitigation controls in their designs, the FDA would not need to issue regulations. But, here we are. Now we get to see if government regulators can produce effective regulations, and keep pace with the ever-evolving security model best practices and methods.
  • Where the HIPAA Security and Privacy rule applies to the healthcare provider organization (that is, it is their responsibility), FDA regulations apply to the registered device manufacturer. Regulatory Affairs staff working for the vendor community are going to have to learn a lot more about cybersecurity. Most of the professionals in this field that I know, know very little about this topic. If you are a cybersecurity consultant that knows even a little about healthcare IT application design patterns and existing medical device regulations, this is a goldmine. Hmmm, maybe I will study this FDA stuff in more detail. 🙂

Article – FCC, FDA, ONC seek input on mHealth regs

dondennison Healthcare IT , , , , , , ,

I find the topic of this article interesting.

Here’s why…

  • We have had notebooks and netbooks on WiFi accessing Web-based and other types of applications deemed medical devices (e.g. PACS) for years. The essential difference between a tablet and a netbook is the keyboard. They pose the same risk as a client application platform.
  • If this is what regulators are worried about, wait til they get a load of the bigger billy goat coming across the bridge next …mobile apps are one thing, but what about a portal framework that aggregates patient data from distributed sources, in real-time? Imagine a screen where each discrete element of the patient record is managed in a different system. The values used to define and indicate normal and abnormal test results are from a public Web site. Where does the “medical device” start and end? Who is the “manufacturer” responsible if an issue arises? How do you manage the medical device labeling? With mobile, we are simply trying to figure out how to do what, in many cases, we do today, only now without a wire. …regulatory affairs folks are in for a world of change (or healthcare will fall ever farther behind the IT curve).

Articles on Mobile Health Applications and FDA Regulation

dondennison Healthcare IT , ,

Check these out…

Dear FDA: Qualcomm’s Robert Jarrin lists his wishes for FDA regulatory action

Where is the ‘fine line’ between safety and free rein for mobile development?

Some thoughts…

  • At risk of ending up on some government list of subversives, I question how often FDA (or equivalent agency in other countries) regulations actually result in protecting patients when they are applied to health IT products. Yes, good design, development, and validation practices are necessary for quality products. And, yes, health IT products are managing very important, not to mention legally protected, information that—when misused or when a defect affects its operation—can result in improper actions being taken …sometimes with adverse effects. But, for those that have worked for a registered medical device manufacturer, we spend more time with our eyes on paperwork than we should be. Time we could be spending on better design, or additional testing before launch. Too much of the paperwork is about evidence creation, and not about actual quality. Many process and method innovations developed in general IT product development are often difficult to adapt to the expected models in the FDA’s so called good manufacturing practices (GMP), and therefore do not achieve the same benefits/results.
  • If the U.S. government is generating revenue from the new medical device excise tax, is it possible that the FDA may be motivated to determine that more, not fewer, mobile apps are medical devices, and therefore subject to taxation? OK, I may have crossed the line into full-fledged conspiracy theory there. Sorry about that.