Proposed Changes in MU’s Attestation Periods: Will They Drive Meaningful Change?

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By Michael Burger, Senior Consultant

How do you spell relief? The Centers for Medicare and Medicaid Services (CMS) apparently hopes that proposed changes in Meaningful Use (MU) attestation periods will give providers some of the breaks they have been seeking and drive up plummeting physician attestation rates.  Is this too little, too late, or will it drive meaningful change?

CMS recently announced it is considering several proposals to help providers garner MU incentive payments and avoid Medicare payment penalties. The proposals suggest that CMS is trying to address providers’ concerns that the 2014 criteria were basically unreachable and unworkable, not to mention the perception that MU itself is too unwieldy and burdensome.  

There are three suggested changes on the table:

  • Realignment of hospital reporting periods for MU stage 2 electronic health record (EHR) use to the calendar year. 
  • Modification of other aspects of the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens.
  • Shorten the reporting period for ambulatory physician use of stage 2-certified EHRs in 2015 to 90 days, down from 365 days.

If adopted, what, if anything, will these changes accomplish?

Hospitals. The new calendar-year attestation period will help give eligible hospitals more time to install  2014 Edition software, incorporate it into their workflows, and get trained on how to use it. This obviously is helpful. However, the new attestation period is unlikely to drive significant changes in how hospitals purchase and use MU-certified EHRs.  That is because most hospitals have already made EHR- and MU-related decisions, and a change to the attestation period at this point isn’t likely to alter those decisions.

According to recently released CMS attestation data, 9 in 10 eligible hospitals had attested to MU use and were using MU-certified EHRs through December 2014.  Very few of those (10%) who had attested between 2011– 2013 dropped out of the MU program. CMS believes that some 4,000 hospitals are scheduled to attest to Meaningful Use Stage 2 in FY 2015 and of those, the vast majority were using 2014 certified technology in FY 2014.

While there is always room for improvement, hospitals seem to be pretty much set for MU adoption and use in 2015.

Ambulatory physicians.  Ambulatory physicians are a whole different story. About three-quarters of eligible professionals (EPs) were unable to attest for 2014. Moreover, roughly 257,000 professionals–about half of those eligible–will have their Medicare payments dinged in 2015 because they didn’t meet MU criteria.  CMS apparently is anticipating that the easy money of MU incentive payments for a year–based on only three months of usage–will draw noncompliant providers back into the fold. And once they start using their EHRs, CMS hopes they will learn to love them. But are those incentive payments enough to make a difference?

We believe they are not enough, because many physicians see the incentive payments as insufficient to cover new EHR or upgrades.  According to one calculation, individual physicians who start MU in 2014 may receive a maximum of $24,000 in cumulative payments through 2016–with $12,000 in 2014, $8,000 in 2015 and $4,000 in 2016. This isn’t enough to cover the acquisition of an EHR, not to mention implementation and training. Such low numbers can be a shock to many physicians, who are disappointed in the small return on what they viewed as semi-heroic efforts to qualify for stage 1. It is such a turnoff that many are concluding that the juice is not worth the squeeze for continued MU participation.

If this paltry carrot isn’t enough to change behavior, neither is the “stick” of payment penalties. CMS estimates that more than half of those facing penalties (142,000 EPs) will see a payment adjustment of between $1 and $1,000. Consider the situation of a three-physician practice with $1.425 million total annual revenue and a 20% Medicare payer mix.  Each physician would earn $95,000 annually for Medicare patients.  A 1% reduction for not meeting MU requirements would translate into a $950 annual penalty per physician, or roughly $4/day.

This isn’t enough of a financial impact to drive a meaningful number of noncompliant docs back to the MU path. Even doubling the financial penalty for noncompliance next year to 2% doesn’t seem like much of a threat in real numbers to many doctors. They are willing to absorb the loss rather than continue in the MU program. Many simply are concluding that the efficiency gained by not focusing on MU-required record-keeping will more than offset the penalties.

Market forces outside of MU also might be impacting attestation numbers. Because many physician practices are being acquired, they are deferring major purchases like EHR upgrades in an effort to keep their balance sheet polished to look good to prospective buyers. 

Finally, the new attestation window may not be long enough for recalcitrant providers to learn to love their EHRs. If doctors need only use their EHRS for three months to qualify for MU attestation, they don’t have sufficient time to be trained and to become proficient enough to integrate new processes into their workflows.

The bottom line.  We applaud CMS for listening to its provider customers and continuing to make improvements to the MU program.  MU’s parameters were set forth in legislation. This didn’t leave CMS much wiggle room on the regulatory side to make implementation improvements. They are playing the hand they’ve been dealt, which, unfortunately, may not be good enough to drive provider behavior toward MU’s requirements. 

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DERF-a-Palooza at NCPDP

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By Michael Burger, Senior Consultant

The February meeting of the National Council for Prescription Drug Programs (NCPDP) ePrescribing and Related Transactions Workgroup 11 will be a real DERF-a-Palooza, with some 26 potential changes to the NCPDP SCRIPT standard offered up for discussion and action.“DERF” is the quirky acronym for a Data Element Request Form – which is the process to propose and approve modifications to the SCRIPT standard used for ePrescribing.   

DERF-a-Palooza came about because of the industry’s desire to get their proposed changes nailed down and approved so they could be incorporated into the next round of Medicare Part D standards adoption. (See the timeline below). An irregular update schedule by standards development organizations (SDOs) has long been a pain point for many government regulators, not just the Centers for Medicare and Medicaid Services (CMS), which runs the Medicare program.  As a result, regulations often were out of sync with the latest version of a standard.

NCPDP listened and the February meeting of Workgroup 11 represents a first step to bring regularity to the process.Kudos to NCPDP for taking the initiative and making this happen.  While the timing may not get all of desired changes into the DERF queue in time for this release, this should be a temporary situation as the idea of a schedule irons itself out.We expect that other SDOs will follow suit.  After all, it’s in everyone’s best interests to have the most up-to-date standards available for timely adoption by Medicare and other programs.

Stay tuned to this space for a summary of the meeting.

DERF

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Biosimilar Recommendation Means Challenges and Opportunities Ahead for HealthIT

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By Tony Schueth, CEO & Managing Partner

Biosimilars now are set to hit the US market with the recent recommendation that the government approve Novartis’s Zarxio cancer drug as a biosimilar alternative to Amgen’s Neupogen. This sets the stage for profound changes in US healthcare, with opportunities and challenges in the world of health information technology (healthIT).

Unlike generic medicines where the active ingredients are identical, biosimilars are similar to but not identical copies of the originator biologic. Biologics made by different manufacturers differ from the original product and from each other.

Biosimilars had no pathway for approval by the Food and Drug Administration (FDA) until 2010, when the Biologics Price Competition and Innovation Act of 2009 was enacted as part of the Patient Protection and Affordable Care Act. The FDA has been under fire because no approvals have been forthcoming. Now the door has been opened and we can expect to see biosimilars coming onstream in a big way in the near future. (For a more detailed primer on biosimilars, see our article in the December 2014 issue of HIT Perspectives.) 

The introduction of biosimilars will create numerous challenges and opportunities for healthIT. We will be discussing them in future issues of HIT Perspectives.But just to whet your appetite, consider the following examples:

  • Adding NDC and lot number to the drug ecosystem.  The Drug Quality and Security Act (DQSA) of 2013—aka the track and trace legislation–calls for adding NDC codes and lot numbers to the drug ordering, prescribing and dispensing processes. The idea is to have this information available to the prescriber to make it easier to identify and trace a particular batch of medications back through the chain in cases of possible adverse drug events (ADEs)—a major issue when it comes to biosimilars. That is easier said than done.For example, the NDC number in NCPDP transactions may be populated with a ‘representative’—not an actual—number.The field for lot number is not universally populated throughout the drug supply chain ecosystem. It is optional for NCPDP’s RxFill, which currently is rarely used but could help facilitate the tracking of ADEs with some modifications.
  • Standards.  The introduction of biosimilars adds new uses of standards and creates new roles for others. For example, a variety of standards already exist for the capture and transport of prescription drug information, including the National Council for Prescription Drug Programs (NCPDP) SCRIPT and the Health Level Seven (HL7) Clinical Document Architecture (CDA). GS1—like CDA—is a broader format that represents information from other sources generally for inclusion in a bar code. GS-1 also can standardize and combine NDC and lot number into a single representation. There also are standards for drug and ingredient identification, which currently are used by different stakeholders in different ways for different use cases.  Which standards will be selected for specific use cases? How will that be decided? By whom?
  • Changes to electronic health records (EHRs).  EHRs are now central to the patient care and prescribing process. However, as currently configured and used, enhancements are needed to enable EHRs to capture and retain NDC and Lot number, as well as to document ADEs and report that information electronically to the FDA and others. EHR vendors will need to adapt to evolving standards related to the adoption and tracking of biosimilars as use cases are developed. To add to the complexity, use cases must be in sync with future regulatory guidance by the FDA, which has not been an active player in the EHR and healthIT spaces to date. 

Needless to say, the healthIT competitive and regulatory landscapes for biosimilars are complex and rapidly evolving.Point-of-Care Partners (POCP) is tracking developments in biosimilars because of our expertise in electronic medication management, EHRs and electronic prescribing, as well as our expertise in identifying and addressing emerging issues in those areas. POCP’s expertise can help stakeholders such as pharmacies, PBMs, pharmaceutical manufacturers and EHR vendors understand how the entrance of biosimilars will impact their business and healthIT. Let us put our knowledge to work for you. 

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