The Opioid Crisis, PDMP, and Interoperability

Barbara Mullarky

Barbara Mullarky

Director, Product Management at SRS Health
Barbara has had a successful career in the healthcare industry, working for both vendors and healthcare provider organizations. She has held roles in sales, marketing, product management and professional services, working with EMR and department-focused solutions for the laboratory and imaging.

Prior to becoming the Director of Product Management at SRS, Barbara was with GE Healthcare (now GE Digital), where she held the positions of Senior Product Marketing Manager for Centricity imaging products, Product Marketing Manager and Customer Collaboration Leader for what is now Caradigm, and Upstream Marketing Manager for Centricity Laboratory. Barbara also worked at the University of Arizona Medical Center, where she managed a team that was responsible for implementing and maintaining 27 departmental IT solutions, the ambulatory EMR and the patient safety initiatives.

Originally from New Jersey, Barbara now lives with her husband in Tucson, AZ. She is a graduate of the West Virginia University College of Medicine and is a registered Medical Technologist. When not at work, she loves traveling, taking photographs, watching football and spending time with her two Brittanys.
Barbara Mullarky

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opioid-blog-image-1The National Crisis

The opioid epidemic makes the news at least once a day in my neck of the woods.  Patients, providers and the government talk about the problem and how they’re going to solve it. Drug companies advertise Naloxone as something that you should have on hand as a first response to an overdose, just like having an Epi-pen on-hand is recommended to respond to severe allergic reactions. One of the most talked about solutions for physicians and eligible provides is the PDMP or Prescription Drug Monitoring Program.

What is a PDMP?

A PDMP is a state run system that records data on prescriptions for Schedule II to V narcotics. Currently, 49 states plus the District of Columbia have implemented a PDMP. Missouri is the only state without a statewide PDMP. The contents of each can vary based on the laws of the state, but generally the database is populated by pharmacies when a prescription is dispensed and, in some cases, by the dispensing physician or insurance claims. There are some holes in the databases. In some cases, federally operated pharmacies such as those on military bases, are not required to submit data. In other cases, prescriptions paid for in cash are not submitted. And they only contain the data for prescriptions written in your state. For those of you who live in towns that border neighboring states, your patients may have their prescriptions filled in a different state than where you practice.

While not perfect, PDMPs are one of the best tools available today to help practitioners understand their patient’s drug history and the patient’s potential to be an abuser.  There are documented successes with PDMPs. New York mandated the use of PDMPs in 2013, and in that first year, doctor shopping decreased by 75%, the number of opioid doses dispensed decreased by 10%, and the number of prescriptions for buprenorphine, a drug used to treat opioid addiction, increased by 15%.[1] In 2012, Kentucky became the first state in the nation to pass legislation mandating comprehensive PDMP use. That legislation led to a 13% decline in opioids dispensed, a 25% decline in prescription opioid deaths, and an almost 90% increase in prescriptions for buprenorphine, a medication to treat opioid addiction.[2]

Making connectivity difficult

Today, 39 states require a provider to check the state’s PDMP before they write a prescription for an opioid. Since not all states use the same software (some are homegrown), the ability for EHR vendors to connect to these databases is not easy or simple.  Some states, like New York, are simply not ready for EHRs to connect. This makes your workflow and the workflow of your staff difficult.opioid-blog-image-2

Figure 1 Information current as of January 2019

Is Your Prescribing Workflow Optimized?

Working with our partners at DrFirst, SRS Health now provides a seamless workflow to allow providers to check the PDMP for 35 states. Three other states are in process. With just one click, the patient’s medication history is displayed and the date that the PDMP check was performed is recorded in your state’s database and made available within the EHR’s prescribing application.

Interstate checking of PDMPs is also available for 47 participating states so practices in border towns can see not only their state PDMP data but that in neighboring states as well. Practices just need to request access to other states at implementation. If access is available across states, it will be set up as part of the installation.opioid-blog-image-3

Figure 2 Connectivity as of November 2018

What else will help?

PDMPs are one of the tools available for clinicians to help fight the opioid crisis. Utilizing electronic prescribing for controlled substances is another tool. EPCS prevents prescriptions from being altered or copied and refilled multiple times.  Pharmacists tell stories about how a 30-day supply has become a 130-day supply.

MYTH: Not many pharmacies accept electronic prescriptions for controlled substances. FALSE

According to Surescripts, > 95% of pharmacies in the US are EPCS enabled[3],[4] while physician and provider adoption remains low, with only 31% of providers using EPCS. New York leads the nation with 93.8% of controlled substances prescribe electronically. North Dakota, Maine, South Dakota and Minnesota round out the top five with 57%, 41.2%, 37.3% and 34.2%.[5]

While only 5 states require EPCS (Arizona joined the ranks as of January 1), ePrescribing of opioids is coming. Six more states have passed laws that go into effect from January 1, 2020 through January 1, 2022. In October, 2018, the federal government passed the Opioid Response Act[6]. A portion of the act called the “Every Prescription Conveyed Securely (EPCS) Act will require electronic prescribing for patients covered by Medicare and Medicare Advantage plans of all Schedule II-V narcotics beginning January 1, 2021. Earlier in the year, retail giants Walmart and Sam’s Club announced that they will require EPCS for all controlled substances by 1/1/2020 – less than 12 months from now!

How can you prepare?

For SRS Health EHR users, the answer is simple. We’re ready so you can be ready too. With our new Rx application, powered by DrFirst, we deliver an integrated eRx, EPCS, PMDP access and mobile application that allows you to meet all the state and federal mandates and help improve patient care. Just contact your account manager to learn more.

For non-SRS Health EHR users, check with your EHR vendor to see what capabilities they offer. Contact us if you’d like to learn more, our team is ready to help.

Citations:

[1]  Shatterproof, et al. “Prescription Drug Monitoring Programs: Critical Elements of Effective State Legislation.” March 2016.

[2]  Shatterproof, et al. “Prescription Drug Monitoring Programs: Critical Elements of Effective State Legislation.” March 2016.

[3] Electronic Prescribing for Controlled Substances, Surescripts

[4] E-Prescribing Pharmacies

[5] E-prescribing up more than 500% since 2015. Health Information Technology, May 8, 2018

[6] Senate easily passes sweeping opioids legislation, Washington Post, October 3, 2018

Congress Authorizes Changes to MIPS

Lynn Scheps

Lynn Scheps

VP, Government Affairs & Consulting Services at SRS Health
Lynn Scheps is a leading resource on MACRA, MIPS, and Meaningful Use. She is the SRS liaison with government policy makers. Representing the voice of specialists and other high-performance physicians, she develops strategies to respond effectively to government initiatives.
Lynn Scheps

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mips-blogHow many times have you heard the expression, “It would take an act of Congress.”? Well, Congress has acted! Had this blog been posted just 2 weeks ago, the message would have been slightly different and a little more ominous in tone. I would have said—and you may have read articles elsewhere where I did—that the MIPS transition period is coming to an end, and providers should begin to prepare in earnest for 2019, when by law, the MIPS threshold would be much higher and the cost category would account for 30% of the MIPS score. These provisions in MACRA were not subject to CMS’ discretion; but apparently, Congress has been persuaded to extend CMS increased flexibility. As part of the Bipartisan Budget Act of 2018, Congress has pushed out the full implementation of MIPS from 2019 to 2022, effectively making 2019, 2020, and 2021 three additional transition years.

This means that:

  • There will still be winners and losers since budget neutrality remains a requirement; however, CMS is now not obligated to set the MIPS threshold at the mean (or median) of prior performance until 2022. Instead, the threshold will be gradually increased to that level over the intervening years, the good news being that it will not be as challenging to avoid a downward adjustment for a few more years. The consequence of this, however, is that the amount of money available to winners will continue to be less than the maximum provided for in the law, (i.e., 5% related to the 2018 performance year, 7% for 2019, and 9% from then on.)
  • The Cost category does not jump to 30% of the MIPS score in 2019. CMS can hold off on the increase until as late as 2022, with the flexibility to set the rate at between 10% and 30% each year until then and to make it 30% only when the Secretary is confident that the resource use, (i.e., cost), measures are ready for adoption. In addition, the bonus points for year-over-year improvement in this category have been eliminated.

Through these changes, Congress has relieved some of the immediate pressure for providers. However, this does not change the fact that it will become progressively harder to score well as providers gain experience, making MIPS increasingly competitive in the coming years:

  • The Quality and Cost categories will remain distinguishing factors among providers.
    • It will become progressively harder to score well in the Quality category. Benchmarks will be more aggressive as providers build experience. The 2018 benchmarks have been posted on the QPP website, and you can already see differences from the 2017 deciles for some measures.
    • Improving your comparative Cost position is not something you can do overnight; it takes time. So, it’s not too early to address this area more vigorously.
  • MIPS performance has implications beyond Medicare payment adjustments. Your reputation could be impacted as CMS makes more and more performance data publicly available on its Physician Compare website. Consider what you want patients, referring physicians, and payers to see about you when they are researching your practice.

So, don’t let down your guard. Take advantage of the additional transition years to secure your future success.

MIPS 2018 New Year Resolutions

Christine Schiff

Christine Schiff

Government Affairs Specialist at SRS Health
Christine has been with SRS for over 5 years, working in Government Affairs and serving as the HIPAA Privacy Officer. She is devoted to providing excellent customer service, and she translates this passion into the work she does to support government program compliance. She has an expert understanding of MU and PQRS and serves as a valuable client resource.

Prior to joining SRS, Christine worked at NYU for 11 years where she also obtained her Bachelor of Science in Healthcare Management.
Christine Schiff

Check out these top 5 tips for starting your 2018 MIPS reporting on the right foot!

  1. Focus on Quality! – 2018 new-years-resolution-mipsrequires full-year reporting. With quality being the highest valued category (50% of your MIPS score), now is the time to review your quality-reporting plan and make sure you are capturing all the necessary data to report successfully. Furthermore, this is the category where providers can really distinguish themselves. It is anticipated that ACI scores will generally be high due to MU experience, and that most providers will earn the full score in the Improvement Activities category.
  1. Understand Your Cost Position – In a change from the original proposal, the cost category will contribute up to 10% of your overall MIPS score. Look for CMS reports later in 2018 to help you understand how cost is assessed and consider ways to reduce the cost of care you provide.
  1. Plan your ACI Reporting Strategy – CMS is allowing the use of 2014-certified software in 2018. Here are your options:
    • Your EHR is 2014 Certified – report the 2017 Transitional Measure Set.
    • Your EHR is 2014 and 2015 Certified – report either 2017 Transitional Measure Set, the ACI Measure Set, or a combination of both.
    • Your EHR is 2015 Certified – report the ACI Measure Set.

Compare the two measure sets and evaluate which set will likely earn you higher performance scores.

  1. Pick Your Improvement Activities – CMS has included some additional Improvement Activities for 2018. Review the list and make sure you will be able to attest to completing them for at least 90 days in 2018.
  1. Strive for Better Performance – Improvement in the Quality (and Cost) category for 2018 over last year will earn you bonus points this year. Review your CQMs and readjust workflows as necessary to support higher performance.

 

 

Why an EHR Solution Is a Must-Have for 2018

Diane Beatini

Diane Beatini

Vice President, Sales at SRS Health
Diane Beatini is the Vice President of Sales. She oversees the Sales, Account Management, and Sales Operations teams. She works to promote the complete SRS product suite of HCIT solutions to medical practices of varied sizes and specialties. Diane’s background includes an MBA in marketing and finance with 15 years of executive sales and customer service management experience in the radiology, medical device, and pharmaceutical industries.
Diane Beatini

Looking back at 2017 as we head into 2018, the resounding theme in healthcare has been the push to bring down costs and drive up quality by increasing efficiency and improving care coordination. As the healthcare landscape shifts and evolves with groundbreaking alliances such as the proposed CVS Health/Aetna partnership, it is interesting to note that the percentage of office-based physicians using an EMR/EHR solution is a significant 86.9%, with only a small percentage of medical practices still using traditional paper charts. (Health IT Dashboard)

Reasons cited by physicians for remaining on paper include failed implementations, fear of a loss in productivity, and security concerns. While these are valid concerns, practicing medicine using traditional paper charts is becoming increasingly difficult as the industry moves to a value-based payment model, with more emphasis placed on patient engagement, interoperability, and shared patient data.

Typically, physicians spend 30–40 hours per week interacting with their patients. In a paper-based office, each patient visit results in approximately 10–13 pieces of paperwork, detracting from the time spent on patient care. (Benefits of Modern EMR vs. Paper Medical Records) Even if the physicians themselves do not handle the paper, their staff must, and a paper-driven staff results in an unproductive office. Since paper charts can only be in one location, clinical and administrative staff spend valuable time locating and providing charts. When there are multiple office locations, the additional chart transport compounds the problem and the practice becomes even more unproductive. Most practice administrators estimate the cost of a chart pull at $5.00 in lost productivity. Multiplied across hundreds and thousands of active charts, the numbers become staggering.

To remain competitive in the ever-changing healthcare environment and to attract patients and physician recruits, an EHR solution is a must-have for 2018 and beyond. As the penalties increase and reimbursements decline year by year, EHRs play a critical role in helping to preserve and drive revenue and reduce costs. Significant benefits of adopting an EHR include:

  • Reduced Administrative Burden An EHR can eliminate redundancies in documentation, provide fast and accurate record transmission, and drive efficiencies throughout the clinic, inclusive of patient intake. This can be accomplished while mimicking the traditional paper chart, which allows for an easy transition from paper to an electronic system.
  • Heightened Cost Efficiencies – An EHR can drive productivity, saving physicians and clinical staff valuable time and reducing the need and/or cost of transcription services, chart rooms, and record clerks. Regulatory resources through a reputable HCIT partner can assist the practice in penalty avoidance and meeting the requirements for MACRA/MIPS.
  • Patient Referrals/Community Presence – A 2006 Harris Interactive Poll reported 55% of adults believed that the use of EHRs would reduce the number of medical errors, and 60% believed the use of EHRs would lower their healthcare costs. (Benefits of Modern EMR vs. Paper Medical Records). Since that time, patients have come to expect electronic access and communication with their providers through the use of a patient portal. In addition to medical records access, secured messaging, and appointment and refill requests, an integrated patient portal embedded in the EHR allows patient-entered information and demographics to automatically populate the chart and the note, saving critical time and expense.
  • Patient Safety – EHRs improve patient safety by providing an organized, all-inclusive electronic chart that houses reminders, messages, and alerts in addition to exam notes, diagnostic images, and medical, medication, and allergy history. Each chart is readily accessible from any office location as well as remotely so providers have the complete information when responding to messages from inside or outside the office.

So why do some practices continue to hold out? The most common reason cited for not making the transition is the inability to obtain a physician consensus—there are differing opinions as to the best EHR, and even as to the best approach, including how much or little interaction they want with the solution, and the degree of elimination of paper from the practice.

Successful adoption of a solution, therefore, can be ensured by working with a vendor who can tailor the implementation to the needs of the practice and its providers, addressing individual physician workflow preferences and providing flexibility and ease of use. Further, practices can ensure that the solution will support their preferred clinical workflows by choosing an established and recognized EHR partner with proven experience in their medical specialty. The right partner will also be able to provide testimonials and client references documenting its ability to implement, train, and transition practices from paper charts without any impact on either patient volume or productivity. Is your practice still on paper and if so, what’s holding you back?

2018 MACRA (MIPS) Proposed Rule: The Abridged Version

Lynn Scheps

Lynn Scheps

VP, Government Affairs & Consulting Services at SRS Health
Lynn Scheps is a leading resource on MACRA, MIPS, and Meaningful Use. She is the SRS liaison with government policy makers. Representing the voice of specialists and other high-performance physicians, she develops strategies to respond effectively to government initiatives.
Lynn Scheps

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lynns-notesThe proposed rule is here, and it’s another long one! So for those who don’t have the patience (or the time) to read through the 1,000+ pages, here are some highlights from what CMS is suggesting for the second year of MIPS. Bear in mind that these are proposals; they must be confirmed in the Final Rule, which will be released by November. (What had already been set in stone within the MACRA legislation itself is the maximum penalty and related incentive: 5% in 2020 based on performance in 2018, up from 4% in 2019 based on performance in 2017.)

  • CMS would allow clinicians to use either 2014- or 2015-Certified EHR technology to report for 2018. Acknowledging the slower-than-anticipated pace at which EHRs are achieving the next required certification, this accommodation will facilitate more successful, non-rushed upgrades and provide sufficient time for training on the new capabilities and associated requirements. To encourage the move to 2015 CEHRT, 10 ACI bonus points would be awarded for its exclusive use. (Finalized as proposed)
  • The Quality reporting period returns to full year, but ACI (Advancing Care Information) and Improvement Activities remain at a minimum of 90 days. Cost is still unscored, but performance in this category will be evaluated by CMS and feedback will be provided to clinicians to prepare them for 2019 when, by law, the cost category must account for 30% of the MIPS score. (Finalized as proposed)
  • The proposed performance threshold separating “the winners” from “the losers”, (i.e., recipients of positive vs. negative payment adjustments), would increase from 3 points out of 100 in 2017 to 15 MIPS points in 2018—still an eminently achievable bar. (Finalized as proposed)
  • CMS would implement increased protection for small groups (≤15 eligible clinicians)—these are the practices that had been predicted to be the most vulnerable to penalties. (Finalized as proposed)
  • Many more clinicians would be exempt from MIPS altogether because the eligibility threshold would increase from $30,000 to $90,000 in annual Medicare revenue and from at least 100 to at least 200 Medicare patients.
  • Small groups that do participate in MIPS would receive 5 bonus points toward their score, in an attempt to level the playing field.
  • And my favorite proposal (Unfortunately, not finalized as proposed) is one that specialists, in particular, will appreciate: the elimination of the restriction that all 6 quality measures had to be reported by the same submission method. In 2018, clinicians would be able to mix and match submission methods within a category. Specialists, who have typically been faced with an insufficient number of relevant eCQMs, would be able to continue reporting those measures which are available by EHR submission, but could supplement them with registry or claims measures that are also specialty specific. The result would be more meaningful reporting and more equitable scoring. This is a request that SRS has included in its comments to each of the previous proposed and final MACRA rules, so we were very happy to see this change.

MIPS is only one of the two MACRA participation options, and CMS has also proposed some changes designed to accelerate the shift from MIPS to Alternate Payment Models. More on that topic in a future post.

CMS Overpaid $729MM in MU Payments: What Does That Mean for You?

Lynn Scheps

Lynn Scheps

VP, Government Affairs & Consulting Services at SRS Health
Lynn Scheps is a leading resource on MACRA, MIPS, and Meaningful Use. She is the SRS liaison with government policy makers. Representing the voice of specialists and other high-performance physicians, she develops strategies to respond effectively to government initiatives.
Lynn Scheps

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overpaid-blogIt’s been all over the press for the past week—CMS paid a lot of money in the form of EHR incentives (Meaningful Use) to providers who did not truly earn them. These inappropriate payments were revealed in a report by the OIG (Office of the Inspector General) that reviewed CMS’s compliance with Federal requirements in the Medicare EHR Incentive Program for eligible professionals from 2011-2014. Although the subject of the OIG’s audit was CMS—in contrast to the audits of providers (pre- and post-payment) that have been conducted by Figliozzi and Company—there are some important implications for providers.

Here are two of the OIG’s major conclusions:

  • 14 EPs (Eligible Professionals), out of a sample of 100 who attested to having met MU one or more times did not actually meet the MU requirements. They either could not support their attestation with sufficient evidence or had errors in their attestation. Affected payments to these providers totaled $291,222. Extrapolating on this data, the auditors estimated that CMS inappropriately paid over $729 million.
  • In addition, 471 payments to EPs who switched between the Medicare and Medicaid incentive programs were incorrectly calculated, accounting for another $2.3 million.

The report recommended that CMS:

  • recover the $291,222 from the EPs who had the unfortunate luck to have been sampled [editorial comment is mine, not the OIGs!] and found to be non-compliant;
  • recover the $2.3 million in overpayments to EPs who switched programs; and
  • try to recover some of the estimated inappropriate payments made to other providers.

It’s likely that CMS will pursue the first two recommendations, but yet to be determined what—if anything—they will do about the third. That said, however, one thing is certain: CMS will intensify its oversight going forward. (This was another of the OIG’s recommendations.) Does this mean you should abandon your plans to participate in MIPS and/or MU (Medicaid program)? Absolutely not! It does, however, imply that it will now be more important than ever to keep full documentation to support everything you submit. And, make sure to keep it somewhere that will survive any future changes in software, hardware, and/or practice staff.

Hot Topics for Orthopaedics

Diane Beatini

Diane Beatini

Vice President, Sales at SRS Health
Diane Beatini is the Vice President of Sales. She oversees the Sales, Account Management, and Sales Operations teams. She works to promote the complete SRS product suite of HCIT solutions to medical practices of varied sizes and specialties. Diane’s background includes an MBA in marketing and finance with 15 years of executive sales and customer service management experience in the radiology, medical device, and pharmaceutical industries.
Diane Beatini

SRS Health attends the annual OrthoForums and AAOS meetings as a way of remaining in sync with the topics that are top of mind for our clients. As an HCIT solutions partner, we are continually striving to provide our clients with relevant solutions, training, and advice on resources so that they can meet challenges head on while remaining productive and focused on the practice of medicine. The forums and academy meetings provide us with additional insight outside of our day-to-day interactions, and often serve as springboards for our collaborative efforts.

This year, the prominent topics in the orthopaedic community include:

  • prescription safety
  • data mining/outcomes;
  • cost reduction/operational efficiencies; and
  • MACRA/ MIPs readiness.

Prescription safety has gained increased focus as numerous studies and reports focus on the increased use and abuse of opioids. As a result, individual states are beginning to enact laws addressing the prescribing of controlled substances. Electronic prescribing of controlled substances (EPCS) is currently legal in all 50 states. New York State was the first to pass mandatory I-Stop legislation requiring ePrescribing of all drugs, with stringent identity authentication requirements for controlled substances as of March 27, 2016. Maine has followed suit with the Act to Prevent Opiate Abuse by Strengthening the Controlled Substances Prescription Monitoring Program, requiring prescriber participation in the Prescription Monitoring Program and setting limits for the strength and duration of opioid prescriptions, beginning January 2017. The law also called for prescribers to undergo addiction training every two years. On February 23, 2017, New Jersey issued a bulletin regarding State Opioid Prescribing Information, alerting prescribers to components of a law governing opioid prescribing that takes effect in May. Minnesota also has a similar CDS law on its books, although not as strictly enforced. The expectation is that stringent monitoring will only become more prevalent, with mandatory requirements that will include patient education. As a result, many providers have voluntarily adopted EPCS practices, and the American Academy of Orthopaedic Surgeons has created a multimedia public service campaign, including display and radio ads, urging physicians and patients to exercise caution in prescribing and taking opioids.Painkillers Campaign Image2

As we embrace the value-based payment model, data mining and patient-reported outcomes are top of mind. The critical piece to the puzzle is the ability to collect and report on pertinent and meaningful data to demonstrate improved outcomes. Many physicians are currently considering the selection of an outcomes solution to integrate within their existing HCIT ecosystem. There is no firm consensus across the orthopaedic space of what constitutes full outcomes data requirements, and many are focused on choosing an optimal solution that delivers minimal PRO requirements—i.e., HOOS (Hip disability and Osteoarthritis Outcome Scores) and KOOS (Knee injury & Osteoarthritis Outcome Scores)—at the right price point.

As the payment model shifts and practices are faced with additional reporting complexities, the ability to drive operational efficiency and reduce costs is a critical focus. Integral to all related topics—prescription safety and the ability to demonstrate outcomes, drive down operating costs and meet regulatory requirements under MACRA/MIPs—is the ability to streamline the patient intake process, satisfy the VDT, meet secure messaging requirements, and integrate patient reported data through a quality patient-portal solution. Core functional capabilities such as ease of use and access; ability to request appointments; facilitated patient communication through notifications; integration of patient information within the EHR; and the enabling of secure messaging/exchange allow orthopaedic practices to reduce the time and resources devoted to patient intake and data input, as well as to limit appointment cancellations and/or no shows. Adoption of a patient-engagement solution supports 20 points under MIPs in 2017 and up to 40 points in 2018 with the addition of patient education. The portal also becomes a critical focal point to enhancing patient care through an ongoing dialogue and supporting patient education.

MACRA/MIPs readiness and the assurance that the EHR software employed by the practice will be 2015 certified is also a topic of interest as the marketplace continues to consolidate and EHR solutions sunset. At the outset of the MU program formulated through the HITECH Act of the American Recovery and Reinvestment Act (also known as the 2009 Economic Stimulus Plan), there were over 500 EHR solutions vendors. Today there are fewer than 300, with continued consolidation expected as companies decide whether to further invest and develop to the 2015 certification requirements. Practices should have regular dialogue with their HCIT solutions vendors regarding their investment and plans to certify; and also the availability of MACRA/MIPs training programs to support their regulatory goals.