Advancements in healthcare technology continue at an explosive pace and nowhere is this more evident than in the field of mobile healthcare applications. Technology giants such as Apple and Garmin are diving into the wearable healthcare device arena and healthcare app companies are rapidly developing technology to enable devices to transmit healthcare information directly to physicians from these devices. Not surprisingly, physicians are also being courted by technology companies to endorse, invest in, Beta test and enter into licensing agreements to utilize these technologies.

As evidenced, however, by three recent settlements between the New York State Attorney General and several healthcare app companies, the marriage between healthcare and technology is fraught with potential legal pitfalls. According to the NY Attorney General’s press release, the settlement involved the makers of Cardiio, Runtastic, My Baby’s Beat, three popular healthcare applications that, among other things, monitor user heart rates. In addition to requiring the companies to pay civil settlements, the settlement agreements require the companies to modify certain of their marketing claims which the Attorney General alleged were misleading, and to change their privacy practices regarding the use and disclosure of user information. In light of these settlements, physicians considering getting involved with app makers or other healthcare technology ventures should carefully vet those arrangements and the applications themselves for compliance with healthcare laws including, without limitation, federal and state kickback prohibitions and privacy and security considerations.

The Medicare incentive programs with which you and your medical practice are familiar will soon be no more.  As of January 1, 2017, these programs (including the Electronic Health Records (EHR) Meaningful Use Incentive Program, the Physician Quality Reporting System (PQRS), and the Physician Value-Based Modifier Program) will morph into the new Medicare Quality Payment Program (QPP).   The QPP will also include a fourth category of incentives entitled “Clinical Practice Improvement Activities”, which we discuss in more detail below.

The purpose of the QPP is to create one central program that will govern Medicare Part B payments to physicians, while incentivizing physicians to increase quality of care and decrease inefficiencies in the cost of care for Medicare patients.  Participation in the QPP will be mandatory beginning January 1, 2017.  The QPP will either reward or penalize physicians and their practices by adjusting their reimbursement rates under the Medicare Physician Fee Schedule two (2) years after the reporting year.  Therefore, physicians/practices will have their reimbursement rates adjusted in 2019 based on their reporting data for the year 2017.

As we noted in our first blog post in the Series, accessible here, physicians will have the option to choose between two payment tracks under the QPP:  (1) the Merit-Based Incentive Payment System (MIPS); and (2) an Advanced Alternative Payment Model (Advanced APM).  This blog post will discuss the basics of the MIPS and how to qualify for the MIPS in 2017, while our next post will touch on the basics of participation in Advanced APMs.

Basics of the MIPS

Each physician or group practice (you may report individually or as a group) participating in the MIPS in 2017 will earn a “composite performance score” based on the physician/group’s scores within the following four (4) categories:

  1. Quality of Care – 60%
    • Explanation: Scored based on the reporting of “quality measures”, which will be published annually by CMS.  Physicians will be able to choose which quality measures they will report each year.
    • Replaces: PQRS and quality component of the Value-Based Modifier.
  2. Advancing Care Information – 25%
    • Explanation: Scored based on the reporting of EHR use-related measures with which you are familiar from the current EHR Meaningful Use Incentive Program.  However, unlike the existing program, the QPP measures will not have “all-or-nothing” targets.
    • Replaces: EHR Meaningful Use Program.
  3. Clinical Practice Improvement Activities – 15%
    • Explanation: Scored based on attestation by the physician/group that the physician/group has performed certain care coordination, beneficiary engagement, population management and patient safety activities.
    • Replaces:   New Program.
  4. Resource Use – 0%
    • Explanation: Scored based on per capita patient costs and episode-based measures.  CMS collects and analyzes the data from your claims submissions.  No additional reporting will be required.
    • Replaces: Cost component of the Value-Based Modifier.

How to Qualify for 2017

CMS has eased the reporting requirements for the first year of the QPP.  No physician/group will be required to begin collecting data in accordance with the QPP’s requirements on January 1, 2017 (but may elect to do so).  To receive a neutral or positive payment adjustment, physicians/groups will need to report data for only a 90-day performance period during the year.  There are also minimum threshold reporting requirements to avoid a negative payment adjustment and full participation requirements which are more likely to result in a guaranteed positive adjustment.  The table below organizes the requirements in an easy-to-read format:

MIPS Measures Chart

Final Thoughts on Qualifying for the MIPS in 2017

  • Get involved sooner rather than later. CMS has kept reporting requirements minimal in 2017 in order to encourage clinicians to participate in the QPP.  Take advantage of that opportunity to ensure your practice has the right software to report the quality and EHR use-related measures.  Since adjustments will be made based on threshold scores, it may be easier in 2017 to earn a positive adjustment, and even an exceptional bonus, than in later years.
  • Ensure that your current EHR technology meets the requirements for the QPP in 2017, including reporting capabilities for quality measures and EHR use-related measures. The easiest way to do this is to contact your EHR vendor.
  • CMS has given providers plenty of time to report 2017 data. The deadline for reporting 2017 data is March 31, 2018.

As always, if you have questions specific to your practice, please contact a knowledgeable and experienced attorney.

You may have heard that a transformation of Medicare’s physician payment program is in the works.  However, you may not know that the structure of the new program, called the “Quality Payment Program”, has been finalized and will begin its first reporting year on January 1, 2017.  Now is the time for you and your practice to get up to speed on the new Quality Payment Program.  This post is the first in a new Blog Series that we will be publishing on Fox Rothschild’s Physician Law Blog to help you and your practice prepare for Medicare’s Quality Payment Program.

In October, the Centers for Medicare and Medicaid Services (CMS) issued a Final Rule setting forth the structure of the Quality Payment Program and the parameters for its first year of operation.  The purpose of the Quality Payment Program is to create one central program that will govern Medicare Part B payments to physicians, while incentivizing physicians to increase quality of care and decrease inefficiencies in the cost of care for Medicare patients.  The Quality Payment Program will consolidate the existing Medicare incentive programs (which include the Electronic Health Records (EHR) Meaningful Use Incentive Program, the Physician Quality Reporting System (PQRS), and the Physician Value-Based Modifier Program), along with a new program incentivizing clinical improvement activities, into a single payment program that will either reward or penalize physicians by adjusting their reimbursement rates under the Medicare Physician Fee Schedule.

In each reporting year under the Program, physicians will be required to qualify for one of two (2) payment tracks:  (1) the Merit-Based Incentive Payment System (MIPS); or (2) the Advanced Alternate Payment Model (Advanced APM) model.  The MIPS is the default payment track, and will be the track used by most physicians over the next five years.  Qualification for the Advanced APM model requires participation in a CMS-approved Advanced APM.  The long-term goal of CMS is for most physicians and practices to participate in Advanced APMs.

While calendar year 2017 will be the first reporting year under the Quality Payment Program, payment adjustments for physician performance in 2017 will not be made until the 2019 calendar year.  This two-year gap between reporting and payment adjustment has been carried over from the existing incentive programs and may eventually be shortened.  However, for now, the gap will allow a smoother transition from Medicare existing incentive programs, which have collected data over the last two years for incentive payments in 2017 and 2018, respectively.  To be clear, incentive payments based on data reported under existing incentive programs in 2015 and 2016 will still be made.

The good news is that CMS has eased the reporting requirements for the first year of the Program.  For example, no physician will be required to begin collecting data in accordance with the Program’s requirements on January 1, 2017.  To receive a neutral or positive adjustment to reimbursements in 2019, physicians will need to report data and perform certain practice activities for a 90-day performance period during the year.

Stay tuned to the Physician Law Blog for upcoming posts on what you and your practice need to know about the Quality Payment Program (QPP).  The next posts in the QPP Blog Series will be:

  1. Basics of the MIPS and How to Qualify in 2017
  2. Basics of Advanced APMs and How to Qualify in 2017
  3. Details of the MIPS Scoring System

In the interim, if you would like to learn more about the QPP, we encourage you to check out the excellent website CMS has developed on the QPP, which can be found at this link:  https://qpp.cms.gov

As always, if you have questions regarding the applicability of the QPP to you and your practice, we advise you to consult with a knowledgeable attorney.

The Affordable Care Act (ACA) requires Medicare providers to return overpayments within 60 days of the date they are identified in order to avoid liability under the False Claims Act.  Four years ago, CMS issued a proposed rule to implement this statutory requirement that would have placed a substantial burden on providers to identify and return overpayments within the 60-day period.  Last week, CMS issued its long-awaited “final rule” on the matter. The final rule is substantially less burdensome than the proposed rule would have been and offers providers a clearer view of their obligations to investigate and report overpayments.

Here are five key aspects of the final 60-Day Overpayment Rule that physicians and medical practices should keep in mind:

  1. What It Means to Identify an Overpayment

CMS clarifies that identifying an overpayment requires reasonable diligence and quantification of the overpayment.  Specifically, a provider has “identified” an overpayment when the provider “has or should have, through the exercise of reasonable diligence, determined that it has received an overpayment and can quantify the amount of the overpayment.”  In contrast, the proposed rule would have held providers to a “deliberate ignorance” or knowledge standard regarding the existence of an overpayment and would have included no leeway for quantification of the overpayment.

  1. The New Timeframe In Which Providers Must Identify Overpayments

One of the biggest questions that arose from the proposed rule was: “When does the 60-day clock to identify overpayments start ticking?”  The proposed rule called for providers to act with “all deliberate speed” to identify overpayments once they became aware of a possible billing error.  In its final rule, CMS provides a clearer answer to the question.  Providers will have up to 6 months to investigate a possible overpayment before the 60-day reporting period begins.

  1. The “Look-Back Period” Is Shortened

Part of a provider’s obligation with respect to overpayments under the ACA is to search through past records for overpayments after a provider identifies that it has received at least one overpayment.  CMS originally proposed a requirement that providers “look back” 10 years in their records for other overpayments in order to comply with this rule.  Acknowledging the unreasonable burden such a time period would impose on providers (both in effort and cost), in the final rule CMS has reduced the duration of the look-back period to 6 years.

  1. Documentation of Reasonable Diligence Is Advisable

In prefatory comments to the rule, CMS stated that it is “certainly advisable” for providers to document their diligence in investigating possible overpayments.  While documenting an investigation may not make a provider’s diligence “reasonable” per se, it may provide strong evidence of the provider’s efforts.

  1. Proactive Compliance

CMS emphasizes in the final rule that “reasonable diligence” requires not only reactive activities, such as a good faith investigation of potential overpayments by qualified individuals, but also “proactive compliance activities conducted in good faith by qualified individuals to monitor for the receipt of overpayments.”

The full text of the final rule may be accessed here:  https://www.federalregister.gov/articles/2016/02/12/2016-02789/medicare-program-reporting-and-returning-of-overpayments.

Be sure to consult experienced legal counsel if you would like further guidance on the Medicare 60-Day Overpayment Rule, including what steps your practice should take to proactively and reactively address potential overpayments.

Earlier this month, the Centers for Medicare and Medicaid Services released a new tool designed to give providers and consumers insight into Medicare drug spending.  The Medicare Drug Spending Dashboard, which at present only includes 2014 data, summarizes information on 80 drugs, 40 of which are covered under Medicare Part B and 40 of which are covered under Medicare Part D.  Data on the dashboard (which is sortable) includes total drug spending, number of beneficiaries utilizing each drug, drug spending per user, beneficiary costs, and the annual change in average drug unit cost.

The Centers for Medicare & Medicaid Services (CMS) has stated its intention to move at least 50% of Medicare payments from fee for service to alternative payment systems based on quality and/or value by 2018.  In furtherance of this goal, the Medicare Access and Children’s Health Insurance Program (CHIP) Reauthorization Act of 2015 (MACRA) passed earlier this year included a requirement that the Department of Health and Human Services publish a draft plan for developing quality measures to support these alternative payment models.  On December 18, 2015, CMS published its draft Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive Payment System (MIPS) and Alternative Payment Models (APMs) to create a framework for the development of these quality measures .  Although the plan is only in draft, it sheds important light on what Medicare payment systems are likely to look like commencing in 2019 and beyond.  Physicians and other providers who rely upon Medicare reimbursement for their livelihood should review the draft plan and keep a close eye on future developments in this area as changes will likely be sweeping.

 

 

This past month, CMS published several new Frequently Asked Questions  (FAQs) on its website addressing questions about the EHR incentive programs, and in particular how to attest to certain measures for health information exchange, patient electronic access, and other objectives that require patient action.  Those FAQs can be found here on the CMS website.

CMS also published the final regulations with a comment period for participation in Stage 3 of the EHR incentive program.  The public may submit comments on the regulations until December 15, 2015.  The regulations can be viewed here in the Federal Register.

A new study in the BMJ suggests that the more services a physician provides to his or her patients, the less likely the physician is to be sued for malpractice.  The study examined the use of resources by attending physicians in several Florida acute care hospitals during a ten-year period from 2000-2009, in relation to the number of malpractice claims brought against the physicians in the year following care.  Researchers found that physicians who billed higher than average hospital charges were sued less often than lower-billing physicians.

The study builds on evidence that most physicians in the United States report practicing “defensive medicine”, commonly understood to be “medical care provided to patients solely to reduce the threat of malpractice liability rather than to further diagnosis or treatment.”  Prior to this study, no research had been published on whether greater resource use by physicians is associated with reduced claims for malpractice.

The researchers focused on physicians from seven specialties, including obstetrics, which tends to have a higher rate of malpractice claims than other specialties.   The evidence clearly showed that a physician’s risk of being sued for malpractice was reduced among those who performed and billed for more services.  However, the authors noted that the data only show a correlation.  Further research is necessary to understand why higher spending is linked to a lower risk of malpractice claims.

Perhaps the greatest value from this study is that the results corroborate the belief that defensive medicine reduces the likelihood of claims for malpractice.  Interestingly, the authors note that the effectiveness of defensive medicine could be a reason why efforts to reduce physician spending have been difficult.

The full study is available online at:  http://www.bmj.com/content/351/bmj.h5516-0.

The long-anticipated implementation of ICD-10 coding finally began this past Thursday, October 1, 2015.  As of that date, government and commercial payors ceased to accept claims under the old coding system (ICD-9).  The transition has been five years in the making due to a government delay in 2012.

The new system has five times the codes of the prior system, including everything from “problems in relationship with in-laws” to “pedestrian injured in collision with roller skater” to “burn due to water-skis on fire”.  The hope is that the breadth and detail of the new codes will provide greater accuracy and increase reimbursement rates.  However, the complexity of ICD-10 could also cause substantial delays in reimbursement from both the provider side and the insurer side.  While CMS and other insurers are committed to ensuring that the implementation of the new system is completed, it is up to each provider to prepare for and manage the transition in their own practice.

Here are a few tips for your practice during the transition:

  • Mitigate the risk of longer-than-expected reimbursement times by setting aside a reserve fund to cover interim operating expenses, such as payroll, in the event of a one to two week delay in reimbursement during the next few months.
  • Whenever your staff has specific claims questions, contact the appropriate payor sooner rather than later.
  • If you haven’t already, consult your practice management and EHR software vendors to find out how they recommend using their technology with the new coding system.
  • In an effort to speed up the learning curve, consider asking your billing and coding staff to dual code a few charts each day.  This will give them additional opportunities to train, while reducing the need for extra training sessions down the line.