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Compliance Challenges in an Uncertain Regulatory Environment Linda Corley, MBA, CPC, CRCR, August 1, 2017
The healthcare shift to value-based care and to new reimbursement methodologies has created regulatory compliance uncertainty for hospitals and physicians. While adapting to the clinical complexities of recording and reporting specific patient care outcomes to support quality, compliance transformation, by necessity, has become the required regulatory focus. 2017 Switch to MACRA Just as the regulatory standards for compliance with Medicare’s Physician Quality Reporting System (PQRS), Meaningful Use and the ValueBased Payment Modifier were being successfully adopted and followed, 2017 brought the replacement of these professional payment plans by the Medicare Access and Chip Reauthorization Act (MACRA). This new regulation consolidates the three previous quality programs under one, but requires compliance with two different payment methods – the Merit-Based Payment System (MIPS) and Alternative Payment Models (APMs). 2017 will be the initial reporting year, to be reflected in 2019 Medicare payments, and meeting the quality performance outcomes will require new operational regulatory decisions related to delivery of care and changing medical practices for communications with patients. Given the wide diversity of clinical practices, the initial development period of the Quality Payment Program implementation was designed to allow physicians to pick their pace of participation for the first performance period that begins January 1, 2017. Eligible clinicians will have three flexible options to submit data to MIPS and a fourth option to join Advanced APMs in order to become Qualifying APM Participants, all of which would ensure they do not receive a negative payment adjustment in 2019. According to the Brookings Institution, the large majority of physicians and other providers likely will be judged under MIPS. The final MACRA regs exclude or exempt between 53% and 57% of physicians and other clinicians from a possible 2019 penalty under MIPS, but this exemption is limited to low-volume providers having less than $10,000 in annual Medicare-allowable charges. CMS projects that only 4 to 11 percent of Medicare providers will qualify for the Advanced APM payment approach in its first year because of the relatively strict standards to qualify. Hospital Meaningful Use Meaningful Use regulations continue to improve hospital staff member interaction with patients, but also exert pressure to ensure compliance with evolving technology. According to a 2016 study by researchers at Weill Cornell Medical College, practices are spending an average of 785 hours per physician – more than 15 hours weekly – and $15.4 billion annually reporting quality measures. The advancements in electronic records and eprescribing allow patients to participate in healthcare options and often provides greater access to personal medical information, but at the same time spotlights increased security compliance. As the Office of Civil Rights (OCR) continues its HIPAA audits of both covered entities and business associates in 2017, the complete understanding of specific regulatory requirements for utilization of electronic data is required. Effect of Patient Consumerism Patients, who are now more informed about their own health data and the quality performance of providers, are exercising their healthcare preferences through selection of providers. According to the Kaiser Family Foundation/Health Research & Educational Trust 2015 Employer Health Benefits Survey, the average deductible that workers must pay for medical care before insurance increased from $303 in 2006 to $1,077 in 2015. This new “consumerism” has proven to be an important driver of innovation in clinical service design and delivery. Both hospitals and physicians are attuned to patients’ stated needs for improvements in care models and service settings, but regulatory guidance for meeting governmental conditions of participation must also be met. Achieving Regulatory Compliance What are the three most important elements of a Compliance program to meet 2017 regulatory changes? First and foremost, ensure vigilance in staying up-to-date with published regulatory guidance.A compliance plan must be built and maintained by active team members who constantly strive to know the rules, understand the rules, and follow the rules – even as these rules are changing. Secondly, strive for consistent communication of compliance goals.Planned education, re-training and informal discussion regarding regulatory guidelines must occur on a daily basis with all team members to ensure a culture of compliance. The third component should be to perform internal audits to evaluate adoption and utilization of updated regulatory rules.These do not have to be formal, but recurring measurements of regulatory competency and proof of documented compliance with all recording, tracking and reporting of patient care must be maintained. The role of compliance continues to grow as "affordable care" is defined as “the right care to the right patient at the right time in the right setting at the right cost.” All of these “rights” are defined by regulations – the challenge is to meet them in today’s changing reimbursement environment. Linda Corley, MBA, CPC, CRCR VP Compliance and QA Xtend Healthcare