ISASS Policy & Advocacy News – March 2016

ISASS Signs on to MedPAC Nomination Letter of Support for Przybylski
March 14, 2016
Vertebral Columns – Spring 2016
April 1, 2016
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News and noteworthy information for March 2016:

  • CPT®Summary of Panel Actions from February 2016 Meeting
  • FDA Issues Proposed Rule to Classify Posterior Cervical Screw Systems
  • PCORI Announces $22 million to Compare Treatment Options for Low Back Pain
  • Healthcare Industry Pledges to Make Electronic Health Record Work Better
  • EHR Incentive Program Hardship Application Deadline Extended to July 1
  • 30% of Medicare Payments Now Tied to Alternative Payment Models
  • S. Physician Practices Spend More than $15.4 Billion Annually to Report Quality Measures
  • 2016 Value Modifier Results and Payment Adjustments
  • Senate HELP Committee Action
  • New President and CEO of AdvaMed Announced
  • Research & Reimbursement Course Scheduled for ISASS16

 

CPT Summary of Panel Actions from February 2016 Meeting

On March 4, the American Medical Association posted the CPT® Editorial Summary of Panel Actions, a high-level summary of the final actions taken by the CPT® Editorial Panel at the February 2016 meeting.

Tab 43 addressed the sundowning of several Category III codes. Category III codes are archived five years from the date of initial publication or extension unless a modification of the archival date is specifically noted at the time of a revision or change to a code. Along with several other codes, the CPT® Editorial Panel accepted the archiving of 0309T (Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft, when performed, lumbar, L4-L5 interspace (List separately in addition to code for primary procedure)).

0309T will not be listed as part of the 2018 code set. Access the full summary of Panel Actions here.

 

FDA Issues Proposed Rule to Classify Posterior Cervical Screw Systems

On March 10, the U.S. Food and Drug Administration (FDA) published a proposed rule to classify posterior cervical screw systems as a Class II device. The comment period runs through June 8, 2016. Posterior cervical screw systems were in use prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), meaning they are considered unclassified “pre-amendments devices” by the FDA requiring premarket notification (510(k)). In 2011, the Orthopedic Surgical Manufacturers Association (OSMA) submitted a petition to the FDA to classify posterior cervical screw systems as Class II devices. In September 2012, the Orthopedic and Rehabilitation Devices Advisory Panel to the FDA agreed and recommended that these screw systems be classified as Class II. In the proposed rule issued on March 10, the FDA agrees with the Panel’s recommendation that posterior cervical screw systems be classified into class II.

Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the issue of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance.

Pedicle screw spinal systems have been classified as Class II devices since July 1998. Cages are also Class II devices.

 

PCORI Announces $22 million to Compare Treatment Options for Low Back Pain

On March 22, the Patient-Centered Outcomes Research Institute (PCORI) announced it will issue a $22 million funding announcement in April soliciting studies to compare treatment strategies for chronic low back pain, a leading cause of disability and the most frequent reason adults seek medical care. The funding announcement will seek patient-centered comparative clinical effectiveness projects, soliciting studies comparing optimal clinical strategies that both do and do not include spinal fusion surgery.

PCORI is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.

 

Healthcare Industry Pledges to Make Electronic Health Record Work Better

On February 29, the U.S. Department of Health and Human Services announced that companies that provide 90 percent of electronic health records used by U.S. hospitals, the nation’s five largest private healthcare systems, and more than a dozen leading professional associations and stakeholder groups have pledged to implement core commitments that will improve the flow of health information to consumers and healthcare providers. These commitments include implementing federally recognized, national interoperability standards, policies, guidance and practices and to help consumers securely access their electronic health information assisting providers in sharing patient health information whenever permitted by law.

 

EHR Incentive Program Hardship Application Deadline Extended to July 1

The Centers for Medicare and Medicaid Services (CMS) extended the hardship application deadline for the Medicare Electronic Health Record (EHR) Incentive Program to July 1, 2016. Eligible professionals will have time to submit their applications to avoid adjustments to their Medicare payments in 2017. In January, CMS posted new, streamlined hardship exception application forms on their website.

 

30% of Medicare Payments Now Tied to Alternative Payment Models

On March 3, the Centers for Medicare and Medicaid Services (CMS) announced an estimated 30 percent of Medicare fee-for-service payments were tied to quality or value through alternative payment models, up from 20 percent in 2014. In January 2015, CMS set the goal of tying 30% of Medicare fee-for-service payments to alternative payment models, such as accountable care organizations, patient-centered medical homes or bundled payments, by the end of 2016, and 50 percent by the end of 2018. 30 percent translates into $117 billion out of a projected $380 billion in Medicare fee-for-service payments now tied to alternative payment models.

 

U.S. Physician Practices Spend More than $15.4 Billion Annually to Report Quality Measures

A recent study in Health Affairs examines the amount of time U.S. physician practices spend dealing with the reporting of quality measures. The authors found that physician practices each week spend more than 15 hours per physician to track and report quality measures for Medicare, Medicaid and private health insurers at an estimated cost of at least $15.4 billion a year. The most time, 12.5 hours per week, was spent entering information into medical records solely for quality reporting. Eight in ten primary care, cardiology, orthopedic and multi-specialty practices reported spending more effort on quality measures than three years ago, nearly half reported significant burden due to multiple similar measures, and only 27% thought that current measures were representative of care quality. The authors conclude “while much is to be gained from quality measurement, the current system is unnecessarily costly, and greater effort is needed to standardize measures and make them easier to report.”

 

2016 Value Modifier Results and Payment Adjustments

On March 7, the Centers for Medicare and Medicaid Services (CMS) made available results from the implementation of the 2016 Value Modifier and the adjustment factor that will be applied to physician groups that are subject to upward payment adjustments under the Value Modifier in 2016.

Of the 13,813 physician group practices with 10 or more eligible professionals that are subject to the 2016 Value Modifier based on performance in 2014, only 128 group practices comprising 4,300 physicians exceeded the program’s benchmarks in quality and cost efficiency and will receive an increase in their payments under the Medicare Physician Fee Schedule. In contrast, physicians in 59 groups will see a decrease in their Medicare payments in 2016 based on their performance. Also, physicians in 5,418 groups that failed to meet minimum reporting requirements will see a decrease in their Medicare payments in 2016. Medicare payments for most physician groups nationwide (8,208 groups) that met the minimum reporting requirements will remain unchanged in 2016 because of their performance on quality and cost efficiency measures or because there was insufficient data to calculate the groups’ Value Modifier.

The upward payment adjustment factor in 2016 is +15.92%. The Value Modifier adjustment factor is determined after the close of the performance period and is based on the estimated aggregate amount of downward payment adjustments. In 2015, the Value Modifier Adjustment applied only to practices with 100 or more eligible professionals; in 2016, it will apply to groups of 10 or more, and in 2017, all physicians and physician groups will be eligible for the program.

 

Senate HELP Committee Action

On March 9, the Senate Health, Education, Labor and Pensions Committee (HELP Committee) approved seven more bills for inclusion in a package of legislation, which could serve as a companion to the House-passed 21st Century Cures bill. The following bills were approved:

  • 1878, The Advancing Hope Act of 2015
  • 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015
  • 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act
  • 2055, The Medical Countermeasures Innovation Act of 2015
  • 1767, The Combination Products Innovation Act of 2015
  • 1597, Patient Focused Impact Assessment Act of 2015
  • 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act

The HELP Committee plans to mark up additional legislation on April 6 before bringing the package of legislation to the floor.

 

New President and CEO of AdvaMed Announced

On February 18, the Advanced Medical Technology Association (AdvaMed) announced Scott Whitaker as its new president and CEO. Whitaker replaces Steve Ubl, who left AdvaMed in October 2015 to take over the Pharmaceutical Research and Manufacturers America (PhRMA).

AdvaMed is the largest medical device trade association in the world. AdvaMed promotes “competitive policies that foster the highest ethical standards, rapid product approvals, appropriate reimbursement and access to international markets”. Before accepting the AdvaMed job, Whitaker was the chief operating officer of the Biotechnology Innovation Organization (BIO) and previously served in the Bush Administration.

Whitaker’s appointment will be effective on April 4, 2016.

 

Research & Reimbursement Course Scheduled for ISASS16

The ISASS Research Committee and the ISASS Coding & Reimbursement Task Force will host an exciting new session, “The Good, the Bad and the Ugly – Reimbursement in a Value-Based World: A Forum for Surgeons and Industry” at ISASS16 in Las Vegas. The session will take place on Friday, April 8 from 3:30 to 4:30 p.m. and will focus on the linkage between research and advocacy. The chairs of both committees, Dr. Lisa Ferrara and Dr. Morgan Lorio, will moderate the session which will consist of presentations of several research papers and an open discussion focused on the following themes: surgeon work and the valuation of spine procedures; measuring clinical and economic outcomes in spine surgery; use of technology in maximizing patient outcomes and cost effectiveness; harnessing the power of data to build advocacy plans and shape policy; and setting the agenda for the future of spine surgery. Don’t miss out on this informative and timely session at ISASS16.

Register for ISASS16: http://globreg.com/isass2016/