News and noteworthy information for April 2016:

• ISASS16 Advocacy Survey Extended
• Open Payments Physician Review and Dispute Period: April 1 – May 15
• FDA Panel Issues Recommendations for Medical Device Evaluation System
• NIH Clinical Center: 3-D Imaging in Children and Adults with Scoliosis
• Senate HELP Committee Approves Last Bills of Medical Innovation Package
• CMS Releases Proposed 2017 Hospital Inpatient and Long-Term Care Hospital Payment Rule
• CMS Releases Proposed Rule Implementing Key Provisions of MACRA

 

ISASS16 Advocacy Survey Extended

Several of the sessions at ISASS16 were “interactive”, where session moderators asked attendees to complete short surveys about their own practice. Your answers to these short surveys are important to help shape ISASS advocacy activities in the months ahead. Thank you to those attendees who completed the short surveys on site; we are pleased to extend the survey period for those who were not able to complete the surveys at the meeting. To access these short surveys, visit www.visiontree.com/isass2016 and enter your badge number from the meeting. Once logged in, the surveys are found by clicking the “Take Survey” button, and then by clicking on each survey link (four surveys in total). All four surveys combined should take no more than 5-8 minutes to complete. If you no longer have your badge number handy, please email Jeff Norris (jnorris@visiontree.com) for your badge number.

 

Open Payments Physician Review and Dispute Period: April 1 – May 15

Review and dispute for the June 30, 2016 Open Payments data publication began on April 1, 2016 and will end on May 15, 2016. Direct or indirect payments or other transfers of value made to physicians, teaching hospitals, physician owners and investors are reported to the Centers for Medicare and Medicaid Services (CMS) by manufacturers and group purchasing organizations on an annual basis. Payments for calendar year 2015 were reported to CMS during February and March 2016. Physicians have the opportunity to review and dispute the data from April 1 to May 15 prior to publication of the data on CMS’ website on June 30, 2016. After reviewing the data, physicians can affirm records or initiate disputes. Note that CMS does not mediate disputes; physicians must contact the reporting entity to work through the dispute. Review and dispute is voluntary, but strongly encouraged.

To Review Your Data (approx. 30 minute process):

1. Register in Enterprise Identity Management (EIDM) via CMS Enterprise Portal – https://portal.cms.gov

2. Request access to the Open Payments system

Physicians who registered during program year 2013 or 2014 do not need to register again. A physician may nominate one authorized representative to perform system functions on their behalf.

More Information: https://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2016-04-12-Open-Payments-Presentation.pdf

 

FDA Panel Issues Recommendations for Medical Device Evaluation System

On April 4, a U.S. Food and Drug Administration (FDA) panel released the second in a series of reports on the development of a Coordinating Center that will be charged with housing a national medical device evaluation system (NMDES) to generate better evidence more efficiently for medical device evaluation and regulatory decision-making. The recommendations were developed by a national medical device evaluation system Planning Board convened in 2014 by the FDA. The Planning Board is composed of representatives from federal agencies, patients, clinicians, provider organizations, health plans, industry and experts in health information systems. The Coordinating Center would act as a long-term and broad-based strategic coordinator of efforts to bring together, organize, evaluate, and secure medical device data through the NMDES.

 

NIH Clinical Center: 3-D Imaging in Children and Adults with Scoliosis

On April 5, researchers at the National Institutes of Health (NIH) Clinical Center announced testing of a new imaging technique called stereophotogrammetry (SP) in children and adults with scoliosis. SP uses four sets of digital cameras to generate a 3-D computer image. Unlike other types of evaluations which require radiation, SP only uses digital photographs to learn more about physical deformities such as scoliosis. NIH is currently recruiting individuals older than two years of age that have been diagnosed with scoliosis or any spine or chest wall deformity to participate in the study.

 

Senate HELP Committee Approves Last Bills of Medical Innovation Package

On April 6, the Senate Health, Education, Labor and Pensions Committee (HELP Committee) approved the last five of 19 bills in a bipartisan legislative package expected to serve as a companion to the House-passed 21st Century Cures Act. The bills include:

• 2700 – FDA and NIH Workforce Authorities Modernization Act
• 185 – Promise for Antibiotics and Therapeutics for Health Act
• 2713 – Advancing Precision Medicine Act of 2016
• 2745 – Advancing NIH Strategic Planning and Representation in Medical Research Act
• 2742 – Promoting Biomedical Research and Public Health for Patients Act

Committee Chairman Lamar Alexander (R-TN) said he is working to bring the legislative package to the Senate floor for full consideration along with a bipartisan agreement on NIH Funding.

 

CMS Releases Proposed 2017 Hospital Inpatient and Long-Term Care Hospital Payment Rule

On April 18, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to update 2017 Medicare payment policies and rates under the Hospital Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS). The proposed rule, which would apply to approximately 3,330 acute care hospitals and approximately 430 LTCHs, would affect discharges occurring on or after October 1, 2016. The proposed rule includes:

• Proposed changes to payment rates under IPPS
• IPPS rate adjustments for documentation and coding and Two-Midnight policy • Medicare uncompensated care payments
• Hospital Acquired Conditions Reduction Program
• Hospital Readmissions Reduction Program
• Notification procedures for outpatients receiving observation services
• Electronic Health Record Incentive Programs and quality reporting
• Hospital Inpatient Quality Reporting Program
• Hospital Value-Based Purchasing Program
• PPS-Exempt Cancer Hospital Quality Reporting Program
• Inpatient Psychiatric Facility Quality Reporting Program
• LTCH PPS changes
• LTCH Quality Reporting Program

Specific to spine procedures in hospital inpatient settings, CMS is proposing:

• To reassign the following ICD-10-PCS procedure codes from MS-DRGs 515 through 517 to MS-DRGs 028 through 030 and MS-DRGs 518 through 520 under the ICD-10 MS-DRGs Version 34:
  • 01N00ZZ – Release cervical plexus, open approach
  • 01N03ZZ – Release cervical plexus, percutaneous approach
  • 01N04ZZ – Release cervical plexus, percutaneous endoscopic approach
  • 01N10ZZ – Release cervical nerve, open approach
  • 01N13ZZ – Release cervical nerve, percutaneous approach
  • 01N14ZZ – Release cervical nerve, percutaneous endoscopic approach
  • 01N80ZZ – Release thoracic nerve, open approach
  • 01N83ZZ – Release thoracic nerve, percutaneous approach
  • 01N84ZZ – Release thoracic nerve, percutaneous endoscopic approach
  • 01N90ZZ – Release lumbar plexus, open approach
  • 01N93ZZ – Release lumbar plexus, percutaneous approach
  • 01N94ZZ – Release lumbar plexus, percutaneous endoscopic approach
  • 01NA0ZZ – Release lumbosacral plexus, open approach
  • 01NA3ZZ – Release lumbosacral plexus, percutaneous approach
  • 01NA4ZZ – Release lumbosacral plexus, percutaneous approach
  • 01NB0ZZ – Release lumbar nerve, open approach
  • 01NB3ZZ – Release lumbar nerve, percutaneous approach
  • 01NB4ZZ – Release lumbar nerve, percutaneous endoscopic approach
• To remove the following four diagnosis codes from the secondary diagnosis list while maintaining the four codes in the logic for the principal diagnosis list:
  • 50 – Lordosis, unspecified, site unspecified
  • 55 – Lordosis, unspecified, thoracolumbar region
  • 56 – Lordosis, unspecified, lumbar region
  • 57 – Lordosis, unspecified, lumbosacral region
• To evaluate nine applications for new technology add-on payments including MAGEC^® Spinal Bracing and Distraction System and Titan Spine Endoskeleton^® nanoLOCK^™ Interbody Device based on established newness, cost and clinical improvement criteria
• To add the following ICD-10-PCS procedure codes to MDC 8 in MS-DRGs 515, 516 and 517:
  • 0PS33ZZ – Reposition cervical vertebra, percutaneous approach
  • 0PS43ZZ – Reposition thoracic vertebra, percutaneous approach
  • 0QS03ZZ – Reposition lumbar vertebra, percutaneous approach
  • 0QS13ZZ – Reposition sacrum, percutaneous approach
• To include three clinical episode-based payment measures in the Hospital IQR Program beginning in 2019 including the Spinal Fusion Clinical Episode-Based Payment (SFusion Payment) Measure
  • The proposed SFusion Payment measure includes the set of medical services related to a hospital admission for a spinal fusion, including treatment, follow-up, and post-acute care. The measure includes five clinical subtypes:
    • Anterior Fusion – Single
    • Anterior Fusion – 2 Levels
    • Posterior/Posterior-Lateral Approach Fusion – Single
    • Posterior/Posterior-Lateral Approach Fusion – 2 or 3 Levels
    • Combined Fusions

CMS will accept comments on the proposed rule until June 17 and will issue the final rule by August 1, 2016.

 

CMS Releases Proposed Rule Implementing Key Provisions of MACRA

On April 27, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule implementing key provisions of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA repealed the Medicare sustainable growth rate (SGR) methodology for updating the physician fee schedule and replaced it with a new Merit-based Incentive Payment System (MIPS). The proposed rule establishes the MIPS, a new program that consolidates components of the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM) and the Medicare Electronic Health Record (EHR) Incentive Program. The proposed rule also establishes incentives for participation in alternative payment models. CMS is accepting comments on the proposed rule through June 26, 2016.