Market Driver FAQs

How big is the medical device market?

The medical device market is a major market with over 6,500 manufacturers in the U.S. and an annual spend of $172 billion for medical devices and supplies. The current growth is 5-6% per year and is projected to reach $225 billion by 2018. With the increasing spend of medical devices and supplies, there are pressures to drive down cost and maximize the value of what is being spent for better patient outcomes.

What is the requirement around the UDI for medical device manufacturers?

  • FDA is mandating a required numbering system, Unique Device Identifier (UDI), and requires medical device manufacturers to:
    • Apply for a UDI for each version of their products
    • Label their products with the UDI
    • Submit their UDIs to the FDA Global UDI Database (GUDID)

What are the new vendor requirements for medical device information systems?

  • ONC 2015 EHR Certification requires UDI inclusion in the Common Clinical Data Set (CCDS), which is a summary of key information on the patient such as medication allergies or immunizations
  • Integration with EHRs with the ability to record, change, access a list of unique device identifiers (UDIs) corresponding to a patient’s implantable devices
  • Parse certain data from a UDI (DI and PI information)
  • Retrieve the ‘Device Description’ attribute associated with a UDI in the GUDID
  • Make accessible to a user both the parsed and the retrieved data to a user
  • Deadline delayed. Target January 2019.

What does Meaningful Use Stage 3 and MACRA require for medical device IT systems?

  • Meaningful Use Stage 3 Incentive Program (hospital & provider requirements) mandates EHR ability to record UDI information about implantable devices as part of a patient’s “implantable device list”
  • Meaningful Use will be transitioned in Medicare Access & CHIP Reauthorization Act (MACRA) to Merit-Based Incentive Payment System (MIPS) and be part of the Advancing Care Information (ACI)
  • UDI relevance so that the initial requirements of MU Stage 3 continue under the ACI
  • Documenting UDI of implantable devices in the EHR
  • Provide a summary of care (includes the UDI) – transfer patient information for transitions of care

Are there new payment models impacting medical device utilization?

The simple answer is yes, because of the trend toward fixed payments. That means providers will need to begin to look at cost-effective approaches and ways to evaluate the way devices impacts their bottom-line. Among the specifics:

  • Comprehensive Care for Joint Replacement Model (CJR) aims to support better and more efficient care for Medicare beneficiaries undergoing the most common inpatient surgeries for hip and knee replacements (also called lower extremity joint replacements or LEJR). This model is voluntary to participate.
  • [New!] BPCI Advance is a voluntary, single retrospective bundle payment with 29 in-patient clinical episodes, 3 outpatient clinical episodes and qualifies as an Advanced APM. Payments are tied to performance on quality measures. First cohort of participants will start on October 1, 2018 and run through December 31, 2023.
    • 29 In-patient Clinical Episodes
      • Disorders of the liver excluding malignancy, cirrhosis, alcoholic hepatitis **(New episode added to BPCI Advanced)
      • Acute myocardial infarction
      • Back & neck except spinal fusion
      • Cardiac arrhythmia
      • Cardiac defibrillator
      • Cardiac valve
      • Cellulitis
      • Cervical spinal fusion
      • COPD, bronchitis, asthma
      • Combined anterior posterior spinal fusion
      • Congestive heart failure
      • Coronary artery bypass graft
      • Double joint replacement of the lower extremity
      • Fractures of the femur and hip or pelvis
      • Gastrointestinal hemorrhage
      • Gastrointestinal obstruction
      • Hip & femur procedures except major joint
      • Lower extremity/humerus procedure except hip, foot, femur
      • Major bowel procedure
      • Major joint replacement of the lower extremity
      • Major joint replacement of the upper extremity
      • Pacemaker
      • Percutaneous coronary intervention
      • Renal failure
      • Sepsis
      • Simple pneumonia and respiratory infections
      • Spinal fusion (non-cervical)
      • Stroke
      • Urinary tract infection
    • 3 Out-patient Clinical Episodes
      • Percutaneous Coronary Intervention (PCI)
      • Cardiac Defibrillator
      • Back & Neck except Spinal Fusion
    • Quality Measures
      • All-cause Hospital Readmission Measure (NQF #1789)
      • Advanced Care Plan (NQF #0326)
      • Perioperative Care: Selection of Prophylactic Antibiotic: First or Second Generation Cephalosporin (NQF #0268)
      • Hospital-Level Risk-Standardized Complication Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) (NQF #1550)
      • Hospital 30-Day, All-Cause, Risk-Standardized Mortality Rate (RSMR) Following Coronary Artery Bypass Graft Surgery (NQF #2558)
      • Excess Days in Acute Care after Hospitalization for Acute Myocardial Infarction (NQF #2881)
      • AHRQ Patient Safety Indicators (PSI 90)