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BIO Comments on Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule

BIO submitted comments on the Medicare Inpatient Prospective Payment System (IPPS) Proposed Rule, which focused on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value-Based Purchasing Program, the Hospital Inpatient Quality Reporting Program, the PPS-Exempt Cancer Hospital Quality Reporting Program, and the Long-Term Care Hospital Quality Reporting Program.

The Biotechnology Innovation Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2017 Rates Proposed Rule (the “Proposed Rule”), including with respect to the Quality Reporting Requirements for Specific Providers and Hospital Notification Procedures Applicable to Beneficiaries Receiving Observations Services.

Our comments focus on several proposals related to, among other things, CMS’s review of New Technology Add-on Applications, the Hospital Value-Based Purchasing Program, the Hospital Inpatient Quality Reporting Program, the PPS-Exempt Cancer Hospital Quality Reporting Program, and the Long-Term Care Hospital Quality Reporting Program. Discussed in greater detail below:

•  BIO is concerned that CMS’s methodology used to calculate and recalibrate Medicare Severity Diagnosis-Related Groups (MS-DRG) relative weights does not adequately ensure appropriate payment for the treatment of patients with rare diseases. We therefore urge the Agency to explore opportunities to better account for these cases and emerging treatments within the MS-DRG system.

•  BIO has ongoing concerns regarding CMS’s review of New Technology Add-on Payment (NTAP) applications. The Agency has improved its review of NTAP applications for FY 2017, but BIO is concerned there were instances in which the agency applied both the “newness” and “substantial clinical improvement” criteria in an inconsistent manner. To address these and other concerns, BIO is supportive of the proposal to add certain patient-centric criteria to guide the Agency’s NTAP application review, provided that these criteria are nonexhaustive, and each application is required to meet only one such criterion. BIO also urges CMS to provide further guidance regarding the use of the new Section “X” ICD-10-PCS codes.

•  BIO supports CMS’s decision to transition to the use of the S-10 Worksheet for purposes of determining the value of “Factor 3” in the multifactorial uncompensated care payment formula, which appears to provide for a better assessment of a hospital’s uncompensated care than the current metric used.

•  For purposes of the Hospital Value-Based Purchasing (VBP) Program:

•  BIO supports CMS’s proposal to include selected ward (non-ICU) locations in the Catheter-Associated Urinary Tract Infections (CAUTI) and Central-Line Associated Blood Stream Infection (CLASBI) measures beginning with the FY2019 program year, and urges CMS, in the interim, to provide these locations with mechanisms to begin voluntarily collecting data related to these measures.
•  BIO supports CMS’s proposal to add two new condition- or treatment-specific Medicare payment measures to the Hospital VBP beginning in FY2021; however, we urge CMS to adopt these measures instead of (not in addition to) the problematic Medicare Spending Per Beneficiary measure.
•  BIO urges CMS to reinstate the IMM-2 influenza immunization measure in the program, which CMS has removed beginning with the FY2018 performance year, as this measure helps ensure that providers continue to administer this important vaccine to patients in the hospital setting, where nosocomial influenza poses a significant threat to patient health and safety.

•  BIO supports CMS’s proposal to implement the NOTICE Act, which amended section 1866(a)(1) of the Social Security Act to require hospitals and critical access hospitals to notify individuals receiving observation services as outpatients for more than 24 hours. We believe that this provision will help prevent abuse and assist beneficiaries to better understand the financial and other implications of the care they receive.

•  For purposes of the Hospital Inpatient Quality Reporting (IQR) Program:

•  BIO supports CMS’s proposal to refine the 30-Day Mortality Following Acute Ischemic Stroke Hospitalization measure to include the National Institutes of Health (NIH) Stroke Scale, which will help ensure that this measure accurately risk-adjusts for different populations.
•  BIO also supports CMS’s proposal to potentially include the National Healthcare Safety Network (NHSN) Antimicrobial Use Measure.
•  BIO does not support the removal of the STK-4 measure.
•  BIO commends CMS for retaining two important immunization measures in the IQR for the FY2018 payment determination and subsequent years—NQF #1659 “Influenza Immunization (IMM-2)” and NQF #0431 “Influenza Vaccination Coverage Among Healthcare Personnel (HCP)”—but we again urge CMS to revisit the Agency’s decision to remove IMM-1, the pneumococcal immunization measure, from the IQR program.

For purposes of the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program:

•  BIO commends CMS for retaining the previously finalized measure NQF#0431 “Influenza Vaccination Coverage Among Healthcare Personnel (HCP).”
•  BIO does not, however, support the proposed inclusion of the “Admissions and Emergency Department (ED) Visits for Patients Receiving Outpatient Chemotherapy.”

•  For purposes of the Long-Term Care Hospital (LTCH) Quality Reporting Program, BIO supports the proposed revisions to the data collection period for NQF #0680 “Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza Vaccine (Short Stay).” BIO also is pleased that the previously adopted measure NQF #0431 “Influenza Vaccination Coverage Among Healthcare Personnel (HCP)” will remain in the LTCH Quality Reporting Program for the FY2018 payment determination year and subsequent years.

BIO Comments - 2017 IPPS Proposed Rule