In the final Physician Fee Schedule for 2019, the Centers for Medicare and Medicaid Services (CMS) made changes to regulations related to the Clinical Laboratory Fee Schedule (CLFS) that will require more hospital outreach laboratories to report private payer data. Hospital laboratories with outreach programs will need to closely review their billing and other circumstances to determine whether they will begin sending information to CMS in 2020.

Under the Protecting Access to Medicare Act (PAMA), CMS determines reimbursement for laboratory tests billed on the CLFS based on a weighted median of private payer rates calculated on a 3-year cycle. AACC and other advocacy organizations have objected to the way CMS wrote regulations that exclude most hospital outreach laboratories and physician office laboratories from data collection. Advocates argued that collecting payment data only from low-margin, high-volume independent labs would skew prices and lead to deeper cuts to the CLFS than Congress intended. Reimbursement for many tests was cut up to 30% on January 1, 2018, when the new payment system went into effect.

CMS’ update to the PAMA regulations expands the definition of an “applicable laboratory” for private payer data collection to include laboratories that submit claims to Medicare using the 14X type of bill used specifically by hospital outreach laboratories. Ostensibly this would lead to a more diverse survey of how laboratory tests are actually paid for. However, it’s difficult to predict whether the changes CMS made will mean a significant bump in rates the next time the agency calculates weighted median rates. According to data compiled by the American Hospital Association, which opposes requiring hospital laboratories to report payment data, only 12% of hospital laboratories use the 14X bill.

A related regulatory change might also mean more laboratories need to report data. Under PAMA, a laboratory only has to report data if more than 50% of its revenue comes through the CLFS or Physician Fee Schedule. In 2019 CMS will no longer count Medicare Advantage Part C payments toward the denominator in this calculation, which CMS expects to expand the number of laboratories submitting payment data.

The next data collection period is January 1, 2019, through June 30, 2019. Those laboratories that determine they will have to report payment data will do so during a 3-month window, January 1–March 31, 2020. Revised rates will go into effect January 1, 2021.

A New Government Strategy Tackles Health IT Problems

After years of complaints and warnings from healthcare professionals, the Department of Health and Human Services (HHS) is taking a new look at some of the unintended consequences of the drive to convert from paper to electronic healthcare records (EHR). HHS issued a draft strategy led by the HHS Office of the National Coordinator for Health Information Technology.

Many of the areas that the strategy identifies as needing improvement relate to clinical laboratory test ordering and result retrieval. These include harmonizing user actions across EHR systems for ordering tests, harmonizing test codes to support mapping across systems, and a uniform presentation of results.

The main goals of the draft -strategy are reducing the effort and time required to record health information in EHRs for clinicians; reducing the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and healthcare organizations; and -improving the functionality and -intuitiveness of EHRs. Public comment on the draft ends January 28, 201.