The Centers for Medicare and Medicaid Services wants to give new money to ambulatory surgery centers (ASCs) to prescribe anything but opioids for immediate post-surgical pain—but not hospitals paid under the Outpatient Prospective Payment System (OPPS).
The proposal, in the lengthy rule proposal which aims to otherwise make payments site-neutral between hospital outpatient surgery centers and ASCs, says:
“… [W]e are proposing to unpackage and pay separately for the cost of non-opioid pain management drugs that function as surgical supplies when they are furnished in the ASC setting for CY 2019.”
The CMS proposed rulemaking frequently mentions one analgesic, Exparel. It’s currently the only branded drug approved by the Food and Drug Administration (FDA) as an immediate post-surgical local analgesic.
Exparel, a liposome injection of bupivacaine, was first approved by FDA in 2011 as a post-surgical anesthetic for bunionectomy and hemmorhoidectomy only. In 2015, FDA, allowed the vendor, Pacira Pharmaceuticals, Inc. to sell the drug as a post-surgical anesthetic for a broad range of surgeries. FDA also approved Exparel on April 6, 2018, for use as an interscalene brachial plexus nerve block after surgery.
Why only ASCs, not hospital outpatient surgery centers?
CMS temporarily gave Exparel “pass-through” status—that is, separate reimbursement from bundled surgical supplies—in calendar years 2012 through 2014 in both the hospital outpatient and ASC settings, then withdrew separate-reimbursement status for both settings.
“From CYs 2013 through 2017, there was an overall increase in the OPPS Medicare utilization of Exparel of approximately 229 percent (from 2.3 million units to 7.7 million units) … The total number of claims reporting Exparel increased by 222 percent (from 10,609 claims to 34,183 claims) … This increase in utilization continued, even after the 3-year drug pass-through payment period ended for this product in 2014, with 18 percent overall growth in the total number of units used from CYs 2015 through 2017 (from 6.5 million units to 7.7 million units). The number of claims reporting Exparel increased by 21 percent during this time period (from 28,166 claims to 34,183 claims).”
However, in ASCs, the end of separate payment had an opposite effect. CMS says, “there was an increase of 238 percent (from 98,160 total units to 331,348 total units) in the total number of units of Exparel used in the ASC setting during the time period of CYs 2013 and 2014 when the drug received pass-through payments.”
When the pass-through ended, “In the ASC setting … the total number of units of Exparel used decreased by 70 percent (from 244,757 units to 73,595 units) between CYs 2015 and 2017. The total number of claims reporting Exparel also decreased during this time period by 62 percent (from 1,190 claims to 441 claims).”
Two other factors behind the CMS plan are:
- A recommendation by the President’s Commission on Combating Drug Addiction and the Opioid Crisis (the Commission) that CMS “review and modify ratesetting policies that discourage the use of nonopioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain.’’
- The Department of Health and Human Services (HHS) April 2017 Five-Point Opioid Strategy, which, CMS said, “aims in part to support cutting-edge research and advance the practice of pain management.”
CMS Isn’t Convinced of Its Own Plan
The rulemaking proposal admits that it needs “… peer-reviewed evidence that demonstrates that use of non-opioid alternatives, such as Exparel, in the outpatient setting actually do lead to a decrease in prescription opioid use and addiction and are seeking comments containing the types of evidence that demonstrate whether and how such non-opioid alternatives affect prescription opioid use during or after an outpatient visit or procedure.”
The proposed rulemaking also acknowledges that CMS is in the dark as to whether to allow unbundled payment for other non-opioid pain treatments:
“We are specifically interested in comments regarding whether CMS should consider separate payment for such items and services for which payment is currently packaged under the OPPS and the ASC payment system that are effective non-opioid alternatives as well as evidence that demonstrates such items and services lead to a decrease in prescription opioid use during or after an outpatient visit or procedure in order to determine whether separate payment may be warranted.”
CMS is also asking whether certain pain management devices which already have pass-through status are reducing opioid prescriptions.
These include “spinal cord stimulators used to treat chronic pain such as the devices described by HCPCS codes C1822 (Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system), C1820 (Generator, neurostimulator (implantable), with rechargeable battery and charging system), and C1767 (Generator, neurostimulator (implantable), nonrechargeable) which are primarily assigned to APCs 5463 and 5464 (Levels 3 and 4 Neurostimulator and Related Procedures).”
