On November 1, 2017, CMS issued the 2018 Hospital Outpatient Prospective Payment System (OPPS) final rule in which it finalized steep cuts to reimbursement for drugs purchased through the 340B Drug Pricing Program, among other significant changes.

Some of the key takeaways from the final rule include:

• The final rule adjusts the amount Medicare pays hospitals under the 340B Discount Drug Program. Specifically, the final rule adopts “a policy for separately payable, nonpass-through drugs and biologicals (other than vaccines) purchased through the 340B Program at the average sales price (ASP) minus 22.5 percent rather than ASP plus 6 percent.”  This policy, however, will not apply to Rural Sole Community Hospitals, PPS-exempt Cancer Hospitals, and Children’s Hospitals for 2018.
• According to the press release, the final rule places a “two-year moratorium on enforcement of the direct supervision requirement currently in place at rural hospitals and critical access hospitals.”
• Overall, the OPPS final rule is increasing payment rates by 1.35 percent for 2018. “CMS estimates an overall impact of 1.4 percent payment increase for providers paid under the OPPS in CY 2018.”  According to the final rule, CMS estimates that the total payments to OPPS providers to be about $70 billion for 2018, “an increase of approximately $5.8 billion compared to estimated [calendar year] 2017 OPPS payments.” 
• According to the press release, CMS previously proposed a policy to package all add-on “integral, ancillary, supportive, dependent, or adjunctive services into payment for primary services,” including “drug administration add-on services.”  With the final rule, CMS “is finalizing its proposal to conditionally package payment for low-cost drug administration services.” 
• The final rule removes the following procedures from the Medicare inpatient-only list (IPO): (i) total knee arthroplasty; (ii) “[l]aparoscapy, surgical, repair of paraesophageal hernia with implantation of mesh”; (iii) “[l]aparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device component only”; (iv) “[l]aparoscopy, surgical, gastric restrictive procedure; removal and replacement of adjustable gastric restrictive device component only”; (v) “[l]aparoscopy, surgical, gastric restrictive procedure; removal of adjustable gastric restrictive device and subcutaneous port components”; and (vi) “[l]aparoscopy, surgical prostatectomy, retropubic radical, including nerve sparing, includes robotic assistance, when performed.” The final rule, however, precludes Recovery Audit Contractors from conducting “site of service” reviews in connection with outpatient total knee arthroplasty procedures for two years.
• The final rule adds one procedure to the IPO list:  “percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of intracoronary stent, artherectomy and angioplasty, including aspiration thrombectomy when performed, single vessel.” 
• Effective January 1, 2018, the final rule adds an exception to the current laboratory date of service regulations; this exception “generally permits laboratories to bill Medicare directly for ADLTs and molecular pathology tests excluded from OPPS packaging policy if the specimen was collected from a hospital outpatient during a hospital outpatient encounter and the test was performed following the patient’s discharge from the hospital outpatient department.” 
• The final rule removes six measures from the Hospital Outpatient Quality Reporting (OQR) Program:  (i) “OP-21:  Median Time to Pain Management for Long Bone Fracture”; (ii) “OP-26: Hospital Outpatient Volume Data on Selected Outpatient Surgical Procedures”; (iii) “OP-1: Median Time to Fibrinolysis; (iv) OP-4: Aspirin at Arrival”; (v)
  “OP-20: Door to Diagnostic Evaluation by a Qualified Medical Professional”; and (vi) “OP-25: Safe Surgery Checklist Use.”

The final rule can be found here.