State Operations Manual (Pub. 100-07), Ch. 2 § 2812.2
Waivers
2812.2 - Waivers
(Rev. 111, Issued: 04-11-14, Effective: 04-11-14, Implemetation: 04-11-14)
A certified hospital/CAH must enter into an agreement only with the OPO designated for
the service area in which the hospital/CAH is located, unless CMS has granted the
hospital/CAH a waiver under §486.308(e). A hospital/CAH may request and CMS may
grant a waiver allowing the hospital to have an agreement with a designated OPO outside
of its service area. To qualify for a waiver, the hospital must submit data to CMS as
detailed in 42 CFR 486.308(e)(1) and (2). In making a determination on waiver requests,
CMS considers the requirement under 42 CFR 486.308 (f)(1)-(4):
• Cost effectiveness;
• Improvements in quality;
• Changes in a hospital’s designated OPO due to changes in the definition of
metropolitan statistical areas, if applicable; and
• The length and continuity of a hospital’s relationship with an OPO other than the
hospital’s designated OPO.
A hospital/CAH may continue to operate under its existing agreement with an out-of-area
OPO while CMS is processing the waiver request. If the waiver is denied by CMS, the
hospital/CAH must enter into an agreement with the OPO designated for its service area
within 30 days of notification of the final determination as noted in §486.308(g).