Knowledge Base Article

My youngest son got married earlier this month, and I have already conveyed to him and his bride my desire for more grandchildren. Grandkids are such fun because you can love on them and spoil them, then turn them back over to their parents for the serious stuff. A friend of mine has a one-year old granddaughter and I love to spend time with her. She is currently learning the word “no,” and I get to sit back and smile as it is obvious that she knows what it means but pretends she doesn’t. That slight hesitation and determined expression are “cute” from my perspective, but frustrating for her parents as she proceeds with her actions, undeterred by their instruction of “No!”

Do you think the judicial system and affected parties are frustrated by CMS’s decisions to go forward with certain actions when the judicial system has given the instruction of “no?” Maybe CMS is more like teenagers than babies, because they are old enough to argue, and are putting forth appeals, the potential to appeal, and alternative options as they proceed with their original actions. The 2020 Outpatient Prospective Payment System (OPPS) Final Rule was released Friday, November 1, 2019 and CMS is continuing for 2020 a couple of policies the courts have already found to be inappropriate.

First is the reduction in payment for clinic visits performed in excepted off-campus provider-based departments (PBDs). A little history here – in November 2015, Congress passed a law to pay “new” off-campus hospital provider-based departments that began furnishing and billing for services on or after November 2, 2015 at a different, lower payment rate than that of OPPS. This was done to address concerns about higher payments for services provided in hospital outpatient departments than the lower payments for the same services provided in a physician office setting. Hospitals were instructed to report the services in these non-excepted off-campus PBDs with a PN modifier and CMS determined to pay these under the physician fee schedule at 40% of the OPPS rate (a payment reduction of 60%). Services provided in excepted off-campus PBDs and reported with the PO modifier continued to be paid at OPPS rates at that time. That is until 2019, when CMS decided to expand site-neutrality payments further to include clinic visits (HCPCS code G0463) provided in excepted off-campus PBDs. They phased in the 60% payment reduction over two years, with a 30% reduction for 2019 and the full 60% reduction in 2020 – this makes the payment for clinic visits at all off-campus PBDs the same as the physician fee schedule payment for non-excepted PBD services of 40% of OPPS payment rates.

CMS claims they are “removing the payment differential that drives the site-of-service decision and, as a result, unnecessarily increases service volume.” They further claim they are doing this under authority of a certain section of the Social Security Act that gives them power “to adopt a method to control unnecessary increases in the volume of covered outpatient department services.” They are also implementing this payment reduction in a “non-budget neutral manner” which means the costs savings to the Medicare program will not be redistributed back to hospitals. So far, the courts have not agreed with CMS on their authority to implement this payment reduction policy.

On September 17, 2019, the United States District Court for the District of Columbia entered an order vacating the portion of the CY 2019 OPPS/ASC final rule that adopted the payment reduction for clinic visit services furnished by excepted off-campus PBDs. In October, the district court denied CMS’s request for stay and entered final judgment. CMS acknowledges the court’s decision and states they are “working to ensure affected 2019 claims for clinic visits are paid consistent with the court’s order.” Despite these statements, CMS chose to proceed with the second year of the two-year phase-in of the clinic visit policy for 2020. This means for CY 2020, clinic visits (G0463) provided in excepted off-campus PBDs and billed with the PO modifier will be paid at 40% of the OPPS payment rate. CMS states they have appeal rights and are still considering whether to appeal the final judgement or not.

The second policy for which the courts have issued a negative opinion is the payment of drugs purchased through the 340B program at Average Sales Price (ASP) minus 22.5%. The district courts have found that for both the 2018 and 2019 payment reductions, CMS exceeded their statutory authority by making such a large adjustment in payment rate. The case is currently under appeal from CMS and although they are requesting comments on options to remedy the underpayments of those years, they are also proceeding for 2020 with the same reduced payment amount of ASP-22.5% for drugs purchased through the 340B program including such drugs in a non-excepted off-campus PBD.

Since this policy was implemented in a budget-neutral manner (money saved was redistributed to all OPPS hospitals) and a remedy is “no easy task, given Medicare’s complexity,” the courts have remanded the issue to HHS to devise an appropriate remedy while also retaining jurisdiction. There is abundant discussion, comments and responses in the Final Rule about possible options to address the underpayments. As part of one such remedy, CMS is conducting a 340B hospital survey to collect drug acquisition cost data for CY 2018 and 2019. Since the district court has acknowledged that CMS may base the Medicare payment amount on average acquisition cost when survey data are available, it is obvious in the FR that CMS expects the survey data to show that ASP minus 22.5% was a conservative adjustment that overcompensates hospitals. If so, this remedy would get CMS out of their bind and possibly allow the current reduced payment rate to stand. The Final Rule does offer other options for consideration.

For other drugs and biologicals, CMS finalized the following policies:

• A packaging threshold of $130 – this means Medicare will package items with a per day cost less than or equal to $130, and identify items with a per day cost greater than $130 as separately payable unless they are policy-packaged (such as anesthesia, intraoperative items, and drugs that function as supplies, etc.)
• A payment rate of ASP plus 6% for pass-through and separately payable non-pass-through drugs other than those purchased through the 340B program
• Payment rate of Wholesale Acquisition Costs (WAC) plus 3% for drugs paid under WAC (such as when ASP data is not available)

Like stubborn children, the policies of the OPPS Final Rule show that just because CMS has been told “no” does not mean they plan to change their ways. We will be addressing other policies and decisions from the OPPS Final Rule in future articles in this newsletter.