CMS cut to 340B spending overshadows OPPS update; associations threaten suit

Reimbursement to outpatient departments in 2018 will increase $5.8 billion compared to 2017, according to the hospital outpatient prospective payment (OPPS) and ambulatory surgical center (ASC) PPS Final rule for calendar year 2018. However, CMS will drastically reduce reimbursement for drugs under the 340B Program, much to the ire of providers and associations, which have already threatened to sue. (Final rule, 82 FR 52356, November 13, 2017).

340B program 

In calendar year (CY) 2018, CMS will change its reimbursement for separately payable drugs and biologics (other than pass-through drugs and vaccines) acquired through the 340B Program from average sales price (ASP) plus 6 percent to ASP minus 22.5 percent. Rural sole community hospitals, PPS-exempt cancer hospitals, and children’s hospitals will be exempt from this policy for CY 2018. This change, said CMS, addresses recent trends of increasing drug prices and will save beneficiaries about $320 million on copayments in 2018. CMS will offset the projected $1.6 billion decrease in drug payments by redistributing this amount for non-drug items and services across the OPPS.

The 340B Program (see 42 U.S.C. §256b, as expanded by Secs. 2501, 7101, and 7102 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148)), has been controversial, as critics have accused hospitals of abusing the program (see Participants in drug delivery system testify to impacts on patient prescription drug costs, Health Law Daily, October 18, 2017). However, the American Hospital Association, the Association of American Medical Colleges, and America’s Essential Hospitals criticized the cut to 340B spending as contrary to Congressional intent and a threat to safety net hospitals (see, e.g., Testimonies focus on benefits of 340B Drug Program, Health Law Daily, October 12, 2017).

Further, said the AHA, the policy “does nothing to address the stated goal of reducing the cost of pharmaceuticals” and could cause increases in beneficiaries’ out-of-pocket costs for non-drug Part B benefits. American’s Essential Hospitals predicted that, “given their fragile financial position, essential hospitals will not weather this policy’s 27 percent cut to Part B drug payments without scaling back services or jobs.” The three associations plan legal action to stop CMS from cutting 340B spending.

OPPS update

For CY 2018, CMS increased the payment rates under the OPPS by an increase factor of 1.35 percent, which is based on the hospital inpatient market basket percentage increase of 2.7 percent, minus the multifactor productivity adjustment of 0.6 percentage point, and minus a 0.75 percentage point adjustment required by Sec. 3401(i) of the ACA.

Direct supervision requirement

42 C.F.R. Sec. 410.27(a)(1) requires therapeutic outpatient services to be furnished under the direct supervision of a physician or nonphysician practitioner. Sec. 16004 of the 21st Century Cures Act (P.L. 114-255) delayed enforcement through 2016 of this requirement for therapeutic hospital services provided by critical access hospitals and small rural hospitals with fewer than 100 beds. The CY 2018 OPPS Final rule continues the nonenforcement of the direct supervision requirement for hospital outpatient therapeutic services for CAHs and small rural hospitals having 100 or fewer beds for CYs 2018 and 2019.

Inpatient only list

Services that typically would be paid in an inpatient setting will not be paid by Medicare under the OPPS (see 42 C.F.R. Sec. 419.22(n)). These are services that require inpatient care because of (1) the invasive nature of the procedure; (2) the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged; or (3) the underlying physical condition of the patient. Effective for CY 2018, CMS will remove total knee arthroplasty (TKA) and five other procedures from the inpatient only list and will add one procedure to the list. CMS is also prohibiting recovery audit contractors from reviewing TKA procedures for “patient status” for two years to give providers time to gain experience with the procedure in the outpatient setting.

Packaging

CMS will conditionally package low-cost drug administration services assigned to Ambulatory Payment Classifications (APCs) 5691 and 5692 effective January 1, 2018. In addition, CMS assigned skin substitutes with a geometric mean unit cost (MUC) or a per day cost (PDC) that exceeds either the MUC threshold or the PDC threshold to the high cost group. For CY 2018, a skin substitute product that was assigned to the high cost group for CY 2017, but does not exceed either the CY 2018 MUC or PDC threshold for CY 2018, will be assigned to the high cost group for CY 2018.

OQR program

CMS removed six measures from the Outpatient Quality Reporting (OQR) program beginning with the CY 2020 payment determination (CY 2018 reporting). CMS stated that the removal of these measures results in a burden reduction of 457,490 hours and a saving of $16.7 million in CY 2020 for hospitals. CMS also delayed the mandatory implementation of the Consumer Assessment of Healthcare Providers and Systems Outpatient and Ambulatory Surgery Survey under the Hospital OQR Program beginning with the CY 2018 data collection.

Laboratory tests

A new exception to the laboratory date of service policy will generally permit laboratories to bill Medicare directly for advanced diagnostic laboratory tests 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.

ASCs

For CY 2018, payments to ASCs will increase 1.2 percent, or $4.62 billion, based on a projected consumer price index of 1.7 percent minus a multifactor productivity adjustment required by the ACA of 0.5 percentage point. For CY 2018, CMS added three procedures to the ASC covered procedures list. In addition, CMS removed three measures from ASC Quality Reporting program for the CY 2019 payment determination and later and added two measures of hospital events following specified surgical procedures for the CY 2022 payment determinations and later (see Approximate 2 percent increase in OPPS, ASC payments proposed for 2018; cuts to 340B drug discount pay, Health Law Daily, July 20, 2017).

‘Mid-build’ outpatient departments: submit paperwork soon to qualify for OPPS exemption

Off-campus provider-based hospital outpatient departments (HOPDs) that qualify for the mid-build exception must submit the required materials to their Medicare Administrative Contractor by February 13, 2017, to qualify for the exception for services provided in 2018. The hospital must (1) attest that department requirements are met; (2) include the department on the provider’s enrollment form; and (3) and submit a written certification that the department met the mid-build requirement that is signed by the CEO or COO of the main provider. All attestations must be audited by HHS for accuracy.

Outpatient prospective payment changes

Under the 2017 Outpatient Prospective Payment System (OPPS) Final rule (81 FR 79562), CMS implemented section 603 of the Bipartisan Budget Act (P.L. 114-74), which disallows payment made to off-campus HOPDs under the OPPS (see OPPS, ASC payment rates updated; off-campus PBD billing system established, Health Law Daily, November 2, 2016). This provision was created to ensure that services are billed at a uniform rate, regardless of the facility in which the services are provided.

21st Century Cures Act

Section 16001 of the 21st Century Cures Act (P.L. 114-255) provides an important “mid-build” exception for off-campus HOPDs that had a written contract with an outside party for construction of the facility before November 2, 2015. CMS’ preliminary guidance outlines the requirements for HOPDs that qualify for the 2018 exception. It also clarifies that attestations received from providers before December 2, 2015, qualifies that provider for the exception, and that these HOPDs should continue to use the ‘PO’ modifier when billing, rather than the ‘PN’ modifier. Those that did not submit timely attestations are to use ‘PN,’ which triggers the Medicare physician fee schedule (MPFS) payment.

The Cures Act also excepted HOPDs of cancer hospitals from the change to OPPS. Departments that met the requirements of 42 C.F.R. section 413.65 between November 1, 2015, and December 13, 2016, will qualify, as long as attestation is received February 13, 2017. HOPDs of cancer hospitals that meet regulatory requirements after December 13, 2016, will be exempt as long as an attestation is received within 60 days of meeting the requirements.

OIG challenges industry to come up with an upgraded statistical sampling tool

CMS handles more than a trillion dollars in Medicare and Medicaid claims every year. Because not every claim can be scrutinized, statistical sampling is essential for effective oversight of these claims. The current sampling tool, RAT-STATS, was originally designed by the HHS Office of Inspector General (OIG) to give nonexperts a robust method for selecting statistically valid samples. It is the primary statistical tool for OIG’s Office of Audit Services. Although OIG does not require the use of RAT-STATS, many providers download the software and use it in their efforts to fulfill the claims review requirements for corporate integrity agreements or provider self-disclosure protocol.

The OIG has recently announced the launch of the Simple Extensible Sampling Tool Challenge (Challenge) to develop the foundation for an upgraded version of RAT-STATS. According to the OIG, while the current version of RAT-STATS is well validated, its user interface can be difficult to navigate and the underlying code makes the software costly to update. Therefore, the OIG needs a new, modern version of the software that is easy to use and can be extended in a cost-effective manner.

Current RAT-STATS

The RAT-STATS software was originally created in 1978 and has gone through several upgrades since then. Unlike a full statistical package that attempts to answer all types of questions for a wide range of users, RAT-STATS serves as a streamlined solution to handle the specific task of developing valid statistical samples and estimates within the health care oversight setting.

For example, an OIG investigator may pull a simple random sample in order to estimate damages for a provider suspected of fraud. RAT-STATS then generates valid pseudo-random numbers and outputs all of the information needed to replicate the sample. Once the investigator finishes reviewing the sample, he or she can then enter the results into RAT-STATS to get the final statistical estimate. While the investigator may need some basic training in statistics, they do not need the same level of expertise as would be required to navigate the many options available in a full-service statistical or data analysis package.

The Challenge

In order to complete the Challenge participants must create a software package that replicates the operation of four of the functions of the original RAT-STATS software: (1) single stage random numbers;
(2) unrestricted attribute appraisal; (3) unrestricted variable appraisal; and (4) stratified variable appraisal.

Teams of one or more members can participate in this Challenge. Each team must have a captain. Individual team members and team captains must register in accordance with the registration process set forth in the Federal Register notice.  The team captain is to serve as the corresponding participant
with OIG about the Challenge and to submit the team’s Challenge entry. While the OIG will notify all registered Challenge participants by email of any amendments to the Challenge, the team captain is expected to keep the team members informed about matters germane to the Challenge.

Submissions must meet all of the 20 rules and requirements outlined in the Federal Register notice. The technical specifications behind the four RAT-STATS functions along with 10 test datasets are available on the OIG website.

The Challenge began on September 28, 2016. The submission period runs from September 28, 2016, to May 15, 2017. The judging period runs from September 28, 2016, to June 15, 2017. A winner will be announced no later than July 1, 2017. The grand prize is $25,000.

 

Innovative payment models may reduce Part B spending

Some of CMS’ payment plan proposals may have the effect of reducing Part B drug costs, even if not specifically designed to do so. Avalere Health reviewed three categories of programs and found that episode payment models (EPMs), a disease-specific model, and accountable care organizations (ACOs), incentivize providers to reduce Part B spending due to the financial responsibilities imposed. The Center for Medicare and Medicaid Innovation (CMMI) is continually developing and testing new models with the goal of offering higher quality care while minimizing costs.

EPMs

EPMs include the Bundled Payments for Care Improvement (BCPI) demonstration and the mandatory (for metropolitan area hospitals) Comprehensive Care for Joint Replacement (CJR) model. Providers are held accountable for costs incurred over a patient’s episode of care, bearing risk for Part A and B expenditures that begin with a hospital stay. A target is provided based on historical expenditures, and providers are financially responsible for excess spending. Over 1,300 providers now participate in BPCI. CJR covers the initial hospital stay and 90-days after discharge for major joint replacements in the lower extremity, including Part B spending. A proposal has been issued to include non-joint replacement hip and femur treatments.

Similarly, the Oncology Care Model (OCM) provides a fixed monthly payment to providers for management and coordination of patient care for six months while a patient is receiving chemotherapy. This model includes payments for novel oncology therapies to ensure that there is no disincentive to use expensive new treatments.

Disease-specific and ACOs

End stage renal disease (ESRD) beneficiaries are often excluded from payment model demonstrations, so CMMI created the Comprehensive ESRD Care (CEC) model to determine whether improved outcomes and savings are possible for these patients. Providers are accountable for Part A and B spending per beneficiary, per year, including dialysis treatments.

The Medicare Shared Savings Program (MSSP), Next Generation ACOs, and Pioneer ACOs all place risk on providers in various ways, allowing them to share in savings and losses. This includes responsibility Part B spending and the opportunity to receive savings based on low-cost decision-making.