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).

‘Fatigued’ providers must concentrate on complying with two-midnight rule

Some providers may be experience two-midnight rule “compliance fatigue” due to the changing rules and current lack of traditional enforcement activity, said presenters at the Health Care Compliance Association webinar, “Two Midnight Rule: Where Are We Now?” The two-midnight rule has been a “moving target” and its evolution has been challenging for providers, with CMS having issued more than 40 items of sub-regulatory guidance over the past 3.5 years. Presenters Lauren Gennett and Isabella Wood of King & Spaulding LLP said, however, that it is important for compliance personnel to emphasize the importance of continued compliance.

Two-midnight rule. The two-midnight rule is codified at 42 C.F.R. Sec. 412.3(d), which provides that an inpatient admission is considered reasonable and necessary under Part A if the admitting physician ordered the inpatient admission based on the expectation that the patient would require at least two midnights of medically necessary hospital services.

If an unforeseen circumstance, such as a beneficiary’s death or transfer, results in a shorter stay than the physician’s expectation of at least two midnights, the patient may be considered to be appropriately treated on an inpatient basis. An inpatient admission for a surgical procedure specified by Medicare as “inpatient only” under 42 C.F.R. Sec. 419.22(n) is also generally appropriate for payment under Medicare Part A, regardless of the expected duration of care.

Rare and unusual circumstances exception. There may be “rare and unusual circumstances” in which an inpatient admission for a service not on the inpatient only list may be reasonable and necessary in the absence of an expectation of a two midnight stay. CMS expanded this exception effective January 1, 2016 (see OPPS payment update a net cut for many, Health Law Daily, November 13, 2015). The exception is determined on a case-by-case basis by the physician responsible for the care of the beneficiary, subject to CMS medical review. Relevant factors include: (1) the severity of the signs and symptoms exhibited by the patient; (2) the medical predictability of something adverse happening to the patient; and (3) the need for diagnostic studies that appropriately are outpatient services.

Wood said that CMS has not provided examples of services that might qualify for the “rare and unusual circumstances” exception. She noted that the exception is challenging for providers, who do not know how rare and unusual the circumstances must be to qualify for the exception. There is, she said, “a lot of wiggle room and uncertainty” for providers.

Inpatient admission orders. Before the two-midnight rule, there was not an express requirement for an inpatient admission order, but now 42 C.F.R. Sec. 412.3(a) requires that the inpatient admission order be in the medical record for the hospital to be paid for inpatient services under Part A. The physician is required to authenticate the order before discharge, which can be difficult for short stays. Gennett said that this requirement is “low hanging fruit for contractor denials.” There is, however, an exception for missing or defective orders that CMS originally included in January 2014 guidance and recently updated in the Medicare Benefit Policy Manual, Pub. 100-02, Ch. 1 (see Change Request 9979, March 10, 2017).

Enforcement. From October 2013 through September 2015 Medicare administrative contractors (MACs) conducted limited “probe & educate” reviews, and quality improvement organizations (QIOs) began conducting reviews in October 2015. QIO review has had its challenges, however, and in 2016 CMS temporarily “paused” QIO patient status reviews (see QIOs back to reviewing Two-Midnight rule claims, Health Law Daily, September 13, 2016). In April 2017 the QIO record selection process changed; QIOs now sample the top 175 providers with a high or increasing number of short stay claims per area with a request for 25 cases, and all other providers previously identified as having “major concerns” in the prior round of review will have a request for 10 cases.

Recovery audit contractors (RACs) may conduct provider-specific patient status reviews for providers that have been referred by the QIO as exhibiting persistent noncompliancewith Medicare payment policies, including consistently failing to adhere to the two midnight rule. The presenters noted that providers should be “extra cautious” in light of the potential for RAC referrals.

The two-midnight rule is also on the HHS Office of Inspector General’s (OIG) radar. In December 2016, the OIG issued a report based on a claims review for fiscal years 2013 and 2014 concluding that hospitals are billing for many inpatient stays that were potentially inappropriate (see Two-midnight Medicare policy succeeding but still lacks full cooperation, Health Law Daily, December 19, 2016). The OIG also stated in its FY 2017 work plan that it intends to review hospitals’ use of inpatient and outpatient stays under the two midnight rule.

‘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.

FTC staff opposes Virginia hospital systems’ cooperative agreement

The Southwest Virginia Health Authority and State Health Commissioner should deny a cooperative agreement application submitted by Mountain States Health Alliance and Wellmont Health System, according to comments submitted by staff of the FTC Bureau of Competition, Bureau of Economics, and Office of Policy Planning.

Mountain States and Wellmont are the two largest hospital systems in the border area of Southwest Virginia and Northeast Tennessee, and they are the only two full-service hospital systems serving the vast majority of patients living in this area, according to the FTC staff’s comments. Together, the hospitals would purportedly hold a near-monopoly over inpatient services in the area and have significant shares in several outpatient services and physician specialty service lines.

Consequently, the FTC staff—after a year-long assessment of the proposed merger—concluded that the proposed deal “presents substantial risk of serious competitive and consumer harm in the form of higher healthcare costs, lower quality, reduced innovation, and reduced access to care.”

The hospitals proposed several commitments they claimed would control and mitigate any anticompetitive effects, including price commitments. However, these commitments would be insufficient and unlikely to mitigate the anticompetitive effects, according to testimony presented by Mark Seidman, FTC Deputy Assistant Director for the Mergers IV Division.

“[T]he price commitments described in the application are ambiguous and appear to leave the hospitals with the opportunity and incentive to obtain higher prices from health insurers,” Seidman stated. “And even if prices were successfully constrained, it would do nothing to prevent harm to quality of care, and in fact would make that harm more likely.”

It also was noted that “once a merger is consummated—whether under a cooperative agreement or otherwise—it is extremely difficult to unwind.” Consequently, approving the cooperative agreement would risk that the deal would become permanent, especially because the plan of separation submitted by the hospitals did little to alleviate the significant challenges of “unscrambling the eggs,” following the merger.