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).

Hospices see modest payment increase, new clinical doc reporting for FY 2018

Hospices serving Medicare beneficiaries would hospices would generally see a $180 million or 1 percent increase in their payments for fiscal year (FY) 2018 under a Proposed rule updating the hospice wage index, payment rates, and cap amounts. In an advance release of the Proposed rule, CMS also detailed new quality measure concepts under consideration for future years, solicited feedback on an enhanced data collection instrument, and described plans to publicly display quality measure data via the Hospice Compare website in 2017. CMS also seeks comments regarding the sources of clinical information for certifying terminal illness and would change the Hospice Quality Reporting Program (Hospice QRP), including adding new quality measures utilizing data collected in the Hospice Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Survey. The Proposed rule is set to publish May 3, 2017.

Annual rates

Section 411(d) of the Medicare Access and CHIP Reauthorization Act of 2015 (P.L. 114-10) (MACRA) amends section 1814(i) of the Social Security Act setting the market basket percentage for hospices in FY 2018 to 1 percent. This translates to about $180 million for hospices in the next fiscal year. In addition to the basket percentage increase, the cap amount for accounting years that end after September 30, 2016, and before October 1, 2025, must be updated by the hospice payment update percentage, rather than the Consumer Price Index (CPI). Therefore, the cap amount for FY 2018 will be $28,689.04 compared to the 2017 cap amount of $28,404.99.

Hospice CAHPS Survey

The Hospice CAHPS® Survey is a component of the Hospice Quality Reporting Program and is important for the hospice community because the results of the survey will allow for comparisons on a national basis. CMS noted that the data would help beneficiaries to select a hospice program, as well as encourage hospices to improve quality of care. Under the Proposed rule, two global CAHPS measures would be adopted. CMS expects to begin public reporting via a Hospice Compare Site in CY 2017 to help customers make informed choices.

Terminal illnesses

CMS’ expectation is that a referring physician/acute/post-acute care facility’s clinical documentation serves as the basis of the certification of terminal illness. As such, the agency is seeking comments on a clarifying proposal that would identify the source of clinical information, whether a referring physician or acute care facility, when certifying that life expectancy in a hospice situation is six months or less. CMS also wants to explore whether the use of clinical documentation from an in-person visit from the hospice medical director or the hospice physician member of the interdisciplinary group could support the certification of terminal illness and whether such documentation is needed to augment the clinical information from the referring physician/facility’s medical records.

Measures under consideration

CMS offered no new proposed measures, but did seek additional feedback on two claims-based measures under future consideration: (1) avoiding hospice care transitions and (2) accessing levels of hospice care. The agency noted it would be detailing the measures in future rulemaking.

CMS solicits applications for Rural Community Hospital Demonstration

CMS is soliciting applications for additional hospitals to participate in the Rural Community Hospital Demonstration Program, which tests payment under a reasonable cost-based methodology for Medicare inpatient hospital services furnished by eligible rural hospitals. No more than 30 hospitals can participate in the program at the same time. Applications are due May 17, 2017, and CMS’ goal is to finalize selections by June 2017.

Section 410A of the Medicare Modernization Act (MMA) (P.L. 108-173) originally authorized the demonstration for five years, and Sections 3123 and 10313 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) extended it for another five-year period. Section 15003 of the 21st Century Cures Act (P.L. 114-255) again amended section 410A to require another five-year extension of the demonstration (see 21st Century Cures clears House, now set for Senate vote, December 1, 2016).

Eligibility

To be eligible to participate in the program, a hospital must: (1) be located in a rural area or be treated as such pursuant to Soc. Sec. Act Sec. 1886(d)(8)(E); (2) have fewer than 51 acute care inpatient beds, as reported in its most recent cost report; (3) make available 24-hour emergency care services; and (4) not be designated or eligible for designation as a critical access hospital pursuant to Soc. Sec. Act Sec. 1820.

Hospitals that were participating in the demonstration as of the last day of the initial five-year period or as of December 30, 2014 may participate in this second extension period, unless the hospital elects to discontinue participation. A newly selected hospital may be located in any state; however, priority will be given to hospitals located in one of the 20 states with the lowest population densities.

Payment

For discharges occurring in the first cost reporting period on or after the implementation of the extension, hospitals participating in the demonstration will receive payment for their reasonable costs of providing covered inpatient hospital services (except for services furnished in a psychiatric or rehabilitation unit that is a distinct part of the hospital). For discharges occurring during the second or later cost reporting period, hospitals will be paid the lesser of their reasonable costs or a target amount.

For most of the previously participating hospitals, there is a gap between the end date of the hospital’s participating in the first five-year extension and the enactment of the Cures Act on December 13, 2016 that the legislation did not address. In the fiscal year 2018 hospital inpatient prospective payment system (IPPS) Proposed rule, CMS solicited comments on proposed terms of continuation for previously participating hospitals (see IPPS spending to increase $3B, LTCH PPS to decrease $173B, April 17, 2017).

The MMA requires the demonstration to be budget neutral. The IPPS proposed rule detailed the status of the demonstration and the methodology for ensuring budget neutrality.

CMS delays implementation of bundled payment models

CMS has further delayed the implementation date of the Cardiac Rehabilitation (CR) Incentive Payment model and modifications to the Comprehensive Care for Joint Replacement (CJR) model by three months. This additional delay, CMS said, is necessary to allow time for additional review, to ensure that the agency has adequate time to undertake notice and comment rulemaking to modify the policy if modifications are warranted, and to ensure that in such a case participants have a clear understanding of the governing rules and are not required to take needless compliance steps due to the rule taking effect for a short duration before any potential modifications are effectuated.

CMS issued a final rule on the two models January 3, 2017. Pursuant to the Trump Administration’s “Regulatory Freeze Pending Review” memorandum, on February 17, 2017, CMS issued a final rule that delayed the effective date of the January 3, 2017 final rule, for provisions that were to become effective on February 18, 2017, to March 21, 2017. CMS’ March 21, 2017, interim final rule postponed the effective date of the January 3, 2017 final rule from March 21, 2017, until May 20, 2017. The applicability date of the new regulations at 42 C.F.R. Part 512 and specific CJR regulations are delayed from July 1, 2017, until October 1, 2017. CMS sought comments on a longer delay of the model start date, including to January 1, 2018.

Under the CJR model, which began April 1, 2016, acute-care hospitals in certain areas receive retrospective bundled payments for episodes of care for hip and knee replacements. All related care within 90 days of hospital discharge from the joint replacement procedure is included in the episode of care. The January 3, 2017, final rule made several changes to the model.

Under the CR Incentive Payment model, acute care hospitals in certain geographic areas will receive retrospective incentive payments for beneficiary utilization of cardiac rehabilitation/intensive cardiac rehabilitation services during the 90 days following hospitalization for an acute myocardial infarction or coronary artery bypass graft surgery.

The American Hospital Association criticized the pace of these mandatory demonstration projects as “too much, too soon” and said, “We will continue to urge that any new bundled payment programs be of a voluntary nature.” In addition, HHS Secretary Tom Price has asserted that CMS exceeded its authority with bundled payment initiatives like the CR and CJR models.