MACRA
CMS Announces Relief for Participants in Quality Reporting Programs in Response to COVID-19
On March 22, 2020, the Centers for Medicare & Medicaid Services (CMS) announced in a press release that it is granting exceptions from reporting requirements and extensions for upcoming data submission and measure reporting deadlines for Medicare quality reporting programs. The exceptions and extensions are intended to reduce data collection and reporting burdens for entities that are responding to COVID-19 so that they can continue to focus on caring for patients. CMS states that this is “unprecedented relief for the clinicians, providers, and facilities participating in Medicare quality reporting programs including the 1.2 million clinicians in the Quality Payment Program and on the front lines of America’s fight against the 2019 Novel Coronavirus (COVID-19).” The CMS programs impacted by this “extreme and uncontrollable circumstances” policy exceptions and extensions include, among others, the Quality Payment Program–Merit-based Incentive Payment System (MIPS), Medicare Shared Savings Program Accountable Care Organizations (ACOs), and various hospital quality reporting programs (e.g., Hospital-Acquired Condition Reduction Program). CMS provided a table in the press release indicating how both 2019 and 2020 data submissions are impacted. For programs that have data submission deadlines in April and May 2020, this submission will be optional. In addition, no data reflecting services provided from January 1 through June 30, 2020 will be used in CMS’s calculations for value-based purchasing programs and Medicare quality reporting. CMS stated as follows: “CMS recognizes that quality measure data collection and reporting for services furnished during this time period may not be reflective of their true level of performance on measures such as cost, readmissions and patient experience during this time of emergency and seeks to hold organizations harmless for not submitting data during this period.” For other Dorsey publications on Medicare’s Quality Payment Program, see here and here.
March 23, 2020
by Alissa Smith and Laura B. Morgan
MACRA
OIG Issues Favorable Advisory Opinion Addressing Gainsharing CMP Arrangement
On January 5, 2018, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”) released a favorable Advisory Opinion 17-09 that addresses Section 1128A(b)(1) of the Social Security Act (the “Gainsharing CMP”) and Section 1128B(b) of the Social Security Act (the “Anti-Kickback Statute”) with respect to a cost-reduction arrangement (the “Arrangement) between a medical center (“Medical Center”) and designated surgeons. The Arrangement called for the Medical Center to share with the designated surgeons a percentage of the Medical Center’s cost savings as a result of the cost-reduction measures agreed to by the parties. This advisory opinion is the first gainsharing advisory opinion issued since the passage of the Medicare Access and CHIP Reauthorization Act (“MACRA”) in 2015. MACRA clarified that the Gainsharing CMP was only violated if the payment to the physician is for the purpose of reducing medically necessary services. However, the clarification under MACRA does not appear to have changed the OIG’s analysis significantly. Gainsharing arrangements have long been considered suspicious by the OIG; although numerous gainsharing arrangements had been reviewed in OIG Advisory Opinions, and have been found to contain enough mitigating factors to not warrant sanctions. The OIG has analyzed these arrangements under the Gainsharing CMP and the Anti-kickback Statute, and has expressed concern that gainsharing arrangements could result in: (i) stinting on patient care; (ii) cherry picking healthy patients and steering sicker (and more costly) patients to hospitals that do not offer such arrangements; (iii) payments to induce patient referrals; and (iv) unfair competition among hospitals that offer incentive compensation programs in order to foster physician loyalty to attract more referrals. This advisory opinion joins the list of previous advisory opinions in which the OIG has analyzed detailed facts and circumstances about a proposed gainsharing arrangement with physicians, and has approved the arrangement because it included certain criteria for minimizing the risk of fraud and abuse. Advisory Opinion 17-09 is helpful to hospitals and physicians that are interesting in entering into gainsharing arrangements because it provides recent insight into the OIG’s perspective on the important factors to include in these arrangements. The Gainsharing CMP prohibits a hospital from knowingly making payments, directly or indirectly, to a physician to induce the physician to reduce or limit medically necessary services to Medicare and Medicaid beneficiaries who are under the physician’s direct care. The Anti-Kickback Statute makes it a criminal offense to knowingly and willfully offer, pay, solicit, or receive any remuneration to induce or reward referrals of items or services reimbursable by a Federal health care program. Here, Advisory Opinion 17-09 addresses an Arrangement between a Medical Center and spine surgeons (“Neurosurgeons”) who are part of a larger multi-specialty physician group (“Group”). In order to participate in the Arrangement, physicians have to be in the Group and be a Neurosurgeon. In total, four physicians were identified as eligible for participation in the Arrangement. All of the Neurosurgeons have medical staff privileges at the Medical Center and all of the Medical Center’s spinal surgeries are performed by the Neurosurgeons. In an effort to reduce costs, a subsidiary of the Medical Center (the “Program Administrator”) conducted a historical practices study of spinal fusion surgeries performed by the Neurosurgeons and identified 34 cost-saving opportunities; including things such as using product standardization. Under the Arrangement, the Medical Center will pay the Neurosurgeons a share of the three-years of cost-savings attributed to the changes the Neurosurgeons make when selecting products to use during the spinal fusion surgeries, among other cost-savings measures. The payment will be distributed to the Neurosurgeons on a per capita basis and the amount allocated to each Neurosurgeon will be subject to a long-standing, pre-existing provision in the Group’s operating agreement that requires the Group to withhold a percentage of collections earned by all physicians for their personally performed services to fund the Group’s administrative and recruitment expenses. The Arrangement includes safeguards such as monitoring and documentation requirements, which are intended to maintain quality of care and protect against inappropriate reduction in services to patients. The parties certified that the cost-savings recommendations will not reduce or limit medically necessary services for patients. Anti-Kickback Analysis: In reaching a favorable opinion, the OIG specifically noted the following safeguards are present in the Arrangement which limit the risk under the Anti-Kickback Statute that the payments to the Neurosurgeons would induce or reward referrals or attract referring physicians: (1) the payment of the cost savings on a per capita (as opposed to an individual) basis reduces the risk the Arrangement creates for any one Neurosurgeon to generate disproportionate cost savings; (2) the potential savings are capped based on the number of spinal fusion surgeries performed by the Neurosurgeons on Federal health care program beneficiaries in the relevant base year, thus limiting the Neurosurgeons’ incentives to increase their referrals to the Medical Center; (3) the aggregate payment to the Neurosurgeons will not exceed 50 percent of the projected cost savings estimated at the beginning of the term of the Arrangement, which reduces the risk of incentivizing referrals; (4) the Program Administrator collects and reviews data on patient severity, age, and payor of the spinal surgeries to confirm historically consistent selection of patients, to prevent data-skewing based on selecting healthier patients; (5) the group of Neurosurgeons retains the portion of the savings, rather than the individual physicians, and the amount retained must be used exclusively for the group’s long-standing formula set forth in their governance documents related to payment of administrative and recruitment expenses, which reduces the risk of inducing or rewarding referrals from non-participating physicians or any particular physician; (6) an annual rebasing method removes savings from prior years and ensures that the performance year savings are calculated only as compared to the most recent base year therefore preventing improper duplicate payments that could constitute unlawful kickbacks; (7) evidence-based medical reviews were completed in order to establish clinical guidelines and evaluations related to the recommended cost-saving measures. Following these reviews, the Requester certified that the recommendations may require additional training for the Neurosurgeons, or changes in their clinical practices/processes, which provided support for the compensation to the Neurosurgeons; (8) the Arrangement ties the incentives to the actual, verifiable cost savings attributable to each recommendation implemented during spinal fusion surgeries, which creates transparency that reduces the risk of the Medical Center accounts being manipulated to “game the system”; (9) Neurosurgeons continue to make patient-by-patient determinations as to the most appropriate device or supply and continue to have access to the same selection of devices and supplies that they had prior to the Arrangement; and (10) no neurosurgeons from other physician groups participate in the Arrangement, thus the risk is reduced that the Medical Center would use the Arrangement to attract others from competitor hospitals to perform surgeries at the Medical Center. Gainsharing CMP: With respect to its analysis of the Arrangement under the Gainsharing CMP, the OIG stated that it relied on the truthfulness of the Requestor’s certification that none of the cost-saving recommendations in the Arrangement will reduce or limit medically necessary services for patients, and that the Program Administrator monitors any changes in cost, resource utilization or quality of patient care; and reports quarterly to a Program Oversight Committee, which is comprised of representatives from the Medical Center, an administrative subsidiary of the Medical Center, the Program Administrator and the Neurosurgeons. The OIG would not opine on whether the recommended cost-saving measures would reduce only non-medically necessary services, but the OIG did evaluate the Requestor’s methodology for developing the recommendations, monitoring safeguards and calculating the savings, and the OIG concluded the methodology was reasonable. The OIG concluded that together, the reasonableness of the methodology and the certifications from the Requestor reduced the risk appropriately that the payments to the Neurosurgeons would limit/reduce medically necessary services to Medicare and Medicaid patients. For more information about gainsharing arrangements, contact your Dorsey & Whitney attorney.
January 22, 2018
by Claire H. Topp and Nicole Burgmeier
MACRA
CMS continues to tinker with new physician Quality Payment Program created by MACRA
The Centers for Medicare & Medicaid Services (CMS) released an advanced copy of its latest proposed rule revising the Quality Payment Program created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The proposed rule, among other things, would further streamline reporting requirements and ease administrative burdens for small and rural providers. By way of background, MACRA created the Quality Payment Program which reforms how Medicare Part B pays more than 600,000 clinicians across the country. Under the Quality Payment Program, eligible clinicians, including physicians, physician assistants, nurse practitioners, clinical nurse specialists and certified nurse anesthetists, can participate in the Quality Payment Program through one of two tracks: the Merit-Based Incentive Payment System (MIPS) or Advanced Alternative Payment Models (Advanced APMs). We are currently in the middle of the first performance year, which began on January 1, 2017. How clinicians perform in the first year will impact Part B payments beginning on January 1, 2019. Given the complexity of the transition, and the significant impact the new payment rules have on Part B clinicians, CMS has continued to seek public input about how it should implement and revise the program going forward. The proposed rule is the latest example of CMS’ efforts to respond to public input, particularly from small physician practices and rural providers. Some of the key changes proposed by CMS in the 1,000+ page proposed rule include: Increasing low-volume threshold. For the current performance year, clinicians and groups are subject to MIPS if they billed more than $30,000 to Medicare Part B and provided care for more than 100 Part B-enrolled Medicare beneficiaries. Clinicians or groups that do not exceed these thresholds are excluded from MIPS participation. CMS has proposed to increase the low volume threshold to less than or equal to $90,000 in Medicare Part B allowed charges or less than or equal to 200 Medicare Part B patients. CMS estimates that approximately 134,000 clinicians currently subject to MIPS will be excluded from MIPS in the 2018 performance year based on the proposed new additional increase in the low-volume threshold. Continuing to allow the use of 2014 Edition CEHRT (Certified Electronic Health Record Technology). CMS is proposing to allow MIPS eligible clinicians to continue to use EHR technology certified to the 2014 Edition for the 2018 performance year. Creation of virtual groups. In the current performance year (Year One), clinicians may only participate in MIPS as an individual or as a group under a common Tax Identification Number. CMS is proposing to allow clinicians to participate in MIPS in virtual groups in future performance years. Virtual groups would be composed of solo practitioners and groups of 10 or fewer eligible clinicians who come together “virtually” with at least 1 other such solo practitioner or small group in order to participate in MIPS. Adding more flexibility for clinicians in small practices. CMS proposes to add a new hardship exception under the MIPS Advancing Care Information performance category for clinicians in small practices. Additionally, for these small practice clinicians, CMS is proposing to add bonus points to their final MIPS score, and continue to award 3 points for measures in the quality performance category that do not meet data completeness requirements. The advanced copy of the Proposed Rule is available here. The official version of the Proposed Rule is scheduled for publication in the Federal Register on June 30, 2017. Comments on the Proposed Rule are due by August 21, 2017. We will continue to provide updates as more information about changes to MACRA are released.
June 21, 2017
by Alissa Smith and Benjamin Fee
