Category: CMS

2017 MIPS Performance Feedback Reports may erroneously report 2019 Medicare payment adjustments

By Tayler Chambless, Class of 2020; Elizabeth N. Pitman, Counsel at Waller

2017 was the first year for participation in the Merit-based Incentive Payment System (MIPS), a Quality Payment Program (QPP) implemented by CMS, to award or penalize participating clinicians with regard to future Medicare reimbursements based upon reporting under four categories:

  1. Quality
  2. Improvement Activities
  3. Promoting Interoperability (2017 Advancing Care Information; previously Meaningful Use)
  4. Cost

In July, CMS released 2017 Performance Feedback Reports detailing clinicians’ MIPS final scores, performance category details, and 2019 MIPS Medicare payment adjustments. According to CMS, approximately 621,700 providers received negative adjustments.  At the same time as release of reports, CMS conducted a “targeted review” and discovered major calculation errors in the following areas:

  • Advancing Care Information and Extreme and Uncontrollable Circumstances Hardship Exceptions
  • Awarding Improvement Activity credit for successful participation in Improvement Activities Burden Reduction Study
  • All-Cause Readmission measure

On September 25th, CMS announced that clinicians have 20 days to request a targeted review of their  MIPS report.  Lack of transparency by CMS has buoyed critic positions that MIPS is too complicated.  CMS, however, states that it has “reviewed the concerns, identified a few errors in the scoring logic, and implemented solutions. The targeted review process worked exactly as intended, as the incoming requests quickly alerted us to these issues and allowed us to take immediate action.”

Clinicians are encouraged to review Performance Feedback Reports and request a Targeted Review by Oct. 15, 2018, at 8 p.m. EDT.

What is a targeted review, and how do I submit a request?

Clinicians must request a Targeted Review through the formal online process established by CMS. The Performance Feedback Report may be found at the QPP Portal.

No targeted review is available for:

  1. Methodology used to determine the amount of the MIPS payment adjustment factor and the amount of the additional MIPS payment adjustment factor and the determination of such amounts;
  2. Establishment of performance standards and performance period;
  3. Identification of measures and activities specified for a MIPS performance category and information made public or posted on the Physician Compare CMS website; and
  4. Methodology used to calculate performance scores and calculation of such scores (weighting measures and activities)

CMS will generally require additional supporting documents that the clinician must provide within 30 days. All targeted review decisions are final and without further review.

Clinicians should be prepared to submit supporting documents:

  • Supporting extracts from the electronic health record (EHR)
  • Performance data provided to third-parties
  • Performance data submitted to CMS
  • QPP Service Center ticket numbers
  • Signed contracts or agreements between clinician/group and third-party intermediaries
  • Alternative Payment Model participation agreements
  • Partial qualified participant (QP) election forms
  • Other requested documents.

CMS is in the process of reviewing over 15,000 comments on a proposed rule that was issued in July to outline changes for year three of the MIPS Quality Payment Program and update the Medicare physician fee schedule. The final rule will be issued later this fall.

 

Pathways to Success: CMS proposes accelerated shift to provider risk in ACOs

By Clay Brewer, Class of 2020; Jesse C. Neil, Partner at Waller

In an effort to facilitate the American healthcare system’s transformation from volume-based to value-based payment, the Centers for Medicare and Medicaid Services (CMS) is requesting public comment regarding its newly proposed rule that would shift the amount of risk participants in Accountable Care Organizations (ACOs) assume under the Medicare Shared Savings Program (MSSP).

An ACO is a group of physicians, hospitals, and other healthcare providers that care for a group of beneficiaries under Medicare Parts A and B. The core principles of the system are to streamline care and reduce costs within a cohesive structure. Under the current MSSP framework, ACOs may join one of three tracks with each differing primarily on the amount of risk each ACO opts to assume. Currently, 561 of the 649 ACOs are members within one of the tracks, with eighty-two percent of the 561 being enrolled in Track 1. Under Track 1, the ACOs only experience “upside-risk,” which means the ACO members are eligible to receive any achieved savings but are not financially responsible if the ACO incurs a loss.[1] CMS Administrator Seema Verma, however, recently opined that “[t]he results show that ACOs that take on regular levels of risk show better results for cost and quality over time.”[2] As a result, CMS is requesting comment on a new proposed rule, entitled “Pathways to Success,” to shift more of the downside risk to providers with the goal of incentivizing more efficient care and across-the-board savings.

The proposed framework establishes two tracks: (1) BASIC and (2) ENHANCED. Each ACO would be permitted to choose the track that best fits its needs while also being able to enter into five-year agreements as opposed to three-year. This would enable the ACOs to adjust to the risk that will need to be assumed over time while also learning to manage the associated costs.

The BASIC approach will permit the ACOs to assume risk over a five-year period with the first two years being upside-only risk with a “glide path” into years three, four, and five with increasing risk assumption. One caveat to the glide path is that ACOs currently within an upside-only risk plan, such as Track 1, would be limited to one of the two years of upside-only risk under the BASIC track. However, after year five, this newly-assumed risk would qualify the ACO as an Advanced Alternative Payment Model (APM), permitting the ACO to receive additional incentive payments for meeting quality thresholds.

Under the ENHANCED approach, ACOs may enter the program immediately qualifying as an APM at a set risk amount for the entire five-year period as long as the risk is greater than year five of the BASIC approach. On the other hand, ACOs that have had no experience under a two-sided risk approach may enter into any of the BASIC’s glide paths or enroll into the ENHANCED model from the start.

Due to the differences that exist between low revenue (i.e., physician practices) and high revenue (i.e., hospitals) entities, those who qualify as low revenue would be eligible to reapply for another five-year BASIC program at the highest level of risk. High revenue entities would be required to move into the ENHANCED track and assume additional risk.

Although efficient care and lower costs are appealing to practically everyone, the timing of the announcement and a change in the economic model will have a material impact on hospitals and physicians that participate in the programs. There are few areas where public policy is so intertwined with the clinical, operational, and financial performance of healthcare providers. Some stakeholders may see a competitive advantage to an accelerated move to downside financial risk. For others, it could lead them to withdraw from participation in the program altogether. Regardless, it is a critical moment in the transition to a value-based system, and these programs will benefit immensely from thoughtful, practical feedback from the physicians, hospitals, payors, and even investors that are trying to lead the way.

 

[1] Tracks 2 and 3 consist of only eighteen percent of enrollees with varying degrees of two-sided risk. Track 3 becomes the ENHANCED approach in the proposed rule.

[2] Seema Verma, Pathways to Success: A New Start for Medicare’s Accountable Care Organizations. August 9, 2018.

Between a rock and a hard place: medical-device stakeholders disappointed by cancelled CMS rulemaking

By Emmie Futrell, Class of 2018; Denise D. Burke, Partner at Waller

Another attempt at bridging the gaping lag between FDA approval for medical devices and CMS’s Medicare coverage determinations has been struck down, after a nine-month standstill.

CMS’s proposed rulemaking included a promising new program called EXCITE, or expedited coverage of innovative technology. The proposed rulemaking had not been made public in substance, and the reasons for its cancellation are still unclear.

CMS officials confirmed that EXCITE was intended to improve access to innovative medical-device technologies for Medicare patients.

Members of the medical-device industry, however, believe that EXCITE was patterned after a 2016 industry proposal that had been presented to CMS to correct the backlog.

The 2016 proposal, known as PACER, or the provisional accelerated coverage to encourage research initiative, suggested that CMS grant provisional coverage under Medicare for FDA-approved devices. This would ensure that patients could access innovative technology, while CMS could gather the information necessary for its own approval process.

The provisional coverage would also alleviate pressure on device sponsors, who would not suffer from having to bankroll expensive and highly specific clinical tests before devices are even on the market.

EXCITE is not CMS’s first attempt to reduce the backlog between FDA and Medicare approval for medical devices.

This backlog, which can sometimes last years, results from the independent statutory mandates that tie the hands of the respective agencies. FDA must ensure that the drugs and devices it approves are “safe and effective,” while CMS can only approve products for Medicare coverage if the products are “reasonable and necessary.” This coverage determination requires CMS to evaluate the necessity of devices for typical Medicare patients, which are generally more medically complex than those of patients in FDA clinical trials.

In 2011, the Department of Health and Human Services attempted to address the lag between FDA and Medicare approval by initiating a parallel review program. This program focused on increasing communication between CMS, the FDA and device manufacturers, including providing medical-device stakeholders and manufacturers with detailed information about the study data that each agency would require in the approval process.

It was believed that this would speed the review process by allowing manufacturers to tailor their studies to encapsulate necessary data for each agency.   Lack of resources, however, largely doomed this program before it was effectively launched. Critics have condemned the program, which only resulted in two approvals by CMS.

CMS’s cancellation of the EXCITE program is a strong indication that, for at least the immediate future, medical-device manufacturers will continue to suffer from the bottleneck between the FDA and CMS and experience lengthy delays between FDA approval and CMS reimbursement.

CMS unveils new bundled payment model

By Chase Doscher, Class of 2018; Elizabeth N. Pitman, Counsel at Waller; Zachary D. Trotter, Associate at Waller

Earlier this month, CMS announced the launch of the Bundled Payment for Care Improvement Advanced (BPCI Advanced) payment model.

This is the first Advanced Alternative Payment Model (Advanced APM) introduced under the Trump Administration and the start of the next generation of BPCI models offered through the Center for Medicare and Medicaid Innovation and authorized under the Affordable Care Act.  Under the MACRA Quality Payment Program, providers will be subject to Medicare payment adjustments through one of two tracks: Merit-based Incentive Payment System (MIPS) or Advanced APM.

Under MIPS, a provider may receive a negative, neutral or positive adjustment with the expectation that the majority of participants will experience either negative or neutral adjustments. The BPCI Advanced model, however, entices providers to participate in an Advanced APM by offering the potential for bonus payments under MACRA for those who meet or achieve certain benchmarks during a 90-day episode of care, including the all-cause hospital readmission measure and advance care plan measure.  As with other Advanced APMs, BPCI Advanced requires that participants assume some of the risk and ties payment to quality performance metrics and the required use of certified healthcare technology.

After cancelling an Obama-era proposal for converting certain of the BPCI episode models to mandatory bundled-payment models, the Trump Administration effort to maintain voluntary participation is an attempt to decrease the administrative burdens such models placed on providers. Voluntary participation in BPCI models, such as Comprehensive Care for Joint Replacement and the Cardiac Rehabilitation Incentive model, has been offered since 2016.

This new model will give providers, “an incentive to deliver efficient care,” Seema Verma, CMS Administrator, said. “BPCI Advanced builds on the earlier success of bundled payment models and is an important step in the move away from fee-for-service and toward paying for value.”

Thirty-two clinical care episodes will initially be included in BPCI Advanced, 29 inpatient-setting episodes of care and three outpatient-setting episodes of care and the potential for episode revision for new and existing participants beginning January 1, 2020.   The clinical care episodes include services such as major joint replacement of a lower extremity, percutaneous coronary intervention and spinal fusion.

BPCI Advanced performance period is from October 1, 2018 through December 31, 2023.  Participants joining in the initial stage may not exit prior to January 1, 2020.

Providers interested in at least one of the 32 clinical episodes to apply to the model have until 11:59 pm EST on March 12, 2018 to apply via the application portal.

Back to the Future: CMS revives Obama-era proposed rule on critical access hospitals

By Emmie Futrell, Class of 2018; Kristen A. Larremore, Partner at Waller; Amber Green Arnold, Associate at Waller

Since the 1997 Balanced Budget Act, which created the designation for Critical Access Hospitals (CAH), the requirements for Medicare and Medicaid participation for these rural facilities have largely remained untouched.  But, a recent decision by CMS to revive and finalize an Obama-era proposed CAH rule will change certain Medicare participation requirements for CAHs.

According to a recent rulemaking notice, CMS intends to issue a final version of the proposed CAH rule sometime in the next 17 months.

The CAH designation was created to protect financially vulnerable rural hospitals that provide vital care to rural communities and combat a string of rural hospital closures. However, the intervening years since 1997 have brought many changes to healthcare in the United States, and in June 2016 CMS issued a proposed rule in an attempt to modernize Medicare participation requirements for CAHs and other hospitals.

Highlights of the wide-ranging proposed rule include a requirement that CAHs maintain an infection prevention program, as well as an antibiotic stewardship program to promote the appropriate use of antibiotics.  CAHs would also be required to designate leaders for each of these programs.

CMS hopes these programs will result in a reduction in hospital-acquired infections, including those that may be drug-resistant, which can lengthen inpatient stays and result in increased costs to the Medicare program. However, critics of these proposed requirements have noted that many drug-resistant organisms come into hospitals from other settings and have questioned whether these anti-infection requirements will improve patient care if care delivered outside of the hospital setting is not subject to similar requirements.

The proposed rule also establishes an explicit requirement that CAHs comply with federal anti-discrimination laws — – a requirement already applicable to Medicare providers.  The proposed rule would address this disparity and seek to address reports of discriminatory barriers to access by requiring CAH facilities to adopt and implement nondiscrimination policies.

In addition, the proposed rule would clarify that each patient’s medical records must contain adequate documentation justifying the patient’s admission and continued hospitalization, support the patient’s diagnoses, and describe the patient’s progress and response to medications and services.  The proposed rule also clarifies that patients should be able to access their medical records in form and format requested by the patient, including electronically, if readily producible in that form and format.

In light of recent findings in a Bipartisan Policy Center report that was published in January 2018, CMS may consider additional revisions to the proposed rule.

The report considered the rural communities of seven upper Midwest states and the relationship between local communities and CAHs. The report indicated that, while in many of the smaller localities studied, there were still barriers to access of critical primary care services, CAHs would not necessarily be helpful in addressing such access issues in each rural community.

The report found that, in some instances, CAHs are not financially sustainable due to low occupancy of patients requiring inpatient services. Proposals are wide-ranging to correct this issue, but many proposals include modifying the CAH designation to allow these facilities to include primary care and other outpatient services in addition to the inpatient care that they are already required to provide.

Although the extent to which the Trump administration will finalize the rule as initially proposed remains unclear, CAHs should closely monitor developments for any new CMS proposals addressing CAHs and a final rule implementing changes, because CAHs continue to be a focus of lawmakers and healthcare policy advisors.

CHOW Time: Change of Ownership Changes

By Chase Doscher, Class of 2018; Colbey B. Reagan, Partner at Waller; Daniel Patten, Associate at Waller

Last April, the Center for Medicare & Medicaid Services (CMS) issued a change request making revisions to Chapter 15 (Medicare Enrollment) of the Medicare Program Integrity Manual. Specifically, this change request made significant alterations to Section 15.7.7.1.5 – Electronic Funds Transfer (EFT) Payment and CHOWs. Prior to the change request, when dealing with a change of ownership (CHOW), Medicare Administrative Contractors (MACs) continued to pay the Seller of a healthcare provider or facility until they received the tie-in notice from the CMS Regional Office. MACs would reject any application submitted by either the Seller or the Buyer to change the EFT account or special payment address prior to receiving approval from CMS. The ultimate responsibility for determining payment arrangements was left to the Buyer and Seller while the MAC and CMS processed the CHOW application.

Effective May 15, 2017, when the Seller and the Buyer initiate a CHOW, the provider agreement in existence, alongside the CMS Certification Number (CCN), is assigned automatically from the Seller to the Buyer effective on the transfer date. It is important to note that the Buyer retains the ability to reject the automatic assignment prior to the transfer date. To reject the automatic assignment of the provider agreement, the Buyer must file an initial participation application with the Medicare program. The assigned provider agreement is still subject to all applicable statutes and regulations as well as the terms and conditions under which it was issued. Any contractor will continue to adjust payments to the provider to account for both prior overpayment and underpayment, even if the claims relate to services provided before the CHOW. Additionally, the Buyer in a CHOW may obtain a new National Provider Identifier (NPI) or maintain the existing NPI. Once the CHOW processing is complete, the Seller will no longer be allowed to bill for services furnished after CHOW processing, and only the Buyer is permitted to submit claims using the existing CCN. It is important for parties undergoing CHOW processing to understand that under the implemented changes, any payment arrangement for services furnished during the CHOW processing period is left up to the parties to work out. One primary implication of this is that the Buyer will have some long-term responsibility to bill for services provided by the Seller during CHOW processing.

 

CMS Proposes Change to Joint, Episodic, and Cardiac Rehabilitation Payment Models

By Emmie Futrell, Class of 2018; Patsy Powers, Partner at Waller; Daniel Patten, Associate at Waller

On August 17, 2017, CMS published a proposed rule that could bring about significant changes to some of its Innovation Center’s major payment models. Specifically, the Proposed Rule would:

  • reduce the number of mandatory geographic area participants of the Comprehensive Care for Joint Replacement (CJR) model;
  • cancel the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) incentive payment model; and
  • increase the pool of practitioners that qualify under the Advanced Alternative Payment Model.

These changes may be surprising to some as these models are still in their infancy. The CJR model started last year, and the EPMs and CRs were not scheduled to begin until January 1, 2018.

Perhaps the most striking element of the Proposed Rule is the removal of 33 geographic areas (of the currently 64 geographic areas) where participation in the CJR model has been mandatory. Instead, CMS proposes that such hospitals participate in the CJR model on a voluntary basis, especially hospitals with low volume or those located in rural areas. These hospitals are provided with a one-time option whereby continued participation in the CJR model will be left to their discretion. CMS believes that moving the CJR model away from a mandatory requirement will increase the likelihood that providers will participate in future voluntary initiatives. Hospitals that choose to continue participation in the CJR model will receive a target price for these procedures from CMS each year, and the proposed rule includes refinements and clarifications to this payment process.

CMS is accepting public comments on these revisions, which can be electronically submitted here, until October 16, 2017.

CMS Modernizes Conditions of Participation for Home Health Agencies

By Will Blackford, Class of 2017

On January 13, 2017, the Centers for Medicare and Medicaid Services (“CMS”) published in the Federal Register its Final Rule pertaining to the Conditions of Participation (“CoPs”) for home health agencies (“HHAs”). The rule represents the first modernization in over two decades of the fundamental requirements for HHA participation in Medicare and Medicaid, despite efforts in 1997 to revise the entire set of HHA CoPs. With enforcement of the new provisions beginning July 13, 2017, CMS has given HHAs a six-month window for adapting their policies, procedures, and practices to comply with the new standards.

The most significant changes under the Final Rule revolve around four categories:

  • Patient Rights. CMS added an expansive CoP that sets forth the specific rights that HHAs owe each patient and the steps they must take to protect such rights.
  • Care Planning. The final rule updates the comprehensive patient assessment requirement to focus on all aspects of patient wellbeing. It also requires that a HHA provide its patients with a written copy of the plan of care and utilize an integrated communication system to identify and coordinate care between the HHA and the patient’s physicians.
  • Quality Assessment and Performance Improvement. To ensure continual evaluation and improvement of care for patients, CMS will now require that HHAs initiate a data-driven, agency-wide quality assessment and performance improvement (QAPI) program that is capable of measuring improvement in indicators that are linked to improvement in patient outcomes, safety and care quality.
  • Infection and Prevention Control. The new infection prevention and control requirement that focuses on the use of standard infection control practices, and patient/caregiver education and teaching.

In addition to the modified care standards, CMS also refined the definition of “Representative” to expressly distinguish between a patient-selected representative and a legal representative with legal decision-making authority under the law. There are numerous updates throughout the Final Rule that are shaped by this two-tiered approach to representation.

To meet these new requirements, HHAs need to familiarize themselves with the Final Rule and analyze their current policies and procedures to formulate a plan for tackling implementation of these significant changes. Agencies that fail to comply with any of the new CoPs by the July 13, 2017 deadline are at risk of penalties ranging from imposition of sanctions for marginal issues, to program termination for major infractions.