Tag: medicare

New access standards for veterans to receive community care

Philip FitzGerald, Class of 2019; Colin H. Luke, Partner at Waller

Last month, the Department of Veterans Affairs (“VA”) proposed new access standards for community care as part of the implementation of the MISSION Act, which President Trump signed into law last June. One goal of the MISSION Act is to provide veterans with greater access to medical care by allowing them to use private care outside the VA system.

Although several confusing avenues currently exist for veterans to qualify for outside care, the new access standards would consolidate and simplify the process by basing eligibility on average drive times and appointment wait times. For primary care, mental health and non-institutional extended care services, the VA is proposing that veterans who must drive an average of 30 minutes for services, or who must wait longer than 20 days for an appointment, may seek care with an eligible community provider. For specialty care, the VA is proposing more stringent standards – a 60-minute drive time or a longer than 28-day wait to obtain an appointment. Veterans will also have access to urgent care that gives them the choice to receive certain services when and where they need it. The new access standards are set to go into effect in June.

According to the VA’s Fiscal Year 2019 Budget Submission, community care accounted for around $9.7 billion in 2018. Under the new access standards, the VA expects the number of veterans eligible for community care to almost triple. Of the $66 billion the VA spent on health care services in 2018, excluding community care, $38.5 billion went to ambulatory services, $14 billion went to inpatient care and $8 billion went to mental health care. The remainder went to prosthetics, dental care, and rehabilitation. With the expansion of access for veterans, a larger portion of these services will likely be supplied by community care providers.

Under the MISSION Act, the VA is required to establish networks to ensure veterans get access to community care from eligible providers. Eligible community care providers include providers who participate in Medicare, aging and disability resource centers, federally qualified health centers, and centers for independent living. Unlike prior community care programs which failed to make timely payments to providers (e.g., Veteran’s Choice Program (“VCP”)), the VA will be required to reimburse services under a prompt payment standard (i.e., within 45 calendar days upon receipt of a clean paper claim, or 30 calendar days upon receipt of a clean electronic claim).

Providers who wish to provide services for veterans must contract with their region’s Community Care Network (“CCN”) administrator. The CCN is a set of contracts awarded to as many as four private sector contractors who are tasked with developing and administering six regional networks of high-performing licensed health care providers. To date, contracts for regions 1-3, which include the East, South, and Midwest, have been awarded to Optum Public Sector Solutions, Inc., a subsidiary of UnitedHealth. Following the deployment of the CCN, the selected contractor in each region will begin contracting with providers.

However, until the CCN is deployed nationwide, providers who meet certain eligibility requirements can partner with TriWest Healthcare Alliance’s community care network, the VCP administrator during the transition. Under the VCP, community providers must meet these eligibility requirements:

  • Accept Medicare rates;
  • Meet Medicare Conditions for Coverage and Conditions of Participation or other criteria established by the VA;
  • Be in compliance with all applicable federal and state regulatory requirements;
  • Have same or similar credentials as VA staff;
  • Submit a copy of the medical records to the TPA for medical care and services provided to Veterans for inclusion in the VA record; and,
  • Be eligible according to the U.S. Department of Health and Human Services Office of Inspector General Exclusion Program.

The Veteran’s Choice Program will statutorily sunset after June 6, 2019, so providers should be cognizant of potential changes in provider eligibility standards as the MISSION Act takes effect.

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.