Hospitals that don’t make money often end up shut down. While care quality is important, clinics and hospitals that aren’t profitable have no future. To ensure that isn’t the case, chronic care management solutions like virtual care and remote patient monitoring services are necessary to keep facilities in the green. Here’s how they help improve ROI for hospitals and clinics. 

• Chronic management paves the way for RPM reimbursements

Facilities can offer chronic care management through remote patient monitoring technology such as that which leading providers Aura Health provides. Here’s the financial potential of RPM reimbursements for facilities of all kinds:

• $21 for patient education and set up of the technology
• $56 for 30-day monitoring and daily recordings
• $53/$42 for additional patient monitoring

You can get the complete breakdown of Medicare reimbursements from Aura website’s page, under Resources. Be sure to pay them a visit to find just how your clinic or hospital stands to gain from using these technologies in your chronic care management process. 

• Fewer physician visitation costs with the right technology 

Chronic care management traditionally attracts regular physician and patient appointments. For critically ill patients, physicians often have to meet them at their residences, which can be costly as facilities have to fork out allowances for doctors and also meet travel expenses, among other costs. 

However, leveraging virtual care solutions in chronic care management can reduce these costs greatly. Physicians can easily follow up with patients regarding their condition and vitals remotely without having to meet them in person. In the end, this means doctors travel less, and thus hospitals also spend less as a whole. 

• Improved clinical staff productivity that increases profitability 

Many factors shape the course of a facility’s ROI. Another critical part of the equation upon which ROI also depends is employee productivity. Chronic care management can be tedious work that causes burnout. But with virtual care solutions, clinical employee output improves leading to a better bottom line due to: 

• Decreased staff turnover which lowers rehiring costs for clinics and hospitals
• Lowered rates of absenteeism and thus facilities maximize their work hours
• Enhanced patient satisfaction levels, which leads to more referrals and new business

• Better patient engagement and satisfaction 

ROI for clinics and hospitals isn’t always a monetary metric. Patient engagement and satisfaction is also another critical ROI indicator. Chronic care management, with the intervention of RPM and virtual care solutions, can bolster patient-physician relationships by allowing patients to seek on-demand clarification and stay connected with their caregivers.

Thanks to a combination of audio and video technology involved in modern chronic care management solutions, there’s better coordination of care, improved health outcomes, and better engagement/satisfaction. In the end, this increases a facility’s brand standing and referral appeal. 

• Fewer readmissions rates and thus a healthier bottom line

Lowering readmission rates has obvious benefits for patients but it can also have positive impacts on ROI for care facilities as well.  For instance, let’s consider the financial repercussions of rehospitalization to put this into perspective: 

• High readmission leads to low patient satisfaction which increases patient turnover
• Rehospitalization piles workload burdens on healthcare staff and thus curtails productivity 
• Readmissions can attract expensive lawsuits

As you can see, hospitals and clinics have much to gain from improving chronic care management to lower readmissions, and modern technology like RPM and virtual care are the solutions. 

• Pay-as-you-use profitable model when outsourced

Often, care facilities have to bring in specialists to help with chronic care management, especially when it comes to cardiology care. This can mean adding clinical staff to a payment payroll when their services are only needed intermittently. 

Modern chronic care management solutions can again help hospitals and clinics dodge this financial bullet. RPM and virtual care solution providers like Aura Health provide these specialists and expertise on a per-use basis, which makes more financial sense and enhances ROI. 

• Virtual chronic care management can expand market base

More so for patients living in rural areas or remote locations, access to proper chronic care can be a huge headache. This also translates to an ROI problem for facilities, as they are unable to serve patients in certain geographical zones. 

However, telehealth chronic care management presents an opportunity for facilities to reach these types of consumers, and thus widen their market reach. On top of that, it also allows facilities to run beyond their occupancy, reserving admissions for high-risk cases while others are tended to remotely. 

Conclusion

Chronic care management paves the way for RPM and virtual care technologies that tremendously increase ROI even beyond the financial perspective. RPM programs alone have been shown to improve cost savings for clinics and facilities annually by over $8,375 per patient. So imagine the financial reprieve on a single facility’s bottom line when this benefit is magnified by its total patient base. If you’d like to improve your facility’s ROI, be sure to visit the Aura Health website for more details. 

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Once mastered, the remote patient monitoring platform gives the practice a pathway to establishing meaningful care management.

June 07, 2021 – As the nation’s healthcare ecosystem looks to embrace value-based care, concepts like remote patient monitoring are gaining favor with providers—particularly medical practices—who want to improve care management.

As with any relatively new service, remote patient monitoring has a few definitions. Basically, it means what it says: monitoring a patient in a remote location, most often the home. This is usually done with mHealth devices that capture selected data and transmit that data back to a provider, who uses that data to manage care. 

From that point, the modifications are endless—different devices in the home that monitor more than just basic vital signs, hubs that gather data automatically, without patient participation, telehealth platforms that allow patient and provider to collaborate, either by voice audio-visual technology, and sophisticated platforms that collect and analyze that data, sometimes using AI technology, so that the provider sees what he or she needs to see and can make informed clinical decisions.

The best guidance for remote patient monitoring comes from the Centers for Medicare & Medicaid Services, which in 2019 began allowing Medicaid coverage for “the collection and analysis of patient physiologic data that are used to develop and manage a treatment plan related to chronic and/or acute health illness or condition.” Medicare coverage for those services is contained in CPT codes 99091, 99453, 99454, 99457, and 99458.

CMS has revised coverage each year for RPM, though at a slow pace. The agency has traditionally held off on embracing new technology until there’s ample proof that it improves outcomes, saves money, and helps providers improve care management. Because RPM is new, there haven’t yet been enough studies and pilot programs that would prove that point. That’s changing, due in large part to the rapid adoption of telehealth and RPM during the coronavirus pandemic. Most connected health advocates expect that CMS will be more receptive to RPM coverage in the future.

The Roots of Remote Patient Monitoring

Providers were experimenting with remote patient monitoring long before COVID-19 thrust the strategy into the spotlight. Intrigued by the fast-growing consumer wearables market and mHealth platforms that introduced mobility to data capture, they wanted to monitor their patients in between visits to the hospital or doctor’s office. These platforms would give them insight into their patients’ daily health and activities, allowing them to chart and adjust care management on the fly.

At that time, payers and even a vast majority of providers were slow to embrace the concept, worried that the devices weren’t capturing reliable and accurate data. They envisioned doctors swamped with information they didn’t need or couldn’t use or basing clinical decisions on inaccurate information. 

While there’s no real “tipping point” for RPM acceptance, the platform gained legitimacy when CMS defined the term and set aside a few CPT codes for coverage in 2019. The agency specifically separated these codes from telehealth coverage, giving RPM its own niche. Reimbursement was minimal, in many cases not enough to steer a provider toward RPM, but the die had been cast. 

As the technology improved—clinical devices that could capture reliable data and safely transmit that data to the cloud, platforms or hubs that could gather and collate that data, and dashboards that could show doctors what they need or want—more providers tried out RPM. Early models focused on patients post-discharge from the hospital (especially following surgeries or major illnesses) and in need of care management or rehabilitation at home or those with chronic conditions requiring monitoring to make sure they were following a care plan. 

COVID-19 changed the game dramatically. Faced with the need to eliminate or at least reduce in-person treatment and push as much care as possible out of the hospital or doctor’s office and into the home, providers rushed to embrace RPM programs. Many were hastily developed and launched, taking advantage of emergency federal and state measures to boost access to and coverage of connected health programs. The idea was to get something up and running quickly, improving and evolving as time permitted.

In this atmosphere, RPM and other telehealth programs accomplished roughly 20 years of evolution in less than two years. The tools and technology are now mainstream, and providers consider them a necessity rather than a luxury. 

How RPM Can Fit Into a Medical Practice’s Playbook

As the nation shifts into gear after the pandemic, medical practices are facing a tough road. They’re pressured on one side by health systems looking to expand their footprint and on the other side by the fast-growing retail health sector—everything from stand-alone and retail health clinics to direct-to-consumer telehealth programs launched by the likes of Amazon, Google, Walmart, and Walgreens. They’re also trying to lure back a patient population still leery of in-person care.

Remote patient monitoring offers these clinics not only a way to restore that relationship with patients but a platform to enhance care and position themselves for the emerging value-based care landscape, one that supports care coordination and management and factors in health and wellness. It’s not out of this world to suggest that this may be a lifeline for some clinics.

In the past, clinics built their business on a busy waiting room. Patients came to them for care, and they kept coming back for that care. Care plans were adjusted in follow-up visits, during which patients filled in the gaps by talking about what had happened since the last visit. 

Connected health technology has changed that paradigm to address those gaps. Providers now have a means of providing continuous care and the tools to look in on patients at any time, communicating and even collaborating with them on their care. They can capture vital signs and track trends, adjust care plans to address those trends, pull specialists in for consults, get a peek at the patient’s home life and daily routine, even push resources out to the patient to address a wide range of issues, from diet and exercise to substance abuse and mental health.

A crucial component of this platform is the ability to provide 24/7 coverage, giving patients the comfort of knowing someone is always keeping an eye on them. More importantly, it allows providers to identify emerging, potentially serious health concerns and quickly step in to address them through a telehealth call or an in-person visit. 

Through remote patient monitoring, a medical practice has the opportunity to create a more robust care plan for its patients, offering more touches along the way to manage health, improve outcomes and reduce the chance of serious and catastrophic health concerns down the road. This fits in with the emerging concept of value-based care, which is patterned on continual collaboration rather than periodic or episodic care.

In addition, a practice that maintains a strong RPM platform and relationship with its patients can market that service to consumers looking for a better relationship with a primary care physician. That’s an important selling point in an era where more and more people are looking for fast, convenient, and inclusive care and relying less and less on in-person visits.

Creating a Foundation for Remote Patient Monitoring

Launching an RPM program within a medical practice is complex and involves not only choosing the right technology but selecting the right patients and parameters and developing the right atmosphere within the practice. There’s a lot of planning that goes into the process long before the go-live date, and a lot of work that goes into making sure the results meet expectations for both patients and providers. Continued and steady success can lead to sustainability, which in turn can pave the way for scalability.

The first question to ask, obviously, is whether to partner with an RPM vendor or go it alone. The answer usually boils down to whether a practice can handle the extra workload without overwhelming doctors and nurses. Because RPM is relatively new, many practices don’t have the experience or the examples to draw from to develop an in-house RPM service. They’re looking for a simple, easy-to-use platform that addresses their goals and fits their workflows.

Some practices may have the resources to launch their own program, but the most viable path forward for most is to partner with a vendor. This offers the freedom to focus on clinical duties, while the vendor handles the administrative tasks and – just as important – audits and billing. 

The foundation upon which an RPM program is built is its technology base, and privacy and security are primary components of that foundation. A platform that gathers personal health data in one place and transmits it to at least one other location has to ensure that the data is secure at every point of that journey. This goes beyond ensuring that the service meets HIPAA (Health Insurance Portability and Accountability Act) guidelines, and includes using reliable and secure technology that protects data, allows the proper people to gain access, and protects the platform from hackers.

Once that base is established, a practice must select the technology that best suits its needs. This goes hand-in-hand with selecting the right patients for the platform. Once that target population is identified, a practice needs to determine what data it wants from the patient in the home and choose the right device (or devices) to capture that data. That’s not always an easy task, especially if you’re taking into account patients with more than one chronic condition or planning on expanding the platform to target other conditions and patients. A small program with a narrow patient base and few measurables might be good for a practice just stepping into the RPM sandbox, but sustainability and scalability will depend on the ability to expand that base.

At this point it’s important to address connectivity. An RPM program won’t work if the devices aren’t able to reliably transmit data back to the care provider. One of the first tasks in launching an RPM service is determining connectivity in the home. Some programs use Wi-Fi networks and Bluetooth-compatible devices, while others use LTE devices and cellular networks. There are arguments to be made for and against both strategies, so it’s important that a practice assess the available networks in its area to determine which platform would work best.

Another important factor to a good RPM platform is its ability to easily access a patient’s medical records. Integration with the EHR (electronic health record) allows providers to enter data directly into the medical record and access data important to care management. RPM platforms that automatically enter all data, including provider-patient interactions and communications, into the EHR give the practice a time-stamped, audit-friendly transcript, an important detail for measuring success and adhering to regulatory requirements.

Because of the emergency measures enacted during the pandemic public health emergency to speed the adoption of telehealth and RPM platforms, many providers rushed into the fray with whatever they could get their hands on. That was fine for that time, but those platforms may not hold up once the PHE ends and more stringent rules shift back into place. Practices need to make sure their RPM platforms hold up to privacy and security standards established before COVID-19, and they need to make sure that the platform—launched to track and treat COVID-19 patients at home—can adapt to other types of patients, other tools, and other benchmarks. 

The telehealth and RPM technology market is robust, made even more so by the innovation spurred on by COVID-19. RPM tools and platforms are popular now, and there’s plenty to choose from. The trick is in finding the right platform to fit the needs of the practice now, one that can adjust to new needs in the future. A practice that fails to plan for growth won’t grow.

Choosing the Right Parameters

Successful remote patient monitoring programs start with a strictly defined patient population – cardiac care, hypertension, post-operative rehab, diabetes – and a clear protocol for tracking data, so that progress can be easily measured and quantified. Many programs start small and then build up, adding new populations, parameters, and devices as they feel comfortable with the system.

Progress is measured in benchmarks, such as a reduction in hospitalizations, improved medication compliance, or a reduction in alarms caused by vital signs that track outside parameters. In that light, it’s important to set the right parameters for data coming in from RPM devices—too narrow, and the alerts come in too often for marginal concerns; too loose, and early indications of a trend that might lead to a serious health concern can be missed. 

A good rule of thumb is to choose a population that’s costing the practice a lot of money in unmanaged care expenses and hospitalizations, such as those with uncontrolled hypertension or diabetes or those who treat the emergency room as a primary care resource. These are patients who would most benefit from remote patient monitoring and who would show measurable results through adherence that prove the program’s success.

The use cases for RPM are growing quickly, as care providers become comfortable with the platform and look for new populations – and care gaps – to address. Cardiac care, hypertension, diabetes, maternal care, post-operative discharge are popular now, but providers are already looking to branch out, with programs that address behavioral health and substance abuse, COPD, asthma, even Alzheimer’s and Parkinson’s. If there’s a patient population that would benefit from monitoring at home, someone is going to develop an RPM program for them.

The Human Factor in Remote Patient Monitoring

Technology may be the underpinning of a successful RPM program, but that success won’t happen without a trained and motivated staff—one that understands what’s necessary to make the program work and, above all else, keep patients engaged. 

Before getting into RPM, a practice must make sure that everyone is on board with the program. It will mean changing workflows and responsibilities, and that means training everyone ahead of time, so there are no surprises. This is especially important for nurses, who see the data coming in from RPM programs and interact with patients more frequently than doctors. They need to understand not only how the system works but also how they make it run better, including when to talk to patients and how to identify those emerging concerns that require a doctor’s intervention.

They also need to know how to work with patients in the program and how to keep them engaged. RPM programs won’t work if patients aren’t invested in the outcomes and interested in helping to manage their own care. 

In short, remote patient monitoring platforms aren’t solely about gathering data. They’re about connecting with patients at home to see how they’re doing, helping them with their care plan, and giving them support, guidance, and resources to improve their health and well-being. 

Setting the State for RPM in a Hybrid Platform

Remote patient monitoring and telehealth won’t and shouldn’t replace in-person care, but they will help medical practices reduce unnecessary, costly, and time-consuming visits and make the visits that are required more meaningful and impactful. The challenge lies in identifying the services that can be handled by virtual care and those which require in-person treatment.

Medical practices stand at a unique crossroads in healthcare, and a robust and scalable remote patient monitoring platform can help them choose the right path to value-based care. This involves a significant transition from episodic care to continuous care management and an understanding that healthcare is best managed with a strategy that combines virtual and in-person care.

Once mastered, the RPM platform gives the practice a pathway to establishing meaningful care management, one that relies on round-the-clock care, virtual interactions and resources that address the gaps in episodic care. Without the platform, you’re left waiting for an episodic healthcare event; with it, you’re managing, and improving, long-term health.

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On December 1, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that includes updates on policy changes for Medicare payments under the Physician Fee Schedule (PFS), and other Medicare Part B issues, on or after January 1, 2021.

Background on the Physician Fee Schedule

Since 1992, Medicare has paid for the services of physicians and other billing professionals under the PFS. Physicians’ services paid under the PFS are furnished in a variety of settings, including physician offices, hospitals, ambulatory surgical centers, skilled nursing facilities and other post-acute care settings, hospices, outpatient dialysis facilities, clinical laboratories, and beneficiaries’ homes. Payment under the PFS is also made to several types of suppliers for technical services, often in settings for which no institutional payment is made. For most services furnished in a physician’s office, Medicare makes payment to physicians and other professionals at a single rate based on the full range of resources involved in furnishing the service. In contrast, PFS rates paid to physicians and other billing practitioners in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center, reflect only the portion of the resources typically incurred by the practitioner in the course of furnishing the service. For many diagnostic tests and a limited number of other services under the PFS, separate payment can be made for the professional and technical components of services. The technical component is frequently billed by suppliers like independent diagnostic testing facilities and radiation treatment centers, while the professional component is billed by the physician or practitioner.

Payments are based on the relative resources typically used to furnish the service. Relative value units (RVUs) are applied to each service for physician work, practice expense, and malpractice. These RVUs become payment rates through the application of a conversion factor. Payment rates are calculated to include an overall payment update specified by statute.

PAYMENT PROVISIONS

CY 2021 PFS Ratesetting and Conversion Factor

CMS is finalizing a series of standard technical proposals involving practice expense, including the implementation of the third year of the market-based supply and equipment pricing update, and standard rate-setting refinements to update premium data involving malpractice expense and geographic practice cost indices (GPCIs).

With the budget neutrality adjustment, as required by law, to account for changes in RVUs including significant increases for E/M visit codes, the final CY 2021 PFS conversion factor is $32.41, a decrease of $3.68 from the CY 2020 PFS conversion factor of $36.09. The PFS conversion factor reflects the statutory update of 0.00 percent and the adjustment necessary to account for changes in relative value units and expenditures that would result from finalized policies.

Medicare Telehealth and Other Services Involving Communications Technology

For CY 2021, we are finalizing the addition of the following list of services to the Medicare telehealth list on a Category 1 basis. Services added to the Medicare telehealth list on a Category 1 basis are similar to services already on the telehealth list:

• Group Psychotherapy (CPT code 90853)
• Psychological and Neuropsychological Testing (CPT code 96121)
• Domiciliary, Rest Home, or Custodial Care services, Established patients (CPT codes 99334-99335)
• Home Visits, Established Patient (CPT codes 99347-99348)
• Cognitive Assessment and Care Planning Services (CPT code 99483)
• Visit Complexity Inherent to Certain Office/Outpatient Evaluation and Management (E/M) (HCPCS code G2211)
• Prolonged Services (HCPCS code G2212)

Additionally, we are finalizing the creation of a third temporary category of criteria for adding services to the list of Medicare telehealth services. Category 3 describes services added to the Medicare telehealth list during the public health emergency (PHE) for the COVID-19 pandemic (COVID-19 PHE) that will remain on the list through the calendar year in which the PHE ends.

We sought comment on services added on an interim basis to the Medicare telehealth list during the COVID-19 PHE that CMS did not propose to add to the Medicare telehealth list permanently or temporarily on a category 3 basis. Based on those comments we are finalizing the addition of a number of services to the Medicare telehealth list on a category 3 basis.

We are finalizing the addition of the following list of services to the Medicare telehealth list on a Category 3 basis:

• Domiciliary, Rest Home, or Custodial Care services, Established patients (CPT codes 99336-99337)

• Home Visits, Established Patient (CPT codes 99349-99350)
• Emergency Department Visits, Levels 1-5 (CPT codes 99281-99285)
• Nursing facilities discharge day management (CPT codes 99315-99316)
• Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes 96136-96139)
• Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521-92524, 92507)
• Hospital discharge day management (CPT codes 99238-99239)
• Inpatient Neonatal and Pediatric Critical Care, Subsequent (CPT codes 99469, 99472, 99476)
• Continuing Neonatal Intensive Care Services (CPT codes 99478-99480)
• Critical Care Services (CPT codes 99291-99292)
• End-Stage Renal Disease Monthly Capitation Payment codes (CPT codes 90952, 90953, 90956, 90959, 90962)
• Subsequent Observation and Observation Discharge Day Management (CPT codes 99217; CPT codes 99224-99226)

In response to stakeholders who have stated that the once every 30-day frequency limitation for subsequent nursing facility (NF) visits furnished via Medicare telehealth provides unnecessary burden and limits access to care for Medicare beneficiaries in this setting, we proposed to revise the frequency limitation from one visit every 30 days to one visit every 3 days. We also sought comment on whether it would enhance patient access to care if we were to remove frequency limitations altogether, and how best to ensure that patients would continue to receive necessary in-person care. Based on information from commenters about creating a disincentive for in-person care and after additional consideration of how patients in the NF setting, in general, tend to have longer lengths of stay when compared to patients in the inpatient setting, we reconsidered, including considering whether the frequency limitations for subsequent visits furnished via telehealth in the NF setting should be the same as in the inpatient setting.  We are therefore finalizing a frequency limitation for subsequent NF telehealth visits of one visit every 14 days.

We also clarified that licensed clinical social workers, clinical psychologists, physical therapists (PTs), occupational therapists (OTs), and speech-language pathologists (SLPs) can furnish the brief online assessment and management services as well as virtual check-ins and remote evaluation services. In order to facilitate billing by these practitioners for the remote evaluation of patient-submitted video or images and virtual check-ins (HCPCS codes G2010 and G2012), we are establishing two new HCPCS G codes.

We have also received questions as to whether services should be reported as telehealth when the individual physician or practitioner furnishing the service is in the same location as the beneficiary; for example, if the physician or practitioner furnishing the service is in the same institutional setting but is utilizing telecommunications technology to furnish the service due to exposure risks. We are, therefore, reiterating in this final rule that telehealth rules do not apply when the beneficiary and the practitioner are in the same location even if audio/video technology assists in furnishing a service.

In the March 31, 2020 COVID-19 interim final rule with comment (IFC), we established separate payment for audio-only telephone (E/M) services. While we did not propose to continue to recognize these codes for payment under the PFS in the absence of the COVID-19 PHE, we noted that the need for audio-only interactions could remain as beneficiaries continue to try to avoid sources of potential infection, such as a doctor’s office. We sought comment on whether CMS should develop coding and payment for a service similar to the virtual check-in but for a longer unit of time and consequently with a higher value. We also sought input from the public on the duration of the services and the resources in both work and practice expense involved in furnishing this service. We sought comment on whether this should be a provisional policy to remain in effect until a year after the end of the COVID-19 PHE, or should be adopted as permanent PFS payment policy. Based on support from commenters we are establishing payment on an interim final basis for a new HCPCS G-code describing 11-20 minutes of medical discussion to determine the necessity of an in-person visit.

Remote Physiologic Monitoring Services

In recent years, CMS has finalized payment for seven remote physiologic monitoring (RPM) codes. In response to stakeholder questions about RPM, CMS clarified in the CY 2021 PFS final rule our payment policies related to the RPM services described by CPT codes 99453, 99454, 99091, 99457, and 99458. In addition, we finalized as permanent policy two modifications to RPM services that we finalized in response to the COVID-19 PHE.

• We clarified that after the COVID-19 PHE ends, there must be an established patient-physician relationship for RPM services to be furnished.
• We finalized that consent to receive RPM services may be obtained at the time that RPM services are furnished.
• We finalized that auxiliary personnel may provide services described by CPT codes 99453 and 99454 incident to the billing practitioner’s services and under their supervision. Auxiliary personnel may include contracted employees.
• We clarified that the medical device supplied to a patient as part of RPM services must be a medical device as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act, that the device must be reliable and valid, and that the data must be electronically (i.e., automatically) collected and transmitted rather than self-reported.
• We clarified that after the COVID-19 PHE ends, 16 days of data each 30 days must be collected and transmitted to meet the requirements to bill CPT codes 99453 and 99454.
• We clarified that only physicians and NPPs who are eligible to furnish E/M services may bill RPM services.
• We clarified that RPM services may be medically necessary for patients with acute conditions as well as patients with chronic conditions.
• We clarified that for CPT codes 99457 and 99458, an “interactive communication” is a conversation that occurs in real-time and includes synchronous, two-way interactions that can be enhanced with video or other kinds of data as described by HCPCS code G2012.  We further clarified that the 20-minutes of time required to bill for the services of CPT codes 99457 and 99458 can include time for furnishing care management services as well as for the required interactive communication.

Immunization Services

In the CY 2021 PFS final rule we are maintaining payment rates for immunization administration services described by CPT codes 90460, 90461, 90471, 90472, 90473, and 90474, and HCPCS codes G0008, G0009, and G0010 at their CY 2019 payment levels in consideration of payment stability for stakeholders, public health concerns and the importance of these services for Medicare beneficiaries.

Direct Supervision by Interactive Telecommunications Technology

For the duration of the COVID-19 PHE, for purposes of limiting exposure to COVID-19, we adopted an interim final policy revising the definition of direct supervision to include virtual presence of the supervising physician or practitioner using interactive audio/video real-time communications technology (85 FR 19245). We recognized that in some cases, the physical proximity of the physician or practitioner might present additional infection exposure risk to the patient and/or practitioner.

In the CY 2021 PFS proposed rule, CMS proposed to allow direct supervision to be provided using real-time, interactive audio and video technology (excluding telephone that does not also include video) through the later of the end of the calendar year in which the PHE ends or December 31, 2021. We sought information from commenters as to whether there should be any guardrails in effect if we finalize this policy through the year in which the PHE ends or December 31, 2021, or if we were to consider it beyond the time specified and what risks this policy might introduce to beneficiaries as they receive care from practitioners that would supervise care virtually in this way. In addition to comments regarding patient safety/clinical appropriateness, we also sought comment on potential concerns around induced utilization and fraud, waste, and abuse and how those concerns might be addressed.

After consideration of public comment, we are finalizing that direct supervision may be provided using real-time, interactive audio and video technology through the later of the end of the calendar year in which the PHE ends or December 31, 2021.

Payment for Office/Outpatient Evaluation and Management (E/M) and Analogous Visits

As finalized in the CY 2020 PFS final rule, in CY 2021 we will be largely aligning our E/M visit coding and documentation policies with changes laid out by the CPT Editorial Panel for office/outpatient E/M visits, beginning January 1, 2021. We are finalizing revisions to the times used for rate-setting for the office/outpatient E/M visit code set.

We are finalizing revaluation of the following code sets that include, rely upon or are analogous to office/outpatient E/M visits commensurate with the increases in values we finalized for office/outpatient E/M visits for CY 2021:

• End-Stage Renal Disease (ESRD) Monthly Capitation Payment (MCP) Services
• Transitional Care Management (TCM) Services
• Maternity Services
• Cognitive Impairment Assessment and Care Planning
• Initial Preventive Physical Examination (IPPE) and Initial and Subsequent Annual Wellness Visits (AWV)
• Emergency Department Visits
• Therapy Evaluations
• Psychiatric Diagnostic Evaluations and Psychotherapy Services

We are also clarifying the definition of HCPCS add-on code G2211(formerly referred to as GPC1X), previously finalized for office/outpatient E/M visit complexity, and refining our utilization assumptions for this code. In the proposed rule, we assumed that this code would be reported with 100% of office/outpatient E/M visits by specialties that rely on office/outpatient E/M visits to report the majority of their services.  Because we think it may take some time for practitioners to begin reporting HCPCS add-on code G2211, for CY 2021, we are assuming that it will be reported with 90% of office/outpatient E/M visits by specialties that rely on office/outpatient E/M visits to report the majority of their services.  

We are also finalizing separate payment for a new HCPCS code, G2212, describing prolonged office/outpatient E/M visits to be used in place of CPT code 99417 (formerly referred to as CPT code 99XXX) to clarify the times for which prolonged office/outpatient E/M visits can be reported   

Policies Regarding Professional Scope of Practice and Related Issues

1. Supervision of Diagnostic tests by Certain Nonphysician Practitioners (NPPs)

CMS is finalizing our proposal to make permanent following the COVID-19 PHE, the same policy that was finalized under the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629) for the duration of the COVID-19 PHE to allow nurse practitioners (NPs), clinical nurse specialists (CNSs), physician assistants (PAs), and certified nurse-midwives (CNMs) to supervise the performance of diagnostic tests within their scope of practice and state law.  We are adding certified registered nurse anesthetists (CRNAs) to this list. These practitioners must maintain the required statutory relationships under Medicare with supervising or collaborating physicians. 

2. Pharmacists Providing Services Incident to Physicians’ Services

CMS is reiterating the clarification provided in the May 1, 2020 COVID-19 IFC (85 FR 27550 through 27629), that pharmacists may fall within the regulatory definition of auxiliary personnel under our “incident to” regulations. As such, pharmacists may provide services incident to the services, and under the appropriate level of supervision, of the billing physician or NPP, if payment for the services is not made under the Medicare Part D benefit. This includes providing the services incident to the services of the billing physician or NPP and in accordance with the pharmacist’s state scope of practice and applicable state law.

3. Therapy Assistants Furnishing Maintenance Therapy

In the CY 2021 PFS final rule, CMS finalized the Part B policy for maintenance therapy services that was adopted on an interim basis for the PHE in the May 1, 2020 COVID-19 IFC (85 FR 27556).  This finalized policy allows physical therapists (PT) and occupational therapists (OT) to delegate the furnishing of maintenance therapy services, as clinically appropriate, to a physical therapy assistant (PTA) or an occupational therapy assistant (OTA). This Part B policy allows PTs/OTs to use the same discretion to delegate maintenance therapy services to PTAs/OTAs that they utilize for rehabilitative services.

4. Medical Record Documentation

In the CY 2020 PFS final rule, CMS finalized broad modifications to the medical record documentation requirements for physicians and certain NPPs. In this CY 2021 PFS final rule, we are clarifying that physicians and NPPs, including therapists, can review and verify documentation entered into the medical record by members of the medical team for their own services that are paid under the PFS. We are also clarifying that therapy students, and students of other disciplines, working under a physician or practitioner who furnishes and bills directly for their professional services to the Medicare program, may document in the record so long as the documentation is reviewed and verified (signed and dated) by the billing physician, practitioner, or therapist.

5. PFS Payment for Services of Teaching Physicians and Resident “Moonlighting” Services

For residency training sites of a teaching setting that are outside of a metropolitan statistical area (MSA), the CY 2021 PFS final rule established a policy to allow teaching physicians to use  interactive, real-time audio/video  to interact with the resident through virtual means in order to meet the requirement that they be present for the key portion of the service, including when the teaching physician involves the resident in furnishing Medicare telehealth services. In addition, for residency training sites of a teaching setting that are outside of an MSA, the CY 2021 PFS final rule allows teaching physicians involving residents in providing care at primary care centers to provide the necessary direction, management and review for the resident’s services using interactive, real-time audio/video communications technology. For these sites, residents furnishing services at primary care centers may furnish an expanded set of services to beneficiaries, including communication technology-based services and inter-professional consults.

These flexibilities do not apply in the case of surgical, high risk, interventional, or other complex procedures, services performed through an endoscope, and anesthesia services. Further, in order to ensure that the teaching physician renders sufficient personal and identifiable physicians’ services to the patient to exercise full, personal control over the management of the portion of the case for which the payment is sought, in accordance with section 1842(b)(7)(A)(i)(I) of the Act, the medical record must clearly reflect how the teaching physician was present to the resident during the key portion of the service.  For example, the medical record could document the physical or virtual presence of the teaching physician during the key portion of the service. 

Finally, the CY 2021 PFS final rule permanently expanded the settings in which residents may moonlight to include the services of residents that are not related to their approved GME programs and which are furnished to inpatients of a hospital in which they have their training program.  In order to prevent the potential duplication of payment with the Inpatient Prospective Payment System (IPPS) for GME, and regardless of whether the resident’s services are performed in the outpatient department, emergency department or inpatient setting of a hospital in which they have their training program, the medical record must show that the resident furnished identifiable physician services that meet the conditions of payment of physician services to beneficiaries in providers in § 415.102(a); that the resident is fully licensed to practice medicine, osteopathy, dentistry, or podiatry by the State in which the services are performed; and that the services are not performed as part of the approved GME program.
 

Medicare Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs (OTPs)

Section 2005 of the Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act established a new Medicare Part B benefit category for opioid use disorder (OUD) treatment services, including medications for medication-assisted treatment (MAT), furnished by opioid treatment programs (OTPs) during an episode of care beginning on or after January 1, 2020. As part of CY 2020 PFS rulemaking, CMS implemented coverage requirements and established new coding and payment describing a bundled episode of care for treatment of OUD furnished by OTPs.

In the CY 2021 PFS final rule, CMS is finalizing the proposal to extend the definition of OUD treatment services to include opioid antagonist medications, specifically naloxone, that are approved by Food and Drug Administration under section 505 of the Federal Food, Drug, and Cosmetic Act for emergency treatment of opioid overdose, as well as overdose education. CMS is also finalizing the proposed creation of a new add-on code to cover the cost of providing patients with nasal naloxone and pricing this code based upon the methodology set forth in section 1847A of the Act, except that the payment amount shall be average sales price (ASP) + 0.  Since auto-injector naloxone is no longer available in the marketplace, CMS is instead finalizing a second new add-on code to cover the cost of providing patients with injectable naloxone and is contractor pricing this code for CY 2021. CMS is finalizing the proposal to apply a frequency limit on the codes describing naloxone, but allowing exceptions in the case where the beneficiary overdoses and uses the supply of naloxone given to them by the OTP, to the extent that the additional supply of naloxone is medically reasonable and necessary.  Additionally, CMS is finalizing our proposal to allow periodic assessments to be furnished via two-way interactive audio-video communication technology. 

Section 2002 of the Support Act

Section 2002 of the SUPPORT Act required the Initial Preventive Physical Examination (IPPE) and Annual Wellness Visit (AWV) to include screening for potential substance use disorders (SUDs) and a review of any current opioid prescriptions. CMS is implementing section 2002 of the SUPPORT Act requirements, which complements existing requirements of the IPPE and AWV. The review of medical history, and therefore, current medications, includes a review of any current opioid prescriptions. Clinicians in the course of conducting the AWV and IPPE may also determine that a referral for further evaluation and management is appropriate for patients who are identified as high risk for SUD. Referral to treatment is a critical component of getting patients who have a possible SUD the necessary care. The new IPPE and AWV elements required by the SUPPORT Act, working in tandem with our existing relevant requirements, will promote the early detection of high risk patients and help empower clinicians to offer appropriate referrals.

Section 2003 of the Support Act

Section 2003 of the SUPPORT Act requires that, effective January 1, 2021, the prescribing of a Schedule II, III, IV, or V controlled substance under Medicare Part D be done electronically in accordance with an electronic prescription drug program, subject to any exceptions, which HHS may specify. To help inform CMS’s implementation of section 2003, we issued a Request for Information entitled “Medicare Program: Electronic Prescribing for Controlled Substances; Request for Information,” as a separate document on July 30, available here. The RFI solicited stakeholder feedback on whether CMS should include exceptions to the electronic prescribing of controlled substances (EPCS) requirement and under what circumstances and whether CMS should impose penalties for noncompliance with the EPCS mandate. We will use this public feedback to draft separate rules to further implement this SUPPORT Act provision in future rulemaking.

To help ensure that section 2003 of the SUPPORT Act is implemented smoothly and with minimal burden to prescribers, in this CY 2021 PFS final rule we are finalizing that prescribers be required to use the National Council for Prescription Drug Programs, (NCPDP) SCRIPT 2017071 standard for EPCS prescription transmissions, the same standard which Part D plans are already required to support. We proposed implementation of the EPCS mandate effective January 1, 2022 but based on comments received, are finalizing the provision with an effective date of January 1, 2021 and a compliance date of January 1, 2022 to encourage prescribers to implement EPCS as soon as possible, while helping ensure that our compliance process is conducted thoughtfully.

Clinical Laboratory Fee Schedule: Revised Data Reporting Period and Phase-in of Payment Reductions

Section 1834A of the Social Security Act, as established by section 216(a) of the Protecting Access to Medicare Act of 2014 (PAMA), required significant changes to how Medicare pays for clinical diagnostic laboratory tests (CDLTs) under the Clinical Laboratory Fee Schedule (CLFS). The CLFS final rule “Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule” (81 FR 41036) was published in the Federal Register on June 23, 2016 and implemented section 1834A of the Act at 42 CFR part 414, subpart G. Under the CLFS final rule, reporting entities must report to CMS certain private payor rate information (applicable information) for their component applicable laboratories. The second data collection period (the 6-month period during which applicable information is collected) for CDLTs that are not advanced diagnostic laboratory tests (ADLTs) occurred from January 1, 2019 through June 30, 2019.

Section 105(a) of the Further Consolidated Appropriations Act, 2020 (FCAA) (Pub. L. 116- 94, enacted December 20, 2019) and section 3718 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136, enacted March 27, 2020) made revisions to the CLFS requirements for the next data reporting period for CDLTs that are not ADLTs and the phase-in of payment reductions under the Medicare private payor rate-based CLFS.

In this CY 2021 PFS final rule, we are finalizing conforming changes to the data reporting and payment requirements at 42 C.F.R. part 414, subpart G, to reflect the revisions to the data reporting period and phase-in of payment reductions enacted in the FCAA and the CARES Act for the Medicare CLFS.

In summary, the revisions are as follows:

The next data reporting period of January 1, 2022 through March 31, 2022, for CDLTs that are not ADLTs will be based on the data collection period of January 1, 2019 through June 30, 2019.

• After the data reporting period in 2022, there is a three-year data reporting cycle for CDLTs that are not ADLTs (that is 2025, 2028, and so on).
• Additionally, the statutory phase-in of payment reductions resulting from private payor rate implementation is extended through CY 2024. There is a 0.0 percent payment reduction for CY 2021 as compared to the amount established for CY 2020, and for CYs 2022 through 2024, payment may not be reduced by more than 15 percent as compared to the amount established for the preceding year.

Principal Care Management Services in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

In the CY 2020 PFS final rule, separate payment was established for Principal Care Management (PCM) services paid under the PFS. For PCM services furnished on or after January 1, 2020, CMS established two new HCPCS codes, G2064 and G2065,that describe comprehensive care management services of a single high-risk disease. We are finalizing the revision of  42 CFR 405.2464 to reflect the current payment methodology that was finalized in the CY 2020 PFS final rule and add the 2 new HCPCS codes, G2064 and G2065, to the general care management HCPCS code, G0511, for PCM services furnished in RHCs and FQHCs beginning January 1, 2021.

RHCs and FQHCs that furnish PCM services will bill HCPCS code G0511, either alone or with other payable services on an RHC or FQHC claim. The current payment rate for HCPCS code G0511 is the average of the national non-facility PFS payment rate for the RHC/FQHC care management and general behavioral health codes (CPT codes 99484, 99487, 99490, and

99491). HCPCS G2064 and G2065 will be added to G0511 to calculate a new average for the national non-facility PFS payment rate. The payment rate for HCPCS code G0511 will be updated annually based on the PFS amounts for these codes.

Rebase and Revise the FQHC Market Basket

We are finalizing rebasing and revising the FQHC market basket to reflect a 2017 base year. The 2017-based FQHC market basket update for CY 2021 is 2.4 percent. The multifactor productivity adjustment for CY 2021 is 0.7 percent. The final CY 2021 FQHC payment update is 1.7 percent.

Medicare Shared Savings Program

CMS is finalizing changes to the Medicare Shared Savings Program (Shared Savings Program) quality performance standard and quality reporting requirements for performance years beginning on January 1, 2021 to align with Meaningful Measures, reduce reporting burden and focus on patient outcomes. For performance year 2020, CMS is finalizing to provide automatic full credit for CAHPS® patient experience of care surveys. For more information, please see the 2021 QPP Final Rule fact sheet at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1207/2021%20QPP%20Final%20Rule%20Resources.zip.

In response to new telehealth code policies finalized in this rule and to update the definition of primary care services used for beneficiary assignment to reflect the codes for assessment and care planning services for patients with cognitive impairment and chronic care management services, CMS is finalizing the inclusion of new evaluation and management and care management CPT and HCPCS codes in the methodology used to assign beneficiaries to ACOs. In addition, CMS is finalizing our proposals to exclude certain services furnished in skilled nursing facilities from the assignment methodology when provided by clinicians billing through FQHCs and RHCs, and to modify the definition of primary care services to exclude advance care planning CPT code 99497 and the add-on code 99498 when billed for services furnished in an inpatient care setting. CMS is also codifying our policy of adjusting an ACO’s historical benchmark to reflect any regulatory changes to the beneficiary assignment methodology in the regulations governing the benchmarking methodology.

CMS is finalizing several policies that will further reduce burden associated with repayment mechanisms.  Beginning with the application cycle for an agreement period starting on January 1, 2022 and annually thereafter, renewing ACOs and re-entering ACOs that are the same legal entities as ACOs that previously participated in the program, that wish to continue use of their existing repayment mechanism in a new agreement period may decrease their repayment mechanism amount if a higher amount is not needed for their new agreement period.  The final rule includes a revised methodology for calculation of repayment mechanism amounts beginning with the application cycle for an agreement period starting on January 1, 2022, and annually thereafter.  The final rule also offers a one-time opportunity for eligible ACOs that renewed their agreement periods beginning on July 1, 2019, or January 1, 2020, to elect to decrease the amount of their repayment mechanisms if the ACO’s recalculated repayment mechanism amount for performance year 2021 is less than their existing repayment mechanism amount.

The interim final rule with comment period (IFC) issued by CMS on March 31, 2020, and the IFC issued by CMS on May 8, 2020, included provisions modifying or clarifying Shared Savings Program policies to address the impact of the PHE for COVID-19 on ACOs. In the CY 2021 PFS final rule, in response to public comments received, CMS is finalizing the Shared Savings Program provisions in these IFCs, with several modifications. CMS is revising the regulations specifying the adjustment to program calculations for episodes of care for treatment of COVID-19 to ensure greater consistency in the policies used to identify inpatient services provided by inpatient prospective payment system (IPPS) and non-IPPS providers that trigger an episode of care for treatment of COVID-19. CMS is finalizing the regulation specifying the expanded definition of primary care services for purposes of determining beneficiary assignment with modifications for greater consistency with the existing beneficiary assignment methodology. Specifically, CMS is are finalizing that the expanded definition, which includes telehealth codes for virtual check-ins, e-visits, and telephonic communication, will apply when the assignment window for a benchmark or performance year includes any months during the PHE for COVID-19 as defined in § 400.200.  CMS is adding a provision specifying that the additional primary care service codes will be applied to all months of the assignment window (as defined in § 425.20), when the assignment window includes any month(s) of the COVID-19 PHE.

Part B Drug Payment for Drugs Approved under Section 505(b)(2) of the Food, Drug, and Cosmetic Act

Some drugs approved under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act share similar labeling and uses with generic drugs that are assigned to multiple source drug codes. CMS proposed to continue assigning certain section 505(b)(2) drug products to existing multiple source drug codes when such drug products meet the definition of multiple source drug set forth at section 1847A(c)(6)(C) of the Act. This approach would apply to section 505(b)(2) drug products where a billing code descriptor for an existing multiple source code describes the product and other factors, such as the product’s labeling and uses, are similar to products that are already assigned to the code.

The proposed approach is consistent with the concept of paying similar amounts for similar services and with efforts to curb drug prices. The proposal also would encourage competition among products that are described by one billing code and share similar labeling.

In response to comments asking for more detail about our proposed approach and requests to delay finalizing a decision, CMS is not finalizing the proposal or the corresponding regulation text for CY 2021.

Removal of Outdated National Coverage Determinations (NCDs)

We are finalizing removal of six outdated or obsolete National Coverage Determinations (NCDs). Removing outdated NCDs means Medicare Administrative Contractors no longer are required to follow those outdated coverage policies when it comes to covering services for beneficiaries. The result will allow flexibility for these contractors to determine coverage for beneficiaries in their geographic areas based on more recent evidence and information.

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The agency has released its long-awaited final document on Medicare coverage for telehealth and remote patient monitoring services in the coming year, building upon trends seen during this year’s coronavirus pandemic.

By Eric Wicklund

December 02, 2020 – Telehealth and remote patient monitoring will see significant improvements in Medicare coverage in 2021.

The long-awaited 2021 Physician Fee Schedule, unveiled on Tuesday by the Centers for Medicare & Medicaid Services, aims to build upon the momentum for telehealth adoption seen during this year’s coronavirus pandemic. With health systems and hospitals rapidly embracing connected health, the agency has been under pressure to improve access and reimbursement guidelines.

While analyses of the final rules will come in over the next few days, here’s what CMS has included in its document.

EXPANDING COVERAGE TO NEW SERVICES AND PROVIDERS

The final rule begins with roughly 60 new telehealth services that can be reimbursed under Medicare, as follows:

• Group Psychotherapy (CPT code 90853);
• Psychological and Neuropsychological Testing (CPT code 96121);
• Domiciliary, Rest Home, or Custodial Care services, Established patients (CPT codes 99334-99335);
• Home Visits, Established Patient (CPT codes 99347-99348);
• Cognitive Assessment and Care Planning Services (CPT code 99483);
• Visit Complexity Inherent to Certain Office/Outpatient Evaluation and Management (E/M) (HCPCS code G2211); and
• Prolonged Services (HCPCS code G2212).

Those services are included under Category 1, making coverage permanent. A separate group, called Category 3, reflects services that were included in emergency waivers issued during the past year to improve connected health coverage and adoption during the public health emergency created by the coronavirus pandemic. CMS has decided these services will continue to be reimbursed through the calendar year that the public health emergency concludes:

• Domiciliary, Rest Home, or Custodial Care services, Established patients (CPT codes 99336-99337);
• Home Visits, Established Patient (CPT codes 99349-99350);
• Emergency Department Visits, Levels 1-5 (CPT codes 99281-99285);
• Nursing facilities discharge day management (CPT codes 99315-99316);
• Psychological and Neuropsychological Testing (CPT codes 96130-96133; CPT codes 96136-96139);
• Therapy Services, Physical and Occupational Therapy, All levels (CPT codes 97161-97168; CPT codes 97110, 97112, 97116, 97535, 97750, 97755, 97760, 97761, 92521-92524, 92507);
• Hospital discharge day management (CPT codes 99238-99239);
• Inpatient Neonatal and Pediatric Critical Care, Subsequent (CPT codes 99469, 99472, 99476);
• Continuing Neonatal Intensive Care Services (CPT codes 99478-99480);
• Critical Care Services (CPT codes 99291-99292);
• End-Stage Renal Disease Monthly Capitation Payment codes (CPT codes 90952, 90953, 90956, 90959, 90962); and
• Subsequent Observation and Observation Discharge Day Management (CPT codes 99217; CPT codes 99224-99226).

In addition, CMS will now cover one nursing facility visit via telehealth every 14 days, down from once every 30 days. Telehealth advocates had argued that the frequency limit should be reduced to once every three days or even eliminated altogether, but the agency noted that these patients require longer care than hospital patients, and that a lax policy on virtual visits could have a detrimental effect on in-person care.

In its final rule, CMS has expanded the list of care providers able to be reimbursed for using telehealth to include clinical social workers, clinical psychologists, physical and occupational therapists and speech language pathologists. The agency is adding two new billing codes so that these providers can bill for virtual check-ins and remote evaluation of patient-submitted video or images.

The agency is also noting that telehealth rules don’t apply if the provider and patient are in the same location, even if the provider is using telecommunications equipment to monitor a patient to, for example, avoid risk of exposure to COVID-19.

With regard to coverage for audio-only phone check-ins, CMS is creating a new code for 11-20 minutes spent on the phone to determine the necessity of in-person care. This reimbursement would be about half as much as equivalent in-person care.

REMOTE PATIENT MONITORING COVERAGE

With more healthcare providers looking to extend care into the home, CMS has been gradually expanding coverage for what it calls remote physiologic monitoring services, and the agency proposed significant changes in the initial PFS released in August. That coverage is now set in place with the 2021 PFS.

The following RPM rules are included in the final document:

• Once the public health emergency ends, a care provider must have an established patient-physician relationship for RPM services to be furnished.
• Consent to receive RPM services may be obtained at the time that RPM services are furnished.
• Auxiliary personnel (including contracted employees) may provide services described by CPT codes 99453 and 99454 incident to the billing practitioner’s services and under their supervision.
• The mHealth technology supplied to a patient in an RPM program must be defined as a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act and must be reliable and valid. In addition, the data coming from these platforms must be electronically (i.e., automatically) collected and transmitted rather than self-reported.
• After the PHE ends, 16 days of data must be collected and transmitted every 30 days to meet the requirements to bill CPT codes 99453 and 99454.
• Only physicians and NPPs who are eligible to furnish E/M services may bill RPM services.
• RPM services may be medically necessary for patients with acute conditions as well as patients with chronic conditions.
• Via CPT codes 99457 and 99458, an “interactive communication” takes place in real-time and includes synchronous, two-way interactions that can be enhanced with video or other kinds of data as described by HCPCS code G2012.  In addition, the 20-minutes of time required to bill for the services of CPT codes 99457 and 99458 can include time for furnishing care management services as well as for the required interactive communication.

EXPANDED TELEHEALTH COVERAGE

In addition, CMS is expanding coverage for direct supervision through interactive communications technology, under the idea that providers can use telemedicine platforms to supervise others and monitor patients without being in the same room. To that end, the agency will allow coverage for direct supervision through real-time interactive audio-visual technology until the end of the PHE or 2021, whichever comes first.

Finally, in a press release accompanying the 2021 PFS, CMS announced that it will commission a study on telehealth use during the pandemic to “explore new opportunities for services where telehealth and virtual care supervision, and remote monitoring can be used to more efficiently bring care to patients and to enhance program integrity, whether they are being treated in the hospital or at home.”

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CMS released the 2021 physician fee schedule Dec. 1 with expanded telehealth services, remote physiologic monitoring updates and an extension for telecommunications tech supervision.

Seven takeaways:

1. CMS clarified its payment policies related to the remote physiologic monitoring services for CPT codes 99453, 99454, 99091, 99457 and 99458, which were finalized in recent years. These services include remote monitoring of weight, blood pressure, pulse oximetry and respiratory flow rate. 

2. Once the COVID-19 public health emergency ends, there must be an established patient-physician relationship for remote physiologic monitoring services to be furnished.

3. Auxiliary personnel, such as contracted employees, may provide services under CPT codes 99453 and 99454 incident to the physician’s billing services while under their supervision. These services include setting the patient up and teaching them how to use the equipment.

4. Medical devices supplied to patients as part of RPM services must fall under Section 201 of the Federal Food, Drug and Cosmetic Act, which requires the device to be valid, reliable and transmit data electronically and automatically, rather than the patient having to self-report.

5. After the public health emergency ends, 16 days of data each 30 days of remote monitoring must be collected and transmitted to meet the requirements to bill CPT codes 99453 and 99454.

6. CMS clarified that for CPT codes 99457 and 99458, which include one-on-one remote monitoring management services with the clinician, interactive communication is defined as a conversation occurring in real-time via synchronous, two-way interactions using video and/or audio.  

7. During the public health emergency, CMS adopted a revised definition of direct supervision to include the virtual presence of the supervising physician or practitioner using audio and video communications technology. Under the final rule, direct supervision can continue being provided virtually through the end of the emergency or Dec. 31, 2021.

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CMS released the 2021 home health final rule on Thursday, October 29, 2020. 

There were minimal changes compared to the home health proposed rule that was released in July 2020. Probably the best news in the rule was the 1.9% aggregate increase (or $390 million) in reimbursement that agencies will realize in 2021. Although the increase was less than the original 2.6% increase that was in the proposed rule.

Other highlights from the final rule are as follows:

• Patient-Driven Groupings Model (PDGM) remains in play with no changes to how HHRG (Home Health Resource Group) rates are determined.
• There were no changes to case-mix rates and LUPA thresholds from 2020 to 2021.
• Behavioral adjustments that were realized in 2020 due to the implementation of PDGM remain intact. This was a controversial component of the final rule given that the preliminary PDGM data does not support that agencies have actually changed behaviors to support the negative adjustment.
• The delivery of infusion services under the Home Health benefit is drastically changing and now requires a rather costly home infusion therapy supplier enrollment as well as a decrease in reimbursement for these services.
• There are no changes to the quality reporting program for home health agencies.
• Some relief has been realized for Value-Based Purchasing states through the public health emergency period where no aggregate increases or decreases in reimbursement will be realized.
• The provision of telehealth services remains the same as what has been realized through the public health emergency period. Telehealth services can be provided by home health agencies with appropriate physician collaboration and care planning, but no direct reimbursement can be realized by agencies providing these services.
• The split-percentage payment will now be 0% (was 20% in 2020) when home health agencies submit RAPs (Request for Anticipated Payment).
• The requirements for RAP submission have been updated to include the following which mirrors the Notice of Admission process that goes into effect 1/1/2022:
  • The appropriate physician’s order (written or verbal) that is inclusive of services required for the initial visit. This order must be received and documented per the Home Health Conditions of Participation.
  • The initial visit within the 60-day certification period has to be made and the individual admitted to Home Health care.
• A non-timely submission payment reduction will occur when a home health agency does not submit a RAP within 5 calendar days from the start of care or any subsequent 30 day payment period.
  • The reduction in payment will be equal to 1/30^th of the 30-day payment period amount for each day that the RAP is delayed not to exceed the total payment of the claim.   Essentially any RAP that is delayed by 30 days or greater will receive $0 in reimbursement for that payment period.
  • Home Health agencies can submit RAPs for multiple 30-day payment periods at the same time to reduce administrative burden.
  • For payment periods resulting in a LUPA (Low Utilization Payment Adjustment), no per visit reimbursement will be provided for any visits that occur on days that fall within the period before the submission of the RAP.

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As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access the healthcare services they need in as safe a manner as possible. In order to provide our clients with quick and actionable guidance on the evolving telehealth landscape, Manatt Health has developed a federal and comprehensive 50-state tracker for policy, regulatory and legal changes related to telehealth during the COVID-19 pandemic. This summary of findings is current as of noon ET, Thursday, October 15.

Federal Actions and Legislation:

Select introduced federal legislation:

Federal Flexibilities and Reports:

Flexibilities

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on October 23 (the date the PHE was previously scheduled to expire) and extending through January 20, 2021. For more information the renewed PHE, please see our Manatt Newsletter.

Reports:

On October 14, CMS released a Preliminary Medicaid and CHIP Data Snapshot to provide information on telehealth utilization during the PHE. This data shows more than 34.5 million services were delivered to Medicaid and CHIP beneficiaries via telehealth between March and June of this year—an increase of 2,600% when compared to the same period in 2019. Additionally, CMS updated its State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth, COVID-19 Version to help providers and other stakeholders understand which policies are temporary or permanent, and to communicate telehealth access and utilization strategies to providers.

On July 28, HHS released the issue brief Medicare Beneficiary Use of Telehealth Visits: Early Data from the Start of the COVID-19 Pandemic. On July 15, CMS director Seema Verma released Early Impact of CMS Expansion of Medicare Telehealth During COVID-19, a blog on Health Affairs. This article highlights CMS’s efforts to expand telehealth during COVID-19 through the addition of 135 allowable telehealth services and the expanded list of types of health care providers who can offer telehealth, and explores how various mechanisms that have allowed for the increase in telehealth utilization during the PHE may continue.

State Laws, Policy, and Guidance

In Medicaid, states have broad authority to permit coverage for telehealth services. Prior to the COVID-19 emergency, many states had implemented broad coverage for telehealth, and in recent months, all 50 states and Washington D.C. have issued guidance expanding telehealth for their Medicaid populations. Medicaid programs have the broad ability to cover telehealth services and the flexibility to rapidly scale up benefits and adjust normal cost-sharing rules, making Medicaid well positioned to quickly address the needs of its beneficiaries during states of emergency.

Select State Legislation and Executive Orders

Since the COVID-19 public health emergency was declared, states have been moving to pass legislation that would permanently expand access to telehealth. The below chart lists telehealth legislation that has been enacted since March 13, the beginning of the PHE, and executive orders that have made the temporarily waived restrictions around telemedicine permanent.

State Trends

Coordination on Telehealth: Colorado, Nevada, Oregon, and Washington announced they will work together to identify best practices around access, confidentiality, equity, standard of care, stewardship, patient choice, and payment/reimbursement. The overarching goal of this partnership is to “ensure that the nation benefits from our knowledge as changes to federal regulations are contemplated, to support continued application and availability of telehealth in our states, and to ensure that we address the inequities faced in particular by tribal communities and communities of color”.

Commercial Payment Parity: In light of the COVID-19 pandemic, states that previously did not require payment parity for telehealth services in commercial plans have begun to issue temporary guidance requiring payment parity for specific telehealth cases. Prior to COVID-19, 9 states (Arkansas, Delaware, Georgia, Hawaii, Kentucky, Minnesota, Missouri, New Mexico, and Utah) had payment parity laws for commercial payers in 2020. California, Arizona and Washington had also recently passed telehealth payment parity legislation in 2019 and early 2020 that would come into effect in January 2021, bringing the total to 12 states. The Governor of Washington recently issued an Executive Order in March which required immediate implementation of its payment parity law.

Appendix K Telehealth Flexibilities: As of October 15, CMS has approved Section 1915(c) Waiver Appendix K (Appendix K) from 47 states and Washington, D.C. Appendix K is a long-standing federal authority that helps states streamline and expedite changes to their 1915(c) home and community-based services (HCBS) waivers to prepare for and respond to emergencies. As of October 15, at least 44 of the approved Appendix K waivers included telehealth flexibilities for states. Some of these flexibilities include adding electronic methods of delivery for case management; permitting personal care services that require only verbal cueing, in-home habilitation, or monthly monitoring; temporarily modifying provider qualifications; temporarily modifying processes for level of care evaluations and re-evaluations; and temporarily modifying medication management.

Audio-Only Telehealth Services: Many state Medicaid agencies are following Medicare’s lead to expand telehealth coverage to audio-only. This includes states that are either adding coverage for telephonic evaluation and management codes or allowing providers to bill the usual service codes when the services are delivered via telephone. As of October 15, all 50 state Medicaid agencies and Washington D.C. have issued guidance to allow for a form of audio-only telehealth services.

Child Well-care and Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Visits: EPSDT is a mandated benefit that provides comprehensive and preventive healthcare services for children under age 21 who are enrolled in Medicaid. Each state is responsible to provide EPSDT services to children and adolescents enrolled in its Medicaid program. The American Academy of Pediatrics has issued guidance recommending all children still receive EPSDT visits. As of October 15, only 19 states and Washington D.C. have issued telehealth guidance for Child Well-care and EPSDT visits.

Early Intervention Services: As of October 15, 16 states have issued guidance to providers to allow for telehealth or remote care delivery for early childhood intervention services. On April 5, Illinois’ Chief Bureau of Early Intervention cleared all previous Illinois Department of Healthcare and Family Services requisites in order to implement and practice Illinois’ first-ever Early Intervention Teletherapy. On April 6, the Illinois Early Intervention Program (IEIP) instituted use of Live Video Visits as a temporary measure until the Illinois state of emergency is lifted. The IEIP is now working on tip sheets for families in English and Spanish and developing resources to help families with internet fees and costs for a computer, camera, and microphone. On April 7, North Carolina (NC) Medicaid released new telehealth guidance expanding the services and provider types eligible to deliver telehealth during the COVID-19 pandemic. Special Bulletin COVID-19 #34 expands telehealth codes and guidance to services delivered through local education and children’s developmental service agencies, and services pertaining to dietary evaluation and counseling, medical lactation, research-based behavioral health treatment for autism spectrum disorder, and diabetes self-management education. NC Medicaid also published an accompanying billing code summary to equip providers with the new codes pertaining to telehealth.

The post Executive Summary: Tracking Telehealth Changes State-by-State in Response to COVID-19 – October 15, 2020 appeared first on mTelehealth.