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December 2020

17,000 more Pee Dee residents to receive broadband access

By News

FLORENCE, S.C. — More than 17,000 homes and businesses in the Pee Dee could soon have a faster connection to the worldwide web.

The Federal Communications Commission announced Monday that it had allocated over $121 million in support funds for 10 years to broadband providers to expand broadband access to more than 108,833 South Carolina residents through a Rural Digital Fund Phase 1 option.

Nearly all locations in South Carolina that were eligible for the auction will receive access to broadband with speeds of at least 100Mbps download speed and 20Mbps upload speed, with 96% getting gigabit-speed broadband.

“This historic auction is great news for the residents of so many rural South Carolina communities who will get access to high-quality broadband service in areas that for too long have been on the wrong side of the digital divide,” Commission Chairman Ajit Pai said.

“We structured this innovative and groundbreaking auction to prioritize bids for high-speed, low-latency services to deliver the best results for rural Americans, and the results show that this strategy worked. This auction was the Commission’s single largest step ever taken toward delivering digital opportunity to every American and is another key success in our ongoing commitment to universal service.”

In the Pee Dee, a subsidiary of Charter Communications will receive $20.71 million in support funds to bring broadband access to 16,098 homes and businesses, including 2,833 homes and businesses in Florence County, 2,861 in Darlington County, 3,079 in Marion County, 1,521 in Williamsburg County, 2,693 in Dillon and 3,111 in Marlboro County.

Charter is the parent company of local cable and broadband provider Spectrum, which was formerly known as Time Warner.

Charter’s subsidiary will receive $4.11 million in support to expand access in Florence County, $4.96 million in support to expand in Darlington County, $2.36 million in Marion County, $2.79 million in Williamsburg County, $5.6 million in Dillon County and $878,977 to expand in Marlboro County.

Horry Telephone Cooperative will receive $65,515 in support to expand broadband access to 754 homes and businesses in Marion County.

And Space Exploration Technologies Corporation, also known as SpaceX, will receive $161,919 in support to expand broadband access to 174 homes and businesses in the Pee Dee, including 63 in Florence County, 31 in Darlington County, 55 in Williamsburg and 25 in Dillon.

SpaceX has developed a plan to use a new satellite system to send broadband access to Americans living in rural parts of the country.

The funding for the expansion support is provided by the Federal Communications Commission’s universal service charge.

That charge is a fee that telecommunication companies − and usually their customers − pay the commission. It was implemented in 1997. It is usually listed separately on the telephone bills of customers.

December 2020 Telehealth Policy and Regulatory Update

By News

 

By:  Scott Moody, MHA

  1. S. Congressman James E. Clyburn’s (SC-06) plan, A Better Deal to Rebuild America, supports the House Democratic Plan to Connect All Americans to Affordable Broadband Internet. “Just as the Rural Electrification Act made electricity accessible and affordable to all Americans, the plan we are announcing today will make broadband accessible and affordable to all Americans. As we see millions of our fellow Americans unable to telework, learn remotely, or access telehealth because they lack broadband, now is the time to act,” said Congressman Clyburn.

https://clyburn.house.gov/sites/clyburn.house.gov/files/documents/ABetterDealToRebuildAmerica.pdf

  1. South Carolina Senators Lindsey Graham (R-S.C.) and Tim Scott (R-S.C.) introduced two new bills in the Fall to develop and expand broadband services.
  • 4422 – Connecting Minority Communities Act creates a pilot program to provide grants to Historically Black Colleges and Universities (HBCUs), Tribal Colleges and Universities (TCUs), and Hispanic-Serving Institutions (HSIs) to expand access to broadband and digital opportunity in their communities.
  • 4411 – Governors Broadband Development Fund prioritizes funding for areas that currently lack service, supports the deployment of advanced technologies, and encourages projects that can provide internet service quickly.

“Too many South Carolinians, and American families, lack access to the global economy, telehealth, and educational tools due to the lack of broadband technology,” said Senator Tim Scott. “These bills will expand access to broadband and digital opportunities, which is needed to bridge the divide for underserved communities. It is critical that we continue to find pathways to increase connectivity for all Americans to ensure that they are equipped with the tools necessary to thrive.”

  1. On October 17, 2020 President Trump signed S. 785 (Public Law N0: 116-171), the ‘Commander John Scott Hannon Veterans Mental Health Care Improvement Act of 2019’.  The bill includes a section on expanding telehealth capabilities and the provision of telehealth services to veterans through the Department of Veterans Affairsby awarding grants to organizations that represent or serve veterans, nonprofit organizations, private businesses, and other interested parties.
  2. The Centers for Medicare and Medicaid Services (CMS) released the 2021 Medicare Physician Fee Schedule final rule on December 1, 2020. The 2,165-page final rule adds more than 60 services to the Medicare telehealth list.  These services will be covered even after the Covid-19 pandemic has ended. Early on in the Covid-19 crisis, CMS added 144 telehealth services to its coverage list through the end of the public health emergency.  Follow the link below for the list of covered telehealth services:

https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes.

  1. The Center for Connected Health Policy’s State Telehealth Laws and Reimbursement Policies Report attached below is an excellent resource to quickly identify the telehealth laws and policies in South Carolina.

Click Here for the policies report

Click Here for PDF of this report

2020 In Review: State Telehealth Policy Legislative Roundup

By News

2020 has been an unprecedented year for telehealth. Spurred by the COVID-19 pandemic, telehealth has become a common form of healthcare delivery over the past year. In no small part, expanded reimbursement and professional practice policies has enabled this transformation. Among 36 states, 104 legislative bills passed in the 2019 legislative session. This was relatively consistent with 2019, when 113 bills were enacted. However, the topics that were addressed were significantly different in 2020. For example, bills either creating or making modifications to laws related to private payers shot up from 12 bills in 2019 to 25 bills in 2020. Likewise, there was also a slight increase in Medicaid reimbursement enacted legislation as well. On the other side, there was a decrease in bills related to pilots, demonstrations and grants as well as cross state licensing legislation. These variations between 2019 and 2020 were most likely due to the need for more expansive telehealth policies on a large scale, rather than confining telehealth flexibilities to pilot projects or demonstrations. The drop in cross state licensing legislation, more than likely occurred because during the pandemic most states implemented licensing waivers allowing for out-of-state practice. Therefore, addressing cross state licensing needs through legislation may not have been at the forefront of minds, while there were more pressing concerns. Thirty-five of the 104 bills were in direct response or explicitly mentioned the COVID-19 public health emergency. CCHP’s 2020 roundup of state approved legislation which includes a detailed listing of all bills by topic area and state is now available.

MEDICAID
While all states already provide some type of reimbursement for telehealth delivered services in Medicaid, there was still a good amount of telehealth legislation focused on broadening Medicaid policies and reducing barriers to the use of telehealth. For example, Louisiana Medicaid is now obligated to have comparable telehealth reimbursement policies to Medicare, according to newly passed bill HB 589. Previously, there was no law obligating Medicaid to cover telehealth at all in Louisiana. Maine passed another bill (LD 1974) requiring Medicaid reimbursement for case management services delivered through telehealth to targeted populations. Expanding the modalities that can be used to deliver care beyond live video was also something noted in a few states. For example, Michigan HB 5415 now requires its Medicaid program to provide coverage for remote patient monitoring services. New York was one of the few states to permanently address the use of telephone in Medicaid, a measure most states have taken on a temporary basis during the pandemic, but not addressed in permanent policy. New York’s SB 8416 adds audio-only to the definition of telehealth that applies to Medicaid. Expanding allowable originating site settings was another common policy expansion made in response to the COVID-19 public health emergency (PHE). For example, Michigan also passed a bill (HB 5416) requiring Medicaid to cover telehealth when patients are at home or a school-based setting.

PRIVATE PAYER
Private payer laws were the category that saw the largest jump in the number of bills between 2019 and 2020. Although only one state (West Virginia – HB 4003) added a new telehealth private payer law, other states took steps to strengthen and/or modify their laws. For example, Utah HB 313 requires that private payers provide coverage of the telemedicine services that are covered by Medicare for network providers and reimburse at a commercially reasonable rate. Washington SB 5385 strengthened their law by providing explicit payment parity, requiring a health plan to “reimburse a provider for a health care service provided to a covered person through telemedicine at the same rate as if the health service was provided in person by the provider”. It does, however, go on to specify that hospitals, hospital systems, telemedicine companies and provider groups consisting of eleven or more providers may elect to negotiate a reimbursement rate for telemedicine services different from the rate of in-person. It also removes the requirement that if the service is provided by store-and-forward that there be an associated office visit.

Louisiana HB 530 addressed reimbursement of remote patient monitoring, and specifies certain requirements that must be met for a provider to receive reimbursement for RPM, such as assessing and monitoring clinical data, detecting changes in condition based on telemedicine or telehealth encounters and implementing a management plan. It also requires that health insurers conspicuously display on their website information regarding their telehealth services and remote patient monitoring services. This is similar to a Texas law passed in 2017 which also requires insurers to conspicuously display on their websites their telehealth policies.

Maryland also passed telehealth bills (HB 1208/SB 502) which specifies explicitly that mental health care services provided to a patient’s home setting falls under the definition of telehealth and that insurers must provide reimbursement for substance use disorder. Iowa also passed a telehealth private payer bill (SF 2261) specifically aimed at schools, requiring that an insurer not deny coverage for behavioral health services provided via telehealth solely because the services are delivered in a school.

CROSS STATE LICENSING
As was the case in 2019, a large proportion of the bills related to cross state licensing were states enacting one of five interstate licensure compacts for out-of-state licensed providers to practice in other Compact states under certain circumstances. Each Compact operates differently with the Interstate Medical Licensure Compact being an expedited licensure process that requires physicians to still submit separate applications and fees to each Compact state they wish to provide services in. The following is a recap of the progress each Compact made in 2020:
• The Interstate Medical Licensure Compact (IMLC) – The IMLC Compact currently stands at 29 states, DC and Guam participating. No new states joined in 2020. Both Wisconsin and Arizona asked to withdraw from the Compact in 2019, however they are still listed as active members on the IMLC website.
• The Nurses Licensure Compact (NLC) – The NLC Compact currently stands at 34 states participating. No new states joined in 2020.
• Audiology and Speech-Language Pathology Interstate Compact (ASLP-IC) – The ASLP-IC currently stands at 7 states participating. Georgia, Louisiana, North Carolina, Oklahoma, Utah, West Virginia, and Wyoming all joined the Compact within the 2020 legislative session.
• The Physical Therapy Compact (PTC) – The PTC currently stands at 28 states. South Dakota and Wisconsin joined within the 2020 legislative session
• The Psychology Interjurisdictional Compact currently stands at 15 states. North Carolina, Pennsylvania and Virginia joined within the 2020 legislative session. The Compact in North Carolina and Virginia does not go into effect until 2021.
DEMONSTRATIONS, PILOTS & STUDIES
2020 still saw its fair share of legislation focused on demonstrations, pilots and/or studies. However, while 2019 pilots primarily focused on mental health or substance use disorder, the vast majority of 2020 enacted legislation were intended to test the efficacy of telehealth or gather data, often in connection with the COVID-19 pandemic or delivery of emergency services. One such bill was Oregon HB 4212 which requires providers to collect encounter data on race, ethnicity and language for encounters that occur, whether performed in-person or via telemedicine, for purposes of providing health care services related to COVID-19, including but not limited to ordering or performing COVID tests. The data collected in Oregon will undoubtedly be used in future studies to determine whether patients of all races, ethnicities and languages receive a high standard of care. Likewise, Mississippi’s SB 2311 also allows the State Board of Health to promulgate rules and collect data on the use of telemedicine and electronic health records to deliver telemedicine services.

PROFESSIONAL PRACTICE & PRESCRIBING
A number of states refined definitions of telemedicine/telehealth within specific professions. For example, Virginia SB 122 defined teledentistry, and Colorado HB 1230 defines telehealth for occupational therapy. A few states also broadened their definitions of telehealth, including Idaho with H 342 which refined their definition of telehealth services in their Telehealth Access Act to include synchronous or asynchronous communication methods, remote monitoring, transfer of medical data, health-related education, public health services and health administration. In some cases, legislation included requirements for establishing the provider-patient relationship and prescribing. For example, Maryland companion bills HB 448 and SB 402 authorize practitioners to establish a practitioner-patient relationship through telehealth under certain circumstances. It also requires health care practitioners to be held to the same standards of practice as in-person health care settings, to perform a clinical evaluation before providing treatment or issuing prescriptions through telehealth, to be subject to certain laws when prescribing a controlled substance through telehealth, and to document information in a patient’s medical record.

Finally, Washington passed a unique piece of legislation, SB 6061, which requires that beginning January 1, 2021, a health care professional who provides clinical services through telemedicine, other than a physician or osteopathic physician, must complete a telemedicine training. They are the first state to require a telehealth specific training in order for professionals to utilize telehealth within their state.

COVID-19 PUBLIC HEALTH EMERGENCY SPECIFIC BILLS
Thirty-four percent of bills that passed in 2020 were directly related to the COVID-19 pandemic. These bills directly referenced either COVID-19 or the public health emergency within their text. The bills spanned the categories previously discussed above, from Medicaid to private payers, pilot projects and professional regulation. All COVID-19 related bills took steps to expand the use of telehealth in some way or waive requirements to make it easier for patients and providers to utilize telehealth to deliver or receive care. New Jersey S 2467, for example, extends the duration of certain laws related to COVID-19 which require reimbursement by Medicaid and private payers for telehealth and telemedicine during the COVID emergency. Kentucky’s SB 150, relaxes standard of care requirements and provider-patient relationship during COVID and expires at the end of state of emergency. Similarly, Vermont, H 960 allows for the provision of telemedicine or store-and-forward until March 31, 2021 without complying with certain provisions in certain circumstances. A number of legislatures required demonstrations, pilots and studies also directly involved the COVID-19 experience, including Pennsylvania SB 841, which requires a Disaster Emergency Report that would, among other things, examine data points on increased costs related to provider and staff training, including training on pandemic preparedness and the use of telemedicine. Vermont HB 966, establishes the COVID-RESPONSE Accelerated Broadband Connectivity Program with the purpose of increasing telehealth connectivity during the public health emergency.

Even bills that didn’t mention the COVID-19 PHE explicitly, were certainly influenced or connected to the pandemic. For example, Connecticut’s HB 6001, didn’t explicitly mention COVID-19 or the public health emergency, but because many of the sections of the bill expire on March 21, 2021, it was undoubtedly precipitated by the COVID-19 pandemic. This bill strengthens Connecticut’s private payer law requiring that payers cannot restrict coverage to a specific telehealth platform and places requirements on prescribing using telehealth.

LOOKING AHEAD
2021 promises to be another active year in telehealth policy. With the pandemic expected to persist into early 2021, and then the aftermath likely lingering into the end of year, we expect to continue to see telehealth legislation that addresses the temporary COVID PHE policies, and make some of them permanent. This is critical as many of the waivers and expansions in telehealth policy that have occurred in 2020 are expected to expire at some point in 2021. In 2020 states and even private payers appear to be taking their cues from Medicare and requiring that at the very least payers cover the services Medicare reimburses under the same conditions. With more restrictive Medicare policies expected to go back into effect (unless federal legislation is enacted to change it), including limitations on the geographic location and restrictions around the home as an eligible site, it will be interesting to see if this trend continues. Legislation addressing how audio-only, asynchronous and remote patient monitoring service delivery can be reimbursed is also expected to continue, as those are details often excluded from telehealth bills in previous years, which often only addressed live video service delivery. A lot will most likely also be contingent on the data collected related to the expanded use of telehealth during the PHE and whether or not researchers determine that telehealth has been effective at delivering quality care.

Medicare Extends COVID-19 Telehealth Coverage in Diabetes Prevention Programs

By News

By Eric Wicklund

As part of the 2021 Physician Fee Schedule, Medicare will continue to reimburse Diabetes Prevention Program providers who use certain telehealth services – but only for the duration of the public health emergency.

December 02, 2020 – Healthcare providers who use telehealth in their Diabetes Prevention Programs will continue to be reimbursed through Medicare during the coronavirus pandemic, according to guidelines issued this week by the Centers for Medicare & Medicaid Services.

But coverage for virtual services in Medicare-based DPPs (MDPPS) will only last for the duration of the public health emergency (PHE), and that coverage doesn’t include providers who offer only a virtual DPP program.

The guidelines, included in the final draft of CMS’ 2021 Physician Fee Schedule, expands on an emergency rule issued on March 31 that allowed MDPPs to use some connected health services during the COVID-19 crisis. The new document adds a few more virtual services and keeps them in place for the duration of the public health emergency, as well as for any future emergencies that require an 1135 waiver.

The new regulations:

Allow care providers to use telehealth in MDPP services in place of or alongside in-person services.
Allowing providers who launch a telehealth platform or switch from in-person to virtual care during a public health emergency to continue those services after the end of the PHE.
Allow certain MDPP beneficiaries to re-enroll in the program, with flexibilities that allow patients to resume treatment if that treatment was suspended or interrupted by a PHE.
Add virtual weight measurements via mHealth devices and allow participants to report their own weights by submitting a time and date-stamped photo or video of their home scale with their current weight measurement. In addition, participants can use online video technology such as video chatting or video conferencing with an MDPP coach.
Extend the flexibilities finalized in the March 31st COVID-19 IFC to all beneficiaries who were receiving MDPP services as of March 31, 2020, instead of March 1, 2020.

While the ruling helps care providers who have replaced or augmented in-person programs with virtual programs, it doesn’t help the growing number of programs that are virtual-only. CMS was quick to point out that the MDPP has always been seen as an in-person program.

READ MORE: Could Telehealth Save the Medicare Diabetes Prevention Program?

“Virtual delivery of MDPP services are allowable during the COVID-19 PHE and future applicable 1135 waiver events to ensure continuity of services when in-person classes are not safe or feasible,” the agency said. “We do not believe it is appropriate to permit virtual-only MDPP suppliers to furnish MDPP services when the Emergency Policy is in effect. Given the difficulty of predicting when the COVID-19 PHE or any applicable 1135 waiver event will end, MDPP suppliers must remain prepared to resume delivery of MDPP services in-person when the Emergency Policy is no longer in effect. Permitting virtual-only MDPP suppliers to furnish MDPP services during the COVID-19 PHE or an applicable 1135 waiver event could disrupt the provision of services to MDPP beneficiaries who want to return to in-person services when MDPP services resume on an in-person basis.”

This doesn’t resolve the long-standing argument that Medicare should cover DPPs that include telehealth services, so that providers can expand access to these programs and more people at risk of developing diabetes can attend them from home or other locations sand on mHealth devices.

This past February – prior to the pandemic – CMS Administrator Seema Verma said the agency was “exploring ways” to support reimbursement for virtual care.

“CMS has done outstanding work developing online resources to show where MDPP suppliers are located, but these resources make clear that there are geographic regions where eligible beneficiaries lack reasonable access to a qualified supplier,” Verma said in a letter to lawmakers. “Including virtual providers could empower these beneficiaries with feasible options for preventive, value-based care.”

But aside from the relaxed rules included in COVID-19 emergency measures, CMS hasn’t done anything to signal long-term coverage for telehealth.

READ MORE: Integrating a Telehealth Platform into a Diabetes Prevention Program

With that in mind, a group of lawmakers submitted a bill in September calling on the agency to expand coverage to MDPP providers who use telehealth.

“It’s no secret that diabetes is a disease that has disproportionately affected minority communities across the country,” the lawmakers said in a press release. “To ensure that all individuals have the tools needed to combat this preventable disease, the Prevent Diabetes Act would help expand access to virtual classes under the existing Medicare Diabetes Prevention Program. This commonsense and cost-saving expansion will ensure that more Americans at-risk of developing diabetes who are living in either rural or medically underserved communities, can participate in this critical program that has been proven to delay the full onset of this preventable disease.”

Tim Scott joins bipartisan group urging permanent Medicare telehealth expansion

By News

Sen. Tim Scott has joined a bipartisan group that’s urging the congressional leadership to to make permanent the expanded use of telehealth services for Medicare beneficiaries during the COVID-19 pandemic.

Scott was among 49 lawmakers to sign a letter to Senate Majority Leader Mitch McConnell of Kentucky,  Senate Minority Leader Chuck Schumer of New York,  House Republican Leader Kevin McCarthy of California,  and House Speaker Nancy Pelosi of California.

The letter says that telehealth visits have been a critical tool during the pandemic because telehealth ensures patients receive needed services while slowing the spread of the virus.

“We continue to hear from our constituents and health care providers that the uncertainty about the long-term future of Medicare telehealth coverage is a barrier to organizations investing fully in telehealth,” the letter continues. “Congress needs to act now to better serve patients and health care providers during the pandemic, and to ensure that telehealth remains an option after the pandemic is over.”

HHS Expands COVID-19 Telehealth Capabilities in PREP Act Amendment

By News

By Eric Wicklund

The Health and Human Services Secretary will allow healthcare providers to use telehealth across state lines to deliver “Covered Countermeasures” against the coronavirus.

December 04, 2020 – The federal government is expanding the telehealth platform for diagnostic tests and other devices that may be used to address the coronavirus pandemic.

The US Department of Health and Human Services has issued its fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness (PREP) Act, adding connected health channels to increase access to countermeasures against COVID-19.

“During the pandemic, the Trump Administration has made broader use of the PREP Act to expand access to potentially life-saving countermeasures than we’ve ever done before in a public health emergency,” HHS Secretary Alex Azar said in a December 3 press release. “This new use of the PREP Act will help expand access to important services via telehealth, increase availability of authorized PPE, and make it easier to administer eventual COVID-19 vaccines.”
Dig Deeper

Medicare Extends COVID-19 Telehealth Coverage in Diabetes Prevention Programs
CMS Finalizes Telehealth, RPM Coverage in 2021 Physician Fee Schedule
New Telehealth Bill Would Penalize States Who Don’t Join Licensure Compact

More specifically, the order allows healthcare providers to use telehealth in any state to administer what are called Covered Countermeasures, such as diagnostic tests that have received Emergency Use Authorization (EUA) from the US Food and Drug Administration.

The order targets a significant barrier to telehealth expansion: state and federal rules that prohibit providers from using telehealth to treat patients in other states. The federal government and some states have enacted emergency measures during the ongoing public health emergency to facilitate license portability and interstate licensure, but the issue is still very murky.

The HHS order defines a “qualified person” as a healthcare provider using telehealth to order or administer Covered Countermeasures for patients in other states. This would include certain pharmacists, pharmacy interns and pharmacy technicians who order or administer certain COVID-19 tests or vaccines.

“When ordering and administering Covered Countermeasures through telehealth to patients in a state where the healthcare personnel are not already permitted to do so, the healthcare personnel must comply with all requirements for ordering and administering Covered Countermeasures to patients through telehealth in the state where the healthcare personnel are licensed or otherwise permitted to practice,” the amendment reads. “Any state law that prohibits or effectively prohibits such a qualified person from ordering and administering Covered Countermeasures through telehealth is preempted. Nothing in this Declaration shall preempt state laws that permit additional persons to deliver telehealth services.”

The PREP Act, enacted in December 2005, allows the HHS Secretary to issue a declaration that provides immunity from liability for certain claims during a public health emergency, including “claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions; determined by the secretary to constitute a present, or credible risk of a future public health emergency; and to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.”

Previous declarations have been issued to deal with the Ebola virus, Zika virus, anthrax, smallpox, acute radiation syndrome, botulinum toxin, the influenza pandemic and nerve agents and insecticides.

Fact sheet Final Policy, Payment, and Quality Provisions Changes to the Medicare Physician Fee Schedule for Calendar Year 2021

By News

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.

The calendar year (CY) 2021 PFS final rule is one of several rules that reflect a broader Administration-wide strategy to create a healthcare system that results in better accessibility, quality, affordability, empowerment, and innovation.

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.

  1. 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.

  1. 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.

  1. 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.

  1. 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 Quality Payment Program fact sheet.

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.

For more information: https://www.federalregister.gov/public-inspection/2020-26815/medicare-program-cy-2021-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part

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