Knowledge Base Category -

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from November 9th through the 12th.

Resource Spotlight: Celebrating Thanksgiving

As we quickly close in on Thanksgiving Day, the CDC has posted a webpage filled with information on how to safely celebrate Thanksgiving. This page opens with the statement that “traditional Thanksgiving gatherings with family and friends are fun but can increase the chances of getting or spreading COVID-19 or the flu…The safest way to celebrate Thanksgiving this year is to celebrate with people in your household. If you do plan to spend Thanksgiving with people outside your household, take steps to make your celebration safer.”

November 9, 2020: ORCHID Trial Debunks Effectiveness of Hydroxychloroquine in Adults Hospitalized with COVID-19

In a November 9, 2020 Press Release, the National Institutes of Health (NIH) announced findings from the trial called Outcomes Related to COVID-19 treated with Hydroxychloroquine among Inpatients with Symptomatic Disease (ORCHID). The ORCHID Trial enrolled participants between April 2 and June 19, 2020 who were a median age of 57. “At day 14, those who received hydroxychloroquine and those who received a placebo had a similar health status, with most participants in both groups discharged from the hospital and able to perform a range of activities.”

Per Wesley Self, M.D., M.P.H., emergency medicine physician at Vanderbilt University, “The finding that hydroxychloroquine is not effective for the treatment of COVID-19 was consistent across patient subgroups and for all evaluated outcomes, including clinical status, mortality, organ failures, duration of oxygen use, and hospital length of stay,”

November 10, 2020: OIG Posts Information about Operation CARE

The OIG has posted details about Operate CARE (Caring, Awareness, & Resources for Elders). With a long history of protecting the health and well-being of HHS beneficiaries they note that “Unfortunately, during the COVID-19 pandemic, we have seen a spike in the number of reports of elder harm and neglect.”

The OIG Operation CARE webpage includes resources (i.e., awareness posters) available to the public to also advocate for this population by reporting patient safety and fraud concerns.

November 12, 2020: COVID-19 Non-Physician Practitioner Billing for CPT Codes 98966-98968

In the Thursday November 12th edition of MLNConnects, CMS reminders non-physician practitioners that “During the COVID-19 Public Health Emergency (PHE), non-physician practitioners who are eligible to bill Medicare directly, including registered dietitians and nutrition professionals, may bill for audio-only telephone assessment and management services:

• CPT codes 98966-98968

• Dates of service on or after March 1 until the end of the PHE”

November 12, 2020: CMS Guidance - COVID-19 Vaccine Shots

CMS added the following new webpages to CMS.gov website regarding COVID-19 Vaccine Shots:

• Enrollment for Administering COVID-19 Vaccine Shots,
• Coding for COVID-19 Vaccine Shots,
• Medicare COVID-19 Vaccine Shot Payment,
• Medicare Billing for COVID-19 Vaccine Shot Administration,
• Beneficiary Incentives for COVID-19 Vaccine Shots, and
• CMS Quality Reporting for COVID-19 Vaccine Shots

November 12, 2020: CMS Monoclonal Antibody COVID-19 Infusion

In addition to information about COVID-19 Vaccine Shots, CMS has added a Monoclonal Antibody COVID-19 Infusion webpage which includes information on the following topics:

• Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction,
• Coding for Monoclonal Antibody COVID-19 Infusion,
• Medicare Payment for Monoclonal Antibody COVID-19 Infusion, and
• Billing for Monoclonal Antibody COVID-19 Infusion Administration.

You can read more about the first Monoclonal Antibody drug to received Emergency Use Authorization for treating COVID-19 in a related FAQ in this week’s newsletter. 

November 12, 2020: Special Edition MLN Connects – COVID-19 Vaccine Codes and PC-ACE Software Update

CMS noted the following in this Special Edition of MLN Connects:

“In anticipation of the availability of a vaccine(s), for the novel coronavirus (SARS-CoV-2) in response to the coronavirus disease 2019 (COVID-19), the American Medical Association (AMA), working with the Centers for Medicare & Medicaid Services (CMS), created new codes for the vaccine and the administration of the vaccine.  To prepare for the vaccine administration claims, the PC-ACE software is also updated and ready for providers to download.

If you intend to administer the COVID-19 vaccines when they become available, or the new monoclonal antibody bamlanivimab, especially if you intend to roster bill these codes, please download and install the new release of PC-ACE. This release includes the coding structure, currently comprised of both a HCPCS Level I CPT code structure issued by the American Medical Association (AMA) and a HCPCS Level II code structure issued by CMS. Together, these codes support the administration of the COVID-19 vaccines and the monoclonal antibody infusions, as they become available; this structure includes the codes for bamlanivimab. This code structure was developed to facilitate efficient claims processing for any COVID-19 vaccines and monoclonal antibody infusions that receive FDA EUA or approval. CMS and the AMA are working collaboratively regarding which codes to submit for COVID-19 vaccines and administration.  Most of these codes are not currently effective and not all codes will be used.  We will issue specific code descriptors in the future.  Effective dates for the codes for Medicare purposes will coincide with the date of the FDA EUA or approval.”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from November 3rd through November 9th.

Resource Spotlight: Telehealth Information for Providers and Patients

Telehealth.HHS.GOV offers resources for Providers and Patients.

Telehealth Resources for Providers: Content available on the Telehealth for Providers webpage includes:

• Getting Started,
• Planning your telehealth workflow,
• Preparing patients for telehealth,
• Policy changes during the COVID-19 Public Health Emergency,
• Billing and Reimbursement during the COVID-19 Public Health Emergency, and
• Legal Considerations

Telehealth Resources for Patients: Content available on the Telehealth for Patients webpage includes:

• Understanding telehealth,
• Telehealth during the COVID-19 emergency,
• Finding telehealth options, and
• Preparing for a video visit.

November 4, 2020: Provider-Specific Fact Sheets on New Waivers and Flexibilities Updated

CMS updated almost all of the Provider-Specific Fact Sheets on News Waivers and Flexibilities to include information from the October 28, 2020 Interim Final Rule (IFC) to ensure all Americans have access to a COVID-19 vaccine when one becomes available. Of note, “for calendar years 2020 and 2021, Medicare will pay directly for the COVID-19 vaccine and its administration for beneficiaries enrolled in Medicare Advantage (MA) plans. Providers should submit COVID-19 claims to Original Medicare for all patients enrolled in MA in 2020 and 2021. MA plans will not be responsible for reimbursing providers to administer the vaccine during this time. MA beneficiaries also pay nothing for COVID-19 vaccines and their copayment/coinsurance and deductible are waived.” All of the Face Sheets can be accessed on the CMS Coronavirus waivers and flexibilities webpage. Note, the Toolkit for States to Mitigate COVID-19 in Nursing Homes found on the COVID-19 Current Emergencies webpage was also updated on November 4th to include the vaccine information.

November 5, 2020: Governor Ivey Extends Safer at Home order until December for the State of Alabama

The Safer at Home order has been extended until December 11, 2020 and include the mask ordinance requiring masks be worn in schools and in public when interacting within 6 feet of someone from another household. Following are two new amendments to the order:

• Occupancy Rates: Emergency occupancy rates will be removed from retailers, gyms and fitness centers, and entertainment venues.
• Use of Partitions: An exception to social-distancing rules will be allowed for many businesses – including barber shops, hair salons, gyms, and restaurants – if people are wearing masks and separated by an “impermeable” barrier.

You can read the Press Release and access Safer at Home Information Sheets on the Alabama Governor’s Newsroom webpage.

November 5, 2020: Preparing to Administer COVID-19 Vaccine when it’s Available

CMS included the following information in their Thursday November 5th edition of MLNConnects:

“Get ready to administer the COVID-19 vaccine when it’s available. Read the enrollment section of our COVID-19 provider toolkit to see if you need to take action now:

• Many Medicare-enrolled providers don’t have to take any action until a vaccine is available – make sure your provider-type enrollment is all set
• Some Medicare-enrolled providers must also separately enroll as a mass immunizer to administer and bill for COVID-19 vaccines when they’re available – find out if you must also enroll as a mass immunizer
• If you’re not a Medicare-enrolled provider, you must enroll as a mass immunizer or other Medicare provider type that can bill for administering vaccines

Enrolling over the phone a mass immunizer is easy and quick — call your MAC-specific enrollment hotline (PDF) and give your valid legal business name, national provider identifier, tax identification number, practice location, and state license, if applicable.”

November 6, 2020: CDC Report: Telework before Illness Onset of COVID-19

The CDC’s Morbidity and Mortality Weekly Report (MMWR) for November 6th focused on employees working in the office versus telework and positive COVID-19 test. Following are answers to questions in the summary section of this report.

“What is added by this report? Adults who received positive test results for SARS-CoV-2 infection were more likely to report exclusively going to an office or school setting in the 2 weeks before illness onset, compared with those who tested negative, even among those working in a profession outside of the critical infrastructure.

What are the implications for public health practice? Businesses and employers should promote alternative work site options, such as teleworking, where possible, to reduce exposures to SARS-CoV-2. Where telework options are not feasible, worker safety measures should continue to be scaled up to reduce possible worksite exposures.”

November 6, 2020: OIG Audit – Office of Refugee Resettlement (ORR) Preparedness to Respond to COVID-19 Pandemic

The OIG released their report where they conducted a communicable disease preparedness audit of 11 selected facilities from March through June 2020 during the COVID-19 pandemic in the United States. They found that the facilities selected for review followed preparation requirements and were prepared to respond to the pandemic. The OIG report contains no recommendations.

“ORR officials stated that, since 2006, ORR has had a policy in place that required its facilities to prepare for and respond to a communicable disease outbreak; therefore, the facilities were generally able to quickly pivot to respond to the COVID-19 pandemic.”

November 6, 2020: FDA Authorizes First Test to Detect Neutralizing Antibodies from Recent or Prior SARS-CoV-2 Infection

Previously issued Emergency Authorization Use (EUAs) for antibody (serology) tests only detect the presence of binding antibodies. The EUA issued to GenScript USA Inc. for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit is “the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.”

In the FDA’s press announcement they caution “against using the results from this test, or any serology test, as an indication that they can stop taking steps to protect themselves and others, such as stopping social distancing, discontinuing wearing masks or returning to work. The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies that the immune system develops in response to the virus, not the virus itself.”

November 9, 2020: FDA Authorizes Monoclonal Antibody Treatment

The FDA announced the issuance of an emergency use authorization (EUA) for Bamlanivimab which is an investigational monoclonal antibody therapy. This drug is not authorized for patients already hospitalized due to COVID-19. Instead, it is to be given in an outpatient setting and  “is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.”

According to the Scope of Authorization in the emergency use authorization (EUA):

• Distribution of the authorized drug will be controlled by the U.S. Government,
• Again, it is authorized for use only by healthcare providers in an outpatient setting,
• The drug may only be administered in a setting where health care providers have immediate access to medications to treat a severe infusion reaction, and
• Use of the drug covered by the authorization must be in accordance with the dosing regiments in the authorized Fact Sheets.

You can also read more about the EUA in a related Lilly Investors announcement.

November 9, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Matters Article Revised

MLN Matters Article SE20011  was originally released March 16, 2020. The most recent iteration of this article includes revisions to clarify the billing instructions in the Skilled Nursing Facility (SNF) Benefit Period Waiver – Provider Information section.

November 9, 2020: Pfizer Announces Vaccine Against COVID-19

In an early Monday morning Press Release, Pfizer announced the success of a joint effort with BioNTech in the development of a vaccine. Specifically, Pfizer indicated that the “vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis.” Once the required safety milestone has been achieved Pfizer is planning to submit for Emergency Use Authorization (EUA) to the FDA. At the time of the Press Release the expectation for reaching that milestone was this week.

CDC COVID Data Tracker – United States COVID-19 Cases

2020 has been a very long and challenging year. In addition to caring for the influx of COVID-19 patients, hospitals have been bombarded with information on how to code and bill for COVID-19. Included in last week’s newsletter was an FAQ detailing the requirement that documentation of a positive COVID-19 test be in the medical record for hospitals to receive the additional 20% payment for the duration of the COVID-19 public health emergency (PHE).

In March, CMS suspended most Medicare Fee-for-Service (FFS) medical reviews because of the COVID-19 pandemic. However, to add to the challenge for hospitals, medical reviews resumed in August. This article focuses on COVID-19 related reviews being conducted by the Office of Inspector General (OIG) and the Supplemental Medical Review Contractor (SMRC).  

Completed OIG Work Plan Reviews Related to COVID-19

As of November 6, 2020, the OIG’s Office of Evaluation and Inspections has issued reports for two Work Plan items related to the COVID-19 PHE.  

COVID-19 Hospital Response Report (OEI-06-20-00300)

In this report, the OIG notes that feedback from hospitals reflects “perspectives at a point in time-March 23-27, 2020.” At that time, the most significant challenges reported by hospitals was related to testing and caring for patients with COVID-19 and keeping staff safe. From anecdotal conversations with our clients, these challenges remain eight months later.

Highlights of OIG’s Emergency Preparedness Work: Insights for COVID-19 Response Reports

Prior to the COVID-19 PHE, the OIG had published several reports about community and health care facility emergency preparedness and response. The OIG developed the following two toolkits “to assist communities in responding to the current pandemic and to other emergencies as they arise.”

• Toolkit: Insights for Communities From OIG’s Historical Work on Emergency Response (OEI-09-20-00440), and
• Toolkit: Insights for Health Care Facilities from OIG’s Historical Work on Emergency Response (OIE-06-20-00470) OEI-06-20-00470

Active OIG Work Plan Reviews Related to COVID-19

Currently, thirteen of thirty Active Work Plan Items that are related to COVID-19 fall under the Centers for Medicare and Medicaid Services. The following table lists when each of these thirteen items were added to the Work Plan and the Titles of the Item.

I want to call your attention to the August 2020 Item: Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed with COVID-19. Specifically, the following summary description for this Work Plan Item:

“Section 3710 of the Coronavirus Aid, Relief, and Economic Security Act directs the Secretary to increase the weighting factor that would otherwise apply to the assigned diagnosis-related group by 20 percent for an individual who is diagnosed with COVID-19 and discharged during the COVID-19 public health emergency period.”  We will audit whether payments made by Medicare for COVID-19 inpatient discharges billed by hospitals complied with Federal requirements.”

It is not clear the claims dates of service that the OIG will request. For claims requested with a date of service on or after September 1, 2020 keep in mind that CMS mandated that a positive COVID-19 test within 14 days of admission must be documented in the record to receive the 20% additional payment. If you receive a notice for records from the OIG and the dates of service are on or after September 1 you should verify whether or not a note for “No Pos Test” was submitted to your MAC. If not, be sure to submit the COVID-19 test results when submitting the record to the OIG. 

Supplemental Medical Review Contractor (SMRC)

Noridian Health Solutions, LLCL (Noridian) is the current SMRC. At the direction of CMS, Noridian conducts nationwide medical reviews for Medicare FFS Part A, Part B and Durable Medical Equipment (DME). On October 15, 2020, Noridian posted a Notification of Medical Review titled DRG COVID 20% Add On Payment.

This project will consist of post-payment reviews of Medicare Part A acute care inpatient hospital claims billed on dates of service from April 1, 2020 through August 30, 2020. Documentation requirements to be included in each Additional Documentation Request (ADR) are listed in Noridian’s notification. Included in this list is “Lab/Diagnostic reports, if applicable, including any that support the COVID-19 diagnosis.” Note, the claims being reviewed are prior to the CMS requirement of a positive COVID-19 test result be in the record to receive the 20% additional payment. This will be important to keep in mind in case you receive a denial based solely on the lack of this documentation being in the record.

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 27th – November 2nd.

Resource Spotlight: November 2, 2020 - CDC Adds to List of Medical Conditions Putting Patients at Risk for Severe Illness due to COVID-19

The CDC webpage People with Certain Medical Conditions has once again been updated to add sickle cell disease and chronic kidney disease to the conditions that might increase the risk of severe illness among children. As we approach the holiday season, this webpage also provides guidance regarding what to consider before being around people and things to consider to help make personal and social activities as safe as possible.

October 28, 2020: FDA Enforcement Policy for Non-Invasive Remote Monitoring Devices during COVID-19 PHE (Revised)

The FDA initially issued guidance in June 2020 “to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency.” They note in this October 28, 2020 Announcement that the guidance has been updated and that it is intended to remain in effect only for the duration of the Public Health Emergency (PHE) related to COVID-19.

October 28, 2020: Fourth COVID-19 Interim Final Rule with Comment Period (IFC-4) – Eliminating Barriers, Flexibilities, Extension CJR Model,

CMS announced, in an October 28 Press Release, the release of a fourth COVID-19 Interim Final Rule. In a related Fact Sheet, CMS indicates that this final rule, “removes administrative barriers to eliminate potential delays to patient access to a lifesaving vaccine. In addition, the rule:

• Creates flexibilities for states maintaining Medicaid enrollment during the COVID 19 PHE;
• Establishes enhanced Medicare payments for new COVID-19 treatments;
• Takes steps to ensure price transparency for COVID-19 tests, and
• Provides an extension of Performance Year 5 for the Comprehensive Care for Joint Replacement (CJR) model; and
• Creates flexibilities in the public notice requirements and post-award public participation requirements for a State Innovation Waiver under Section 1332 of the Patient Protection and Affordable Care Act during the COVID-19 PHE.”

October 28, 2020: Fourth COVID-19 Interim Final Rule with Comment Period (ICF-4): New COVID-19 Treatments Add-On Payment (NCTAP)

As a segue to the new add-on payment, Section D. of ICF-4 reviews section 3710 of the CARES Act and the IPPS New Technology Add-On Payment process before transitioning to the FDA Coronavirus Treatment Acceleration Program created for possible coronavirus therapies. One aspect of this program is the issuance of Emergency Use Authorizations (EUAs) during the COVID-19 Public Health Emergency (PHE). “CMS has determined that it is appropriate for CMS to consider drug and biological products which are authorized for emergency use for COVID-19, with letters of authorization, and are used to treat COVID-19 disease, to fall within the drugs and biologicals” Medicare benefit category.

CMS believes that as “drugs or biological products become available and are authorized or approved by FDA for the treatment of COVID-19 in the inpatient setting, it would be appropriate to increase the current IPPS payment amounts to mitigate any potential financial disincentives for hospitals to provide these new treatments during the PHE.”

CMS indicates effective with the date of ICF-4 and until the end of the PHE, when a therapy meets specific criteria it will be eligible for NCTAP. They also note that currently there are only two drug and biological products that meet the criterion. The following table highlights the two products and the ICD-10-PCS codes assigned to the products.

“CMS is setting the NCTAP amount for a case that meets the NCTAP eligibility criteria equal to the lesser of: (1) 65 percent of the operating outlier threshold for the claim or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment, including the adjustment to the relative weight under section 3710 of the CARES Act. As with the new technology add-on payment and outlier payments, the costs of the case are determined by multiplying the covered charges by the operating cost-to-charge ratio. In addition, the NCTAP will not be included as part of the calculation of the operating outlier payments.”

To date, no drug or biological product has a EUA for treatment of COVID-19 patients in the outpatient setting. However, this Interim Final Rule includes the criteria for separate payment for New COVID-19 Treatments in the Outpatient Setting for the remainder of the PHE if and when a product is granted EUA.

October 28, 2020: Incentive Payments to Nursing Home Curing COVID-19 Deaths and Infections

Over 10,000 nursing homes will be receiving money from the approximately $333 million in first round performance payments to be made by HHS through the Health Resources and Services Administration (HRSA). HHS Secretary Alex Azar indicated in an HHS Press Release that "These $333 million in performance payments are going to nursing homes that have maintained safer environments for residents between August and September. We've provided nursing homes with resources and training to improve infection control, and we're rapidly providing incentives to those facilities that are making progress in the fight against COVID-19."

October 30, 2020: CDC Morbidity & Mortality Report: COVID-19 Exposure and Infection Among Health Care Personnel

The CDC’s Morbidity and Mortality Weekly Report (MMWR) for October 30th focused on COVID-19 exposure and infection among health care professionals in Minnesota from March 6th through July 11, 2020. The report summary acknowledges that it is already known that health care personnel (HCP) are at increased risk for COVID-19 from workplace exposures. The authors of this report found that “HCP in congregate living and long-term care setting experience considerable risk and post a transmission risk to residents. Improved access to personal protective equipment, flexible medical leave and testing is needed.”

October 30, 2020: CMS Announces Launch of the Nursing Home Resource Center

CMS announced the launch of this new online platform which “consolidates all nursing home information, guidance and resources into a user-friendly, one-stop-shop that is easily navigable so providers and caregivers can spend less time searching for critical answers and more time caring for residents. Moreover, the new platform contains features specific to residents and their families, ensuring they have the information needed to make empowered decisions about their healthcare.”

The Resource Center includes information for Providers & CMS Partners and Patients & Caregivers. Resource Topics specific to Providers and CMS Partners includes the following:

• Regulations & Guidance,
• Training & Resources,
• Technical Information,
• COVID-19 Data & Updates, and
• Payment Policy Information.

October 30, 2020: Supply Kits to Safely Administer COVID-19 Vaccines to Americans

An HHS news release indicates that they have “recently contracted with McKesson Corporation to produce, store and distribute these vaccine ancillary supply kits on behalf of the Strategic National Stockpile. Each kit will contain enough supplies to administer up to 100 doses of vaccine and will include:

• Needles (various sizes for the population served by the ordering vaccination provider)
• Syringes
• Alcohol prep pads
• Surgical masks and face shields for vaccinators
• COVID-19 vaccination record cards for vaccine recipients
• Needle information card”

October 31, 2020: BinaxNOW COVID-19 Tests Distribution

HHS announced that in ongoing efforts to prevent COVID-19 outbreaks in high risk communities, 389,040 Abbott BinaxNOW COVID-19 rapid tests have been distributed at no cost to 83 Historically Black Colleges and Universities (HCBU’s) in 24 states. “The Abbott BinaxNOW test is the only rapid point of care test that does not require instrumentation – is easy to use, produces COVID-19 test results within fifteen minutes and costs just five dollars. In addition to responding quickly to flash outbreaks, these tests are ideally suited for the screening and ongoing surveillance of underserved demographic groups and in congregate settings such as group homes, nursing homes, K-12 schools and institutions of higher learning.”

CDC COVID Data Tracker – United States COVID-19 Cases

CMS announced the release of the Transparency in Coverage Final Rule [CMS-9915-F] on October 28, 2020. According to a related CMS Fact Sheet, “This final rule is a historic step toward putting health care price information in the hands of consumers and other stakeholders, advancing the Administration’s goal to ensure consumers are empowered with the critical information they need to make informed health care decisions.”

Figuring out the plot to a mystery novel involves asking questions and looking for answers to basic questions asked when gathering information (who, what, when, where, and why). CMS Final Rules can at first glance seem like a mystery and require the same process of asking and answering these questions. This article asks key questions and provides you with answers to help you figure out what is included in the Transparency in Coverage Final Rule.

Who is required to Disclose Cost-Sharing Information? 

Group Health Plans and Health Insurance issuers in the Individual and Group Markets.

• Note, the term group health plan includes both insured and self-insured group health plans.

What Type of Cost-Sharing Information is required to be disclosed?

• An estimate of the individual’s cost-sharing liability for covered items or services furnished by a particular provider.
• In-network provider negotiated rates,
• Historical out-of-network allowed amounts, and
• Drug pricing information

What is the required format for Disclosure of Cost-Sharing Information?

• This information must be available on an internet website in machine-readable files, and
• If requested, in paper form.

How many and what type of machine-readable files are required?

Plans and issuers must disclose pricing information in three machine-readable files

• One file will disclosure of payment rates negotiated between plans or issuers and providers for all covered items and services,
• A second file will disclose unique amounts a plan or issuer allowed, as well as associated billed charges, for covered items or services furnished by out-of-network providers during a specific time period.
• A third file will include pricing information for prescription drugs.

How often will issuers be required to update the machine-readable files?

“The final rules adopt, as proposed, the requirement for a plan or issuer to update the information required to be included in each machine-readable file monthly. The final rules clarify that this requirement to update the machine-readable files monthly applies to all three machine-readable files being finalized through the final rules: the In-network Rate File, the Allowed Amount File, and the Prescription Drug File”

What are the benefits of Disclosing Cost-Sharing Information?

CMS indicates in the Final Rule that “by requiring the dissemination of price and benefit information directly to consumers and to the public, the transparency in coverage requirements will provide the following consumer benefits:

• enables consumers to evaluate health care options and to make cost-conscious decisions;
• strengthens the support consumers receive from stakeholders that help protect and engage consumers;
• reduces potential surprises in relation to individual consumers’ out-of-pocket costs for health care services;
• creates a competitive dynamic that may narrow price dispersion for the same items and services in the same health care markets; and
• Puts downward pressure on prices which, in turn, potentially lowers overall health care costs.”

Where can you find a list of the 500 Items and Services Identified by the Departments?

This information is included in the Final Rule in Table 1: 500 Items and Services List. The table includes the applicable HCPCS/CPT code with the code description and a plain language description. For example, the first item in the list is J0702: BETAMETHASONE ACET&SOD PHOS with the plain language description being “Injection to treat reaction to a drug.”

Where can you find definitions of key terms in the Final Rule?

There is a Transparency in coverage – Definitions section towards the end of the final rule. Here you will find definitions for the following key terms:

• Accumulated amounts,
• Beneficiary,
• Billed charge,
• Billing code,
• Bundled payment arrangement,
• Copayment assistance,
• Cost-sharing liability,
• Cost-sharing information,
• Covered items and services,
• Derived amount,
• Historical net price,
• In-network provider,
• Items or services,
• Machine-readable file,
• National Drug Code,
• Negotiated rate,
• Out-of-network allowed amount,
• Out-of-network provider,
• Out-of-pocket limit,
• Plain language,
• Prerequisite, and
• Underlying fee schedule rate.

What are the CMS Intended Outcomes from implementation of this Final Rule?

• Informed Consumers,
• Consumers may become more cost conscious,
• Timely payment of medical bills, and
• Increase competition among Providers

When will the regulations in this Final Rule go into effect?

“The final rules adopt a three-year, phased-in approach with respect to the scope of the requirement to disclose cost-sharing information. Plans and issuers must make cost-sharing information available for 500 items and services identified by the Departments for plan years (in the individual market, for policy years) beginning on or after January 1, 2023, and must make cost-sharing information available for all items and services for plan years (in the individual market, for policy years) beginning on or after January 1, 2024.”

How will Requirements in the Final Rule be enforced?

“States will generally be the primary enforcers of the requirements imposed upon health insurance issuers by the final rules. 233 The Departments expect to work closely with state regulators to design effective processes and partnerships for enforcing the final rules.”

Of note, this final rule also includes amendments to the Department of Health and Human Services (HHS) medical loss ratio (MLR) program “to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.”

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 20th through October 26th.

Resource Spotlight: Tips for Voters

As we are just days away from the election, the CDC has created a Tips for Voters to Reduce Spread of COVID-19 webpage which includes 6 steps to follow before you vote and 6 steps to take the day you vote. For those of you who plan to vote in person, the CDC provides a checklist of recommended items to bring with you to your voting site, including:

• Necessary documentation such as your identification (check with your voting site),
• A mask,
• An extra mask,
• Tissues,
• Hand sanitizer with at least 60% alcohol,
• Water,
• Black ink pen, and
• Bring prepared items with you (e.g., registration forms, sample ballots)

October 20, 2020: New FAQs added to COVID-19 FAQs on Medicare Fee-for-Service (FFS) Billing

Three new FAQs were added to this now 150 page document on October 20, 2020. Two pertain to Medicare Telehealth (questions 46 and 47 in the Medicare Telehealth section of this document). The third FAQ is related to Medicare beneficiary SNF benefits as follows:

“Question: If a new benefit period was granted pursuant to the section 1812(f) waiver, and the PHE ends in the middle of that new benefit period, would the beneficiary be entitled to the full 100 days of renewed SNF benefits, or would that entitlement end on the day the PHE ends?

Answer: If a beneficiary has qualified for the special one-time renewal of SNF benefits under the benefit period aspect of the section 1812(f) waiver while the section 1812(f) waiver is in effect, that reserve of 100 additional SNF benefit days would remain available for the beneficiary to draw upon even after the waiver itself has expired.

New: 10/20/20”

As a reminder, Secretary Azar issued the most recent continuation of the Public Health Emergency (PHE) due to the COVID-19 pandemic on October 2, 2020 with an effective date of October 23, 2020.

October 21, 2020: CDC Guidance: Test for Current Infection Updated

The CDC webpage Test for Current Infection has been updated and lists the following considerations for who should get tested:

• People who have symptoms of COVID-19,
• People who had had close contact (within 6 feet of an infected person for a total of 15 minutes or more) with someone with confirmed COVID-19,
• People who have been asked or referred to get testing by their healthcare provider, local or state health department.

October 21, 2020: Expanding Access to COVID-19 Tests and Vaccines

HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) authorizing qualified pharmacy technicians and State-authorized pharmacy interns to administer, childhood vaccines, COVID-19 Vaccines when available, and COVID-19 tests. All those authorized to administer tests and vaccines are subject to several requirements. HHS provides a link to the guidance document in their Press Release.

October 22, 2020: Nursing Home COVID-19 Preparedness for Fall & Winter Web-Based Training

The Thursday October 22nd edition of the CMS MLNConnects newsletter informs providers about web-based training available to Nursing Homes to help them prepare for COVID-19, provide resident-centered care, and prevent and control infection. You can visit the Quality, Safety & Education Portal to access free scenario-based trainings for managers and frontline staff. See the flyer for more information.

October 22, 2020: FDA Approved First Treatment for COVID-19

The FDA announced their approval of the “antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.” 

Reminder, effective August 1, 2020, CMS implemented 12 new ICD-10-PCS codes related to COVID-19 became effective, including the administration of Remdesivir.

October 22, 2020: Relief Fund Eligibility Expansion and Updated Reporting Requirements

Relief Fund Eligibility Expansion: HHS announced the expansion of Providers eligible to receive Phase 3 Provider Relief Funding. The announcement includes a list of eligible providers “regardless of whether they accept Medicaid or Medicare.” Note, applicants have until 11:59PM EST on November 6, 2020 to submit an application for payment consideration.

Reporting Requirement Update: An update to the reporting requirements was also included in the announcement. “In response to concerns raised, HHS is amending the reporting instructions to increase flexibility around how providers can apply PRF money toward lost revenues attributable to coronavirus. After reimbursing healthcare related expenses attributable to coronavirus that were unreimbursed by other sources, providers may use remaining PRF funds to cover any lost revenue, measured as a negative change in year-over-year actual revenue from patient care related sources.” Note, this announcement includes links to a policy memorandum and the amended reporting requirements.

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 13th through October 19th.

Resource Spotlight: Hypertension Control Call to Action by Surgeon General

On October 8, 2020, Surgeon General, VADM Jerome M. Adams, M.D., M.P.H., “issued a Call to Action urging Americans to recognize and address hypertension control as a national, public health priority. The Surgeon General's Call to Action to Control Hypertension - PDF* provides strategies for those on the frontlines of health care and public health to address this costly, dangerous and far too common chronic health condition.”

This HHS Press Release includes a video by the Surgeon General and goes on to note that “currently, there are limited data and information about the impact of underlying medical conditions – including hypertension – on the risk for severe illness from COVID-19. While our understanding of COVID-19 is still improving and evolving, we know that people with hypertension may be at an increased risk for severe illness from COVID-19.”

October 8, 2020: CMS Halt to Advance Payment Applications

CMS updated the Fact Sheet: Repayment Terms for Accelerated and Advance Payments Issued to Providers and Suppliers During COVID-19 Emergency. New to this Fact Sheet is the following statement: “Please note that, as of October 8, 2020, CMS will no longer accept applications for accelerated or advance payments as they relate to the COVID-19 PHE, although CMS will continue to monitor the ongoing impacts of COVID-19 on the Medicare provider and supplier community.”

You can also read more about the Accelerated/Advance Payment (AAP) Repayment process in an FAQ document posted to Palmetto GBA’s website on October 14, 2020.

October 9, 2020: Trick or Treating and Other Halloween Activities

With just a little over one week until October 31st, the CDC has created the webpage Trick or Treating and Other Halloween Activities.  On this page you find guidance on the following topics for this spookiest of nights:

• Make trick-or-treating safer,
• Wear a mask,
• Stay at least 6 feet away from others who do not live with you,
• Wash your hands,
• Steps to take for Other Halloween Activities,
• Decorate and carve pumpkins,
• Visit an orchard, forest, or corn maze. Attend a scavenger hunt, and
• Links to posters in pdf format with all of the information on this webpage.

October 14, 2020: AHIP Blog: Health Insurance Providers Respond to Coronavirus (COVID-19)

The America’s Health Insurance Plans (AHIP) national association has compiled an A to Z listing of some health insurance providers who are taking action to ensure Americans have access to the prevention, testing, and treatment needed for COVID-19.

https://www.ahip.org/health-insurance-providers-respond-to-coronavirus-covid-19/

October 14, 2020: List of Covered Telehealth Services Covered During the COVID-19 PHE Expanded

CMS announced in a Press Release the expansion of telehealth services to be covered during the COVID-19 Public Health Emergency (PHE) for Medicare Fee-for-Service beneficiaries. Effective immediately, CMS will begin paying for the new telehealth services for the duration of the PHE.

CMS also announced, in the same Press Release, the release of a supplement to its State Medicaid & CHIP Telehealth Toolkit: Policy Considerations for States Expanding Use of Telehealth, COVID-19 Version that provides numerous new examples and insights into lessons learned from states that have implemented telehealth changes.

October 15, 2020: CMS Changes Medicare Payment for COVID-19 Diagnostic Testing

CMS announced changes to Medicare payment to laboratories for high throughput diagnostic tests effective January 1, 2021. The following highlights the timeline of changes:

• April 2020: CMS increased Medicare payment from approximately $50 to $100 per test.
• Effective January 1, 2021:
• Medicare will pay $100 only to laboratories who can complete COVID-19 diagnostic tests within two days of the specimen collection.
• Medicare will pay $75 for laboratories taking longer than two days.

You will also find a link to CMS’ document, COVID-19 FAQs on Medicare Fee-for-Service Billing, at the end of the Press Release. Note, CMS has added a new section, D. High Throughput COVID-19 Testing, (see pages 12 through 16 of the document). 

October 15, 2020: Supplemental Medical Review Contractor (SMRC) Medical Review Notification: DRG COVID-19 20% Add On Payment

Noridian Healthcare Solutions, the current SMRC added Project 01-043 to their list of active projects on October 15, 2020. They will be conducting post-payment Medicare Part-A acute inpatient reviews of claims billed with dates of service from April 1, 2020 through August 30, 2020. Following is the background information included in this Notification:

“Medicare Severity Diagnosis Related Group (MS-DRG) is a system used to classify various diagnoses and procedures for acute care inpatient hospital stays so Medicare can accurately reimburse the hospital under the Inpatient Prospective Payment System (IPPS). In response to the declaration of the COVID-19 outbreak as a Public Health Emergency (PHE), the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Public Law 116-136), was enacted on March 27, 2020. Section 3710 of the CARES Act directs the Secretary to increase the weighting factor of the assigned Diagnosis-Related Group (DRG) by 20 percent for an individual diagnosed with COVID-19 discharged during the COVID-19 PHE period. Discharges of an individual diagnosed with COVID-19 will be identified by the presence of appropriate International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes. Notably, in August of 2020, the Office of Inspector General (OIG) placed an “Audit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed With COVID-19” on its active work plan.”

October 16, 2020: Medicare Fee-for-Service (FFS) Response to the Public Health Emergency on the Coronavirus (COVID-19) MLN Article Revised

MLN SE20011 was originally released March 16, 2020. This latest revision to the article clarifies HCPCS codes that Critical Access Hospitals (CAHs) should use in the, Families First Coronavirus Act Waives Coinsurance and Deductibles for Additional COVID-19 Related Services section. The Skilled Nursing Facility (SNF) Benefit Waiver Period section, now clarifies that the SNF waiver applies to swing-bed services in rural hospitals and CAHs.

October 16, 2020: Special Edition MLNConnects: Enforcement Discretion Relating to Certain Pharmacy Billing

CMS announced that in order to provide onsite COVID-19 vaccines to Skilled Nursing Facility (SNF) residents, CMS is exercising discretion during this global emergency to “allow Medicare-enrolled immunizers, including but not limited to pharmacies working with the United States, to bill directly and receive direct reimbursement from the Medicare program for vaccinating Medicare SNF residents.”

In a related Press Release, the U.S. Department of Health and Human Services (HHS) also announced on October 16th “agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs.”

October MAC Talk: The Local Scene

September 28, 2020: Noridian Provider Outreach & Education Webinar: Compliance Program – What Every Provider Needs to Know

Noridian’s Provider Outreach and Education (POE) will be hosting the Compliance Program webinar next Wednesday October 28, 2020 at 3 p.m. CT. Topics to be covered include:

• What is the Compliance Program,
• Compliance Fundamental Elements,
• Compliance Laws and Statues,
• Documentation and Functions of Medical Records, and
• Noteworthy Information and Resources.

Link to Webinar Announcement: https://med.noridianmedicare.com/web/jfa/article-detail/-/view/10529/compliance-program-what-every-provider-needs-to-know-webinar-october-28-2020

September 29, 2020: Novitas Solutions Reminds Providers about Requirements to be Eligible for 20 Percent Increase in MS-DRG Weighting Factor

This Novitas article opens by reminding the reader that the CARES Act established a 20 percent increase in the relative weight of the diagnosis related group (DRG) billed for a Medicare fee-for-service inpatient hospitalization during the COVID-19 public health emergency. They go on to reinforce that effective for admissions on after September 1, 2020 that without documentation of a positive COVID-19 test in the record, the hospital is not eligible to receive the 20 percent increase. I encourage you to read this article as it goes on to provide coding and billing guidance.

September 29, 2020: Palmetto GBA Article: Cardiovascular Disease and Intensive Behavioral Therapy

Palmetto highlights the fact that hypertension (HTN), coronary artery disease (i.e., myocardial infarction and angina pectoris), heart failure and stroke are all Cardiovascular Disease (CVD) diagnoses. This article reminds health care providers that CMS believes “Intensive Behavioral Therapy (IBT) for CVD is reasonable and necessary for the prevention or early detection of illness or disability, and is appropriate for” Medicare beneficiaries. This article highlights risk factors for CVD, the HCPCS code for IBT for CVD (G0446), discusses the components of IBT and provides resources including a link to the National Coverage Determination (NCD) 210.11 Intensive Behavioral Therapy for Cardiovascular Disease.

October 1, 2020: Novitas Solutions: Prior Authorizations for hospital Outpatient Department Tips and Reminders

Similar to WPS, Novitas released an article including tips and reminders to assist you in avoiding a delay or dismissal of a prior authorization request (PAR).

October 2, 2020: Palmetto GBA Article: TPE Notifications Coming to eServices!

Palmetto GBA announced the addition of TPE notification letters to their eServices portal beginning October 10, 2020. At that time, letters will be issued as before through standard mail for non-eServices Users or the new option of electronically for eService Users. At the end of this announcement, Palmetto reminds providers that TPE reviews are on hold due to the COVID-19 pandemic and you will be notified when it TPE reviews do resume.

October 2, 2020: Palmetto GBA Article: Procedure Codes that Require Additional Documentation

This article  opens by reminding providers that “the submission of additional documentation is required only when certain CPT/HCPCS codes are billed or when additional documentation is needed for Palmetto GBA to process and/or price a service.” Palmetto GBA has included a list of codes requiring additional documentation in the article.

October 6, 2020: Novitas Article: Change to Amount in Controversy (AIC) for Appeals in 2021

This Novitas article provides updated information to the AIC for Appeals filed on or after January 1, 2021, includes the AIC amount, explains how the AIC is calculated and provides examples.

October 6, 2020: Palmetto GBA Article: General Appeals Information

Palmetto GBA reminds providers that you have the right to request an appeal if you disagree with an initial claim determination. This article walks through the five levels of Medicare Fee-for-Service appeals including time limits to appeal, minimum amounts in controversy (AIC) and notes providing additional guidance at the first three levels of appeal.

October 13, 2020: Palmetto GBA Article: Consider Reopening a Claim Instead of a Written Redetermination

Palmetto GBA advises, in the opening of this article, that “there is no need to appeal a claim if you have made a minor error or omission in filing the claim, which in turn caused the claim to be denied. In the case where a minor error or omission is involved, you may request that Palmetto GBA reopen the claim so the error or omission can be corrected rather than going through the written appeals process.” The article goes on to provide examples of what is considered a minor error or omission that can be reopened, modifiers considered simple claims corrections, and provide answers to questions about the process.

October 15, 2020: First Coast Services Options Prior Authorization for Certain Outpatient (OPD) Services FAQs and Retroactive Authorization for Services in the ED

First Coast has recently posted two documents providing information about the Prior Authorization for Certain OPD Services program that began in July of this year.

• FAQ Document based on questions posed during webinars: https://medicare.fcso.com/Prior_authorization/0466250.asp, and
• Retroactive Services in the Emergency Department: https://medicare.fcso.com/Prior_authorization/0474891.asp

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from October 6th through October 12th.

Resource Spotlight: CDC Updates Guidance on How Coronavirus Spreads

On October 5th, the CDC updated their guidance on how Coronavirus spreads. The CDC’s How COVID-19 Spreads webpage opens by noting the spread of COVID-19 is mainly through close contact (within about 6 feet) and that people who are infected but asymptomatic can also spread the virus. The next sentence in the opening paragraph reminds the reader how much is still unknown about this disease as the CDC states “we are still learning about how the virus spreads and the severity of illness it causes.”

New to this page is the fact that the CDC is now on record as stating they believe “COVID-19 can sometimes be spread by airborne transmission” The following example provided by the CDC brings to mind the choir practice in March that resulted in multiple people testing positive for COVID-19, including three patients being hospitalized and two dying.

“There is evidence that under certain conditions, people with COVID-19 seem to have infected others who were more than 6 feet away. These transmissions occurred within enclosed spaces that had inadequate ventilation. Sometimes the infected person was breathing heavily, for example while singing or exercising.

• Under these circumstances, scientists believe that the amount of infectious smaller droplet and particles produced by the people with COVID-19 became concentrated enough to spread the virus to other people. The people who were infected were in the same space during the same time or shortly after the person with COVID-19 had left.”

September 29, 2020: CMS Updates COVID-19 Testing Methodology for Nursing Homes

Although this update occurred in late September. After talking with my mother, who is now a permanent resident of an Assisted Living Community where a Skilled Nursing Unit (SNF) is housed on the opposite side of the building, I felt it was important to share. Especially after my mom mentioning during a phone conversation that she is getting testing weekly for COVID-19 and the employees are getting tested twice a week.

The September 29th updated guidance came about in response to CMS receiving concerns from some governors of rural states that the frequency guidelines were not working well for some rural areas and updates the August 26th guidance.

October 6, 2020: CMS Interim Final Rule (IFC) –Requirements & Enforcement Process for Reporting COVID-19 Data Elements

CMS summarized the IFC as follows:

“CMS is committed to continuing to take critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-10) Public Health Emergency (PHE). On September 2, 2020, the Federal Register published an interim final rule with comment period (IFC) (85 FR 54820). CMS has released new regulatory requirements for all hospitals and critical access hospitals (CAHs) at 42 C.F.R. §§482.42(e) and 485.640(d), respectively, to report information in accordance with a frequency and in a standardized format as specified by the Secretary during the PHE for COVID-19. Failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.”

You will find a link to the memorandum sent to CMS Locations State Agencies, Hospitals/CAHs, and other stakeholders as well as Hospital Mandatory COVID-19 Reporting Enforcement Workflow pdf document on this CMS webpage.

October 6, 2020: FDA Launches New Webpage: COVID-19 Vaccines

In their October 6, 2020 COVID-19 Daily Roundup, the FDA announced the launch of a new webpage, COVID-19 Vaccines, to highlight new information as it becomes available. On this webpage, Stephen M. Hahn, M.D., FDA Commissioner, and Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research indicate that “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”

October 7, 2020: Regeneron Seeks Emergency Use Authorization Request

Regeneron announced their submission to the FDA for an Emergency Use Authorization (EUA) for their REGN-COV2 investigational antibody combination for COVID-19. The announcement goes on to indicate that “if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.”

October 7, 2020: FDA Recommendations on Instructions for Patients Self-Collecting Nasal Samples for COVID-19 Testing

In an FDA Letter to Health Care Providers, the FDA is recommending that “providers provide visual (written or video) step-by-step instructions, in addition to verbal instructions, to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing…the instructions provided to patients should incorporate the following information:

• The entire tip of the swab (usually ½ to ¾ of an inch) should be placed inside the nose, and the side of the swab tip should be rubbed with moderate pressure against as much of the wall of the anterior nares region as possible, moving the tip through a large circular path inside the nose.
• At least four of these sweeping circles should be performed in each nostril using the same swab. This should take approximately 10-15 seconds per nostril.
• Simply twirling the swab against one part of the inside of the nose or leaving the swab in the nose for 10-15 seconds, is not proper technique and may result in an insufficient sample.”

The letter also includes links to additional resources and how to report problems with SARS-COV-2 testing to the FDA.

October 7, 2020: AMA Press Release – New CPT codes for Multi-Virus Tests Detect COVID-19 and Flu – Approved for Immediate Use

The AMA announced an update to the Current Procedural Terminology (CPT®) code set including “new code additions and editorial revisions for reporting medical services sparked by the public health response to the COVID-19 pandemic.”

The following two new codes allow for detection of COVID-19 and common viral infections, including influenza A/B and respiratory syncytial virus.

• 87636 - Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]) and influenza virus types A and B, multiplex amplified probe technique
• 87637- Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), influenza virus types A and B, and respiratory syncytial virus, multiplex amplified probe technique

It is important to note that revisions to the code set have been approved for immediate use.

October 8, 2020: New Repayment Terms for Medicare Loans made to Providers during COVID-19

The recently enacted “Continuing Appropriations Act, 2021 and Other Extensions Act” amended the repayment terms for the Expanded Accelerated and Advance Payments (AAP) Program. CMS released a Special Edition MLNConnects providing details regarding the new recoupment terms giving providers and suppliers one additional year to start their loan repayments. “CMS issued $106 billion in payments to providers and suppliers in order to alleviate the financial burden health care providers faced while experiencing cash flow issues in the early stages of combating the Coronavirus Disease 2019 (COVID-19) public health emergency.” This article includes links to a Fact Sheet (PDF) and FAQs (PDF) document providing more information about the repayment terms.

Palmetto GBA, the Medicare Administrative Contractor (MAC) for Jurisdictions J and M also released an

Article on October 8th letting providers know that they will be issuing “letters to any provider or facility that received an APP with full details regarding repayment of their accelerated or advanced payment. The letter will include a list of the provider’s accelerated or advance payment(s), including the amount(s), the date(s) that repayment will begin, and the related Accounts Receivable (AR) number(s). If a provider received accelerated or advance payment(s) in multiple disbursements, each disbursement amount will be listed, along with the corresponding date that repayment for each disbursement will begin.”

October 8, 2020: MLNConnects Notification – COVID-19: Optimizing PPE and Child Health and Wellness

CMS provided the following information in their Thursday October 8th edition of MLNConnects:

The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released:

• Optimizing Healthcare PPE and Supplies Webinar Q&A: Read responses to questions from the September 24 webinar
• PPE Preservation Planning Toolkit: Reuse, repurpose, or reduce the use of Personal Protective Equipment (PPE)
• Crisis Standards of Care  in Post-Acute and Long-Term Care Facilities: Respond to crisis standards of care
• Child Health and Wellness Webinar Recording: Listen to the first webinar in the Hidden Consequences: How the COVID-19 Pandemic is Impacting Children series

For More Information:

• ASPR TRACIE Fact Sheet
• ASPR TRACIE website
• ASPR TRACIE Novel Coronavirus Resources webpage

October 8, 2020: SNF and LTCH Quality Reporting Programs: COVID-19 Public Reporting – Revised

Also included in the Thursday October 8th edition of MLNConnects, are updated COVID-19 public reporting tip sheets for Skilled Nursing Facilities (SNFs) and Long-Term Care Hospitals (LTCHs).

October 9, 2020: CMS Takes Action to Protect Integrity of COVID-19 Testing

CMS notes in an October 9th Press Release that “since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without an appropriate CLIA certificate. Of those 171 letters, 34 percent went to facilities conducting laboratory testing without a CLIA certificate and 66 percent were issued to laboratories performing COVID-19 testing outside the scope of the existing CLIA certification. The letters ordered these laboratories to stop immediately to safeguard the integrity of COVID-19 testing, and protect patients from potential endangerment if provided inaccurate or unreliable test results. Following receipt of the letter, laboratories are required to provide CMS an attestation certifying they have ceased testing.”

CDC COVID Data Tracker – United States COVID-19 Cases

MMP remains committed to continuing to monitor for COVID-19 updates specific to our reader base. This week we highlight key updates spanning from September 28th through October 5th.

Resource Spotlight: CDC Guidance on Personal and Social Activities

Fall is my favorite time of year as there are so many opportunities to gather with friends and family. Unfortunately, this year is like no other in my lifetime. As you consider activities with friends and family, review guidance on the CDC website regarding personal and social activities which includes among other activities, hosting gatherings or cook-outs.

September 28, 2020: Alabama Medicaid COVID-19 Relief Grants

The state of Alabama is offering cash grants up to $15,000 for Alabama Health Care and Emergency Response Providers that meet eligibility requirements. Key things to note in this Alabama Medicaid Alert are:

• Disbursements will be awarded on a first-come, first-served basis up to $35 million aggregate cap,
• The application period for the Alabama Health Care and Emergency Response Provider Grant Program will be open on noon October 5, 2020 and end at noon October 16, 2020, and
• Eligible providers for this grant program include:
• Health care providers including primary care clinics, ambulance/EMS service providers, pharmacies, physician offices, dentist offices, outpatient care centers, medical and diagnostic laboratories, home health care businesses, assisted living facilities, physical therapy offices, and other provider types.
• Emergency response providers including rescue squad organizations, volunteer fire departments, 911 boards, and other provider types.

September 29, 2020: OIG Report – National Snapshot of State Agency Approaches to Child Care During the COVID-19 Pandemic

The objective of this Audit was to identify what measures Child Care and Development Fund (CCDF) program lead agencies have undertaken “to ensure access to safe child care as well as to protect the providers rendering the care in their CCDF programs in response to the COVID-19 pandemic.” The OIG compiled responses to a questionnaire and follow-up interviews conducted with State agencies between April 30 and June 16, 2020. Not surprising to parents, the OIG found that nationally about 63 percent of child care centers and 27 percent of family child care providers had closed during the COVID-19 pandemic. The OIG made no recommendations. Instead they note that the Administration for Children and Families (AFC) should “use this report to support State agencies as they work to address ongoing issues that could impede access to child care as a result of the COVID-19 pandemic.”

October 1, 2020: HHS & The Rockefeller Foundation to Share Best Practices for Increased COVID-19 Testing

HHS announced their agreement with the Rockefeller foundation “to identify and share effective approaches for using rapid point-of-care (POC) antigen tests to screen for COVID-19 in communities, with a focus on safely reopening K-12 schools.”

October 1, 2020: Remdesivir Now Available Directly from Distributor

HHS announced in a Press Release that beginning October 1, 2020, American hospitals can purchase Veklury (remdesivir) directly from the drug’s distributor. What you need to know:

• Also on October 1st, the FDA revised the Emergency Use Authorization for Veklury removing the U.S. government’s role in directing the allocation of the drug,
• The current supply of the drug exceeds the market demand,
• The cost of the drug will not change in the transition away from U.S. government oversight. Hospitals will continue to pay no more than Gilead’s wholesale acquisition price (WAC), approximately $3,200 per treatment course, and
• AmerisourceBegen will remain the sole distributor through the end of 2020 to ensure a smooth distribution process.

October 1, 2020: MLNConnects Notification – Optimizing Health Care PPE and Supplies

The Office of the Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) released an Express message with new resources:  

• COVID-19: Optimizing Healthcare Personal Protective Equipment (PPE) and Supplies webinar recording: Hear from public and private sector partners

• COVID-19 Response Assistance Field Observations webpage: Learn about institutions of higher learning, K-12 schools, minority/vulnerable populations, and critical infrastructure
• Maintaining Healthcare Safety During the COVID-19 Pandemic speaker series: Listen to health care professionals share their experiences

For More Information:

• ASPR TRACIE Fact Sheet

• ASPR TRACIE website
• ASPR TRACIE Novel Coronavirus Resources webpage

October 1, 2020: $20 Billion in New Phase 3 Provider Relief Funding

The Department of Health and Human Services (HHS) announced $20 billion in new funding for providers and can begin applying for funds on Monday October 5th and can apply through November 6, 2020. Under this Phase 3 General Distribution allocation eligibility has expanded to the following:

• Providers who have already received Provider Relief Fund payments are invited to apply for additional funding,
• Previously ineligible providers, such as those who began practicing in 2020 will be invited to apply, and
• An expanded group of behavioral health providers confronting mental health and substance issues exacerbated by the pandemic will also be eligible for relief payments.

“HHS is urging all eligible providers to apply early; do not wait until the last day or week of the application period. Applying early will help to expedite HHS’s review process and payment calculations, and ultimately accelerate the distribution of all payments.”

October 2, 2020: Public Health Emergency Renewed

The Secretary of Health and Human Services, Alex M. Azar II, has renewed the Public Health Emergency (PHE) due to the COVID-19 pandemic effective October 23, 2020. The extension of the PHE means that current waivers will remain in place.

• Renewal of Public Health Emergency: https://www.phe.gov/emergency/news/healthactions/phe/Pages/covid19-2Oct2020.aspx
• CMS Coronavirus Waivers & Flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers

CDC COVID Data Tracker – United States COVID-19 Cases