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How Can I Keep Up with Current Medicare Review Contractors’ Review Targets?
Published on Mar 31, 2021
20210331
 | CERT 
 | Coding 

My youngest nephew is currently the number one pitcher for his high school baseball team. His team recently participated in a spring break tournament in Memphis, Tennessee. Unfortunately, they only won one game. However, as my brother said, it was a valuable experience for the coaches to identify what the challenges are for the team for the rest of the season.

Similarly, hospitals are challenged with identifying who all of the players are that perform Medicare Fee-for-Service record reviews and what risk areas are they targeting. So, instead of Abbott and Costello trying to clarify “Who’s on First, What’s on second, and I Don’t Know’s on third,” this article identifies the Who’s (OIG, MAC, RAC, SMRC, CERT, and PEPPER), so you won’t feel like the third baseman “I Don’t Know.”

Office of Inspector General (OIG):

In June of 2017 the OIG began updating their once Annual Work Plan on a monthly basis. In an announcement they indicated that the Work Planning Process is “dynamic and adjustments are made throughout the year to meet priorities and to anticipate and respond to emerging issues with the resources available. You can learn more about the work plan, recently added items, all active work plan items and a work plan archive on the OIG website. You can access the Work Plan on the OIG website.

Medicare Administrative Contractors (MACs):

In October 2017, CMS implemented a Target Probe and Educate (TPE) Review Process for the MACs. With this type of approach, MACs focus on providers/suppliers who have the highest claim error rates or billing practices that vary significantly from their peers. In general, MACs will post a current Active Medical Log to their website. Depending on the MAC, this can sometimes be a challenge to find.

At this time, due to the ongoing COVID-19 Pandemic, TPE Reviews are on hold. However, MACs are conducting Post-Payment Reviews. Similar to TPE Reviews, MACs have been posting their post-payment review targets and audit findings to their websites.

If you are unsure of who your MAC is, you can find out on the CMS MAC Website List webpage.

Recovery Audit Program (RACs)

The RACs review claims on a post-payment basis. CMS maintains a RAC webpage where you will find links to each of the RACs across the country, Proposed Topics and Approved RAC Topics for review. A few of their current Approved Topics includes Total Knee Arthroplasty, Polysomnography, and Implantable Automatic Defibrillators (ICDs) medical necessity and documentation requirements reviews.

Supplemental Medical Review Contractor (SMRC)

The SMRC performs reviews at the direction of CMS with the aim of lowering improper payment rates.

On February 13, 2018 CMS announced that Noridian Healthcare Solutions, LLC, was awarded the new $227 million contract. Similar to the RACs, one of the current projects for Noridian is polysomnography. They are also conducting a medical review of COVID-19 claims in response to the 20% add on payment as a result of the Coronavirus Aid, Relief, and Economic Security (CARES) Act enacted on March 27, 2020.

The Comprehensive Error Rate Testing (CERT) Program

CMS implemented the CERT program to measure improper payments in the Medicare Fee-for-Service program. Annually, the CERT selects a stratified random sample of approximately 50,000 claims submitted to Part A/B MACs and Durable Medical Equipment MACs (DMACs) for review. It is important to keep in mind that the CERT reports a measurement of payments not meeting Medicare requirements and is not a “fraud rate.”

Every year an Annual Report and Report Appendices is published on the CERT CMS webpage. Reviewing these reports can help you identify high error prone case types. For example, in the 2020 Medicare Fee-for-Service Supplemental Improper Payment Data, the top four service types with highest improper payments in the hospital inpatient setting included:

  • Major Hip and Knee Joint Replacement or Reattachment of Lower Extremity (MS-DRGs 469 and 470),
  • Endovascular Cardiac Valve Replacements (MS-DRGs 266, and 267),
  • Spinal Fusion Except Cervical (MS-DRGs 459 and 460), and
  • Percutaneous Intracardiac Procedures (MS-DRGs 273 and 274).

Beneficiary and Family Centered Care Quality Improvement Organizations (BFCC-QIOs)

In 2015, CMS made the decision to move Short Stay reviews from the MACs to the BFCC-QIOs. These reviews are for hospital inpatient admissions with a length of stay less than two midnights and focus on ensuring doctors and hospitals are following the Part A payment policy for inpatient admission. Effective May 8, 2019, CMS temporarily suspended Short Stay reviews to find one contractor to perform Short Stay and Higher Weighted DRG (HWDRG) reviews. To date, CMS has not announced who this will be. In the meantime, you can find out who your BFCC-QIO is at this website: https://qioprogram.org/contact.

Program for Evaluating Payment Patterns Electronic Report (PEPPER)

The PEPPER is an electronic data report containing a single hospital’s claims data statistics for MS-DRGs and discharges at risk for improper payment due to billing, coding and/or admission necessity issues. Each report compares a hospital to their state, MAC Jurisdiction and the nation. “The Office of Inspector General encourages hospitals to develop and implement a compliance program to protect their operations from fraud and abuse. As part of a compliance program, a hospital should conduct regular audits to ensure charges for Medicare services are correctly documented and billed. The Program for Evaluating Payment Patterns Electronic Report (PEPPER) can help guide the hospital’s auditing and monitoring activities.” In general, a hospital’s Quality Department can provide the report to key departments (i.e. Case Management and HIM).

MMP’s Protection Assessment Report (PAR)

In January of 2017, the OIG, in collaboration with a group of compliance professionals, released a Resource Guide to measure the effectiveness of compliance programs.  Items 5.27-5.36 emphasize that a Risk Assessment is key to developing an effective Compliance audit/work plan.  As you can see from the list of Contractors above, the number of Medicare risk areas to consider can be overwhelming and the financial risk is great.

Medical Management Plus, Inc. (MMP) can help.  Our proprietary Protection Assessment Report incorporates current OIG, MAC, RAC, SMRC, CERT, and PEPPER risk areas into one report. Working closely with RealTime Medicare Data (RTMD), hospital specific Medicare fee-for-service paid claims data (volume, charges and payments) for risk areas is included in this report. If you are interested in learning more about this Report, please contact us using the form below or 205-941-1105.

Beth Cobb

COVID-19 in the News November 19th - 30th
Published on Dec 01, 2020
20201201

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 19th through the 30th.  

Resource Spotlight: Accessing COVID-19 Lab Testing and Vaccine CPT Codes

The American Medical Association (AMA) announced on November 10th new codes for immunizations for COVID-19. Note, the “CPT codes are unique for each of two coronavirus vaccines as well as administration codes unique to each such vaccine. The new CPT codes clinically distinguish each coronavirus vaccine for better tracking, reporting and analysis that supports data-driven planning and allocation.” From this AMA webpage (https://www.ama-assn.org/practice-management/cpt/covid-19-cpt-coding-and-guidance) you can access a file with the new CPT codes for testing and vaccine products and vaccine administrations.

November 19, 2020: FDA Authorizes Drug Combination for Treatment of COVID-19

The FDA announced in a News Release  that an emergency use authorization (EUA) has been issued for the drug baricitinib (Olumiant), in combination with remdesivir (Veklury), for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).”

November 19, 2020: Alabama Board of Nursing Emergency Rule for Administering Vaccines

The Alabama Board of Nursing (ABN) announced emergency rule ABN Administrative Code §610-X-4-.16 ER allowing nurses with a retired or lapsed licenses “to administer vaccines during a declared state or national pandemic, provided that the individual nurse’s license was otherwise in good standing at the time of lapse or retirement. A permanent version of the same rule, which is intended to assist the healthcare community in rapidly deploying vaccinations for COVID-19 and any subsequent pandemics, will be published for public comment on November 30, 2020, after which the Board will certify the permanent change.”

November 20, 2020: New Condition Codes for Services Provided as Part of Expanded Access (EA) Approval and Emergency Use Authorization (EUA)

CMS Change Request (CR) 12049 implements the newly created condition code “90” in order to allow providers to report when the service is provided as part of an Expanded Access approval and condition code “91” in order to allow providers to report when the service is provided as part of an Emergency Use Authorization (EUA). The new codes will be effective for claims received on or after February 1, 2021.

November 20, 2020: Palmetto posts COVID-19 Allowances for Laboratory Test Codes

Palmetto GBA notes that CMS established new codes for lab test for COVID-19 and provided pricing for codes U0001 and U0002. However, MACs were instructed to develop the allowance for the remaining codes. This Palmetto GBA article includes a listing of the codes and the code allowance.

November 21, 2020: EUA for Casirivimab and Imdevimab

The FDA posted a News Release regarding an EUA “for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 poundshttps://www.federalregister.gov/documents/2020/11/24/2020-25795/effective-and-innovative-approachesbest-practices-in-health-care-in-response-to-the-covid-19">Request for Information (RFI) in the Federal Register and will be accepting comments through their portal no later than midnight Eastern Time (ERT) on December 24, 2020. The summary statement in this document indicates that HHS is seeking “to gain a comprehensive understanding of the impact of changes adopted by health care systems and health care providers in response to the COVID-19 pandemic. Many healthcare systems and clinicians have rapidly reengineered their policies and programs to improve access, safety, quality, outcomes including mortality and morbidity, cost, and value for both COVID-19 and non-COVID-19 related medical conditions. HHS plans to identify and learn from effective innovative approaches and best practices implemented by non-HHS organizations in order to inform HHS priorities and programs.”

November 24, 2020: FDA Publishes New Webpage – Face Masks, Surgical Masks, and Respirators for COVID-19

The FDA indicated in their November 24 Daily Update that this new webpage is “a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks and respirators.

November 25, 2020: CMS’ Comprehensive Strategy to Enhance Hospital Capacity Amid COVID-19 Surge

CMS announced “comprehensive steps to increase the capacity of the American health care system to provide care to patients outside a traditional hospital setting amid a rising number of coronavirus disease 2019 (COVID-19) hospitalizations across the country.” One example is the expansion of Hospitals without Walls to include an innovative Acute Hospital Care At Home program. The CMS Press Release announcing these steps also includes links to the Acute Hospital Care At Home initiative and application, a link to more ambulatory surgical center flexibilities, comments from hospitals already participating in the Acute Hospital Care at Home program and a link to related FAQs.

CDC COVID Data Tracker – United States COVID-19 Cases

Data DateTotal CasesTotal DeathsCases in Last 7 Days
September 8, 20206,287,362188,688282,919
October 5, 20207,396,730209,199301,438
November 2, 20209,182,628230,383565,607
November 9, 20209,913,553237,037764,280
November 12, 202010,314,254241,069883,827
November 24, 202012,333,452257,0161,197,200
November 30, 202013,142,997265,1661,114,930
Resource: CDC COVID Data Tracker at https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases_totalcases

Beth Cobb

Hospitals Put on Notice: OIG to resume Short Stay Reviews
Published on Dec 01, 2020
20201201

The Office of Inspector General (OIG) added several new items to their Work Plan in November. Today we focus on one posted in late November, CMS Oversight of the Two-Midnight Rule for Inpatient Admissions. This type of review is not new for the OIG. In fact, targeting “short inpatient stays” has been on the OIG’s radar since before the Two-Midnight Rule.

OIG Report prior to the implementation of the Two-Midnight Rule

In July 2013, the OIG posted the completed report Hospitals' Use of Observation Stays and Short Inpatient Stays for Medicare Beneficiaries. One reason cited by the OIG for performing this review was CMS’ concern “about improper payments for short inpatient stays when the beneficiaries should have been treated as outpatients.” At that time the OIG noted that “to address these concerns, CMS recently proposed policy changes-through a Notice of Proposed Rulemaking (NPRM)-that, if promulgated as proposed, would substantially affect how hospitals bill for these stays.”

Key Findings in the OIG Report  

  • Short inpatient stays were often for the same reason as observation stays, but Medicare paid nearly three times more for a short inpatient stay than an observation stay, on average.
  • Beneficiaries also paid far more for short inpatient stays than for observation stays, on average
  • Hospitals varied widely in their use of short inpatient and observation stays.
  • Some beneficiaries had hospital stays that lasted three nights or more, but did not qualify for SNF services under Medicare.

 

October 1, 2013 Implementation of Two-Midnight Rule

With the implementation of the Two-Midnight Rule, in addition to scrutiny by the OIG, several Medicare Contractors have been tasked with performing short stay reviews as highlighted in the following timeline.

Timeline of Short Stay Inpatient Reviews

  • October 1, 2013: As part of the FY 2014 IPPS Final Rule the Two-Midnight Rule went into effect. Initially Medicare Administrative Contractors (MACs) were tasked with performing short stay pre-payment reviews under the then new Probe and Educate Program process.
  • October 1, 2015: The responsibility for short stay reviews shifted to the Beneficiary and Family Centered Care Quality Improvement Organizations (BFCC-QIO). Unlike the MACs, BFCC-QIO’s conducted post-payment reviews.
  • May 4, 2016: Short stay reviews were temporarily paused. At that time CMS indicated that they “took this action in an effort to promote consistent application of the medical review of patient status for short hospital stays.” In simple terms, CMS needed time to re-educate the educators.
  • September 12, 2016: BFCC-QIOS resumed short stay reviews after the following tasks were completed:
  • BFCC-QIOs completed re-training on the Two-Midnight policy;
  • BFCC-QIOs completed a re-review of claims that were previously formally denied;
  • CMS examined and validated the BFCC-QIOs peer review activities related to short stay reviews;
  • The BFCC-QIOs performed provider outreach on claims impacted by the temporary suspension; and
  • The BFCC-QIOs initiated provider outreach and education regarding the Two-Midnight policy.
  • May 8, 2019: BFCC-QIO short stay reviews were put on hold as CMS planned to procure a new BFCC-QIO contractor who would perform short stay reviews and higher-weighted-DRG reviews on a national basis. CMS anticipated awarding this contract by the 3rd quarter of calendar year 2019. To date, no contract has been awarded.

 

CERT Annual Supplemental Improper Payment Data

The Comprehensive Error Rate Testing (CERT) Program calculates improper payment rates for the Medicare Fee-for-Service program. Annually, the CERT publishes a report of their findings along with Medicare Fee-for-Service Supplemental Improper Payment data.

Since the Two-Midnight Rule was implemented, the annual data has included a table comparing improper payment rates for Part A hospital claims by Length of stay. While the Improper Payment Rate has dropped for “0 or 1 day” LOS claims, this group of claims continues to have the highest improper payment rate and from 2018 to 2019 seems to be going in the wrong direction.

 Percent of Improper Payments by Length of Stay
 2014 Report2015 Report2016 Report2017 Report2018 Report2019 Report
0 or 1 Day37.1%27.8%18.6%18.2%17%18.4%
2 Days20.2%11.2%7.1%5.1%6.3%5.0%
3 Days12.9%8.7%4.5%4.8%5.0%4.7%
4 Days10.9%6.0%3.4%3.3%4.1%3.5%
5 Days7.5%6.5%2.9%3.2%5.5%2.0%
> 5 Days7.1%3.9%2.7%2.6%2.8%2.3%
Data Source: CERT Report Table B7

 OIG Focus on Short Inpatient Stays after implementation of the Two-Midnight Rule

One year after implementation of the Two-Midnight Rule, the OIG included the item: New Inpatient Admission Criteria in their FY 2015 Work Plan. Specifically, the OIG indicated that they “will determine the impact of new inpatient admission criteria on hospital billing, Medicare payments, and beneficiary copayments. This review will also determine how billing varied among hospitals in FY 2014. Previous OIG work identified millions of dollars in overpayments to hospitals for short inpatient stays that should have been billed as outpatient stays. Beginning in FY 2014, new criteria state that physicians should admit for inpatient care those beneficiaries who are expected to need at least 2 nights of hospital care (known as the “two midnight policy”). Beneficiaries whose care is expected to last fewer than 2 nights should be treated as outpatients. The criteria represent a substantial change in the way hospitals bill for inpatient and outpatient stays.”  

For the FY 2016 Work Plan, the OIG followed up with a slightly different look at short stay reviews, the item, Hospitals’ use of outpatient and inpatient stays under Medicare’s two-midnight rule. The OIG noted that they “will determine how hospitals’ use of outpatient and inpatient stays changed under Medicare’s two-midnight rule, as well as how Medicare and beneficiary payments for these stays changed, by comparing claims for hospital stays in the year prior to the effective date of the two-midnight rule to stays in the year following the effective date of that rule. We will also determine the extent to which the use of outpatient and inpatient stays varied among hospitals. CMS implemented the two-midnight rule on October 1, 2013. This rule represents a substantial change to the criteria that hospital physicians are expected to use when deciding whether to admit beneficiaries as inpatients or treat them as outpatients.

On December 19, 2016, the OIG published the Report Vulnerabilities Remain Under Medicare's 2-Midnight Hospital Policy. They noted in the report that while they “found that the number of inpatient stays decreased, the number of outpatient stays increased since the implementation of the 2-midnight policy. Further, short inpatient stays decreased more than long outpatient stays. Despite these changes, vulnerabilities still exist.

  • Hospitals are billing for many short inpatient stays that are potentially inappropriate under the policy; Medicare paid almost $2.9 billion for these stays in FY 2014.
  • Medicare pays more for some short inpatient stays than for short outpatient stays, although the stays are for similar reasons.
  • Hospitals continue to bill for a large number of long outpatient stays.
  • An increased number of beneficiaries in outpatient stays pay more and have limited access to SNF services than they would as inpatients.
  • Hospitals continue to vary in how they use inpatient and outpatient stays.”

Here we are in December of 2020 and hospitals have been put on notice as the OIG once again targets short stay reviews. They note in this new Work Plan item that “Prior OIG audits identified millions of dollars in overpayments for inpatient claims with short lengths of stay. Instead of billing the stays as inpatient claims, they should have been billed as outpatient claims, which usually results in a lower payment. To reduce inpatient admission errors, CMS implemented the Two-Midnight Rule in fiscal year 2014. Under the Two-Midnight Rule, CMS generally considered it inappropriate to receive payment under the inpatient prospective payment system for stays not expected to span at least two midnights. The only procedures excluded from the rule were newly initiated mechanical ventilation and any procedures appearing on the Inpatient Only List. Revisions were made to the Two-Midnight Rule after its implementation. We plan to audit hospital inpatient claims after the implementation of and revisions to the Two-Midnight Rule to determine whether inpatient claims with short lengths of stay were incorrectly billed as inpatient and should have been billed as outpatient or outpatient with observation. We also plan to review policies and procedures for enforcing the Two-Midnight Rule at the administrative level and contractor level. While OIG previously stated that it would not audit short stays after October 1, 2013, this serves as notification that the OIG will begin auditing short stay claims again, and when appropriate, recommend overpayment collections.” The expected issue date of their findings is FY 2021.

 

Moving Forward: Compliance with Short Stay

In general, for any given review target, hospitals with high volume and or high paid claims tend to be subject to medical review. Questions to ask and find answers to moving forward:

  • Do you track your short stay volume overall, by MS-DRG or Physician over time?
  • Do you know what percentage of your Medicare Fee-for-Service inpatient claims are for short stays?
  • If so, is this subset of your overall claims increasing year over year at your facility?
  • Does the documentation in short stay medical records support a short stay inpatient admission?
  • Do you know if your hospital is an outlier?
  • Where can you look to find these answers?

 

PEPPER

One resource available to hospitals is the Short-Term Acute Care PEPPER (Program for Evaluating Payment Patterns Electronic Report). The PEPPER is made available to hospitals on a quarterly basis and compares your hospital to your state, MAC Jurisdiction and the nation. One-day Stays for Medical and Surgical MS-DRGs are two of the “Target Areas” at risk for improper payments included in this report.

The PEPPER Short-Term Acute Care Hospitals User's Guide provides the following suggested interventions for high One-day Stays Hospitals: 

“This could indicate that there are unnecessary admissions related to inappropriate use of admission screening criteria or outpatient observation. A sample of same- and/or one-day stay cases should be reviewed to determine if inpatient admission was necessary or if care could have been provided more efficiently on an outpatient basis (e.g., outpatient observation). Hospitals may generate data profiles to identify same- and/or one-day stays sorted by DRG, physician or admission source to assist in identification of any patterns related to same- and/or one-day stays. Hospitals may also wish to identify whether patients admitted for same- and/or one- day stays were treated in outpatient, outpatient observation or the emergency department for one or more nights prior to the inpatient admission. Hospitals should not review same- and/or one- day stays that are associated with procedures designated by CMS as “inpatient only.”

 

RealTime Medicare Data

Another source that can help assist you is our sister company, RealTime Medicare Data (RTMD). RTMD collects over 1.2 billion Medicare claims annually from 48 states and the District of Columbia, and allows for searching of over 10 billion historical claims and counting.

In response to the “Two-Midnight” Policy, RTMD has available in their suite of Inpatient Hospital reports a One Day Stay Report. To give you a true picture of your “at risk” volume, this report excludes claims with a discharge status for Expired (20), left against medical advice (07), hospice (50 & 51) and /or were transferred to another Acute care facility (02). This report enables a hospital to view one day stay paid claims data by DRG and Physician to direct where audits should be focused. For further information on all that RTMD has to offer you can visit their website at https://rtmd.org.

Beth Cobb

COVID-19 in the News November 9th - 12th
Published on Nov 18, 2020
20201118

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:

 

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

Data DateTotal CasesTotal DeathsCases in Last 7 Days
September 8, 20206,287,362188,688282,919
October 5, 20207,396,730209,199301,438
November 2, 20209,182,628230,383565,607
November 9, 20209,913,553237,037764,280
November 12, 202010,314,254241,069883,827
Resource: CDC COVID Data Tracker at https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases_totalcases

Beth Cobb

November 2020 MAC Talk
Published on Nov 18, 2020
20201118

October 26, 2020: Novitas Article – Billing Outpatient Observation Services

Novitas Solutions posted the article Billing Outpatient Observation Services which defines outpatient observation, clarifies that observation is a service not a status, discusses the physician order for observation, reminds providers about delivery of the Medicare Outpatient Observation Notice (MOON), covers observation hours and billing requirements, and general reminders about observation.

 

October 29, 2020: CGS Article – Use of Human Amniotic Based Products

CGS posted the following information about the use of human amniotic based products:

“CGS has seen multiple claims where cellular and/or tissue-based products (CTPs), specially micronized or particulated human amniotic membrane and/or placental tissue matrix, are being injected into joints and tissues for osteoarthritis, plantar fasciitis, and other complaints. The labeled indications for these products are to treat non-healing wounds and burn injuries and are intended for external application to the wound. CGS covers the application of CTPs for ulcers or wounds as outlined in the LCD L36690 Wound Application of Cellular and/or Tissue-Based Products, Lower extremities. Use of these products topically or as an injection outside of the labeled use and as defined in L36690 is considered off-labeled and may not be a covered service.

Off label usage may be reviewed pre-pay or on appeal. The appeal request should include medical record documentation supporting the unique usage and include full-text copies of evidence-based, peer-reviewed articles from core medical journals supporting such use. Such articles should include the results of robust CMS and/or FDA approved clinical trials and/or meta-analysis that support any additional indications.”

 

November 2, 2020: First Coast Service Options Prior Authorization Program Q&As Modified

First Coast most recently modified their list of Q&A's related to the CMS Prior Authorization (PA) program for certain hospital outpatient department (OPD) services that went into effect in July. They note the document consists of questions and answers posed during their educational webinars.

 

November 3, 2020: Noridian JE and JF Local Coverage Determination (LCD) for Treatment of Osteoporotic Vertebral Compression Fracture Finalized

Noridian announced that their LCD and Local Coverage Article (LCA) for Percutaneous Vertebral Augmentation (PVA) for Osteoporotic Vertebral Compression Fracture (VCF) has completed the Open Public Meeting and Contractor Advisory Committee (CAC) comment period and is now final.

  • Noridian JE
  • LCD L34228 / Article A56572
  • Effective Date: January 10, 2021
  • Noridian JF
  • LCD L34160 / Article A56573
  • Effective Date: January 10, 2021

 

November 5, 2020: Noridian JF Article: Hospital Discharge Status Assistance

Nordian JF reminds providers in this article that “overpayment or underpayment of Medicare claims may result when facilities incorrectly bill a discharge status code.” Included in this article are tips to getting the discharge status correct and links to a quick reference guide of patient status codes and MLN Article SE1411 – Clarification of Patient Discharge Status Codes and Hospital Transfer Policies.

 

November 6, 2020: Noridian Article: Computed Tomography Cerebral Perfusion Analysis (CTP) Final LCD and Billing and Coding Article

Effective December 13, 2020, Noridian’s LCD and related Coverage Article will be effective meaning that CTP will be considered medically reasonable and necessary in patients with small acute ischemic stroke (AIS) caused by unilateral large vessel occlusion (LVO) in the proximal anterior circulation evaluated at stroke centers.

  • Noridian JE
  • LCD L38709 / Article A58223
  • Effective Date: December 13, 2020
  • Noridian JF
  • LCD L38700 / Article A58225
  • Effective Date: December 13, 2020

 

November 6, 2020: The SMRC Goes Green

Noridian announced that the Supplemental Medical Review Contractor (SMRC) has started mailing additional documentation requests in green envelopes to assist with proper notification review. Noridian advises providers to let you mail department know of this change to allow requests be received by the appropriate departments and handled timely. Palmetto GBA also included a similar announcement in their November 10th Daily Newsletter.

Beth Cobb

COVID-19 in the News November 3rd through November 9th
Published on Nov 11, 2020
20201111

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

Data DateTotal CasesTotal DeathsCases in Last 7 Days
September 8, 20206,287,362188,688282,919
October 5, 20207,396,730209,199301,438
November 2, 20209,182,628230,383565,607
November 9, 20209,913,553237,037764,280
Resource: CDC COVID Data Tracker at https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases_totalcases

Beth Cobb

Who's Scrutinizing COVID-19 Claims
Published on Nov 10, 2020
20201110

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.

Announced or RevisedAgencyTitle
Oct-20CMSMedicare Telehealth Services During the COVID-19 Pandemic: Program Integrity Risks
Oct-20CMSUse of Medicare Telehealth Services During the COVID-19 Pandemic
Oct-20CMSNursing Home Oversight During the COVID-19 Pandemic
Sep-20CMSInfection Control at Home Health Agencies During the COVID-19 Pandemic
Aug-20CMSAudit of Medicare Payments for Inpatient Discharges Billed by Hospitals for Beneficiaries Diagnosed with COVID-19
Aug-20CMSInfection Control and Emergency Preparedness at Dialysis Centers During the COVID-19 Pandemic
Aug-20CMSA Review of Medicare Data To Understand Hospital Utilization During COVID-19
Jul-20CMSEnd Stage Renal Disease Networks' Responsibilities During COVID-19
Jul-20CMSMedicaid: Expedited Provider Enrollment During COVID-19 Emergency
Jun-20CMSTrend Analysis of Medicare Laboratory Billing for Potential Fraud and Abuse With COVID-19 Add-on Testing
Jun-20CMSMedicaid—Telehealth Expansion During COVID-19 Emergency
Jun-20CMSMeeting the Challenges Presented by COVID-19: Nursing Homes
Jun-20CMSAudit of Nursing Homes' Reporting of COVID-19 Information Under CMS's New Requirements
Source: OIG Active Work Plan Items at https://oig.hhs.gov/reports-and-publications/workplan/active-item-table.asp

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.

Beth Cobb

HHS Releases Transparency in Coverage Final Rule
Published on Nov 03, 2020
20201103

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.”

Beth Cobb

COVID-19 in the News October 27th - November 2nd
Published on Nov 03, 2020
20201103

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.

Drug & Biological ProductICD-10-PCS CodeCode Description
RemdesivirXW033E5Introduction of Remdesivir Anti-infective into Peripheral Vein, Percutaneous Approach, New Technology Group 5)
XW043E5Introduction of Remdesivir Anti-infective into Central Vein, Percutaneous Approach, New Technology Group 5)
Convalescent PlasmaXW13325Transfusion of Convalescent Plasma (Nonautologous) into Peripheral Vein, Percutaneous Approach, New Technology Group 5
XW14325Transfusion of Convalescent Plasma (Nonautologous) into Central Vein, Percutaneous Approach, New Technology Group 5)
Source: ICF-4 at https://public-inspection.federalregister.gov/2020-24332.pdf?utm_campaign=pi+subscription+mailing+list&utm_source=federalregister.gov&utm_medium=email

“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

Data DateTotal CasesTotal DeathsCases in Last 7 Days
September 8, 20206,287,362188,688282,919
October 5, 20207,396,730209,199301,438
November 2, 20209,182,628230,383565,607
Resource: CDC COVID Data Tracker at https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases_totalcases

Beth Cobb

COVID-19 in the News October 20th - 26th
Published on Oct 27, 2020
20201027

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

Data DateTotal CasesTotal DeathsCases in Last 7 Days
September 8, 20206,287,362188,688282,919
September 14, 20206,503,030193,705241,814
September 20, 20206,748,935198,754281,490
September 28, 20207,095,422204,328310,020
October 5, 20207,396,730209,199301,438
October 11, 20207,694,865213,614335,009
October 26, 20208,617,022224,601488,498
Resource: CDC COVID Data Tracker at https://covid.cdc.gov/covid-data-tracker/?deliveryName=USCDC_2067-DM37553#cases_totalcases

Beth Cobb

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