LCD Reference Article Response To Comments Article

Response to Comments: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs)

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A57732
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Article Title
Response to Comments: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs)
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Response to Comments
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11/14/2019
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The following are the comment summaries and contractor responses for Novitas Solutions Proposed Local Coverage Determination (LCD) DL38229 Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) which was posted for comment on 06/27/2019, and presented at the Open Meeting on July 11, 2019. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

A commenter supports the inclusion of PLA code 0097U (Gastrointestinal pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 22 targets) in LCD DL38229/A56642 and requested a dialogue with Novitas to discuss positioning and rates for PLA code 0097U.

Novitas appreciates this request which was forwarded to the appropriate area for consideration. Please see our website at Novitas-solutions.com in order to contact Medical Affairs with any future request.

2

A commenter agreed with the honest discussion regarding limitations of NAAT for pathogens and mentioned it is important to also include a robust discussion about the limitations of current standard methods including stool culture, fecal O&P, and antigen based testing.

Thank you for the comment. As the LCD title indicates, the LCD topic is gastrointestinal panels (GIP) utilizing multiplex NAATs. The policy was clarified to state the GIP panels utilizing NAATs are to be conducted on diarrheal stool samples except as noted for ileus. The focus of the LCD is GIP panels utilizing NAATs and mention of the current standard testing methods is included as necessary when sharing information from literature or guidelines.

3

A commenter agreed gastrointestinal panels should only be used when it is reasonable and necessary. The commenter stated they are in favor of appropriate use of diagnostic testing as outlined in the current guidelines and believes that rapid and comprehensive diagnostic testing leads to better patient care and overall lower health care costs. It is reasonable to believe that better patient care is achieved when the health care provider can rapidly arrive at the patient diagnosis and treatment plan. The ideal diagnostic test would support this goal by providing a fast, accurate and comprehensive test result in a clinically actionable time frame.

Novitas agrees that GIP panels should only be used when medically reasonable and necessary as outlined in current guidelines. The policy development process allowed Novitas to discuss literature with subject matter experts, have dialogue and receive comments. As a result of the information and discussions, Novitas was able to make revisions to the policy to better reflect current guidelines. Please see other comments and responses in this article for more information.

4

A commenter commented on the importance of identifying agent(s) causing diarrhea noting many causative agents of gastroenteritis cannot be reliably determined by clinical presentation.

Novitas appreciates the comment. The literature supports this as did the CAC Advisory Panel when the panel agreed that the GIP multiplex NAAT testing panels are not to be ordered on the otherwise healthy patient stating these tests are more appropriate when the provider needs specific information quickly for the patient who is already ill, such as transplant patients or immunosuppressed patients. Please see other comments in this article regarding changes and clarifications made to the final LCD.

5

A commenter commented about the use of antibiotics with certain causative agents. This is an important consideration, especially when treating elderly patients that are at higher risk of poor outcomes. Patients over the age of 65 have the highest rates of hospitalization and mortality associated with diarrheal disease. In all cases, the recommended antibiotic therapy (drug and dosage) is dependent on the pathogen and the patient’s presentation. Use of antibiotics is not appropriate when gastroenteritis is caused by a viral pathogen and pathogen-specific therapies may be indicated for the treatment of parasitic infection (antibiotics or anti-parasitic agents) and C. difficile disease (metronidazole or oral vancomycin). As identification of etiologic agents in infectious gastroenteritis is important to patient management, it is medically necessary and should be a covered benefit.

Novitas appreciates the comment. Language was added to clarify that the LCD, and related LCA, pertains to outpatient testing of gastrointestinal pathogen (GIP) panels utilizing multiplex NAATs. The policy provides limited coverage for the use of GIP panels using multiplex NAATs in the outpatient setting.

6

A commenter commented on the unique value of their product stating all the clinical utility and outcome studies discussed were performed by academic medical centers using their panel.

Novitas appreciates the comment. The policy addresses the reasonable and necessary requirements for FDA approved tests recognizing the provider community as the appropriate entity to select the most appropriate test that would be medically necessary for the beneficiary.

7

Two groups of commenters recommended coverage of panels utilizing multiplex NAATs for persistent or chronic diarrhea when medically reasonable and necessary. The use of NAATs, with eleven or fewer targets, for patients with persistent or chronic symptoms for longer than two weeks is specifically mentioned especially in travelers with persistent symptoms. The commenters reference the Infectious Disease Society of America (IDSA) 2017 guidelines which recommend culture-independent testing, including NAATs, when persistent diarrhea is present.

Novitas appreciates the comment. After further consideration of the guideline, the indications and limitations in the policy have been modified. After reconsideration of the IDSA 2017 guideline, Limitation #2 was revised to address chronic diarrhea and abdominal symptoms through the redetermination process. Please see our website at Novitas-solutions.com for more information on that process.

8

A group of commenters recommended revision of Limitation #3 to align coverage indications and limitations with Table 3 of IDSA 2017 guidelines to ensure the symptoms listed in the coverage policy are consistent with GIPs. The group states gastroenteritis can present as symptoms other than diarrhea including weakness, nausea, constipation, weight loss and vomiting.

Thank you for the comment. After consideration of the comment and IDSA guidelines, Limitation #3 has been clarified to state GIP panels using NAATs are not medically reasonable and necessary for asymptomatic beneficiaries. To better align the policy with Table 3 of IDSA 2017 guidelines, the indications have been clarified and an indication specifically for paralytic ileus has been added. After further review, Novitas notes Table 3 of the IDSA 2017 guidelines list ‘fever’ but it would be extremely rare to order GIP panels utilizing NAATs on every patient with fever only. Severe abdominal pain and persistent abdominal pain with fever are noted in the guideline, as is nausea and vomiting 24 hours or less; these have been added to the indications and the billing and coding article. ‘Weakness’ is not listed in the guidelines nor are the isolated symptoms of nausea, constipation, weight loss or vomiting; therefore, these symptoms will not be added.

9

A group of commenters recommended that the final LCD and related coding article allow stepwise testing utilizing smaller panels on the same date of service.

Novitas appreciates the comment. The limitations have been clarified to state performance of more than one GIP panel utilizing multiplex NAAT on the same date of service is not medically reasonable and necessary. This will not allow the same GIP test to be performed on the same date of service. When a test is a medically necessary utilization in a stepwise fashion, it would not be the same test. In alignment with the guidelines, the limitations also clarify repeat testing of beneficiaries negative by GIP panel within 7 days during the same episode of diarrhea. Please refer to CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 23, Section 10 regarding National Correct Coding Initiative and A56642-Billing and Coding: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) for more information.

10

A group of commenters suggested additional language for the Summary of Evidence citing Shim et al., 1998; Kyne et al., 2000; Leekha et al., 2013; and Daniel-Wayman et al, 2018.

Novitas appreciates the comment. No full-text peer-reviewed literature was submitted for the articles therefore, no change is warranted.

11

A group of commenters requested the following ICD-10-CM codes be added to the related billing and coding article:

A00.0 Cholera due to Vibrio cholerae 01, biovar cholera

A01.00 Typhoid fever, unspecified

A01.1 Typhoid meningitis

A01.2 Typhoid fever with heart involvement

A01.3 Typhoid pneumonia

A01.4 Typhoid arthritis

A02.0 Salmonella enteritis

A02.1 Salmonella sepsis

A02.20 Localized salmonella infection, unspecified

A02.22 Salmonella pneumonia

A02.8 Other specified salmonella infections

A02.9 Salmonella infection, unspecified

A03.0 Shigellosis due to Shigella dysenteriae

A03.1 Shigellosis due to Shigella flexneri

A03.2 Shigellosis due to Shigella boydii

A03.3 Shigellosis due to Shigella sonnei

A03.8 Other shigellosis

A03.9 Shigellosis, unspecified

A04.0 Escherichia coli enteropathogenic

A04.1 Escherichia coli enterotoxigenic

A04.2 Escherichia coli enteroinvasive

A04.3 Escherichia coli enterohemorrhagic

A04.4 Escherichia coli enteroaggregative

A04.5 Escherichia coli

A04.6 Yersinia enterocolitica

A04.7 Clostridium difficile

A04.9 Bacterial intestinal infection, unspecified

A05.0 Foodborne staphylococcal intoxication

A05.1 Botulism food poisoning

A05.2 Foodborne Clostridium perfringens [Clostridium welchii] intoxication

A05.3 Foodborne Vibrio parahaemolyticus intoxication

A05.4 Foodborne Bacillus cereus intoxication

A05.5 Foodborne Vibrio vulnificus intoxication

A05.8 Other specified bacterial foodborne intoxications

A05.9 Bacterial foodborne intoxication, unspecified

A06.0 Acute amebic dysentery

A07.1 Giardiasis [lambliasis]

A07.2 Cryptosporidiosis

A07.8 Other specified protozoal intestinal diseases

A08.0 Rotaviral enteritis

A08.2 Adenoviral enteritis

A08.11 Acute gastroenteropathy due to Norwalk agent

A08.19 Acute gastroenteropathy due to other small round viruses

A08.31 Calicivirus enteritis

A08.32 Astrovirus enteritis

A08.39 Other viral enteritis

A08.8 Other specified intestinal infections

A09 Infectious gastroenteritis and colitis, unspecified

A28.2 Extraintestinal yersiniosis

A49.1 Methicillin susceptible Staphylococcus aureus infection, unspecified site

A49.2 Methicillin resistant Staphylococcus aureus infection, unspecified site

A49.3 Mycoplasma infection, unspecified site

A49.9 Bacterial infection, unspecified

A87.0 Enteroviral meningitis

A87.8 Other viral meningitis

A87.9 Viral meningitis, unspecified

A88.8 Other specified viral infections of central nervous system

B08.4 Enteroviral vesicular stomatitis with exanthema

B15.0 Hepatitis A with hepatic coma

B15.9 Hepatitis A without hepatic coma

B19.0 Unspecified viral hepatitis with hepatic coma

B19.9 Unspecified viral hepatitis without hepatic coma

B33.8 Other specified viral diseases

B34.1 Enterovirus infection, unspecified

B34.9 Viral infection, unspecified

B95.0 Streptococcus, group A, as the cause of diseases classified elsewhere

B95.1 Streptococcus, group B, as the cause of diseases classified elsewhere

B95.2 Enterococcus as the cause of diseases classified elsewhere

B95.3 Streptococcus pneumoniae as the cause of diseases classified elsewhere

B95.4 Other streptococcus as the cause of diseases classified elsewhere

B95.5 Unspecified streptococcus as the cause of diseases classified elsewhere

B95.6 Staphylococcus aureus as the cause of diseases classified elsewhere

B95.7 Other staphylococcus as the cause of diseases classified elsewhere

B95.8 Unspecified staphylococcus as the cause of diseases classified elsewhere

B96.1 Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere

B96.2 Escherichia coli [E. coli] as the cause of diseases classified elsewhere

B96.3 Hemophilus influenzae [H. influenzae] as the cause of diseases classified elsewhere

B96.4 Proteus (mirabilis) (morganii) as the cause of diseases classified elsewhere

B96.5 Pseudomonas (aeruginosa) (mallei) (pseudomallei) as the cause of diseases classified elsewhere

B96.6 Bacteroides fragilis [B. fragilis] as the cause of diseases classified elsewhere

B96.7 Clostridium perfringens [C. perfringens] as the cause of diseases classified elsewhere

B96.81 Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

B96.82 Vibrio vulnificus as the cause of diseases classified elsewhere

B96.89 Other specified bacterial agents as the cause of diseases classified elsewhere

B97.0 Adenovirus as the cause of diseases classified elsewhere

B97.10 Unspecified enterovirus as the cause of diseases classified elsewhere

B97.11 Coxsackievirus as the cause of diseases classified elsewhere

B97.12 Echovirus as the cause of diseases classified elsewhere

B97.89 Other viral agents as the cause of diseases classified elsewhere

B99.8 Other and unspecified infectious diseases

B99.9 Unspecified infectious disease

K52.0 Gastroenteritis and colitis due to radiation

K52.1 Toxic gastroenteritis and colitis

K52.2 Allergic and dietetic gastroenteritis and colitis

K52.81 Eosinophilic gastritis or gastroenteritis

K52.82 Eosinophilic colitis

K52.89 Other specified noninfective gastroenteritis and colitis

K52.9 Noninfective gastroenteritis and colitis, unspecified

Z51.11: Encounter for antineoplastic chemotherapy (i.e. associated with chemotherapy-induced immunosuppression)

Thank you for the comment. After review, the requested ICD-10-CM diagnosis codes could be considered secondary diagnoses for the beneficiary and should be coded per American Medical Association (AMA) ICD-10-CM guidelines. The policy addresses GIP panels utilizing NAATs and disease processes with diarrhea and symptoms outlined in the LCD. These codes are not a requirement for this LCD and will not be added at this time. Please see A56642-Billing and Coding: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) for billing and coding information.

12

A group of commenters requested allowing the use of GIP NAATs with 12 or more targets for acute diarrheal infections. Literature was provided for the following references:

  1. Riddle MS, DuPont HL, Connor BA. ACG Clinical Guideline: Diagnosis, treatment, and prevention of acute diarrheal infections in adults American Journal of Gastroenterology: May 2016 - Volume 111 - Issue 5 - p 602–622 doi: 10.1038/ajg.2016.126.
  2. Shane AL, Mody RK, Crump JA et.al. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea Multiplex polymerase chain reaction tests for detection of pathogens associated with gastroenteritis. Clin Lab Med. 2015;35(2):461–486. doi:10.1016/j.cll.2015.02.006.
  3. Platts-Mills JA, Operario DJ, Houpt ER. Molecular diagnosis of diarrhea: Current status and future potential. Curr Infect Dis Rep. 2012;14(1):41–46. doi:10.1007/s11908-011-0223-7.
  4. DuPont HL1. Persistent diarrhea: A clinical review. JAMA. 2016 Jun 28;315(24):2712-23. doi: 10.1001/jama.2016.7833.
  5. Pawlowski SW, Warren CA, Guerrant R. Diagnosis and treatment of acute or persistent diarrhea. Gastroenterology. 2009;136(6):1874–1886. doi:10.1053/j.gastro.2009.02.072
  6. Slotwiner-Nie, Brandt LJ. Infectious diarrhea in the elderly. Gastroenterol Clin North Am. 2001 Sep;30(3):625-35.

Novitas appreciates the comment and submitted literature. After consideration of the guidelines cited and literature provided, limited coverage is allowed for acute or persistent diarrhea as outlined in the LCD. The submitted full text peer-reviewed articles have been added to the Bibliography.

13

A commenter indicated Limitation #2 seemed to contradict a statement in the Summary of Evidence from the IDSA 2017 guideline (Shane).

Novitas appreciates the comment. The definition of Traveler’s diarrhea has been clarified to remove any unintentional contradiction. Limitation #2 has been revised; please see comments above for more information.

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