Wednesday, May 26, 2021

Regulation about Medicare Advantage Payment Rates (Out of Contract)

 As I understand it, Medicare regulations do not tell MA plans they must pay Medicare rates, but they give providers rights to appeal UP TO Medicare rates, which the provider must accept as payment in full.  (Unless otherwise contracted).

In my understanding, by paying out of network providers Medicare rates, the MA plan avoids tying itself up in appeals on pricing which it would probably lose (unless it has clear evidence and testimony why the best rate is less than the CMS rate).

Previously, I've written,
"Medicare Advantage plans may contract with in-network provides at rates at, above, or below Traditional Medicare rates.  For out-of-network providers, Medicare provides some protection to Medicare Advantage plans, by requiring such providers to accept Traditional Medicare payment rates as payment-in-full.[FN] "   
Special rules for services furnished by noncontract providers.
(a) Services furnished by non-section 1861(u) providers. (1) Any provider (other than a provider of services as defined in section 1861(u) of the Act) that does not have in effect a contract establishing payment amounts for services furnished to a beneficiary enrolled in an MA coordinated care plan, an MSA plan, or an MA private fee-for-service plan must accept, as payment in full, the amounts that the provider could collect if the beneficiary were enrolled in original Medicare.

Friday, May 21, 2021

May 2021 MOLDX NAAT/Pathogen Panel Testing

 https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=38987&ver=11&contractorName=all&updatePeriod=938&sortBy=updated&bc=AAAABAAAAAAAAA


Proposed Local Coverage Determination (LCD):
MolDX: Multiplex Nucleic Acid Amplification Test (NAAT) Panels for Infectious Disease Testing (DL38988)


As released by MOLDX on May 20, 2021,for public comment.

Coverage Indications, Limitations, and/or Medical Necessity

This policy provides limited coverage for outpatient testing with panels using multiplex nucleic acid amplification techniques (NAATs) for infectious disease testing. This policy does NOT address coverage for the inpatient setting.

This policy defines a panel as a NAAT test that detects > 1 pathogen. This policy also differentiates (where appropriate) between small, targeted panels (up to 5 pathogens) and larger, expanded panels (≥6 pathogens). This distinction is primarily applied to the Respiratory and Gastrointestinal Panels.

This is NOT a coverage policy for metagenomic next-generation sequencing, mass spectrometry, fluorescence in situ hybridization (FISH), or testing using techniques other than multiplex polymerase chain reaction (PCR).

General Criteria For Coverage For A Multiplex NAAT Infectious Disease Test Panel

This Medicare Contractor will cover multiplex NAAT infectious disease panel tests when ALL of the following criteria are met:

  • The patient has a clinical indication for infectious disease testing:
    • For immunocompetent patients, the clinical indication includes a presumption of active infection OR infection-associated complications (which may include exacerbation of underlying disease) that require the identification of a causative organism for appropriate managementAtypical clinical presentations of disease are considered appropriate indications for special populations who may not present with classic symptoms of infection (i.e., the elderly).
    • For immunocompromised patients, atypical clinical presentations of disease are considered appropriate indications for testing. In this patient population, testing may be performed ONCE as part of a pre-transplant evaluation, regardless of the presence of symptoms.
    • Note: For certain panels, such as the Urogenital/Anogenital Panel, epidemiologic indication or potential exposure to pathogens as a result of a high-risk experience is considered a covered clinical indication, even in the absence of clinical symptoms. These are specifically noted below in LIMITED COVERAGE FOR EXPANDED (>5 Pathogens) PANEL TESTING.
  • The results of testing will impact clinical management in a manner already demonstrated in the peer-reviewed published literature to improve patient outcomes.
  • Testing is performed according to the intended use of the test in the intended patient population for which the test was developed and validated.
    • This includes performing the test using the intended sample types along with parallel testing that must accompany the test (i.e., the meningoencephalitis and bloodstream pathogen tests include requirements for parallel testing using conventional Gram stain and culture-based detection for correlation of results).
    • This also includes the provision - by the laboratory to ordering providers - of the major limitations of a given panel test.
  • An evaluation for more than 1 pathogen by NAAT testing is necessary for patient management (testing for a single pathogen is NOT reasonable and necessary for the specific infection, patient, or indication). The panel performed includes at least the minimum pathogens required for clinical decision making for its intended use that can be reasonably detected by the test.
  • Expanded panel testing is only indicated when targeted panel testing is not appropriate (i.e., will not provide sufficient information for the appropriate clinical management of the patient). See LIMITED COVERAGE FOR EXPANDED (>5 Pathogens) PANEL TESTING below.
  • The test demonstrates equivalent or superior test performance characteristics - analytical validity (AV) and clinical validity (CV) - to established standard-of-care (SOC) methods (i.e., culture, pathogen-specific PCR) for the majority of targets included on the panel.
    • CV of any new analytes that are not already established as SOC or that do not have a predicate test that is covered by this contractor must be established through a study published in the peer-reviewed literature for the intended use of the test in the intended population.
    • Tests that perform identification of new analytes or are performed according to new intended uses not already covered by this contractor will require a Technical Assessment (TA) for compliance of that service with this policy.
  • Documentation of the following is clearly stated in the medical record:
    • Specific clinical indications for testing (i.e., clinical suspicion of a pathogen as the cause of the patient’s condition)
    • Specific reasons for performing panel testing as opposed to single-pathogen testing
    • In the case of expanded panel testing, the specific reasons for performing expanded panel testing as opposed to targeted panel testing
    • Provider type/specialty and Place of Service

Non-Coverage Criteria

Multiplex NAAT Panel Tests will NOT be covered in the following circumstances:

  • If the test is performed as a test of cure.
  • If the patient has been previously tested by molecular diagnostic methods for the same pathogens within 14 days for the same clinical indication.
    • If a previous panel test was performed with a similar/duplicative intended use, a subsequent test is only reasonable and necessary if the non-duplicative content of the second test is reasonable and necessary.
    • Exception: Repeat panel testing for the same clinical indication will only be covered if first panel yielded a negative result AND there is a high index of suspicion for a pathogen as the cause of symptoms AND the patient’s clinical condition is not improving or is deteriorating after a clinically appropriate length of time. In such cases, 1 additional panel test may be covered between 1 and 14 days after the initial panel test, so long as the test fulfills the criteria for coverage as set forth in this policy.

LIMITED COVERAGE FOR EXPANDED (>5 Pathogens) PANEL TESTING

FOR THE SPECIFIC PANEL TYPES LISTED BELOW, ALL OF THE FOLLOWING ADDITIONAL CRITERIA MUST BE MET:

  • Respiratory (RP) and Pneumonia (PNP) Panels will only be covered when targeted testing is not appropriate AND according to the following additional criteria:
    • For immune-competent patients, at least 1 of the following must apply:
      • Testing is ordered by a clinician specialist in Infectious Diseases or Pulmonology for a patient with severe and established underlying respiratory pathology (i.e., severe asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, radiation therapy to the lung) AND treatment with antibiotics may be indicated according to established guidelines.1,2 Specific examples that do NOT meet coverage criteria according to established guidelines include the following:
        • Asthma exacerbations without the additional presence of either fever and purulent sputum or radiographic evidence of pneumonia2
        • Uncomplicated community acquired pneumonia (CAP)1
      • The patient is seriously or critically ill (as defined by the American Hospital Association’s “General Guide for the Release of Information on the Condition of Patients”)3 as a result of a presumed respiratory infection AND the patient is being treated in an appropriate critical care facility.
    • For immune-suppressed patients: Testing is ordered by a clinician specialist in 1 of the following: Infectious Diseases, Pulmonology, Oncology, Transplant OR the patient is being managed in an appropriate critical care facility.
    • For ALL patients: Only 1 of the following panels - RP OR PNP- will be covered for a given patient for the same clinical indication. The PNP should be prioritized in the evaluation of pneumonia from lower respiratory tract specimens (i.e., bronchoalveolar lavage samples (BALs)).
  • Gastrointestinal (GI) Panels will only be covered when targeted testing is not appropriate AND according to the following additional criteria:
    • For immune-competent patients, at least 1 of the following must apply:
      • Testing is ordered by a clinician specialist in Infectious Diseases or Gastroenterology for a patient with severe and established underlying GI pathology (i.e., inflammatory bowel disease (IBD), paralytic ileus, radiation therapy to the intestine) AND identification of an infectious cause is necessary to determine next steps in patient management.
      • The patient is seriously or critically ill (as defined by the American Hospital Association’s “General Guide for the Release of Information on the Condition of Patients”)3 as a result of a presumed GI infection AND the patient is being treated in an appropriate critical care facility.
      • The patient’s clinical indication for GI panel testing is diarrhea, and ALL of the following apply:
        • The diarrheal illness MUST be acute or persistent with signs or risk factors for severe disease (fever, bloody diarrhea, dysentery, dehydration, severe abdominal pain that may warrant hospitalization) AND/OR not resolving after 7 days, AND
        • The patient has NOT taken laxatives within 24 hours of the test
    • For immune-suppressed patients:
      • Testing is ordered by a clinician specialist in 1 of the following: Infectious Diseases, Gastroenterology, Oncology, Transplant OR the patient is being managed in an appropriate critical care facility.
  • Urogenital/Anogenital (UG/AG) Panels
    • For the UG/AG panels, epidemiologic indication or potential exposure to sexually transmitted pathogens (i.e., in the case of clinical concern for multiple sexually transmitted infections (STIs) due to a high-risk experience) is considered a covered clinical indication, even in the absence of clinical symptoms. Documentation of the high-risk reason for panel testing is clearly stated in the medical record.
    • In the absence of a high-risk experience, if the primary clinical concern is for 1 or few specific pathogens due to specific signs and symptoms (i.e., lesions suggestive of herpes simplex virus (HSV)), then it is expected that only a small targeted panel (i.e., including HSV-1 and HSV-2) will be performed. In such cases, expanded panels are NOT considered reasonable and necessary and will NOT be covered.
  • Meningoencephalitis (ME) Panels will be covered according to the following additional criteria:
    • For immune-competent patients: the patient has at least 2 of the following indicators of central nervous system (CNS) infection: cerebrospinal fluid (CSF) markers, radiology, clinical signs and symptoms consistent with meningitis or encephalitis, epidemiologic indication or exposure. For immune-compromised patients, at least 1 of these indicators is required.
    • For all patients: Testing is from a sample collected via lumbar puncture, and NOT an indwelling medical device (i.e., CSF shunts).
  • Bloodstream Infection (BSI) Panels will be covered according to the following additional criteria:
    • There is clinical concern for bacteremia or sepsis AND microbe(s) were seen on a Gram stain from the patient’s blood AND the patient is being managed in an appropriate critical care facility, AND
    • Personnel (i.e., an antimicrobial stewardship team) are equipped for rapid (same-day) tailoring of antimicrobial therapy as a result of rapid testing
  • Urinary Tract Infection (UTI) Panels will be covered according to the following additional criteria:
    • The patient is symptomatic AND at higher risk for UTI complications (i.e., the elderly, patients with recurrent symptomatic UTIs and/or complicated urinary tract anatomy) OR is seen in urogynecology or urology specialty care settings.

Additional information related to specific panels may be found in the related Billing and Coding article.

Tests that demonstrate similar indicated uses and equivalent or superior performance to SOC or other covered tests, as demonstrated in a TA, may similarly be covered under this policy.

Thursday, May 6, 2021

MCIT COSTS

 SEPTEMBER TRUMP RULE

page 54335-7

Regulatory Alternatives.
     Take no action.  Always combine with CED.   These would be inconsistent with the Trump EO to speed access to innovation.
     We consider MCIT for 1 year (e.g. to allow LCD development).

Impact.
    Difficult since many technologies would be covered anyway, or, under DRG.  Acceleration could be as little as a few months, anyway.
    It is not possible to generate a point estimate.
    Either no cost on CMS spending or temporary cost due to acceleration which may be short.
    MCIT may help mitigate chronic health burdens.
    Calculated SPENDING impact based on lowest and highest examples from NTAP.   The highest NTAP patients were 6,500.
   Table 2 shows variance from 0 to $9M to $2B.
    Most companies with MCIT devices due not meet certain definitions of small businesses.
    Regulatory costs on businesses would be de minimis (e.g. sending email to CMS that you have just awarded a BT device).

FINAL TRUMP RULE
page 3005-7

They now include an estimate of application costs as 15 minutes to several hours of staff time at $69.72 per hour for a handful of products.

There is a table of projected budget impact of the R&N rulemaking itself (only in January final).  Main estimate is $0.

BIDEN RULE REOPENING

Primarily asked for public comment on operational aspects of MCIT, as well as welcoming comments on whether the Trump rulemaking was procedurally flawed or overlooked comments of certain types.
No additional cost section.

Wednesday, May 5, 2021

HILL Conference May 8 2021 on New Health Tech

 THE HILL.COM sponsored a workshop today, FUTURE OF HEALTHCARE: BOLD BETS.

 


The agenda listing is all-star - Fauci, Janet Woodcock FDA, Surgeon General etc.



I clip the agenda below.

###

The last year in healthcare has been one of unprecedented challenges and innovation leaps. While gaps in our healthcare system were laid bare, researchers and pharmaceutical manufacturers achieved what seemed impossible: multiple vaccine candidates in record time. Healthcare heroes risked their lives to save others and went virtual in efforts to bridge divides, showing us examples of courage and ingenuity.

Once we realize our goal of shots in arms, what’s next on the innovation front? And what policies and new models of care do we need to embrace to make sure these innovations reach everyone?

The Hill will host a discussion with policymakers and healthcare trailblazers to explore how we can push the frontiers of science and lean forward on innovation, all while keeping rising costs in check.

 

Wednesday, May 5, 2021

Sessions starting at 12:30 PM ET / 9:30 AM PT

Treatments and Breakthroughs (12:30 PM - 1:15 PM ET)

As medical technology innovates at warp speed, what new treatments and digitized care tools can patients look forward to? How might these advancements improve quality of life? And how can policymakers play a supporting role?

Balancing Cost and Innovation (2:00 PM - 3:00 PM ET)

Innovation takes time and money. But how can we balance the time and dollars spent developing new technologies and treatments with what patients can afford to pay? What tweaks or changes can the healthcare ecosystem withstand in order to increase both affordability and access to care?

Speakers:

  • Dr. Toyin Ajayi, President and Co-Founder, Cityblock Health
  • Dr. Katrina Armstrong, Physician-in-Chief, Department of Medicine, Massachusetts General Hospital
  • Dr. Anthony Fauci, Director, NIAID; Chief Medical Advisor to the President
  • David Benshoof Klein, Co-Founder & CEO, Click Therapeutics
  • Dr. Vivian Lee, President, Health Platforms, Verily
  • Paul Meyer, CEO, Commons Project
  • Dr. Vivek H. Murthy, US Surgeon General
  • Kabir Nath, President and CEO, Otsuka America Pharmaceutical, Inc.
  • Sen. Debbie Stabenow (D-MI), Chair, Finance Committee Subcommittee on Health
  • Dr. Janet Woodcock, Acting Commissioner, FDA

Moderators:

  • Julia Manchester, Political Reporter, The Hill
  • Steve Clemons, Editor-at-Large, The Hill


Lab Startups YouTube Pitches

MEDCITY held an INVESTOR PITCH meeting for startup labs.

Archived on YouTube.

https://www.youtube.com/watch?v=9QyhpF1Oe1A


Startups in the diagnostics field present their solutions to the investor judges. Loop Diagnostics Virtuleap EDP Biotech Patheous Health GRIP Molecular Inanovate




Monday, May 3, 2021

Precision Health and Integrated Diagnostics at Stanford

 http://med.stanford.edu/phind/events/2021.html





99446-9 - Codes for Physician to Physician EHR Evaluation and Consult; RUC

Interprofessional telephone/Internet/electronic health record assessment and management service provided by a consultative physician, including a verbal and written report to the patient’s treating/requesting physician or other qualified health care professional.  This is a representative vignette (99446-94449).

RUC Rationale

In June 2010, the CPT Editorial Panel created the Telephone Consultative Services Workgroup to address a proposal to create codes describing telephone/internet consultative services. 


The workgroup was charged with the following: Clarify use by non-physicians; Review the appropriateness of time increments for physician to patient calls; Clarify the typical patient/service descriptions based upon literature supplied; Consider appropriate use of term “consultation”; and Consider time interval for non-reporting as being distinct from a patient call (ie, if a face to face service occurs the next week or if co-management is in progress and the patient is seen every month, but more than 7 days previously, is the service reported). 


In May 2012, the CPT Editorial Panel approved a new Evaluation and Management subsection, guidelines and four codes to describe and report telephone/internet consultative services. An interprofessional telephone/internet consultation is an assessment and management service in which a patient’s treating (eg, attending or primary) physician or other qualified health care professional requests the opinion and/or treatment advice of a physician with specific specialty expertise (the consultant) to assist the treating physician/qualified health care professional in the diagnosis and/or management of the patient’s problem without the need for the patient’s face to face contact with the consulting physician. These services are typically provided in complex and/or urgent situations where a timely face to face service with the consultant may not be feasible (eg, geographic distance). 


These codes should not be reported by a consultant who has agreed to accept transfer of care before the telephone/internet assessment, but are appropriate to report if the decision to accept transfer of care cannot be made until after the initial interprofessional telephone/Internet consultation. 


The patient for whom the interprofessional telephone/internet consultation is requested may be either a new patient to the consulting physician or an established patient with a new problem or an exacerbation of an existing problem. However, the consultant should not have seen the patient in a face to face encounter within the last 14 days. 


When the telephone/internet consultation leads to an immediate transfer of care or other face-to-face service (eg, a surgery, hospital visit or a scheduled office evaluation of the patient) within the next 14 days or next available appointment date by the consultative physician, these codes are not reported. 


99446 


Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient’s treating/requesting physician/qualified healthcare professional; 5-10 minutes of medical consultative discussion and review The RUC reviewed the survey results from 48 multi-specialty physicians and determined that the survey respondents overestimated physician work. The specialty societies proposed and the RUC accepted modifications to the survey times to more accurately reflect the CPT descriptor: 3 minutes for pre-service; 8 minutes for intra service; and 5 minutes for post service. The RUC reviewed key reference service, CPT code 99441 Telephone evaluation and management service provided by a physician to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion (work RVU=0.25) and agreed that 99446 is a more intense procedure. Typically, the patient is unknown to the consulting physician, the service is provided in a complex/urgent situation and the medical decision-making required is more intense than the key reference service. In order to maintain the proper rank order in relation to 99447 (described below), the RUC used magnitude estimation and determined that a work RVU between the survey 25th percentile (0.50) and the work RVU of 99441 (0.25) is appropriate. The RUC also compared 99446 to 99281 Emergency department visit for the evaluation and management of a patient, which requires these 3 key components: A problem focused history; A problem focused examination; and Straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self limited or minor (work RVU = 0.45) and determined that 99281 is a more intense service and should be valued higher. The RUC recommends a work RVU of 0.35 for CPT code 99446. 


99447 


Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient’s treating/requesting physician/qualified healthcare professional; 11-20 minutes of medical consultative discussion and review The RUC reviewed the survey results from 31 multi-specialty physicians and determined that the survey respondents overestimated physician work. The specialty societies proposed and the RUC accepted modifications to the survey times to more accurately reflect the CPT descriptor: 3 minutes of pre-service; 15 minutes of intra service; and 5 minutes of post service. The RUC reviewed key reference service, 99442 Telephone evaluation and management service provided by a physician to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11-20 minutes of medical discussion (work RVU=0.50) and agreed that 99447 is a more intense procedure. Typically, the patient in unknown to the consulting physician, the service is provided in a complex/urgent situation and the medical decision-making required is more intense than the key reference service. In order to maintain the proper rank order within the family of services, the specialty society indicated and the RUC agreed that a work of 0.70, lower than the survey 25th percentile is appropriate. The 0.35 increment increase in work RVU is similar to that within the telephone evaluation and management services, 99441-99443. The RUC also reviewed CPT code 99241 Office consultation for a new or established patient, which requires these 3 key components: A problem focused history; A problem focused examination; and Straightforward medical decision making. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the presenting problem(s) are self limited or minor. Physicians typically spend 15 minutes face-to-face with the patient and/or family (work RVU = 0.64 and 15 minutes of intra-service time) and agreed that 99447 should be valued higher since it is typically provided in a complex/urgent situation. The RUC recommends a work RVU of 0.70 for CPT code 99447. 


99448 


Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient’s treating/requesting physician/qualified healthcare professional; 21-30 minutes of medical consultative discussion and review The RUC reviewed the survey results from 31 multi-specialty physicians and determined that the survey respondents overestimated physician work. The specialty societies proposed and the RUC accepted modifications to the survey times to more accurately reflect the CPT descriptor: 5 minutes for pre-service; 25 minutes for intra service; and 5 minutes of post service. The RUC reviewed CPT code 99443 Telephone evaluation and management service provided by a physician to an established patient, parent, or guardian not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 21-30 minutes of medical discussion (work RVU=0.75) and agreed that 99448 is a more intense procedure. Typically, the patient in unknown to the consulting physician, the service is provided in a complex/urgent situation and the medical decision-making required is more intense than the key reference service. In order to maintain the proper rank order within this family of services, the RUC used magnitude estimation and determined that a work RVU of 1.05 is appropriate (99447 work RVU of 0.70 + 0.35 = 1.05). The RUC compared 99448 to 99374 Physician supervision of a patient under care of home health agency (patient not present) in home, domiciliary or equivalent environment (eg, Alzheimer's facility) requiring complex and multidisciplinary care modalities involving regular physician development and/or revision of care plans, review of subsequent reports of patient status, review of related laboratory and other studies, communication (including telephone calls) for purposes of assessment or care decisions with health care professional(s), family member(s), surrogate decision maker (work RVU = 1.10) and determined that 99374 is a more intense service and should be valued higher. The RUC recommends a work RVU of 1.05 for CPT code 99448. 


99449 


Interprofessional telephone/internet assessment and management service provided by a consultative physician including a verbal and written report to the patient’s treating/requesting physician/qualified healthcare professional; 31 minutes or more of medical consultative discussion and review The RUC reviewed the survey results from 26 multi-specialty physicians and determined that the survey respondents overestimated physician work. The RUC noted that 99449 will typically be utilized by behavioral/mental health professionals as there is a perceived need with access to care. The specialty societies proposed and the RUC accepted modifications to the survey times to more accurately reflect the CPT descriptor: 9 minutes for pre-service; 31 minutes for intra service; and 10 minutes for post service. The RUC reviewed CPT codes 92014 Ophthalmological services: medical examination and evaluation, with initiation or continuation of diagnostic and treatment program; comprehensive, established patient, 1 or more visits (work RVU=1.42) and 99304 Initial nursing facility care, per day, for the evaluation and management of a patient, which requires these 3 key components: A detailed or comprehensive history; A detailed or comprehensive examination; and Medical decision making that is straightforward or of low complexity. Counseling and/or coordination of care with other providers or agencies are provided consistent with the nature of the problem(s) and the patient's and/or family's needs. Usually, the problem(s) requiring admission are of low severity. Physicians typically spend 25 minutes at the bedside and on the patient's facility floor or unit. (work RVU=1.64) and agreed that both services require less intra-service time and are more intense than 99449. The RUC recommends a work RVU of 1.40 for CPT code 99449. New Technology This service will be placed on the New Technology list and be re-reviewed by the RUC in three years to ensure correct valuation and utilization assumptions.