DR. PANKAJ SHUKLA MD
NPI 1114937190
Internal Medicine in Bakersfield, CA

Medicare Participation & PECOS Enrollment Status

Pankaj Shukla is registered with Medicare and accepts claims assignment, this means the provider accepts the approved amount for the cost of rendered services as full payment. Participating providers may not charge beneficiaries more than the approved amount for their services. Please keep in mind that beneficiaries still have to pay a coinsurance or copayment amount for a visit or service.

Pankaj Shukla is enrolled in PECOS and is eligible to order or refer health care services for Medicare patients. The provider is eligible to order or refer: Part B Clinical Laboratory and Imaging, Durable Medical Equipment (DME), a Home Health Agency (HHA) and Power Mobility Devices.

What is PECOS?
PECOS is the online Medicare enrollment management system or Provider, Enrollment, Chain and Ownership System. The PECOS system is a database of providers who have registered with CMS as providers or suppliers. PECOS is the primary source of information about verified Medicare professionals. Providers that want to participate in this program need to enroll in PECOS with their NPI number to avoid denied claims.

• Is the provider registered in PECOS? Yes

• PECOS PAC ID: 3476442062

  What is the PECOS Associate Control ID?
  A PAC ID is a unique 10-digit number assigned to an individual or organization healthcare provider in PECOS. The PAC ID is used to link together all the provider information, like tax identification numbers and organizational names. A PAC ID can be connected to multiple Enrollment IDs if an individual or organization has enrolled in PECOS more than once.

• PECOS Enrollment ID: I20040311001488

  What is the Provider Enrollment ID?
  The Enrollment ID is a unique alphanumeric 15-digit code assigned to each new provider's PECOS enrollment application. The Enrollment ID is used to link together all the provider enrollment information like enrollment type, state, provider specialty, and reassignment of benefits.

• Accepts Medicare Assignment? Yes

  What does it mean "accepts medicare assignment"?
  When a provider accepts Medicare assignment, the provider agrees to be paid directly by Medicare and to accept the payment amount approved by Medicare. Additionally, the provider agrees to not bill patients for more than the Medicare deductible and coinsurance amounts.
  A provider who doesn't accept assignment may charge you up to 15% over the Medicare-approved amount. This is known as the limiting charge. You may have to pay this amount, or it may be covered by another insurer.

• Eligible to Order or Refer Part B Clinical Laboratory and Imaging: Yes

• Eligible to Order or Refer Durable Medical Equipment (DMEPOS): Yes

• Eligible to Order or Refer a Home Health Agency (HHA): Yes

• Eligible to Order or Refer Power Mobility Devices: Yes

Provider Referred Orders for Durable Medical Equipment, Devices & Supplies

The following list reflects the services, supplies or durable medical equipment ordered by this provider to a DME supplier on behalf of patients. The information below is derived from Medicare claims data and reflects the BETOS category, HCPCS code information and the number times each service was submitted under the Medicare fee-for-service program.

Durable Medical Equipment

• DME-Other DME (DE017N)

  Replacement battery, alkaline (other than j cell), for use with medically necessary home blood glucose monitor owned by patient, each (HCPCS:A4233)

  2 DME suppliers used 13 Medicare Claims 26 Services Paid

• DME-Other DME (DE017N)

  Blood glucose test or reagent strips for home blood glucose monitor, per 50 strips (HCPCS:A4253)

  40 DME suppliers used 252 Medicare Claims 685 Services Paid

• DME-Other DME (DE000N)

  Normal, low and high calibrator solution / chips (HCPCS:A4256)

  5 DME suppliers used 33 Medicare Claims 33 Services Paid

• DME-Other DME (DE000N)

  Spring-powered device for lancet, each (HCPCS:A4258)

  5 DME suppliers used 12 Medicare Claims 12 Services Paid

• DME-Medical/Surgical Supplies (DA000N)

  Lancets, per box of 100 (HCPCS:A4259)

  31 DME suppliers used 143 Medicare Claims 203 Services Paid

• DME-Other DME (DE000N)

  Administration set, with small volume nonfiltered pneumatic nebulizer, disposable (HCPCS:A7003)

  1 DME suppliers used 37 Medicare Claims 68 Services Paid

• DME-Other DME (DE000N)

  Administration set, with small volume nonfiltered pneumatic nebulizer, non-disposable (HCPCS:A7005)

  1 DME suppliers used 12 Medicare Claims 12 Services Paid

• DME-Other DME (DE000N)

  Aerosol mask, used with dme nebulizer (HCPCS:A7015)

  1 DME suppliers used 14 Medicare Claims 14 Services Paid

• DME-Other DME (DE001N)

  Full face mask used with positive airway pressure device, each (HCPCS:A7030)

  1 DME suppliers used 15 Medicare Claims 15 Services Paid

• DME-Other DME (DE001N)

  Face mask interface, replacement for full face mask, each (HCPCS:A7031)

  1 DME suppliers used 21 Medicare Claims 41 Services Paid

• DME-Other DME (DE001N)

  Nasal interface (mask or cannula type) used with positive airway pressure device, with or without head strap (HCPCS:A7034)

  3 DME suppliers used 12 Medicare Claims 12 Services Paid

• DME-Other DME (DE001N)

  Headgear used with positive airway pressure device (HCPCS:A7035)

  3 DME suppliers used 17 Medicare Claims 17 Services Paid

• DME-Other DME (DE001N)

  Tubing used with positive airway pressure device (HCPCS:A7037)

  3 DME suppliers used 25 Medicare Claims 25 Services Paid

• DME-Other DME (DE001N)

  Filter, disposable, used with positive airway pressure device (HCPCS:A7038)

  3 DME suppliers used 36 Medicare Claims 156 Services Paid

• DME-Other DME (DE000N)

  Walker, folding, wheeled, adjustable or fixed height (HCPCS:E0143)

  4 DME suppliers used 14 Medicare Claims 14 Services Paid

• DME-Other DME (DE000N)

  Seat attachment, walker (HCPCS:E0156)

  3 DME suppliers used 13 Medicare Claims 13 Services Paid

• DME-Hospital Beds (DB000N)

  Hospital bed, semi-electric (head and foot adjustment), with any type side rails, with mattress (HCPCS:E0260)

  1 DME suppliers used 33 Medicare Claims 33 Services Paid

• DME-Oxygen and Supplies (DC000N)

  Portable gaseous oxygen system, rental; includes portable container, regulator, flowmeter, humidifier, cannula or mask, and tubing (HCPCS:E0431)

  3 DME suppliers used 83 Medicare Claims 85 Services Paid

• DME-Other DME (DE005N)

  Home ventilator, any type, used with non-invasive interface, (e.g., mask, chest shell) (HCPCS:E0466)

  2 DME suppliers used 18 Medicare Claims 18 Services Paid

• DME-Other DME (DE001N)

  Respiratory assist device, bi-level pressure capability, without backup rate feature, used with noninvasive interface, e.g., nasal or facial mask (intermittent assist device with continuous positive airway pressure device) (HCPCS:E0470)

  2 DME suppliers used 15 Medicare Claims 15 Services Paid

• DME-Other DME (DE001N)

  Humidifier, heated, used with positive airway pressure device (HCPCS:E0562)

  1 DME suppliers used 31 Medicare Claims 32 Services Paid

• DME-Other DME (DE000N)

  Nebulizer, with compressor (HCPCS:E0570)

  1 DME suppliers used 86 Medicare Claims 86 Services Paid

• DME-Other DME (DE001N)

  Continuous positive airway pressure (cpap) device (HCPCS:E0601)

  1 DME suppliers used 36 Medicare Claims 37 Services Paid

• DME-Other DME (DE017N)

  Home blood glucose monitor (HCPCS:E0607)

  8 DME suppliers used 12 Medicare Claims 12 Services Paid

• DME-Other DME (DE000N)

  Patient lift, hydraulic or mechanical, includes any seat, sling, strap(s) or pad(s) (HCPCS:E0630)

  1 DME suppliers used 16 Medicare Claims 16 Services Paid

• DME-Oxygen and Supplies (DC002N)

  Oxygen concentrator, single delivery port, capable of delivering 85 percent or greater oxygen concentration at the prescribed flow rate (HCPCS:E1390)

  5 DME suppliers used 209 Medicare Claims 209 Services Paid

• DME-Oxygen and Supplies (DC002N)

  Portable oxygen concentrator, rental (HCPCS:E1392)

  2 DME suppliers used 32 Medicare Claims 32 Services Paid

• DME-Wheelchairs (DD000N)

  Standard wheelchair (HCPCS:K0001)

  2 DME suppliers used 76 Medicare Claims 76 Services Paid

• DME-Wheelchairs (DD000N)

  Lightweight wheelchair (HCPCS:K0003)

  3 DME suppliers used 23 Medicare Claims 23 Services Paid

• DME-Other DME (DE017N)

  Supply allowance for therapeutic continuous glucose monitor (cgm), includes all supplies and accessories, 1 month supply = 1 unit of service (HCPCS:K0553)

  4 DME suppliers used 156 Medicare Claims 156 Services Paid

• DME-Other DME (DE017N)

  Receiver (monitor), dedicated, for use with therapeutic glucose continuous monitor system (HCPCS:K0554)

  3 DME suppliers used 12 Medicare Claims 12 Services Paid

• DME-Other DME (DE000N)

  Pharmacy dispensing fee for inhalation drug(s); per 30 days (HCPCS:Q0513)

  9 DME suppliers used 99 Medicare Claims 99 Services Paid

Orthotic Devices

• DME-Orthotic Devices (DF000N)

  For diabetics only, fitting (including follow-up), custom preparation and supply of off-the-shelf depth-inlay shoe manufactured to accommodate multi-density insert(s), per shoe (HCPCS:A5500)

  1 DME suppliers used 14 Medicare Claims 28 Services Paid

Drugs Administered Through DME

• DME-Drugs Administered Through DME (DG006N)

  Albuterol, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose, 1 mg (HCPCS:J7613)

  7 DME suppliers used 72 Medicare Claims 17502 Services Paid

• DME-Drugs Administered Through DME (DG006N)

  Albuterol, up to 2.5 mg and ipratropium bromide, up to 0.5 mg, fda-approved final product, non-compounded, administered through dme (HCPCS:J7620)

  2 DME suppliers used 28 Medicare Claims 2280 Services Paid

Areas of Expertise

The following services and procedures, recently provided to Medicare patients, illustrate the range of care this provider offers. This list reflects the variety of services available to all patients visiting the practice and is based on 2022 Medicare dataset. In general, the more frequently a provider treats specific conditions or performs particular procedures, the more experienced they become in addressing similar patient needs. The provider has delivered many of the services listed below to Medicare patients. Please note that this list does not include services provided to patients who are not covered by Medicare.

Administration of influenza virus vaccine

The administration of the influenza virus vaccine, also known as the flu shot, is a simple procedure to protect against the flu. A healthcare provider injects a small dose of the vaccine into your arm. This stimulates your immune system to produce antibodies, which will help your body fight off the flu if exposed.

This service was performed 359 times for 352 patients

Annual wellness visit, includes a personalized prevention plan of service (pps), subsequent visit

An annual wellness visit is a yearly appointment with your primary care provider to create or update a personalized prevention plan. This plan helps prevent illness based on your current health and risk factors. It's a subsequent visit, meaning it follows an initial assessment.

This service was performed 36 times for 36 patients

Aspiration and/or injection of fluid from large joint

This procedure involves using a needle to remove (aspiration) or introduce (injection) fluid into a large joint like the knee or hip. It can help diagnose conditions, relieve discomfort, or deliver medication directly to the joint.

This service was performed 86 times for 41 patients

Blood glucose (sugar) test performed by hand-held instrument

A blood glucose test uses a handheld device to measure the amount of sugar in your blood. A small prick on your finger allows a drop of blood to be placed on a test strip, which is then read by the device. This helps monitor and manage diabetes effectively.

This service was performed 852 times for 243 patients

Complete ultrasound scan of abdomen

A complete ultrasound scan of the abdomen is a non-invasive imaging procedure. It uses sound waves to produce images of the organs in your abdomen, such as the liver, gallbladder, spleen, pancreas, and kidneys. It helps in diagnosing, monitoring, and planning treatments.

This service was performed 121 times for 118 patients

Electrocardiogram (ecg) 2-day continuous with review and report by health care professional

An Electrocardiogram (ECG) is a non-invasive test that records the electrical activity of your heart. In a 2-day continuous ECG, sensors attached to your chest monitor your heart's rhythm over 48 hours. A healthcare professional then reviews the data to identify any irregularities.

This service was performed 11 times for 11 patients

Established patient office or other outpatient visit, 20-29 minutes

This is a routine visit for patients who have already been seen by the healthcare provider. During this approximately 20-29 minute appointment, your health status will be evaluated and any necessary treatments or tests will be discussed. It's a chance to address any health concerns you may have.

This service was performed 4,684 times for 705 patients

Established patient office or other outpatient visit, 30-39 minutes

This is a routine check-up for patients who have previously visited our clinic. It involves a comprehensive review of your health and any ongoing treatments. The consultation lasts between 30-39 minutes, allowing enough time to discuss any concerns.

This service was performed 775 times for 489 patients

Hyaluronan or derivative, hyalgan, supartz or visco-3, for intra-articular injection, per dose

Hyaluronan or derivatives like Hyalgan, Supartz, or Visco-3, are used in intra-articular injections for joint pain relief. They help by improving joint lubrication, reducing inflammation, and promoting tissue healing. Each dose is administered directly into the joint space.

This service was performed 43 times for 13 patients

Influenza vaccine, quadrivalent, preservative free, 0.5 ml dosage

The quadrivalent influenza vaccine is a shot to protect you from four different flu viruses. It's preservative-free and given in a 0.5 ml dose. It helps your body build immunity to the flu, reducing your risk of getting sick.

This service was performed 360 times for 353 patients

Injection of drug or substance under skin or into muscle

This procedure involves administering medication directly under the skin or into a muscle. A small needle is used to inject the drug, allowing it to be absorbed quickly into the bloodstream. It's a common method for delivering a variety of medications.

This service was performed 4,200 times for 567 patients

Injection of trigger points, 1-2 muscles

Trigger point injection is a procedure used to treat painful areas of muscle that contain trigger points, or knots of muscle that form when muscles do not relax. 1-2 muscles are typically treated in one session. The procedure involves injecting medications into these points to alleviate pain.

This service was performed 172 times for 54 patients

Injection, cefazolin sodium, 500 mg

Cefazolin sodium is an antibiotic injection used to treat a variety of bacterial infections. By stopping the growth of bacteria, this medication helps in the treatment of infections. The 500 mg dosage refers to the strength of the medicine.

This service was performed 184 times for 79 patients

Injection, ceftriaxone sodium, per 250 mg

Ceftriaxone sodium is an antibiotic injection used to treat a variety of bacterial infections. Each injection contains 250 mg of the medicine. It works by stopping the growth of bacteria in your body.

This service was performed 1,152 times for 168 patients

Injection, furosemide, up to 20 mg

Furosemide is a medication given via injection, often to help your body eliminate excess fluid or salt. It's typically used to treat issues like heart failure or high blood pressure. The dose mentioned, up to 20 mg, will be adjusted based on your specific needs.

This service was performed 75 times for 46 patients

Injection, ketorolac tromethamine, per 15 mg

Ketorolac tromethamine is a medication administered through injection, often used to manage moderate to severe pain. Each 15 mg dose helps to reduce hormones causing inflammation and pain in the body. It is not recommended for long-term use.

This service was performed 3,561 times for 273 patients

Injection, ondansetron hydrochloride, per 1 mg

Ondansetron hydrochloride is a medication given via injection to help prevent nausea and vomiting, often due to chemotherapy or surgery. It works by blocking certain chemicals in the body that trigger these symptoms.

This service was performed 176 times for 31 patients

Injection, triamcinolone acetonide, not otherwise specified, 10 mg

Triamcinolone acetonide is a medication used to reduce inflammation in the body. It's given as a 10 mg injection for conditions like allergies, arthritis, or skin problems. The injection helps to decrease swelling, redness, and itching.

This service was performed 4,180 times for 330 patients

Injection, vitamin b-12 cyanocobalamin, up to 1000 mcg

This is a procedure where a small dose of Vitamin B-12, also known as Cyanocobalamin, is injected into your body. This vitamin is essential for nerve function and the production of red blood cells. It's often used to treat vitamin B-12 deficiency.

This service was performed 2,068 times for 461 patients

Limited ultrasound scan of joint or other extremity structure lacking blood vessels

A limited ultrasound scan of a joint or other extremity structure lacking blood vessels is a non-invasive procedure that uses sound waves to create images of the inside of your body. This helps in diagnosing and monitoring conditions related to your joints or other similar structures.

This service was performed 26 times for 25 patients

New patient office or other outpatient visit, 45-59 minutes

This is a first-time office or outpatient visit lasting between 45-59 minutes. The healthcare provider evaluates your health, discusses your medical history, and may suggest further tests or treatments. It's an opportunity to ask questions and understand your health better.

This service was performed 65 times for 65 patients

Physician or allowed practitioner certification for medicare-covered home health services under a home health plan of care (patient not present), including contacts with home health agency and review of reports of patient status required by physicians and

This is a service where a doctor or authorized practitioner certifies that you require Medicare-covered home health services. They will communicate with the home health agency and review reports on your health status to ensure you receive appropriate care. This does not involve an in-person visit.

This service was performed 82 times for 68 patients

Physician or allowed practitioner re-certification for medicare-covered home health services under a home health plan of care (patient not present), including contacts with home health agency and review of reports of patient status required by physicians a

This procedure involves a doctor or approved practitioner reviewing your health status and re-certifying your need for Medicare-covered home health services. It includes communication with the home health agency and assessment of your health reports, even when you're not physically present.

This service was performed 76 times for 22 patients

Removal of impacted ear wax

Impacted ear wax removal is a safe procedure to clear blockages in the ear canal caused by hardened ear wax. A healthcare professional uses specialized tools or a gentle irrigation method to loosen and remove the wax, improving hearing and alleviating discomfort.

This service was performed 15 times for 15 patients

Routine electrocardiogram (ecg) using at least 12 leads with interpretation and report

An electrocardiogram (ECG) is a non-invasive test that records your heart's electrical activity. Using 12 leads attached to your body, it captures data to help identify heart conditions. A doctor interprets the results and provides a report.

This service was performed 321 times for 268 patients

Transitional care management services for problem of high complexity

Transitional care management services are designed to ensure a smooth transition from a hospital to home or another care setting for patients with complex health issues. These services include medication management, patient education, and coordination with healthcare providers.

This service was performed 40 times for 34 patients

Transitional care management services for problem of moderate complexity

Transitional care management services focus on coordinating and managing your care after you leave the hospital. For moderate complexity problems, this involves managing your medications, arranging further treatments, and ensuring you have the necessary follow-ups.

This service was performed 23 times for 22 patients

Ultrasound of both sides of head and neck blood flow

An ultrasound of the head and neck blood flow is a safe, non-invasive procedure that uses sound waves to create images of blood vessels. It helps detect abnormalities like blockages or clots, ensuring optimal blood flow.

This service was performed 248 times for 246 patients

Ultrasound of heart with color-depicted blood flow, rate, direction and valve function

This is a heart ultrasound, also known as an echocardiogram. It uses sound waves to create pictures of your heart, showing how blood flows through it. The color depicts the blood flow's speed and direction. It also checks the heart's valves to ensure they're working properly.

This service was performed 324 times for 320 patients

Ultrasound of leg arteries or artery grafts

An ultrasound of leg arteries or artery grafts is a non-invasive imaging test. It uses high-frequency sound waves to capture live images from inside your body, specifically your leg arteries or grafts. This helps in detecting any blockages or abnormalities.

This service was performed 63 times for 63 patients

Ultrasound scan of head and neck soft tissue

An ultrasound scan of the head and neck soft tissue is a non-invasive procedure that uses sound waves to create images of the soft tissues in these areas. It helps identify any abnormalities or issues, such as tumors, cysts, or infections. It's painless and doesn't involve radiation.

This service was performed 20 times for 20 patients

Ultrasound study of arm or leg veins with compression and maneuvers

An ultrasound study of arm or leg veins with compression and maneuvers is a non-invasive procedure that uses sound waves to create images of your veins. This helps identify blood clots or other vein problems. During the procedure, pressure is applied to the veins and certain movements are performed to assess blood flow.

This service was performed 20 times for 20 patients

Physician Visit Costs

The typical physician office visit costs for Medicare beneficiaries in this area are: $33.76 for a new patient copayment and $26.02 for an established patient copayment.

The pricing information below displays the copayment minimum, maximum and average amount that patients under Medicare are charged when visiting this provider as a new or established patient. Please keep in mind that these prices are just for reference purposes, and the actual prices charged by the provider might be different.

For patients covered under private health plans the prices below are also useful as healthcare pricing for private insurance is usually established as a function of Medicare prices. Private insurance covered patients should check their individual plans to determine the exact pricing.

The prices below reflect the costs for new and established patients in the 93311 ZIP code area.

* The physician office visit costs information is generated by statistical analysis of similar providers in the same geographical area. The pricing information above IS NOT the amount charged by this provider.

Overall MIPS Quality Performance

The provider participated in CMS Quality Payment Program under the Merit-based Incentive Payment System (MIPS) and has an overall final score of 100, based on four performance areas: quality, improvement activities, promoting interoperability, and cost. The purpose of this information is to help people with Medicare make informed decisions and incentivize doctors and clinicians to maximize performance. The provider also has detailed performance information the following quality measures: .

The Merit-based Incentive Payment System (MIPS) is a way providers could use to participate in CMS Quality Payment Program (QPP). The MIPS program affects clinician reimbursement for Part B covered professional services and also rewards them for improving the quality of patient care and outcomes.

• Final Score: 100 out of 100

  The MIPS program evaluates providers across multiple categories with a specific weight for each category resulting a in a MIPS final score that ranges from 0 to 100 points. The MIPS Final Score determines whether providers receive a negative, neutral or positive MIPS payment adjustment.
  
  

• Quality Score: 100

  The Quality category assesses providers performance on clinical practices and patient outcomes under the traditional MIPS program. The quality measures help identify the quality of healthcare processes, outcomes, and patient experiences. The Quality measure category compromises 40% providers final MPIS scores.
  
  There are six collection types for MIPS quality measures: Electronic Clinical Quality Measures (eCQMs), MIPS Clinical Quality Measures (CQMs), Qualified Clinical Data Registry (QCDR) Measures, Medicare Part B claims measures, CMS Web Interface measures and The Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS Survey.
  
  

• Promoting Interoperability Score: N/A

  The Interoperability category measures the providers ability to use technology to exchange and make use of healthcare information in a way that is less burdensome and improves outcomes. The Interoperability measure category compromises 25% providers final MPIS scores.
  
  The MIPS Interoperability measure focuses on the use of certified electronic health record technology (CEHRT) to improve patient access health information, the exchange of information between clinicians and pharmacies and the systematic collection, analysis, and interpretation of healthcare data.

• Improvement Activities Score: 40

  The Improvement Activities performance category evaluates the providers participation in clinical activities that support the improvement of clinical practice, care delivery, and outcomes. Providers have the option to choose 2 to 4 activities from an inventory of over 100 improvement activities. Providers typically choose the activities that best fit their needs. The improvement activities measure category compromises 15% providers final MPIS scores.
  
  The Improvement measures aim to better patient engagement, patient safety and other areas of patient care. The Improvement Activities category compromises 15% of providers final MPIS scores.

• Cost Score: 81.76

  The Cost performance category asses the amount and types of services provided and how clinicians coordinate care and seek improvement of health outcomes by ensuring patients receive the appropriate services.
  
  Although providers don't determine the price of healthcare services they are important in delivering high-quality care at a reasonable cost. The Cost measures category compromises 20% of providers final MPIS scores.

• Cost Score: 81.76

  The Cost performance category asses the amount and types of services provided and how clinicians coordinate care and seek improvement of health outcomes by ensuring patients receive the appropriate services.
  
  Although providers don't determine the price of healthcare services they are important in delivering high-quality care at a reasonable cost. The Cost measures category compromises 20% of providers final MPIS scores.

MIPS Quality Measures

CLIA Information

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 applies to facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CLIA Program sets standards for clinical laboratory testing and issues certificates. The NPI / CLIA crosswalk information for this NPI number is:

CLIA Number

05D1015660

Facility Type

Physician Office

Certificate Effective Date

August 11, 2025

Certificate Expiration Date

August 10, 2027

Laboratory Director

PANKAJ SHUKLA MD

Certificate Type

Certificate of Waiver

Certificate Type Description

This CLIA certificate is issued to Pankaj Shukla to perform only waived tests. CLIA defines waived tests as simple tests with a low risk for an incorrect result. Waived tests include certain tests listed in CLIA regulations, tests cleared by the FDA for home use and tests approved by the FDA for waived status and that meet CLIA waiver criteria.

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