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what is a data waiver

by Olin Lindgren III Published 2 years ago Updated 2 years ago
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The Drug Addiction Treatment Act of 2000 (DATA 2000) permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved by the FDA – including buprenorphine – in treatment settings other than OTPs. Must receive waiver (known as “DATA Waiver”) to prescribe.

A Data 2000 Waiver refers to the Drug Addiction Treatment Act (DATA 2000) "waiver" legislation that authorized the outpatient use of buprenorphine for the treatment of OUD. The DATA 2000 Waiver helps improve access to OUD and substance-use disorder (SUD) treatment.Aug 15, 2022

Full Answer

What is DEA X waiver?

The X-waiver is a rare regulation in American medicine that requires an 8-hour training and documented DEA permission before a medical doctor can prescribe Suboxone to treat opioid use disorder.

What is a DD Waiver Program?

Developmental Disabilities (DD) Waiver: Program that provides home and community-based services to children and adults with a diagnosis of a developmental disability or a related condition who require the level of care provided in an intermediate care facility for persons with developmental disabilities (ICF/DD). These services are an ...

What is a D waiver?

Developmental Disabilities Waiver. The Developmental Disabilities (DD) Waiver program also known in New Mexico as the “traditional DD waiver” is designed to provide Services and Supports that assist eligible children and adults with Intellectual and Developmental Disabilities (IDD) to participate as active members of their communities.The DD Waiver is one of several waivers available in ...

What is an ESTA waiver?

ESTA is an electronic program that determines the eligibility of visitors to travel to the United States without a visa. It stands for Electronic System for Travel Authorization. ESTA is the main requirement of the Visa Waiver Program, and those who do not have an approved or valid ESTA cannot enter the United States even if they fulfill all the other requirements of the VWP.

What is a data 2000 waiver?

What is a SLA?

What is a standard amendment coversheet?

What is a data processing lease?

What is a data terms website?

What is a term of service agreement?

What is technical agreement?

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How long is a buprenorphine waiver good for?

Practitioners at the 30- and 100-level do not need to renew their waivers. Practitioners who are at the 275-patient limit need to renew their patient limit every 3 years and submit a yearly report annually.

How can I increase my Suboxone limit?

Practitioners who have had a waiver to treat 30 patients for at least one year may apply to increase their patient limit to 100. After one year at the 100-patient limit, physicians and qualifying other practitioners who meet certain criteria can apply to increase their patient limit to 275.

What is an XDEA?

XDEA. An X-number, or “DATA-waived,” registration allows providers holding the registration to avoid U.S. Drug Enforcement Agency (DEA) registration requirements for narcotic treatment programs such as organized methadone clinics.

What class of drug is buprenorphine?

Buprenorphine is a schedule III narcotic analgesic. It was first marketed in the United States in 1985 as a schedule V narcotic analgesic.

What's the most Suboxone you can be prescribed?

What Is the Highest Dose Prescribed? In the early stages of MAT, Suboxone doses of up to 24 mg/6 mg may be prescribed. Suboxone doses above 16 mg/4 mg are generally considered high doses.

What is the most Suboxone you can take in a day?

The recommended target dosage of SUBOXONE sublingual film during maintenance is 16 mg/4 mg buprenorphine/naloxone/day as a single daily dose. Dosages higher than 24 mg/6 mg daily have not been demonstrated to provide a clinical advantage.

Do prescriptions go into a database?

Yes. For controlled substances, each state has a monitoring database for every prescription dispensed. Every database is linked, so if you go to a physician in Alaska and get a prescription for hydrocodone, your physician will know it.

Can Suboxone be used for pain?

Suboxone can help patients simultaneously manage chronic pain and the uncomfortable symptoms during withdrawal from opioids. Individuals with opioid use disorder and chronic pain have a higher risk of overdose when they take certain pain medications, but Suboxone can reduce their pain while helping them avoid relapse.

What is the most common treatment for opioid use disorder?

The most common medications used in the treatment of opioid addiction are methadone, buprenorphine and naltrexone. Counseling is recommended with the use of each of these medications.

What is the Suboxone spit trick?

The medication is designed to perform at its best when dissolved sublingually. Suboxone dissolves under the tongue. When the medication has completely dissolved, and you can no longer see the Suboxone film, you can spit out the residue – the Suboxone spit trick! You won't receive any extra Suboxone by swallowing it.

What kind of narcotic is in buprenorphine?

Buprenorphine is an opioid partial agonist. It produces effects such as euphoria or respiratory depression at low to moderate doses. With buprenorphine, however, these effects are weaker than full opioid agonists such as methadone and heroin. When taken as prescribed, buprenorphine is safe and effective.

What pain med can you take with Suboxone?

Managing non-surgical short and long-term pain while on Suboxone. Maximizing non-opioid pain medications (i.e., non-steroidal anti-inflammatory drugs - NSAIDs - and acetaminophen) whenever possible and not contraindicated is the preferred first-line treatment.

How do you know if you need to increase your SUBOXONE?

If you are taking buprenorphine (Suboxone®) for pain, and you are not taking any other opioids, the dose may need to be increased if you are still in pain and it isn't well controlled. The lowest dose for pain can be 2 mg. For chronic pain, you would typically be taking a dose three times a day.

Will my doctor increase my SUBOXONE?

As a new patient, you'll return to your clinic in a few days to determine your dose's effectiveness. The doctor will then adjust the amount or ask you to come back again after more time with your current dose. Most patients stop receiving an increase in dosage when they take a moderate amount of Suboxone.

How much SUBOXONE can you take in 24 hours?

The suggested target total dose for Day One is in the range of 8 - 16 mg Suboxone Film. A maximum daily dose of 32 mg should not be exceeded. During the initiation of treatment, patients need frequent monitoring. Suboxone Film should be dispensed in multiple doses over the first 4 to 6 hours of the transfer.

What happens if you take more than 24 mg of SUBOXONE?

Symptoms of an overdose on Suboxone are like those of other opioid drugs. A person overdosing on Suboxone may experience: Nausea and vomiting. Seizures.

DATA 2000 Waiver Training Payment Program FAQs - DATA 2000 Waiver ...

Overview; What is the DATA 2000 Waiver Training Payment Program? The DATA 2000 Waiver Training Payment Program aims to improve health care, including for rural populations, by promoting greater access to substance use disorder treatment through payments to Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), providing a set amount for each eligible provider possessing a ...

DATA 2000 Waiver Training Payment Program

Overview This page is for Federally Qualified Health Center (FQHC) and Rural Health Clinic (RHC) organizations who are applying for payment under the Drug Addiction Treatment Act of 2000 (DATA 2000) Waiver Training Payment Program. This program aims to im

Find Buprenorphine Waiver Training | SAMHSA

Find Buprenorphine Training. The Drug Addiction Treatment Act of 2000 (DATA 2000), the Comprehensive Addiction and Recovery Act (CARA) and the Substance Use-Disorder Prevention Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act allows qualified practitioners to dispense or prescribe buprenorphine for the treatment of opioid use disorders (OUD) in settings other than ...

How to apply for your X-waiver on your DEA License

5. DONE! 6. Wait for your new DEA license to arrive in the mail. Your new DEA license will have BOTH your old DEA number and a new one that replaces the first letter of your old DEA number with the letter “X”

What is the determination report?

The Determinations Report: A Report on the Physician Waiver Program Established by the Drug Addiction Treatment Act of 2000 (“DATA”) – 2006 (PDF | 48 KB). This report from SAMHSA’s administrator to the Secretary of Health and Human Services and Congress summarizes and comments on key findings from the study.

When was buprenorphine approved?

Since October 2002 when the Food and Drug Administration (FDA) approved buprenorphine for clinical use in treating opioid dependency, SAMHSA has worked with practitioners to help them obtain waivers to meet the requirements of the Drug Addiction Treatment Act of 2000 (DATA 2000).

How many patients can you take buprenorphine?

The 30-patient limit on individual practitioner practices, as well as continuing cost and reimbursement issues, have dampened the full potential of buprenorphine to improve access

What is data 2000?

Results from a 2005 congressionally mandated evaluation study show how DATA 2000 has expanded opioid-assisted treatment. The study presents practitioner and patient survey results on treatment outcomes, patient characteristics, prescribing trends, barriers to treatment, and other information.

Does the waiver program help with opioid addiction?

Overall, the study found that: The waiver program appears to have increased the availability of medication-assisted treatment (MAT) for opioid dependency. Treatment provided under the wavier program has been safe and effective.

What is the date of waiver attainment?

HRSA considers the date of waiver attainment to be the certification date indicated on the approval letter providers receive from SAMHSA notifying them of their waiver level.

How much does HRSA pay for opioid use disorder?

If HRSA determines that one of the three submitted providers has already been counted toward a payment issued under a previously submitted application (e.g., an application submitted by a different site or parent organization at which the provider is employed and opioid use disorder services are rendered), then the applicant will receive a payment in the amount of $6,000, for the two eligible providers.

How does HRSA validate an application?

HRSA will validate some elements of the application at the point of entry and notify the applicant during the application process if an entry is not valid. Following acceptance of the applicant’s submission, HRSA, in collaboration with the Substance Abuse and Mental Health Services Administration (SAMHSA), will conduct a more rigorous review to determine whether the applicant is eligible to be paid for each claimed provider. HRSA will process a payment in an amount commensurate with the total number of validated providers (see: Payment, below). For those providers not successfully validated, the applicant will receive a notification from HRSA and be offered an opportunity to submit another application with corrected information, subject to the availability of funds.

How many patients can you treat with buprenorphine?

The Practice Guidelines for the Administration of Buprenorphine for Treating Opioid Use Disorder exempt eligible physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and certified nurse midwives from federal certification requirements related to training, counseling and other ancillary services that are part of the process for obtaining a waiver to treat up to 30 patients with buprenorphine. Submission and approval of a Notice of Intent (NOI) remains legally necessary in order to use buprenorphine in the treatment of patients with OUD. Providers who do not wish to practice under the exemption and its attendant 30 patient limit may seek a waiver per established protocols.

What is UFMS in financial management?

The Unified Financial Management System (UFMS) is the system used to process payments for the Data 2000 Waiver Training Payment Program.

How much does HRSA pay?

HRSA will pay $3,000 for each eligible provider submitted on the application. HRSA will only pay for an eligible provider once.

What is the Data 2000 waiver?

The DATA 2000 Waiver Training Payment Program aims to improve health care, including for rural populations, by promoting greater access to substance use disorder treatment through payments to Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs), providing a set amount for each eligible provider possessing a DATA 2000 waiver on or after January 1, 2019.

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How Does DATA-Waiver Provider Patient Capacity Relate to Opioid and Buprenorphine Prescribing? Issue Brief

ABSTRACT

This brief examines how increases in patient capacity among buprenorphine waivered providers relates to prescribing of buprenorphine and opioids at the county-level.

Introduction

Opioid misuse and use disorder continue to be a significant public health crisis in the United States. In response to the crisis, interventions are being implemented at the state and federal level to reduce opioid prescribing and to increase access to treatment among individuals with opioid use disorder (OUD) (HHS 2018).

Increases in Buprenorphine Treatment Capacity Predict Increases in Buprenorphine Prescribing and Decreases in Other Opioid Prescribing

From 2016 to 2017, 48% of counties in our sample experienced an increase in buprenorphine patient capacity. The mean increase in capacity was 0.25 patients per 100 residents. At the same time, counties on average experienced a 8.0% decrease in non-buprenorphine opioid prescribing, and a 9.4% increase in buprenorphine prescribing.

Discussion

The findings from the study show that an increase in patient capacity among buprenorphine waivered providers are associated with an increase in buprenorphine prescribing and a decrease in non-buprenorphine opioid prescriptions.

Appendix: Data, Methodology and Detailed Statistical Results

Data on opioid prescriptions are drawn from the Prescription Behavioral Surveillance System housed at Brandeis University, which compiles data from state prescription drug monitoring programs (PDMPs).

What is a government information system?

Government information system, which includes (1) this computer, (2) this computer network, (3) all computers connected to this network, and (4) all devices and storage media attached to this network or to a computer on this network. This information system is provided for U.S. Government-authorized use only.

Does the government record email?

The government may record and audit your information system usage, including usage of personal email systems to conduct HHS businesses. Any communication or data transiting or stored on this information system may be disclosed or used for any lawful Government purpose.

Can social media be a disciplinary action?

Personal use of social media on this system may result in disciplinary action unless otherwise authorized.

Is training certificate required for new waivers?

Your Training Certificate Information (Only Required for new Waivers)

What is SAMHSA training?

SAMHSA offers tools, training, and technical assistance to practitioners in the fields of mental and substance use disorders. Find information on SAMHSA training and resources. SAMHSA has developed a Buprenorphine Quick Start Guide (PDF | 1.4 MB) and pocket guide (PDF | 200 KB) for all practitioners seeking to prescribe buprenorphine.

What does CSAT do after reviewing a Buprenorphine request?

After reviewing the practitioners immediate to treat request, CSAT’s Buprenorphine Information Center will send an email to the practitioner approving their intent to treat one patient immediately .

What is a waiver form for buprenorphine?

The waiver form contains all the data items necessary to complete the processing of the buprenorphine waiver notification. The NOI must contain information on the practitioner’s qualifying credentials and additional certifications.

How many patients are required to submit information to SAMHSA?

Every year, per 42 CFR 8.635, qualified practitioners approved to treat up to 275 patients must submit information about their practice to SAMHSA for purposes of monitoring regulatory compliance. The goal of the reporting requirement is to ensure that practitioners are providing buprenorphine treatment in compliance with the final rule Medication Assisted Treatment for Opioid Use Disorders ( 81 FR 44711 ).

How many patients can you treat with buprenorphine?

Qualified practitioners who undertake required training can treat up to 100 patients using buprenorphine for the treatment of opioid use disorder (OUD) in the first year if they possess a waiver under 21 U.S.C. § 823 (g) (2) (i.e., a DATA 2000 waiver) and meet certain conditions. One of two conditions must be satisfied for qualified practitioners ...

How many patients can you treat with a no-in-practice exemption?

Practitioners utilizing this training exemption are limited to treating no more than 30 patients at any one time (time spent practicing under this exemption will not qualify the practitioner for a higher patient limit). This exemption applies only to the prescription of Schedule III, IV, and V drugs or combinations of such drugs, covered under the CSA, such as buprenorphine.

How long does it take for a DEA to approve a waiver?

Once the application process is complete and the application is approved, SAMHSA will email an approval letter to the practitioner indicating their waiver level with certification date, and informing them they will receive their x-designation from the DEA within seven to ten business days.

How to become a buprenorphine waivered practitioner?

To become a Buprenorphine waivered practitioner, submit an NOI buprenorphine waiver application.

How many hours of training do you need to prescribe buprenorphine?

A 30-level waiver allows providers who wish to treat up to 30 patients to prescribe Buprenorphine. For this level waiver, physicians need 8 hours of training and APRNs or PAs need 24 hours of training.

What is 30E exemption?

The 30E (E for “exempt”) is an alternative that does not require training or attestation to provide counseling and other ancillary services ( i.e., psychosocial services). Time spent practicing under this exemption will not qualify the practitioner for a higher patient level.

How to print a copy of a DEA certificate?

You can print a copy of your DEA certificate with the x-waiver listed . You will need to enter your last name, the business zip code you have listed on the DEA registration and your social security number.

What is an X waiver?

Your X-waiver is your DEA number with the first letter replaced with an X. Example: DEA AB1234567 will have an X-waiver number as XB1234567.

What is 21 CFR 1306.07 B?

The intent of 21 CFR 1306.07 (b) is to provide practitioner flexibility in emergency situations where he or she may be confronted with a patient undergoing withdrawal. In such emergencies, it is impractical to require practitioners to obtain a separate registration. The 72-hour exception offers an opioid dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program. This provision was established to augment, not to circumvent, the separate registration requirement. The three-day (72-hour) emergency exception cannot be renewed or extended.

Where is correspondence sent to on a job application?

All correspondence is by email to the address you included on your application.

What is a data 2000 waiver?

DATA 2000 Waiver means the registered authority given to a qualified health care professional by the U.S. Drug Enforcement Administration to prescribe FDA - approved narcotic medication for opioid detoxification or maintenance treatment pursuant to 21. Sample 1.

What is a SLA?

Service Level Agreement or “SLA” : the service levels for the Cloud Service as set out in the then current document (s) made available by Us as “Service Level Agreement for Celonis Software-as-a-Service Offerings” on the Celonis website (under https://www.celonis.com/terms-and-conditions/).

What is a standard amendment coversheet?

Standard Amendment Coversheet refers to the form used by the Judicial Council to amend agreements with other parties. Several originally signed, fully executed versions of a Standard Amendment, together with the integrated Contract Documents, shall each represent an Amendment as an individual contract counterpart.

What is a data processing lease?

Data Processing Lease means any lease or licensing agreement, binding on the Failed Bank as of Bank Closing, the subject of which is data processing equipment or computer hardware or software used in connection with data processing activities. A lease or licensing agreement for computer software used in connection with data processing activities shall constitute a Data Processing Lease regardless of whether such lease or licensing agreement also covers data processing equipment.

What is a data terms website?

Data Terms Website means http://bnymellon.com/products/assetservicing/vendoragreement.pdf or any successor website the address of which is provided by the Custodian to the Fund.

What is a term of service agreement?

Terms-of-service agreement means an agreement that controls the relationship between a user and a custodian.

What is technical agreement?

Technical Agreement means any technical or quality agreements signed by You (or Your Affiliate) and RB (or RB’s Affiliates) specifying technical and quality responsibilities in respect of the Output entered into prior to the date of the Order.

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Abstract

  • This brief examines how increases in patient capacity among buprenorphine waivered providers relates to prescribing of buprenorphine and opioids at the county-level. This brief was prepared through intramural research by the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. For additional information about this subject, y…
See more on aspe.hhs.gov

Introduction

  • Opioid misuse and use disorder continue to be a significant public health crisis in the United States. In response to the crisis, interventions are being implemented at the state and federal level to reduce opioid prescribing and to increase access to treatment among individuals with opioid use disorder (OUD) (HHS 2018). Expanded utilization of medication-assisted treatment (MAT) i…
See more on aspe.hhs.gov

Discussion

  • The findings from the study show that an increase in patient capacity among buprenorphine waivered providers are associated with an increase in buprenorphine prescribing and a decrease in non-buprenorphine opioid prescriptions. This study did not identify if there is a differential effect of increasing the number of waivered providers vis-à-vis increasing individual provider cap…
See more on aspe.hhs.gov

References

  • Ali, Mir M., Robin Ghertner, Laurel Fuller, and Joel Dubenitz. (2019.) Public Listing Status of Data-Waivered Providers: Data Brief. Washington, DC: U.S. Department of Health and Human Services. Available at https://aspe.hhs.gov/basic-report/public-listing-status-data-waivered-providers-data-brief. Dick, Andrew W., Rosalie L. Pacula, Adam J. Gordon, Mark Sorbero, Rachel M. Burns, Dougl…
See more on aspe.hhs.gov

Appendix: Data, Methodology and Detailed Statistical Results

  • Data Sources and Measures
    Data on opioid prescriptions are drawn from the Prescription Behavioral Surveillance System housed at Brandeis University, which compiles data from state prescription drug monitoring programs (PDMPs). The non-OAT opioid prescription rate is measured as total opioid prescripti…
  • Study Sample
    The unit of analysis for this study is the United States county. Data were available for 2016 and 2017 in nine states from different geographic regions of the country: California, Idaho, Kentucky, Louisiana, Ohio, Texas, Virginia, Washington, and West Virginia. After accounting for missing dat…
See more on aspe.hhs.gov

1.DATA 2000 Waiver Definition | Law Insider

Url:https://www.lawinsider.com/dictionary/data-2000-waiver

36 hours ago DATA 2000 Waiver. definition. DATA 2000 Waiver means a DEA authorization for a licensed clinician who has met the training and credentialing registration requirements of DATA 2000 to …

2.Buprenorphine Pharmacist Verification - DATA Waiver …

Url:https://www.samhsa.gov/medication-assisted-treatment/pharmacist-verification/data-waiver-lookup

12 hours ago Buprenorphine Practitioner Resources and Information. Pharmacist Verification of Buprenorphine Providers. Buprenorphine Pharmacy Lookup. Become an Accredited and Certified Opioid …

3.Practitioner and Program Data | SAMHSA

Url:https://www.samhsa.gov/medication-assisted-treatment/practitioner-resources/data-program-data

1 hours ago  · This information is also used to track the number of DATA-waived practitioners by state who are eligible to treat up to 30, up to 100, or up to 275 patients at a time. Evaluation of …

4.DATA 2000 Waiver Training Payment Program FAQs

Url:https://help.hrsa.gov/display/EHBSKBFG/DATA+2000+Waiver+Training+Payment+Program+FAQs

4 hours ago What is the DATA 2000 Waiver Training Payment Program? The DATA 2000 Waiver Training Payment Program aims to improve health care, including for rural populations, by promoting …

5.How Does DATA-Waiver Provider Patient Capacity Relate …

Url:https://aspe.hhs.gov/reports/how-does-data-waiver-provider-patient-capacity-relate-opioid-buprenorphine-prescribing-issue-brief-0

20 hours ago A waiver form is a type of legal protection businesses use to reduce liability and risk. This agreement between business and customers certifies that both parties know the potential …

6.SAMHSA DATA Waiver - Buprenorphine

Url:https://buprenorphine.samhsa.gov/forms/100.php

3 hours ago Buprenorphine Waiver Notification . View Practitioner Profile; System Use Notification. You are accessing a U.S. Government information system, which includes (1) this computer, (2) this …

7.DATA 2000 Waivers - IU

Url:https://oudecho.iu.edu/resources/downloads/ECHO%20DATA%20Waiver%20slides%20update.pdf

14 hours ago DATA 2000 Waivers The Drug Addiction Treatment Act of 2000 (DATA 2000) permits physicians who meet certain qualifications to treat opioid dependency with narcotic medications approved …

8.Become a Buprenorphine Waivered Practitioner | SAMHSA

Url:https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner

9 hours ago  · The NOI buprenorphine waiver application contains all the data items necessary to complete the processing of the buprenorphine waiver application. The NOI must contain …

9.Frequently Asked Questions for Buprenorphine Waiver …

Url:https://www.samhsa.gov/medication-assisted-treatment/become-buprenorphine-waivered-practitioner/buprenorphine-waiver-faqs

14 hours ago  · The physician must meet the criteria for obtaining a waiver and contact the Buprenorphine Information Center at 1-866-BUP-CSAT (866-287-2728) or …

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