AGD Policies

In 2023, AGD’s House of Delegates adopted a statement on “Artificial Intelligence in Dentistry” that had been developed by the DPC Subcommittee. “The DPC recognizes that the use of AI/AuI is trending upwards and it was important to us to have a statement that established guardrails for this technology that has the potential to shift how we provide care for our patients and how outside entities assess whether that care was appropriate,” said Callan D. White, DDS, FAGD, chair of the DPC Subcommittee on AI/AuI. “The most crucial element of AGD’s policy is the position that AI should never supersede or replace the dental practitioner in clinical decisions or in any way erode the patient/practitioner relationship.” (Read full study.)

Increasing Access to Utilization of Oral Health Care Services

The AGD believes that charitable foundations such as Pew Charitable Trusts (Pew) and the W.K. Kellogg Foundation (Kellogg) should focus their resources to fund the solutions that are identified by the AGD, including the solutions contained within the AGD White Paper Increasing Access to and Utilization of Oral Health Care Services, to improve the status of oral health in underserved and vulnerable populations.

The appropriate entity or entities of the AGD should determine the feasibility, advisability and when appropriate, the mechanism and timing, to engage charitable foundations such as Pew and Kellogg with the purpose of seeking funding for the solutions that are identified by the AGD including specific solutions that are contained within the AGD White Paper with regard to improving the status of oral health in underserved and vulnerable populations.

Access to dental care

Incentives for dentists to practice in underserved areas

The Academy of General Dentistry believes that in order to encourage dentists to practice in underserved areas, the following must occur:

a. The period over which student loans are forgiven must be extended to 10 years, without a tax liability for the amount forgiven in any year.

b. Tax credits must be provided for establishing a dental practice in said areas.

c. Scholarships must be offered to dental students in exchange for serving in said areas.

d. Federal loan guarantees must be provided for the purchase of dental equipment and materials.

e. Appropriations for funding an increase in the number of dentists serving in the National Health Service Corps must be enacted.

f. Active recruitment of applicants for dental schools from underserved areas.

Legislative agenda for providing

The Academy of General Dentistry believes that any effort to get the necessary personnel to improve access to and utilization of dental care for indigent populations will be multi-factorial and complex, and includes but is not limited to the following items (understanding that these items are not prioritized and will vary from state to state):

a.Take steps to facilitate effective compliance with government-funded dental care programs to achieve optimum oral health outcomes for indigent populations.

i. raise fees to at least the 75th percentile of fees which dentists currently charge
ii. eliminate extraneous paperwork
iii. simplify Medicaid rules
iv. mandate prompt reimbursement
v. educate Medicaid officials regarding the unique nature of dentistry
vi. provide block grants to states from the federal government for innovative programs
vii. require mandatory annual dental examinations for children entering school (analogous to immunizations) to determine their oral health status
viii. encourage education of patients in proper oral hygiene and in the importance of keeping scheduled appointments
ix. utilize case management to ensure that the patients are brought to the dental office
x. increase general dentists’ understanding of the benefits of treating the indigent

b. Establish alternative oral health care delivery service units

i. provide oral health care, education, and preventive  programs in schools
ii. arrange for transportation to and from the centers
iii. solicit volunteer participation from the private sector to staff the centers

c. Encourage private organizations such as Donated Dental Services, fraternal organizations, and religious groups to establish and provide service

d. Provide Mobile and Portable Dental Units to service the underserved and indigent of all age groups

e. Identify educational resources for dentists on how to provide care to pediatric and special needs patients and increase AGD dentist participation

f. Provide information to dentists and their staffs on cultural diversity issues which will help them reduce or eliminate barriers to clear communication and enhance understanding of treatment and treatment options

g. Pursue development of a comprehensive oral health education component for public schools’ health curriculum in addition to providing editorial and consultative services to publishers of primary and secondary school textbooks

h. Increase supply of dental assistants and dental hygienists

i. Strengthen alliances with the American Dental Education Association and other professional organizations

j. Expand the role that retired dentists can play in providing service to the indigent.

Adjusted for complying with governmental regulations

Methodology and source of funding must be disclosed if used for benefit determination

If information gathered from analyzed health care data is used for either benefit determination or dentist preferential selection, then the methodology and source of funding involved in the analysis must be publicly disclosed and verified by a process that ensures the quality, integrity, and validity of the analysis methodology.

Uses for, procedures must be publicly disclosed

The Academy of General Dentistry supports the concept that if health care data is analyzed, it should only be used to advance scientific knowledge or improve the oral health of the patient, while still allowing for professional judgments by practitioners.

The procedures involved in the analysis must be publicly disclosed and reviewed by the affected communities of interest in order to ensure the quality, integrity, and validity of the analysis methodology.

Appropriate charges made for administrative work

The AGD recognizes that it is ethical and proper for appropriate charges to be made when a dentist completes a claim form, a narrative report or other paperwork requiring secretarial, clerical, and professional time as long as the fee is identified.

Benefit coverage for dental surgery performed in office

The AGD supports the inclusion of clauses in hospitalization and surgical benefits contracts that provide for coverage for dental surgery in the office setting if such surgery would normally be covered were the patient hospitalized for the procedure.

Cash method of accounting, not accrual

The Academy of General Dentistry supports the use of the cash method of accounting, and not the accrual method, where preferred, by dentists engaged in the private practice of dentistry.

The Academy of General Dentistry communicates this position, when necessary, to legislative and regulatory entities.

Bill payer system

The AGD recognizes the 'bill payer system' (direct reimbursement) as one of the acceptable forms of dental prepayment.

Claim contested by dental consultant of

Should a patient's claim be contested by the third party's dental consultant, patient, or the patient's dentist, it shall be submitted to the local level of organized dentistry's peer review system and the third party, the patient, and the dentist should agree that the action of the peer review system is binding.

Considerations in deliberating dental health insurance programs

The Academy of General Dentistry takes into consideration the needs of the public, the various third party pre‑payment mechanisms, and the entire dental profession in deliberating on dental health benefits programs which might be of concern to the general dentists which compose its organization.

Consultant, ground rules for claims denial

When a third‑party dental consultant applies an alternative benefit provision to the treatment plan submitted by the provider dentist, or when a third‑party dental consultant denies benefits for reasons other than contract exclusions, the dental consultant must sign the report and provide his/her telephone number.

Consultant, should make no representation to patient regarding dentist's service or fee

When a patient's claim is considered for modification, and/or review, the third party dental consultant should contact the patient's dentist to discuss the matter fully rather than making any representation to the patient with respect to the dentist's services or fees.

Coordination of Benefits Guidelines

1. When a patient has coverage under two or more dental plans, the coverage from those plans should be coordinated so that the patient receives the maximum allowable benefit from each plan.  The aggregate benefit should be more than that offered by any of the plans individually, but not such that the patient receives more than the total charges for the dental services received.
2. In determining order of payment for benefits, the following rules should apply:

   a. The plan covering the patient other than as a dependent is the primary plan.

   b. When both plans cover the patient as a dependent child, the plan of the parent whose birthday occurs first in a calendar year should be considered as primary.

   c. When a determination cannot be made in accordance with the above, the plan that has covered the patient for the longer time should be considered primary.

   d. When one of the plans is a medical plan and the other is a dental plan, and a determination cannot be made in accordance with the above, the medical plan should be considered as primary.

3. In coordinating benefits with a dental plan which contractually reduces the fees for services which participating dentists accept as payment in full, the following rules should apply:

   a. When the reduced‑fee plan is primary and treatment is provided by a participating dentist, the reduced fee is that dentist's full fee.  The secondary plan should pay the lesser of its allowed benefit or the difference between the primary plan's benefit and the reduced fee.

   b. When the reduced‑fee plan is primary and treatment is provided by a non‑participating dentist, the reduced fee plan should provide its allowed amount for non‑participating dentists and the secondary plan should pay the lesser of its allowed benefit for the service or the difference between the primary plan benefits and the dentist's full fee.

   c. When a full‑fee plan is primary and a reduced‑fee plan is secondary, the full‑fee plan should provide its allowed amount for the service and the secondary plan should pay the lesser of:  its allowed benefit for the service or the difference between the primary plan benefits and the dentist's full fee.

4. In coordinating benefits between an indemnity and a capitation dental plan, the following rules should apply:

   a. When the capitation plan is primary, the capitation payments to the treating dentist remain the capitation plan's usual benefits.  The indemnity plan should pay benefits for the patient's surcharges or copayments up to the indemnity plan's allowable benefit.

   b. When the indemnity plan is primary, and treatment is received from a capitation‑participating doctor, the indemnity plan should pay its allowable benefits.  The capitation payments to the dentist are the secondary coverage since they constitute benefits up to the capitation plan's allowable amount.

   c. When the indemnity plan is primary, and treatment is received from a non‑capitation‑participating dentist, the indemnity plan should pay its allowable benefits.  The capitation plan will pay benefits, in keeping with the capitation plan's allowed amount for treatment by non‑participating dentists.

   d. No dental plan should contractually direct a dentist to charge a secondary carrier for more than the amount which would be charged to the patient absent secondary coverage.

5. Third‑party payers, representing self‑funded as well as insured plans, should be urged to adopt the above guidelines as an industry‑wide standard for coordination of benefits.
6. Constituent societies are encouraged to seek enactment of legislation that would require all policies and contracts that provide benefits for dental care to use these rules to determine coordination of benefits.

Third‑party payers, representing self‑funded as well as insured plans, should be urged to adopt these guidelines as an industry‑wide standard for coordination of benefits.

Constituent societies are encouraged to seek enactment of legislation that would require all policies and contracts that provide benefits for dental care to use these rules to determine coordination of benefits.

Co‑payment and overbilling, waiver of

The Academy of General Dentistry adopts policies regarding waiver of copayment and overbilling, which read:

Constituent dental societies be urged to pursue enactment of legislation that:

1. prohibits systematic non‑disclosure of waiver of patient co‑payment/overbilling by a dentist and
2. prohibits bad faith insurance practices by third party payers, consistent with Association policy.

Third‑party payers should be urged to support this legislative objective.

Dental Consultant

Must be a licensed dentist

The AGD recognizes that a dental consultant must be a duly licensed dentist within said state.

Dental insurance plan to include all facets of dentistry

The AGD recognizes that an optimum dental benefits plan includes all facets of dentistry.

Dentist's right to collect a larger fee from patient

The AGD is opposed to any administrative procedure by a third party payment mechanism which interferes with the dentist's right to collect from a patient a fee greater than that allowed by the carrier's benefit structure except when a dentist has agreed to become a participant in a benefits program that utilizes a usual, customary, and reasonable method of reimbursement as payment in full.

Differentials in levels of reimbursement in

The Academy of General Dentistry is opposed to differentials in levels of reimbursement in third party programs based on whether or not a practicing dentist is a 'participating' or 'non‑participating' dentist in such a program.
The AGD is unequivocally opposed to any type of separate fee schedules for reimbursement to general practitioners and specialists for the same or similar services.

Direct Reimbursement

Definition of

'Direct reimbursement' is defined as follows:

'Direct reimbursement is a self‑funded program in which the individual is reimbursed based on a percentage of dollars spent for dental care provided, and which allows beneficiaries to seek treatment from the dentist of their choice.'

Exclude ‘Least Expensive but Adequate’ Provisions

In the interest of providing the best possible level of dental care for the patient, the Academy of General Dentistry is opposed to the inclusion of 'least expensive but adequate treatment', 'alternate mode of treatment', or similar contract language, in prepayment dental plans.
Such language should be eliminated from prepayment contracts wherever possible.

This type of language in existing dental contracts should be implemented in such a manner so as not to impugn the integrity of the attending dentist or intrude upon the patient‑dentist relationship by either informing or implying that an alternate mode of treatment is appropriate, or influence the patient in any way in his choice of the attending dentist's treatment.

Fees, adjustment of

The Academy of General Dentistry recognizes that dentists may, upon occasion, adjust fees to classes of individuals, such as relatives, clergy, staff, senior citizens, and the indigent.
Any occasional fee adjustments should not be reflected in determination of UCRs by third parties. 

The Academy of General Dentistry recommends that this be properly recorded in the dentist's records.

Fee Determination

Third party payers should not determine fees for procedures not covered and/or not reimbursed in their policies.  

The appropriate AGD agencies should be directed to help AGD constituents develop legislation that will prevent third party payers from setting fees for non-covered and/or non-reimbursed procedures.

Fee schedules based on utilization reviews considered arbitrary

The Academy of General Dentistry believes that any fee schedule by third party dental benefit administrators or other entities that separates dentists into different payment levels as determined by statistically based ‘utilization reviews’ is arbitrary, discriminatory, and not consistent with appropriate patient care.

Fees; i.e., usual, reasonable, customary: definition of

The Academy of General Dentistry adopts definitions of and policies regarding 'usual, customary and reasonable fees,' which read:

'Usual fee' is the fee which an individual dentist most frequently charges for a specific dental procedure.

'Reasonable fee' is the fee charged by a dentist for a specific dental procedure which has been modified by the nature and severity of the condition being treated and by any medical or dental complications or unusual circumstances, and therefore may differ from the dentist's "usual" fee or the benefit administrator's "customary" fee.

'Customary fee' is the fee level determined by the administrator of a dental benefit plan from actual submitted fees for a specific dental procedure to establish the maximum benefit payable under a given plan for the specific procedure.

Flexible Spending

The AGD supports the expansion of Flexible Spending Account (FSA) reimbursable health items to include oral health items.

Include all phases of preventive dental services

The AGD recognizes the necessity of having all phases of preventive dental services in the dentist's office included in dental prepayment plans.

Managed care, AGD's legislative priorities regarding

The AGD’s legislative priorities with regard to dental managed care encompass the following:

Patients will have the choice to select a plan with a point-of-service option, with reasonable cost-sharing requirements in premiums and per-service costs provided that those costs are not excessive.

Patients in a plan will be allowed to select their dentist, and change that selection as the patient feels is necessary.

The plan shall provide access to an adequate mix and number of dentists, including both general dentists and specialists, to ensure access to those services covered by the plan C including patients in rural and dentally under-served areas.

The plan shall allow patients with special needs to be referred to appropriate providers including specialists.

The plan shall provide an appropriate appeals and grievance procedure that allows for timely responses to patient and/or provider complaints.

The plan shall provide a dentist, licensed to practice in that state or province where the services are provided, to be responsible for dental treatment policies, protocols, and quality assurance activities.

The plan shall define and disclose limitations on coverage of experimental treatments and provide timely written justification for denial of such treatment to patients.

The plan shall not discriminate in participation, reimbursement, or indemnification against any dentist solely on the basis of his/her license.

The plan shall not prohibit or limit a dentist or other health professional from engaging in communications regarding the patient’s health status, health care, treatment options, or utilization review requirements.

The plan shall not provide any financial incentives to dentists, other health professionals, or reviewers to deny or limit care.

The plan shall provide dentists with reasonable notice of termination and allow the dentist to appeal such a decision and take corrective action if necessary.

The plan shall assume any liability resulting from the plan’s denying or restricting treatment or referral to specialists.

Mandated Health Benefits

AGD policy on:

The Academy of General Dentistry opposes federal and state laws mandating health and related benefits because such laws may increase health care costs, reduce employers' incentives to hire full time staff members, increase a trend toward underemployment of auxiliaries, and reduce incentives for employers to provide health care benefits since such laws place solo and small group practitioners at an economic disadvantage.

The Congress and the states should explore alternatives to government mandated benefits, including favorable tax incentives that encourage employer expansion of health care and related benefits.

Mandating preferred provider organizations

The Academy of General Dentistry opposes any federal legislation for the purpose of mandating preferred provider organizations, or pre empting state laws that regulate preferred provider organizations.

Medicare, amendment to reimburse dentists for rendering same service as a physician

The AGD supports the concept of amending Medicare so that a dentist shall be reimbursed for a dental service rendered under this program if a physician would have been reimbursed for rendering the same service.

Not to interfere with dentist's diagnosis and treatment

The AGD recognizes a third party payment mechanism's responsibility to determine its liability and extent of dental benefits but is unalterably opposed to any administrative procedure that interferes with the attending dentist's diagnosis and treatment plan.

Alternative payment systems for all dental care delivery should not infringe upon the right and responsibility of the licensed practicing dentist to diagnose and treat patients according to the proper standard of care.

Overpayment recovery practices

The Academy of General Dentistry opposes third party overpayment recovery practices, except as contractually obligated, when the overpayment was the result of a mistake made by the insurer and accepted by the dentist in good faith without prior or reasonable knowledge of the error.

The Academy of General Dentistry opposes third party payers from withholding fully assigned benefits to a dentist when an incorrect payment has been made to the dentist on behalf of the subscriber with the same third party payer.

Participation should not be contingent upon participation in government regulated programs

The retention of a license to practice dentistry and participation in third party plans should not be contingent upon participation in government regulated programs.

Preferred Provider Organizations

The Academy of General Dentistry supports the following concepts relating to preferred provider organizations:

A. Patients' freedom of choice of provider must be guaranteed.

B. Preferred provider policies or contracts and preferred provider subscription contracts shall provide the same benefits level to the patient whether rendered by non preferred providers or preferred providers.

C. No dentist willing to meet the terms and conditions offered by a PPO shall be excluded.

D. All types of licensed health care providers whose services are required shall have the same opportunity to qualify for payment as a preferred provider under any such policies.

E. The terms and conditions of any PPO policies or contracts shall not discriminate against or among health care providers.

F. A preferred provider subscription contract should be defined as a contract which specifies how services are to be covered by the plan when rendered by non participating providers and by preferred providers.

G. Preferred provider policies or contracts should be defined as insurance policies or contracts which specify how services are to be covered by the plan when rendered by preferred and non preferred providers.

H. When preferred provider organizations are promoted to the public, they cannot do so with any implications of superiority, and all promotional materials used by PPOs must state if a preferred provider is a reduced fee contract.

I. The PPO shall make provision for a periodic adjustment in level of reimbursement based on the Consumer Price Index or some other equitable basis.

Prepayment plans

Prohibit fee capping of non-covered procedures

The AGD encourages and supports federal legislation to prohibit fee capping of non-covered procedures by federally sponsored dental insurance plans.

Protect dental insurance as a fringe benefit

The AGD works to ensure that legislation would not adversely affect an employer's decision to provide dental insurance.

The AGD resist efforts being made by third party dental benefits programs to prohibit payment based on the specific technique used by the dentist to render treatment for the patient.

Reduction/denial of dental benefits must be signed by licensed dentist

The Academy of General Dentistry believes that any third party reduction or denial of dental benefits on the basis of ‘not medically necessary or appropriate’ must be made on an individual basis and signed by a dentist licensed in the state or province in which the procedures are being performed.

The Academy of General Dentistry believes that any third party reduction of dental benefits on the basis of ‘least expensive alternative treatment’ be made on an individual basis and signed by a dentist licensed in the state or province in which the procedures are being performed.

The Academy of General Dentistry believes that any review of clinical records for the purpose of reducing or denying dental benefits must be made on an individual basis and signed by a dentist licensed in the state or province in which the procedures are being performed.

Regulated by law or state governmental agency
All third party payment mechanisms should be regulated by law or through the appropriate state governmental agency to ensure fiscal responsibility and protection of the interests of the public.

Resource Based Relative Value Scale

The Academy of General Dentistry opposes use of the Resource Based Relative Value Scale as a method of determining payment for services provided by dentists.

Rights of employers to provide health care benefits

The AGD agrees in principle with the traditional rights of all employers to provide health care benefits for their employees.

Structuring of dental prepayment programs

Third party mechanisms, including government programs, take differences into consideration in structuring dental prepayment programs.

Dental prepayment programs for the non indigent have a provision whereby the patient will pay the difference between the fee authorized under the program and the normal fee charged.

Table of Allowances

Acceptable reimbursement mechanism

The Academy of General Dentistry endorses the table of allowances as an acceptable reimbursement mechanism.

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Additional Reading 

"Dental to Medical Cross-Coding Tips"
"Exploring the Landscape of Leased PPO Networks"
"Measuring the Quality of Care"
"The McCarran-Ferguson Act: What a Repeal Could Mean for Dentistry"
"What to Know about the CDT Code"

Deduction of interest paid on student loans

The Academy of General Dentistry supports efforts to restore the full deduction of interest paid on student loans regardless of income.

Dental schools, support state funding for

The AGD recognizes the need for adequate funding to enable dental schools to provide a proper dental education, but at the same time, AGD encourages dental schools to seek state and/or private support in lieu of federal capitation funding.

The AGD supports the concept of using state funds to assist in maintaining and operating the physical facilities of existing dental schools.

Formal academic process leading to a degree or certificate

The AGD endorses the concept of a formal academic process of structured, sequential continued or post doctoral education, earned through universities or academically accredited teaching institutions over an extended amount of time, which lead to a degree or a certificate.

Four year curriculum, support of

The AGD expresses its concern with the dilution and shortening of dental school programs for purpose such as the receiving of federal capitation grants.

The AGD supports a minimum of a four year approved curriculum to achieve a dental degree.

Licensure

In states where laws are already in effect which mandate involvement in continuing education as a condition of dental licensure and/or dental license renewal, AGD's constituent AGD in that state's jurisdiction work with the state board of dental examiners and other appropriate dental agencies to protect the interests of AGD members in that state as mechanisms for enforcement and administration of that requirement are developed and implemented.

The Academy of General Dentistry encourages its constituent academies to work with state or provincial boards of dental examiners, state legislatures, or regulatory bodies in implementing the following provisions for mandatory continuing dental education when legislation or regulations are under consideration in their states or provinces:

1. acceptance of program providers approved by the AGD’s Program Approval for Continuing Education (PACE) Program and the ADA Continuing Dental Education Recognition Program;
2. the acceptability of self-instruction programming;
3. acceptance of the AGD member printout as one form of documentation of the requirement;
4. acceptance of courses relative to the access and delivery of dental care.

EPA Amalgam Separator Frequently Asked Questions

Brief Summary: EPA Finalizes Amalgam Separator Rule

The Environmental Protection Agency (EPA) issued its final rule on amalgam separators. The rule requires most general dentists to install an amalgam separator to prevent mercury contained in dental amalgam from entering the air, water, and land. The rule is in effect on July 14, 2017; however, compliance for the majority of dentists is July 14, 2020. New dental offices established after July 14, 2017 and using dental amalgam, must comply with the rule immediately. Exemptions apply for some dental specialties and emergency removals of amalgam. The EPA has maintained the same fact sheet that was produced in December 2016.

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AGD's Policy on Amalgam

Based on current scientific evidence, the Academy of General Dentistry maintains that amalgam is safe and effective as a dental restorative material.

Off-Label Use of Dental Products

Terminology

The term “off-label use” refers to any use of approved drugs, licensed biologics, and approved or cleared medical devices in any manner that is inconsistent with the U.S. Food and Drug Administration’s (FDA) approved labeling of the medical product. “Clinician-directed application” or “physician-directed application” are also terms that are indicative of off-label use.

Labeling means any written material that may accompany a medical product such as prescribing information, a package insert, and professional product instructions.

Off-label use means the use of a medical product for an unapproved indication, patient population, dosage, route of administration, or use outside of the product labeling.

Background- Regulatory Authority

The FDA evaluates medical products for safety and effectiveness. Additionally, the agency regulates the marketing approval, clearance, and licensing of pharmaceutical, over-the-counter, medical device, and biological products in the United States.

The FDA’s regulatory authority extends to the labeling and promotion of medical products. Promotion of the manufacturer’s product entails all written, oral, video, or other activities that contribute to the sales growth of the product. Manufacturers determine the appropriate product claims prior to submission of their application to the FDA, based on scientific data.

The FDA does not regulate the practice of dentistry or medicine. Often referred to as the “Practice of Medicine Exception,” dentists and physicians may prescribe or administer legally marketed products for an off-label indication.

Generally Accepted Practices/ Standard of Care

The practice of dentistry is regulated by state laws and regulations. Dentists should comply with all relevant federal, state, and local laws and regulations.

While the FDA recognizes the Practice of Medicine Exception, tensions remain in efforts to protect the public’s health and safety. Health care practitioners may prescribe any legally marketed product to a patient within a legitimate health care practitioner-patient relationship.^[1] Dental professionals may use medical/dental products in the manner they deem appropriate for their patients. Dentists should be aware of product safety concerns and use a sound scientific basis, along with professional judgment, for off-label indications. Adverse patient reactions can be voluntarily reported to the FDA’s MedWatch^[2] program.

Standard of care is a medical-legal term that changes over time due to experience and the accumulation of data with a medical product. In some instances, the off-label use of a product is considered standard of care.

Legal Developments

Decisions in several recent court cases have changed the landscape for findings in off-label issues. Truthful off-label promotional speech^[3], the FDA’s pursuit of misbranding provisions (for statements that were truthful and not misleading)^[4], and speech that is solely truthful and not misleading^[5] cannot be the basis for a misbranding charge for a manufacturer. Additionally, a problematic decision from the Ninth Circuit^[6] appears to confuse the use of adulterated devices caused by unsanitary practices with the use of legally marketed off-label products. Cases may be appealed to the Supreme Court or the FDA may elect to alter their policies.

First Amendment Issues

The FDA recognizes that recent First Amendment jurisprudence creates tension with agency policies intending to protect the public’s health. In 2016, the agency convened a Part 15^[7] meeting to solicit input from stakeholders. For some patients, approved or cleared products are not available or have failed. The off-label use of medical products by health care professionals provides a necessary treatment for some patients without options.

U.S. health agencies seek to promote robust research and development for medical therapies. Conducting rigorous research studies for some products is difficult, particularly for those therapies intending to treat rare disease indications. The FDA supports medical decision-making for patients in the absence of better options while maintaining a structure meant to incentivize the development of medical products, and encourage the use of labeled indications.  

The FDA produced a memorandum^[8] in January 2017 summarizing recent court challenges on speech restrictions regarding evidence of intended use, commercial free speech, content and speaker-based restrictions. The document is intended to solicit public feedback on free speech issues while maintaining government interests in protecting the public’s health.

Restricted Use of Medical Products

In 2007, a law^[9] was passed granting the FDA new authority to require Risk, Evaluation, and Mitigation Strategies (REMS) to ensure that the benefits outweigh the risks for a particular drug or biological product. A REMS designation may require additional safety procedures prior to prescribing, shipping, or dispensing the drug or biologic. Post-approval studies may also be ordered if serious risk is associated with the use of the product.

Elements of a REMS may include a medication guide or patient package insert, a communication plan, elements to assure safe use (ETASU), and an implementation system. The ETASU may require any of the following: prescribers with specific training, experience, or special certifications, pharmacies, practitioners, or health care settings that dispense the drug may need to be specially certified, a drug or biologic may be dispensed only in certain health care settings, a drug or biologic may be dispensed with evidence of laboratory test results, and patients may require monitoring or enrollment in a registry. As such, a drug or biologic with a REMS may be limited to the labeled indications of the product, constraining the practice of medicine or dentistry.

Humanitarian use devices are also restricted for use and are authorized in limited populations, for example, with patients with rare diseases. These types of devices require prior institutional review board (IRB) authorization and must be used according to the FDA approved indication.

FDA Guidance

In 2017, the FDA released two guidance documents^{[10], [11]}meant to clarify the agency’s current thinking on communications about medical and dental product labeling. The guidance documents are non-binding and do not carry the force of law. Alternative approaches may be used if the requirements satisfy applicable statutes and regulations.  

Enforcement Trends

Health care practitioners are not immune from prosecution if they engage in off-label sales and marketing activities on behalf or in conjunction with manufacturers of medical products. It should be noted that off-label promotion is strictly scrutinized by federal authorities. 

Traditionally, rather than risk potential criminal or civil enforcement actions as a result of an unfavorable verdict at trial, manufacturers have settled high profile suits alleging off-label promotion.  Manufacturers of medical products are reticent to risk exclusion of participation in federal health programs administrated by the Department of Health and Human Services (DHHS). With recent legal verdicts favorable to manufacturers, they may be unwilling to settle future disputes with federal authorities as readily.

Dental Product Example

Silver diamine fluoride is one example of a dental product that is used off-label. While silver diamine fluoride is FDA-cleared as a Class II medical device to reduce sensitivity in teeth, it is often used to delay tooth decay.

Policy Statement

The Academy of General Dentistry believes that dentists may prescribe or administer legally marketed medical and dental products for an off-label use within the Practice of Medicine Exception. Health care practitioners may prescribe legally marketed medical and dental products in an off-label manner if they believe that such an application is in the best interest of their patient. The practice of dentistry is regulated by state laws and regulations. Dentists should comply with all relevant federal, state, and local laws and regulations. Dentists should be aware of product safety concerns and use a sound scientific basis, along with professional judgment, for off-label indications. Adverse patient reactions can be voluntarily reported to the FDA’s MedWatch program.

The Academy of General Dentistry (AGD) supports educating the dental profession and the public as to the value of dental screenings and HPV vaccination to help prevent oral cancer.

Resources 

HPV and Oral Cancer

AGD Policy on Dental Benefits for the Medicare Population

The AGD’s policy on dental benefits for the Medicare population is as follows:

The Medicare program was established to provide medical benefits to the elderly U.S. population. Signed into law in 1965, the Medicare program has been amended numerous times since its inception. Some public health advocates and consumer groups seek to have dental benefits added into the Medicare Part B program. The Academy of General Dentistry (AGD) does not support this approach, as its research indicates this is not a viable solution. Rather, the AGD supports market-based private insurance solutions for dental benefits intended for the Medicare population.

The AGD’s positions on dental benefits for the Medicare population are:

1. General dentists are committed to delivering quality dental care to patients of all ages and to advocating for optimal oral health. 
2. The AGD believes that the Medicare Part B program cannot sustain the inclusion of dental benefits. 
3. The AGD supports enhanced benefits and reimbursement in private sector initiatives for dental benefits. 
4. The AGD believes that it is the responsibility of every person to exercise good oral health habits that will provide them with a foundation for optimal oral and systemic health throughout their lifetime, and that resources directed toward increasing oral health literacy will support this effort.

AGD Background on Dental Benefits for the Medicare Population

Benefits for military personnel and their dependents

The AGD supports the concept of enhancing the benefits offered to individuals serving in the military by providing dental services for their dependents.

That these dental services shall be provided by the private sector where possible.

The AGD works to have provisions under which these services are to be provided conform to AGD policy.

Salary reimbursement for military dentists

AGD recognizes that factors such as the following items should be taken into consideration in the salary reimbursement for federal service dentists:

• the amount of education acquired by the dentist
• the proficiency of the dentist
• the level of experience of the dentist and the individual's ability to handle the more complex dental procedures in a competent manner
• status, rank, or duties within the group
• tenure
• the cost of living in one geographical area as opposed to another.

The salaries for physicians and dentists in the Federal Services should be determined by the following factors:

1. The scope of responsibility which may be determined by rank, title, etc.
2. The degree of education which may include specialty training, general practice residencies, advanced educational programs in general dentistry, passage of a certifying board, etc.
3. A relationship with the remuneration generally earned by that profession within the practicing civilian sector.
4. Length of service.

Military dentists, special pay and incentives for

The Academy of General Dentistry requests immediate action to stem the exodus of current military dental officers and assure a continuing supply of quality accessions.

The AGD favors increasing additional special pay, establishing incentive pay for dentists, and increasing Health Professions Scholarship Program (HPSP) scholarship funding.

Nutrition
Sugar & Health Consequences

In 2016, the American Heart Association published a scientific statement on the “Added Sugars and Cardiovascular Disease Risk in Children.”^[1] Evidence supports the correlation that the consumption of added sugars leads to a myriad of human health problems.

The term “sugar” refers to any number of carbohydrates with the general chemical formula of C_n (H₂O)_n.  Sugars are categorized into monosaccharides (simple sugars) and disaccharides (a sugar formed by two monosaccharides or simple sugars). Scientific research indicates a preference for a sweet taste is evident in infants and childhood.^[2] Furthermore, sugar functions as a pain reliever in children^[3] and elicits an endogenous opioid release^_.[4] Carbohydrates provide a ready source of energy for children and assist in their growth. From an evolutionary standpoint, there is a rationale for humans’, particularly children’s, affinity for sweet tasting substances. Notwithstanding, many communities world-wide find that the consumption of sugar has evolved into the over-consumption of sugar.

Knowledge and data acquired about the health consequences from sugar consumption continue to accumulate. The over ingestion of sugar has adverse effects on local and systemic anatomical structures in the human body.

The Academy of General Dentistry (AGD) has a vested interest in the health and well-being of children and adults. Sugar consumption is the most important contributing factor of caries,^{[5],[6], [7]} which is the most prevalent of worldwide diseases.^{[8], [9], [10]}

Physiological Issues Resulting from Sugar Consumption

Caries

Sugars in beverages and foods including breads and other carbohydrates act with bacteria in the mouth to form acid reactions. Over time, a lowered pH in the mouth creates an environment where bacteria infiltrate the enamel of the tooth and can cause decay. If left untreated, tooth decay, also known as cavities or caries, can lead to grave consequences including death. 

Obesity

The inability to feel full contributes to excess eating and calories. High levels of fructose and other sugars in blood obscure leptin levels in the brain so that satiation is not achieved and consumption continues beyond normal. The most common causes of obesity are overeating and physical inactivity.

Consumption of too many sugary foods and beverages contribute to excess calories and may lead to an increase in weight. Furthermore, studies have confirmed a relationship between childhood and adult obesity^[11] and dental caries.^[12] Obesity is associated with heart disease, stroke, high blood pressure, diabetes, osteoarthritis, gout, select cancers, and sleep apnea.^[13]

Diabetes

A diet high in sugar can increase the likelihood of a diabetes diagnosis. Type 2 diabetes is linked to high levels of sugar in the blood; however, consuming sugar is only one risk factor in acquiring diabetes. Adding one serving of a sweetened beverage to a diet per day increases the risk of diabetes by 15 percent.^[14]

Increased Cholesterol

A high sugar diet is linked to unhealthy cholesterol and triglyceride levels. In one study, the cohort that ate the most sugar were more than three times likely to have low high density lipoprotein levels.^[15]

Heart Disease

A diet high in sugar may increase the risk of dying from heart disease^[16] absent an indication of being overweight. High insulin levels cause abnormal cell growth around artery walls resulting in blood vessel restriction, high blood pressure, heart attack, or stroke.

Beverages and Food

Beverages

Sugar sweetened beverages (SSB), or drinks with added sugars, are associated with weight gain, obesity, heart disease, type 2 diabetes, and tooth decay.^[17] High fructose corn syrup (HFCS) is one type of sugar in SSBs and consists of both glucose and fructose. It allows for rapid absorption in the blood steam, which leads to increased metabolic disturbances. Moreover, HFCS triggers an immune reaction leading to inflammation. HFCS consumption is associated with adult chronic bronchitis^[18], childhood asthma^[19], and other diseases. Public health officials recommend limiting the intake of SSBs, particularly for children. Limitations should be extended to the consumption of 100% fruit juice, as well.

Foods

While much public health focus is relegated to SSB consumption, the intake of sugary foods is equally problematic. Starchy foods in bread, beans, fruit, potatoes, and many others, act with bacteria in the mouth to form acids that can eat away at teeth enamel and lead to caries.^{[20], [21]} Consumption of sugary foods should not be substituted for adherence to sugar-free beverage ingestion. A diet of nutrient rich foods is recommended with minimal intake of added sugars.

Alternate sweeteners

Consumers seeking to replace sugar in food and beverages may pursue sugar substitutes. Alternative sweetener options include sugar alcohols and high-intensity sweeteners.

Sugar alcohols, not considered high intensity sweeteners, include sorbitol, xylitol, mannitol, and others, do not promote tooth decay or cause a precipitous increase in blood glucose. Primarily, this class of sweeteners are added to chewing gum, sugar-free candies, and other foods. Sugar alcohols are between 25%-100% as sweet as sugar.^{[22], [23]}

High-intensity sweeteners are many times sweeter than sucrose (table sugar); therefore a smaller amount is needed to achieve the same level of sweetness as sugar. Stevia, monk fruit, saccharine, aspartame, and sucralose are some of the high-intensity sweeteners permitted for use in food and beverages by the U.S. Food and Drug Administration.

Water

An uncontaminated ready source of water must be available to all residents of cities and municipalities. Lead and copper contaminants must be kept out of the water supply and are particularly harmful to fetuses, infants, and young children due to their inherent physiology and size. When used appropriately, fluoride is safe and effective in preventing and controlling dental caries.  Regular use throughout life may help protect teeth against decay. 

Taxes

Public health advocates are nearly unanimous in support of the adoption of taxes on SSB. ^{[24],[25],[26], [27]} Taxes are proposed to effect changes in policies at local, state, and national levels. Further, taxes are advocated to decrease consumption of sugar sweetened beverages and to fund public health education efforts aimed at a change to healthy nutritional behaviors and choices.

Free market advocates contend that citizens in the U.S. are taxed sufficiently already. SSB taxes may disproportionally affect the poor and tax exemptions apply differently in each locale. For instance, the proposed Cook County, Illinois tax exempts individuals using federal food assistance programs such as the supplemental nutrition assistance program (SNAP).

Lawmakers and citizens should consider what is being attempted by imposing taxes on SSB. Potential reasons cited to adopt a SSB tax are to raise revenue, to change beverage consumption from unhealthy beverages to healthy beverages, decrease incidence of disease, to fund pre-kindergarten, or other rationales. Public policy should be well thought out and aim to address solutions that benefit citizens. Moreover, policy makers should discuss the effects of federal subsidies that have artificially inflated the price of sugars over the last 80 years.

Role of media in promoting poor nutrition

Marketing to children is one factor in the childhood obesity epidemic.^[28] Several national and international organizations have advocated for restrictions on marketing to children due to concerns about food and beverages and resulting adverse health consequences.^[29] Prior television exposure predicts unhealthy food preferences and diet, as well as parenting factors^.[30] Parents may want to set limits on childhood exposure to media in order to establish healthy eating habits for children.

School/Educational Issues

Food and beverage choices available to children should be of high nutritional value. Contractual arrangements, such as beverage pouring rights, that influence increased access to soft drinks for children should be kept out of schools. Parental and caretaker education is needed on what and how to feed children to optimize health and development.

Science evolves over time as more data is known. Health professionals are discovering that food and beverage nutritional content is necessary in order to make informed choices. Federal regulations have assisted in efforts of transparency on ingredient labels.

Education

As society considers the importance of the role of proper nutrition in human health, it is appropriate to consider educational improvement for health care professionals. Dentists and physicians receive limited education on nutrition during their training, and yet, proper nutrition is an essential component to prevent many diseases. Cultural differences also affect food choices therefore, cultural competency is needed to ensure that health professionals dispense the most appropriate advice to parents and children.

Screening for Obesity

Screening for obesity is unlike screening for other systemic diseases and can be accomplished easily by calculating a body mass index (BMI). While a BMI measurement has limitations, it provides an assessment of a standardized height/weight metric.  If the patient’s BMI measurement is in the overweight or obese categories, dentists may choose to seek a referral to an appropriate health professional to assist in providing relevant nutritional information and advice.

Academy of General Dentistry Policy Statements and Recommendations

1. Prevalence of and Connection between Sugar Consumption and Caries: The Academy of General Dentistry (AGD) has a vested interest in the health and well-being of children and adults. Sugar consumption is the most important contributing factor of caries, which is the most prevalent of worldwide diseases.

    

2. Levels of Sugar Consumption: AGD supports recommendations of sugar consumption for children not to exceed 6 teaspoons per day. However, consumption of less than 3 teaspoons of sugar per day is more optimal. Consumption of sugary foods should not be substituted for adherence to sugar-free beverage ingestion.

    

3. Diabetes Identification and Management: General dentists, as primary health care professionals, have an important role in the identification and management of diabetes. General dentists should be provided the ability, training, and resources to screen for diabetes, and to collaborate with the patient’s primary care physicians, as deemed appropriate, to identify and manage diabetes.

    

4. Screening for Obesity: General dentists, as primary health care professionals, have an important role in the prevention of childhood obesity. General dentists should be provided the ability, training, and resources to screen children for obesity using a BMI score and to refer children to pediatric primary care physicians or qualified nutritionists, where deemed appropriate by the dentist. While not a perfect measurement, BMI scores can be helpful in establishing a general assessment of a child’s propensity toward obesity.

    

5. Taxation and Subsidies: Lawmakers and citizens should consider all the objectives of taxation when considering imposing taxes on SSB. Potential reasons to adopt an SSB tax may include, but not necessarily be limited to, to raise revenue, change beverage consumption from unhealthy beverages to healthy beverages, decrease incidence of disease, or fund pre-kindergarten. Public policy should be well thought out and aim to address solutions that benefit the health of the U.S. population. Moreover, policy makers should discuss the effects of federal subsidies that have artificially inflated the price of sugars since the 1930s.

    

6. Nutrition Education and Training: Public health professionals should design a campaign for parents and caretakers to target what and how to feed children to optimize health and development. Given that proper nutrition is an essential component to prevent many diseases, resources should be directed to providing dentists and physicians with additional education and/or training on nutrition.

Download the full policy statement.

 

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Additional Reading 

"What You Can Learn from Flint and Other Water Crises"

Child’s first visit to dentist

The Academy of General Dentistry officially endorses the position that a child’s first visit to the dentist should occur within six months of the eruption of the first tooth.

School issues

School curricula – oral health education

The Academy of General Dentistry advocates incorporation of oral health education into primary and secondary school curricula with measurable outcomes, as a proven and cost effective disease prevention and universal health promotion program.

Soft drink consumption/pouring rights contracts

The Academy of General Dentistry, through its appropriate agencies, continue to review the supporting data concerning the oral health effects of the increasing consumption of beverages containing sugars, carbonation or acidic components.  These products are commonly referred to as “soft drinks,” including but not limited to juice drinks, sports drinks and soda pop.

The Academy of General Dentistry encourages its constituents to work with education officials, pediatric and family practice physicians, dietetic professionals, parent groups, and other interested parties, to increase the awareness of the importance of maintaining healthy vending choices in schools, and to encourage the promotion of fluoridated water and beverages of high nutritional value.

The Academy of General Dentistry opposes contractual arrangements, including pouring rights contracts that influence the consumption patterns that promote increased access to ‘soft drinks’ for children.

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Additional Reading 

"Getting Real About Tobacco"
"Six Steps to Advance Oral Health Literacy"
"The Rise of HPV-Related Oral Cancer" 

Botox and other facial injectables

The AGD supports general dentists receiving education on, and the performance of botulinum toxin and cosmetic dermal filler procedures.

The Academy of General Dentistry encourages its constituents to lobby their state/provincial dental licensing authorities to expand the scope of practice for general dentists to include the administration of facial injectables for therapeutic and cosmetic purposes.

Corporate Guidelines and Mandates

The AGD is opposed, as unduly burdensome to general dentistry and the patients it serves, to all corporate mandates that require specified quantities of utilization of the corporation’s products in patient’s dental treatment, without any qualitative assessment of each dentist’s proficiency with the products and without substantial clinical evidence of patient harm as a result of utilization in less than the specified quantities, as prerequisites for continued access to the use of the corporation’s product.

Dental Sealant

Dental sealants shall be placed only following proper diagnosis by a licensed dentist, with periodic evaluation by a licensed dentist.

Environmental “best management” practices

The AGD urges dentists to support environmental “best management” practices, and that the AGD constituents be encouraged to work with their counterpart dental societies to promote environmental best management practices. Read "AGD Successfully Advocates for Changes to EPA’s Proposed Amalgam Rule."

Vaccinations

The AGD supports the administration of influenza vaccinations and other vaccinations by general dentists who have attained the training and education to do so.

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Additional Reading 

"9 Questions You Should Ask Before Buying a Practice"
"Controlling Overhead to Increase New Income"
"How to Reduce Fraud Risk In Your Dental Practice"
"Informed Consent & Other Lessons Learned at Trial" 
"Planning for a Financially Secure Future"
"Preparing Your Team to Treat Sleep Apnea Patients" 
"Protecting Patient Privacy on Social Media"
"The Data Bank Evolution"
" The Impact of Drug Shortages in Dentistry"

Amalgam

Based on current scientific evidence, the Academy of General Dentistry maintains that amalgam is safe and effective as a dental restorative material.

Dental products, materials, and medications

The AGD takes appropriate action when necessary to ensure that safe and effective dental materials, products, and/or medications remain approved for use in oral health care.

Bisphenol (BPA)

There is no conclusive evidence that currently exists relative to health risks of Bisphenol-A (BPA) exposure from dental materials.  AGD fully supports the continued research of BPA safety as it relates to dentistry.

Indigent population, AGD as a voice

The AGD continues to be an advocate for the oral health of the general population, including but not limited to the underserved.

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Additional Reading 

"Addressing Polypharmacy with Medically Complex Patients"
"Taking Care: How Dentists Should Prepare for Treating Aging Patients" 

Guidelines for dealing with state legislation

The Academy of General Dentistry uses the following guidelines in dealing with members requesting AGD action on legislation being proposed in their state or when lobbying on an issue is deemed appropriate by the AGD:

1. Members have the right to know existing policies.
2. The AGD shall make a reasonable effort to work with the constituent prior to undertaking any legislative activity.
3. The AGD may intervene in the legislative affairs of a state or province with the oversight of the Executive Committee and the LGA Council.
4. Members requesting support from the AGD for a legislative position may be asked to work through their constituent.
5. Constituent secretaries/executive directors and Trustees will be provided with copies of AGD correspondence with their members regarding concerns about legislative issues being considered.

Dental Auxiliaries

Training, education, and utilization of

In the training, education and utilization of dental auxiliaries for the purpose of assisting the dentist in providing high quality dental care through performance of expanded functions, it shall be the recommendation of the Academy of General Dentistry that such auxiliaries be permitted to perform under the direct supervision of the dentist those functions which do not require the professional skill and judgment of the dentist and are in compliance with laws of states which have provisions for expanded functions.

Dentists, and only the dentist, is responsible for the examination, making the diagnosis and formulating the plan of treatment, performing surgical or cutting procedures on hard or soft tissue, fitting and adjusting corrective and prosthodontic appliances, prescribing therapeutic agents and making impressions for other than study casts.

Final decisions related to dental practice and utilization of dental auxiliaries rest with the state board of dentistry.

The AGD recognizes the necessity of effectively utilizing dental auxiliaries to maximize the efficient use of the dentist's time and skills.

Dental hygienists, authority of State Boards of Dental Examiners

Because of the nature of dentistry and the manner in which it is delivered to the public, it is the policy of the Academy of General Dentistry that dental hygiene should remain under the authority of the various state boards of dental examiners and that dental hygiene education should remain under the purview of and be accredited by the Commission on Dental Accreditation.

Expanded Function Dental Assistant (EFDA)

It is the position of the AGD that the utilization of expanded function dental assistants (EFDA), under the direct supervision of the dentist, providing only reversible procedures is an effective, safe and efficient way to increase capacity and access to care while reducing barriers to utilization of care.

Mid-Level Providers

The AGD does not believe that an alternative oral health provider model like the a midlevel provider model is a viable workforce alternative because it is not an economically sustainable solution to treatment delivery and it also creates a two-tier delivery system in which a provider with much less training and education than a dentist treats populations of patients that have far more critical medical and health issues. The AGD has grave concerns that the clinical and didactic education and training of a midlevel provider falls extremely short of the education and training that is required to treat those patients that the proponents of this alternative provider model claim the midlevel provider will treat.  

Further, the AGD has published its “White Paper on Increasing Access to and Utilization of Oral Health Care Services” (2008) as well as “Barriers and Solutions to Accessing Care” (2012), which propose various proven solutions to oral health disparities. The AGD believes there are two key components of improving oral health care in America: including fluoridated water, adequate funding and oral health literacy. The AGD hopes all who have concerns with oral health disparities would agree that these two viable options are key to solving the oral health disparities in America.

Workforce, adequacy of present dental workforce           

The Academy of General Dentistry adopts the following statement relative to the adequacy of the dentist workforce:

The dentist workforce in the United States is sufficient to meet the needs of the public demand for dental services. Geographic imbalances exist in localized areas due to a variety of factors.  Where these imbalances result in shortages, the affected regions must be examined and addressed individually for appropriate solutions. The development of a responsive, competent, diverse, and “elastic” workforce should address potential increases in demand for dental services.

Read AGD's Workforce Whitepapers 

Read AGD's Workforce Policy Statement