Does Red Tape Tie Dentistry’s Hands?

As the government moves to cut red tape,we explore if dentistry is an over- or under-regulated profession.

According to the Trump administration, over-regulation is holding the economy back and reducing the supply of jobs. Cutting red tape is now a priority of the Republican-led Congress. At press time, the House Ways and Means Committee Subcommittee on Health planned to address burdensome regulations in health care, reviewing hundreds of ideas submitted to the Committee by the public. This raises an interesting question: How big an issue is over-regulation in the dental market?

Experts from the American Dental Association (ADA) and the Dental Trade Alliance (DTA) say the issue is complex. Regulation undoubtedly adds costs to running a dental practice. It raises the price of dental products and may even limit the ability of practices to fill the needs of some underserved populations. However, it also protects product suppliers, dental practices, and most importantly patients from potentially unsafe products and devices. In addition, it can create fairness in the market — for example, protecting domestic product manufacturers from having to compete with imports that do not adhere to U.S. manufacturing quality standards, or ensuring a dental office is not forced to adopt unethical management practices simply to keep up with less scrupulous competitors.

The Case for Over-regulation

In health care, dental could be considered fortunate. It is not nearly as regulated as hospitals or physician practices. However, it is still subject to a large amount of government oversight from multiple state and federal agencies. Dental practices will typically need to navigate as many as 100 to 150 different state and federal rules and regulations covering their agreements with their employees and contractors. Because they use products like amalgam that could impact the environment, they need to adhere to environmental protection rules. The devices and products they use are regulated for safety by the Food and Drug Administration (FDA). How they store and share their patient data is regulated by the Health Insurance Portability and Accountability Act. Many drugs used fall under the purview of the U.S. Department of Justice’s Drug Enforcement Agency. State licensing boards set rules for training, continuing education, and even how a practice may be managed. Regulations from the U.S. Department of Health and Human Services, as well as state-level regulations, cover care for Medicare and Medicaid beneficiaries, including when a non-participating provider, like a dentist, prescribes a product or service that is covered by Medicare.

Staying up to date with these regulations is not easy, particularly as they change from state to state and over time. In June, the ADA even launched a new member resource called Managing the Regulatory Environment on the ADA Center for Professional Success website, Success.ADA.org.

“Many practicing dentists report that knowing all of the applicable regulations and guidelines is one of the most challenging aspects of running a dental practice,” stated Terry G. O’Toole, DDS, chair of the Council on Dental Practice, in the announcement of the new resource.

Regulation is necessary, but the complexity of adhering to a large web of regulations from different oversight organizations and agencies adds cost that must either be passed on to patients or absorbed by practices. Higher prices for patients and less income for dentists create access issues, where fewer patients can afford care and fewer young people enter the dental profession.

Over-regulation can also drive consolidation. One of the reasons the dental service organization business model has rapidly grown is that it is designed to take on the work of regulatory adherence — not to mention, more efficiently through economies of scale. On the product and device manufacturer side, the cost of meeting rigorous requirements for FDA-approval is part of the reason many new products are developed and brought to market by large corporations with deep-pockets.

How Over-regulation Happens

Legislators and government policymakers introduce new rules to fix perceived problems, and often the industries that are being regulated work cooperatively with regulators on the development of rules. An example of this is the FDA Unique Device Identification (UDI) system that requires manufacturers (and distributors’ private label products) to carry a unique bar code on the package or the device itself for tracking once it enters the market.


LEXICON

510(k) clearance: When a device is being approved for sale in the U.S., it is said to have 510(k) clearance. The term comes from section 510(k) of the Food, Drug and Cosmetic Act, which mandates that device manufacturers register to notify the Food and Drug Administration of their intent to market a medical device at least 90 days in advance. This is also known as premarket notification, or PMN.

Sunshine Act: Short name for the Physician Payments Sunshine Act, a bipartisan bill that was introduced in 2007. It failed to pass initially but later became law when its provisions were incorporated into the Patient Protection and Affordable Care Act of 2010. It requires manufacturers of drugs, medical supplies and medical devices that Medicare, Medicaid and the Children’s Health Insurance Program pay for to report financial relationships with doctors/hospitals that could create a conflict of interest.


In dentistry, the DTA helps legislators who create the laws governing the dental product and device market and the policymakers charged with implementing those rules through the issuing of new regulations. By providing expert advice and formal commentaries on new proposed rules, they help ensure that the regulations will indeed address potential problems without creating unintended consequences. “DTA works closely with domestic and foreign regulators and standard-setting agencies to ensure that requirements are, first, necessary and, second, reasonably implemented to minimize impact on our members’ businesses,” says Gary Price, DTA president. “We maintain regular contact to ensure input into the processes.”

However, regulatory efforts sometimes go awry. Two common ways this happens is when regulators either try to prescribe a too specific solution to a more complex problem or apply a rule in an overly broad fashion to fields where the rule does not make sense.

It is not as simple as saying dentistry is or isn’t over-regulated, explains Joe Crowley, DDS, president-elect of the ADA. “When it comes to federal regulations, the ADA takes each on a case-by-case basis,” he explains. “There are some regulations we think are necessary for patient protection, like those dealing with oral health products or drug safety, and there are those that are an unnecessary burden to a dental practice and detract from patient care.”

The government advocacy branch of the ADA is very involved in pushing back on regulations that the association sees as problematic. Among medical specialty associations, the ADA has the fourth highest spending on lobbying, according to 2017 data from the Senate Office of Public Records. ADA officials provided examples of both regulations that are problematic because they are too specific and those that are too broadly applied.

One example of an overly specific rule is a 2016 requirement from the Health and Human Services Office of Civil Rights that requires specific posted notices of nondiscrimination and taglines in the 15 top languages spoken in a dentist’s state that alert individuals with limited English proficiency to the availability of language assistance services. The ADA supports efforts to prevent discrimination. Its member code of conduct specifically dictates “dentists shall not refuse to accept patients into their practice or deny dental service to patients because of the patient’s race, creed, color, sex or national origin.” However, creating a rule that spells out exactly how, where, and in what languages the notices must be posted sets up a “gotcha” situation where a small mistake could expose the practice to a lawsuit, ADA officials state. Some small practices, not wanting to take this risk, could conclude that it would be easier and less costly to simply not accept any patients with a government-funded health plan like Medicaid or the Children’s Health Insurance Program, better known as CHIP. In this way, a rule meant to reduce access problems due to discrimination worsens access problems for underserved, low-income populations.

An example of a rule applied too broadly is the upcoming requirement that dentists who refer patients to care covered by Medicare, such as imaging, or write prescriptions for drugs covered under Medicare Part D do one of two things: enroll as Medicare providers or opt out of Medicare.

Dentists have little financial incentive to go through all the paperwork needed to enroll as a Medicare provider because traditional Medicare does not cover dental care. (Private insurance Medicare Advantage plans sometimes include a small dental benefit.) To lump dentists in with other providers that do get paid by Medicare and require them to enroll or opt out based solely on their referrals and prescribing makes little sense, in the ADA’s view. In addition, according to the ADA’s February letter to the Centers for Medicare & Medicaid Services (CMS) asking that dentists be exempted from this rule before it goes into effect on Jan. 1, 2019, there is little, if any, evidence that dentists are behind the type of large-scale fraudulent prescribing and billing that the requirement to enroll in Medicare was meant to stop.

Regulation for Manufacturers and Suppliers

Over-regulation is also an issue for dental manufacturers and product suppliers. A good example of over-regulation for this group is the Sunshine Act, Price explains. The Physician Payments Sunshine Act (PPSA) is a provision within the Patient Protection and Affordable Care Act of 2010 that requires medical product manufacturers to report payments or other transfers of value to doctors or teaching hospitals. It was written to address the problem of Medicare-participating physicians being overly influenced by manufacturers’ gifts and payments to change their practice patterns in ways that would benefit the manufacturer. While it was not written in response to a specific problem in the dental market, it is having a big impact on dental product manufacturers all the same.

“Because of the PPSA requirement to aggregate transfers of value on an annual basis, the payments or transfers must be tracked and reported, even if they are less than $10,” Price tells Mentor, explaining that this creates a paperwork burden far larger than the problem the rule was intended to solve. “According to CMS, total expenditures for dental services in Medicare and Medicaid programs covered by this provision amount to less than 1% of total expenditures for these programs,” he continues. “Likewise, while dentists are covered under the definition of physician, only about 25% of dentists participate in CMS programs, yet expenditures need to be accounted for all dentists. As a result, the burden of collecting and reporting these expenditures for dental manufacturers far exceeds any intended benefit of transparency in relationships with providers.”

The DTA is currently lobbying Congress to increase the PPSA threshold amount for reporting from every $10 transaction to $200 and to eliminate the requirement to aggregate payments for a whole year.

How Regulation Can Help

On the flip side, the DTA and the ADA support regulation that ensures the safety of dental products and the dental product supply chain. Having a device like a dental X-ray malfunction or a drug be tampered with could harm patients and create public mistrust of dental care. In 2015, the ADA wrote to the FDA demanding that the agency “aggressively enforce” rules about who can purchase dental equipment, materials and supplies, as well as rules ensuring that dental products sold meet FDA standards.

With false and misleading health information on the internet, dentists also need all the help they can get to protect the public from misinformation. This is one area ADA officials say might be considered under-regulated in dentistry. There are no real restrictions on what types of false health claims can be made online unless a product of some kind is being directly sold.

Finally, when it comes to federal regulations, making a national rule can help clear up a confusing patchwork of state and local regulations. The ADA supports the EPA regulation for the separation and disposal of amalgam, as published in December 2016. The ADA had worked with the government for nearly a decade to have amalgam disposal rules put in place that mirrored its own recommended best practices. The EPA withdrew the amalgam rule in January when the Trump administration froze all pending federal regulations. However, the EPA rule was reinstated in July, though dental practices are not required to comply until July 14, 2020.


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HOW TO REPORT A REGULATORY CONCERN

The Food and Drug Administration (FDA) Office of Criminal Investigations maintains a website, accessdata.fda.gov/scripts/email/oc/oci/’contact.cfm, where you can anonymously report suspected criminal activity related to an FDA-regulated product. For concerns about products you think may be hazardous, but not necessarily criminal, contact your relevant state regulatory agency. The specific agency regulating a product may vary by state and product type. For example, X-rays and other products that emit radiation may have their own dedicated state-level regulatory agency. Finally, if you observe a hazard that could harm employees, report it to the Department of Labor Occupational Health and Safety Administration at: osha.gov/workers/file_complaint.html.

 


Hitting the Right Balance

The best regulations hit the sweet spot between needed oversight and freedom to let market forces play out. Regulators work on behalf of the public and are as interested as medical and trade groups in getting the balance right, even though they may not always agree. At the FDA, for example, a large concern is determining the right amount of pre-market testing and post market follow up. If the testing requirements are too stringent, it could keep dental patients from benefitting from new, innovative products and state-of-the-art technology. If the restrictions are too loose, a product that may harm patients could hit the market. For example, in 2010, the FDA had to contact makers of electric dental handpieces because some of these new handheld devices were malfunctioning and seriously burning patients during procedures.

“The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of medical devices, which we balance with our responsibility for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable, and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health,” explains Sara Anderson, the designated federal officer who sits on the FDA’s Dental Products Panel.

Anderson works with dentists, physicians and other experts on the panel to review and evaluate data on the safety and effectiveness of dental products. “FDA and the industry share the responsibility for achieving the objective of reducing the total time to decision, while maintaining standards for safety and effectiveness,” states Anderson.

As the federal government moves to review more health care regulations and loosen some requirements, the ADA, DTA and other organizations plan to be at the table sharing their concerns. However, the push for improving regulations is not the same as wanting a completely unregulated market. They and regulators want the same thing: a safe, high-quality dental industry that the public trusts.

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Featured photo by EFENZI/ISTOCK/GETTY IMAGES PLUS

From MENTOR. October 2017;8(10): 14-16.

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