Print Page | Contact Us | Sign In | Join
AmSpa Now
Blog Home All Blogs

What You Need to Know About Parallel Importation

Posted By Administration, Wednesday, May 22, 2019

package delivery

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

In June 2018, Oregon-based physician Brenda Roberts had her medical license revoked for obtaining and using prescription medication from foreign countries. Roberts was a family practice doctor who was administering Botox treatments at her home on the side. She wasn’t necessarily doing anything inappropriate in terms of patient care, and she kept detailed records on her patients, but she was buying Botox from United Pharmacies—a “rogue pharmacy” that operates outside of U.S. Food and Drug Administration (FDA) governance—because Allergan noticed it was sending Botox to her home and cut off her account. FDA agents went through her trash and found that the Botox she used was intended for sale in Europe.

Roberts was participating in a practice called parallel importation, and while it is extremely enticing for medical spa owners looking after their bottom lines, it should be avoided at all costs, as Roberts’ case demonstrates.

A Controversial Practice

In countries such as the United Kingdom, Germany, France, Sweden and Canada, governments regulate the cost of pharmaceuticals. These measures are ostensibly designed to prevent drug manufacturers from charging excessive prices for essential medicine, but they also apply to pharmaceuticals used for elective procedures, including Botox.

In the U.S., however, FDA does not regulate drug prices, so drug manufacturers essentially can charge whatever they feel the market will bear for their products; that price is invariably much higher than what is charged in countries that have cost controls.

Because of this, it has become somewhat common for U.S.-based providers to buy drugs from licensed dealers in countries where cost controls are enforced. The prices are up to 50% lower than what the buyers would have to pay if they were purchasing the drugs directly from the manufacturer.

Both parties benefit from this arrangement. The buyers get legitimate pharmaceuticals for much less than they would pay if they bought directly from the manufacturers, and the dealers can make their money simply by marking the product up slightly. These are not counterfeit pharmaceuticals like the ones that are typically manufactured in China that have flooded the market in recent years—these are almost invariably the same drugs that are approved by the FDA and sold in the U.S.

Understanding the Rules

While parallel importation of consumer goods is broadly legal in the U.S.—the Supreme Court ruled that to be the case in a 2013 case involving textbooks—Roberts’ case demonstrates that the distribution of drugs that are not explicitly intended for use in the U.S. is absolutely illegal, and that FDA and the U.S. Drug Enforcement Agency (which also participated in the investigation) are taking cases such as this extremely seriously. There hasn’t been much enforcement yet, but this demonstrates that the issue is definitely on the agencies’ radars.

Despite the relatively low risk of being caught, ByrdAdatto and AmSpa steadfastly believe that medical aesthetics practices should not participate in parallel importation. The potential consequences definitely outweigh the cost savings. If your practice’s profitability depends on buying cheap drugs, you need to re-evaluate the way you do business. Practices should remain compliant with FDA and other regulatory agencies, regardless of whether they think a drug is overpriced. It is absolutely possible to run a medical aesthetic practice that is both very profitable and compliant with all laws and regulations.

If you need more information about parallel importation, consult with your healthcare attorney. AmSpa members can take advantage of their annual compliance consultation with ByrdAdatto. You can also learn the keys to running a medical spa practice profitably and compliantly at an AmSpa Medical Spa & Aesthetic Boot Camp.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (1)
 

What Is Required of a Medical Spa’s Good Faith Exams?

Posted By Administration, Tuesday, May 21, 2019

doctor consultation

By Sam Pondrom, JD, Associate at ByrdAdatto

There are two points that we can never reiterate enough regarding med spas: They are medical practices, and many of the services they render are considered the practice of medicine.

Accordingly, it is a crucial first step for med spas to establish the physician-patient relationship and ensure that a med spa patient is a good candidate for the procedures he or she is seeking. This is the purpose of the good faith exam. Good faith exams go by many names, and, in fact, the term “good faith examination” has been replaced in many states’ laws. It is common to hear the good faith exam referred to as the “initial exam,” “physical exam” or “initial consult.” Regardless of the nomenclature, it is important to remember that the good faith exam is an encounter that must happen before a patient receives a treatment to assess their current condition, note their medical history and ensure they are fit for the procedure. The goal of the good faith exam is to make a diagnosis and determine an appropriate treatment plan for the patient.

Here’s what you need to know about the good faith exam:

  • Who can do it? The good faith exam must be performed by a physician, physician assistant (PA) or advanced practice nurse (APN). Typically, the PA or APN must be delegated the ability to perform good faith exams by their supervising or collaborating physician. Registered nurses (RN) may aid the physician, PA or APN in administering the good faith exam, but they cannot generate orders for treatment based on the exam. A physician, PA or APN would need to review the RN’s findings and generate the treatment plan and order.
  • What constitutes a good faith exam? The good faith exam proceeds in two parts: obtaining a patient’s medical history and performing an appropriate physical examination of the patient. The medical history is a brief account of the patient’s general lifestyle, medical events and on-going treatments that may contain relevant information regarding the patient’s health. The appropriate physical examination is an assessment of the patient’s physical condition, generally and specifically, of the areas where the patient will receive treatment.
  • When does the good faith exam need to be performed? The good faith exam should be performed prior to a patient receiving a treatment for the first time, but it does not have to be performed every time you see the patient. Especially in the med spa context, a treatment plan will likely encompass multiple treatments over a period of time. If a patient seeks additional treatments not covered in the initial treatment plan, the patient’s health substantially changes or enough time has elapsed since the initial good faith exam, a new good faith exam should be performed. It is a good rule of thumb that a good faith exam should be performed at least annually on a patient.

To learn about legal and business best-practices to keep your med spa compliant and profitable, attend one of AmSpa’s Medical Spa & Aesthetic Boot Camps and be the next med spa success story.

For more medical spa legal and business tips sign up for AmSpa’s email newsletter to receive business strategies, news and med spa law directly in your inbox.

As the youngest of three brothers, Sam Pondrom learned early on how to work effectively as part of a team. After graduating from Oklahoma State, an intrinsic sense of curiosity and a keen eye for details led Sam to work as an accountant for two Engineering-News Record top 40 construction firms. It was here where he honed his ability to analyze complex issues and craft clear, concise answers. Sam utilizes these skills to work in partnership with our clients to resolve their complex business and regulatory concerns in the most simple, straightforward way.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

Forest Park Verdicts Reshape Health Care Compliance in Texas

Posted By Administration, Tuesday, May 14, 2019

gavel

By Jay Reyero, JD, Partner, ByrdAdatto

After years of anticipation, seven guilty verdicts in the Forest Park Medical Center criminal trial—in addition to the 10 pre-trial guilty pleas—have reshaped the health care landscape in Texas, and the nation is watching. While the exact fallout from the stunning conclusion will take some time to play out (appeals will be filed), there are two immediate takeaways of how health care compliance has permanently been impacted.

The federal government’s use of the Travel Act, a federal law criminalizing business activities that are illegal on the state level, was one of the most closely watched elements of the Forest Park case. While originally geared towards organized crime, prosecutors in the Forest Park case used the Travel Act in the health care context to target a physician kickback scheme where federal programs were not involved. The most interesting but unresolved issue is exactly how successful, if at all, the Travel Act can be in health care enforcement efforts in Texas. Unlike the federal government’s success in New Jersey, the verdicts in Forest Park reveal the Travel Act was not expressly relied upon by the jury to convict the physicians involved.

Nevertheless, Forest Park demonstrates that the Travel Act is a very real and controversial enforcement tool the federal government believes can be successful and is willing to use to combat fraud and abuse. Based on this new federal strategy, health care arrangements in Texas must include a risk assessment of the application of the Travel Act. We would recommend this risk assessment even when no funds from federal programs are involved. The possibility of the federal government’s involvement naturally increases risk and the specter of scrutiny. Anyone involved in a health care arrangement should take immediate steps to reevaluate the arrangement, taking into account this heightened level of risk.

The importance placed on the intent of the parties involved is another aspect of the Forest Park case that was illuminating. At the center of the case were marketing agreements developed with the assistance of qualified health care counsel, which on their face appeared to be bona fide arrangements. More importantly, the agreements were developed and appeared to be structured in compliance with applicable kickback regulations. However, throughout trial, the federal government pressed that the parties intended to induce referrals, despite what the terms of the marketing agreement indicated. The Forest Park case reinforces a critical understanding in health care compliance that form must equal substance. Even when parties attempt to structure arrangements within the requirements of applicable rules and regulations, the underlying intent must be aligned, as any deviation can give rise to significant issues regardless of the form. As evidenced by the Forest Park case and the testimony supplied by many of those involved in the scheme who had already pled guilty, the greatest risk of exposing the truth behind the intent of the parties of any arrangement is those individuals involved in the arrangement. Therefore, anyone involved in a health care arrangement should examine the circumstances beyond the document and ensure the intent and actions of all involved are consistent with compliance expectations.

The Forest Park case is a signal that a bigger and brighter spotlight is now shining on the health care industry in Texas from a fraud and abuse perspective. Gone are the days when one could be comfortable with the historical inaction of the Texas government in kickback enforcement efforts, as now the federal government has a powerful new tool that allows it to step in to enforce state laws. Even if the Travel Act is not successful on the technical merits, the Forest Park case is a clear signal the federal government can still use it to get in the door to obtain criminal indictments and potentially lead to convictions. With the use—and possible success—of the Travel Act, all health care arrangements in Texas, regardless of which payors are involved, are facing a heightened level of scrutiny. Every provider in the state should be reevaluating their arrangements from a regulatory compliance risk perspective.

Jay Reyero, JD, is a partner at the business, healthcare, and aesthetic law firm of ByrdAdatto. He has a background as both a litigator and transactional attorney, bringing a unique and balanced perspective to the firm’s clients. His health care and regulatory expertise involves the counseling and advising of physicians, physician groups, other medical service providers and non-professionals. Specific areas of expertise include federal and state health care regulations and how they impact investments, transactions and various contractual arrangements, particularly in the areas of federal and state anti-referral, anti-kickback and HIPAA compliance.

Tags:  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

How to Legally Offer Anti-Aging Treatments at Your Medical Spa

Posted By Administration, Tuesday, May 7, 2019

legalities medical

By Brad Adatto, JD, Partner, ByrdAdatto

“Alternative medicine,” “wellness treatments” and “anti-aging procedures” all have one element in common: Each has treatments and procedures that fall within the practice of medicine. Most states’ statutory definition of “the practice of medicine” includes any diagnosis, treatment or offer to treat a physical disease, disorder, deformity or injury by any system or method. Further, anytime the outermost layer of the epidermis is penetrated—whether by injection, abrasion or incision—the procedure is considered a medical treatment.

As such, treatments or therapy that include hormone replacement, stem cell and ozone administration are considered the practice of medicine. This limits who can actually perform these procedures and where these procedures can be performed. Over the years, we have had many individuals that choose to either ignore this advice or push back on this explanation, asking, “How is everyone else doing it?” As more individuals open “alternative medicine facilities,” “wellness clinics” and “anti-aging centers,” we have seen an increase in enforcement from state agencies, medical boards and law enforcement. Therefore, businesses must be extremely careful when navigating state laws regulating the practice of medicine, including anti-aging therapies. Here’s what you need to know.

  • The practice of medicine. Every state’s statutory definition of the practice of medicine includes diagnosis and treatment of a medical condition. Specifically, Texas’s definition of the practice of medicine includes diagnosing or treating any physical disease or disorder. Florida’s definition includes the diagnosis, treatment, operation or prescription for any human disease, pain, deformity or other physical or mental condition. As an example, diagnosing a person as an appropriate candidate for hormone therapy and giving orders for such treatment is the practice of medicine. Furthermore, facilities that offer ozone therapy as a medical treatment may be outside the scope of what is consistent with the standard of care for that state. At this time, the FDA has not approved of ozone therapy as a drug or device. Additionally, ozone therapy is not recognized nor approved as part of the practice of allopathic medicine by federal law or any state medical board. As such, providers offering this as a treatment must check with their state medical boards to confirm restrictions apply on “who” can provide complementary and alternative medicine.
  • Ownership. Essentially, the corporate practice of medicine doctrine prohibits non-physician-owned business entities from engaging in the practice of medicine. States adopting the doctrine are attempting to ensure a medical provider is responsible for the control and direction of a medical facility. You should develop your business and ownership model according to the laws of the state(s) in which you plan to practice. Because these laws vary from state to state, you need to know how to legally structure your business and the type of liability that may be associated with the structure you choose. For example, in New York, the state limits the ownership of businesses that provide medical treatments to licensed physicians; other non-physician health care providers are prohibited from ownership of the medical facility.
  • Staffing. Medical professional scopes of practice not only vary from state to state, but also vary depending on the training, experience and skill of a medical professional. Therefore, you need to know who can legally perform anti-aging treatments in your facility. For example, let’s assume you meet the state requirements to provide stem cell therapy, and you recommend the injection of mesenchymal stem cells into a patient’s skin to improve skin tone. This is the practice of medicine. Who has the authority to recommend the treatment—physician, NP or PA? Who can actually inject the patient—RN or MA? It is critical to understand the diagnoses, delegation and supervision regulations before performing these procedures.

Brad Adatto, JD, is a partner at ByrdAdatto, a business, healthcare, and aesthetic law firm that practices across the country. He has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions, and contract terms, including Medicare fraud and abuse, anti-trust, anti-kickback, anti-referral, and private securities laws.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends 

Share |
PermalinkComments (0)
 

EmSculpt Laws and Your Med Spa

Posted By Administration, Monday, December 10, 2018

By Michael S. Byrd, JD, Partner, ByrdAdatto

Unless you’ve been living under a rock, you may have noticed the increasing number of medical spas and aesthetic practices popping up in areas across the country. Similarly, the variety of non-invasive cosmetic procedures are continuing to attract ― and now contract ― bodies into its facilities.

Using high-intensity focused electromagnetic energy, or HIFU, Emsculpt is the newest non-invasive aesthetic procedure in the body contouring market.  It induces supramaximal muscle contractions to burn fat and strengthen abdomen and buttocks muscles in weeks instead of the months it would take to get the same or similar results in the gym, or with the alternative butt-lift.

Emsculpt, and similar non-invasive procedures, are commonly referred to as “cosmetic” procedures which may suggest that the procedures are different from other medical treatments; but as names can mean almost nothing, so do many states that broadly define what constitutes the practice of medicine and medical treatments. In other words, states couldn’t care less about the attractive name of your business ― if it operates like a medical facility, employs like a medical facility and treats physical conditions like a medical facility, then it’s a medical facility.

Emsculpt, as is the consistent case with Coolsculpting and SculpSure, will be considered the practice of medicine and constitute a medical treatment in most states.  Although the law and enforcement of the law lag behind advances in technology, the various states generally look to see what happens to the body with the treatment.  For example, Coolsculpting causes changes in the body to eliminate fat;  Microneedling stimulates collagen production.  Both of these treatments are routinely considered the practice of medicine.

If Emsculpt is indeed the practice of medicine, this can legally impact who can own a business that provides Emsculpt.  Virginia and California are two examples of states that broadly define the practice of medicine and that would characterize Emsculpt the practice of medicine; however, Virginia allows  anyone to own a business that practices medicine, while California’s ownership laws are more restrictive. These state specific nuances are just as important when determining who can and cannot perform the procedure.

Compliance is not stagnate; rather it is a moving target that changes as the laws, technology, and providers change.  For more information and state law guidance on Emsculpt or other aesthetic procedures, please contact ByrdAdatto. AmSpa members receive a complimentary 15-20 minute annual compliance consultation call.

Michael S. Byrd , JD, is a partner with the law firm of ByrdAdatto. With his background as both a litigator and transactional attorney, Michael brings a comprehensive perspective to business and health care issues. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2016) and recognized as a Best Lawyer in Dallas by D Magazine (2013, 2016).

Tags:  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

New Ohio Law Provides Affirmative Defense to HIPAA Liability in Data Breaches

Posted By Administration, Friday, November 30, 2018

By Robert J. Fisher, Attorney, ByrdAdatto

If you work in a medical spa, you are undoubtedly using the internet in more ways than one. In the age of electronic health records, online patient portals, and rapidly expanding telemedicine, there is an ever growing amount of personal and medical information available to be illegally accessed by wrongdoers with keyboards. As a result, federal and state governments and agencies have taken the “stick” approach by penalizing those who fail to protect their data, such as the $16 million payment Anthem made to the federal government in August for a breach that exposed the personal information of nearly 79 million people, and by recognizing a private cause of action for individuals to sue companies who violate HIPAA standards (see our previous article here).

In contrast, Ohio has recently taken the “carrot” approach by passing the Cybersecurity Safe Harbor Act (“Cyber Act”) that takes a new angle on the data breach issue by incentivizing companies to develop data security plans by offering legal protection rather than by fear of penalty. In the first law of its kind, the Cyber Act allows companies to use an affirmative defense against tort claims resulting from a data breach if an adequate cyber-protection program was in place at the time of the breach.

However, for a company to use the safe harbor, its cyber-protection protocol must meet the criteria set forth by the Cyber Act. Specifically, healthcare companies and practices must meet sector-specific laws and standards such as HIPAA and HITECH both in the written plan protocol, and its implementation. Additionally, the Cyber Act is not one size fits all as each security plan must be tailored in complexity and scope based on certain factors such as structure of the company, sensitivity of information, cost effectiveness of security improvements, and availability of tools.

While this law is specific to Ohio, it may be a sign of laws to come nationwide that would further encourage healthcare companies to protect themselves from suit by implementing strengthened data protection plans. Further, it indicates that HIPAA continues to be the standard on which healthcare companies need to base their compliance programs, regardless of whether HIPAA specifically applies to them. As such, we continue to recommend that all healthcare companies and medical practices protect themselves by preparing and enacting a HIPAA compliant data protection plan, or having their current plan audited for sufficiency.

For more information on best practices, laws and regulations, attend The 2019 Medical Spa Show in Las Vegas, NV.

Robert J. Fisher’s passion for healthcare traces back to his high school days of shadowing doctors. His passion evolved in college to study as a pre-med major. The last major evolution of Robert’s interest in health care was the transition to an interest in health care law. With this education, a business attorney for a father, and a renowned orthopedic surgeon for a father-in-law, Robert has the pedigree for success as a business and health care attorney at ByrdAdatto.

Tags:  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

Medical Provider Health Care Laws and Your Med Spa

Posted By Administration, Friday, October 12, 2018

By Michael S. Byrd, JD, Partner, ByrdAdatto

Is your med spa compliant with health care laws and regulations? Owners and operators of a clinical practice must navigate traditional business and employment laws similar to any other business. On top of this, clinical providers must operate in the heavily regulated and often confusing world of health care laws. The following is a list of the primary health care laws and regulations that affect providers:

  • Patient Protection & Affordable Care Act
  • Affordable Care Act Implementation
  • Out-of-network Referrals
  • Medicare-Medicaid Anti-Fraud & Abuse Amendments
  • Anti-Kickback Statute
  • Management Service Organizations
  • Anti-Referral Regulations (Stark II)
  • The False Claims Act (FCA)
  • Increased Joint Venture Activity and Market Consolidation
  • Occupational Safety and Health Administration Regulations (OSHA)
  • Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
  • Physician Payments Sunshine Act (Sunshine Act)

The essence of almost all health care law is patient protection. Because of this, many traditional business strategies are problematic or even prohibited in health care. We do not advise our clients to memorize each of these laws. At the same time, the “head in the sand” strategy to avoid health care compliance does not usually end well.  Communicating business arrangements and strategies with your counsel are key to compliance.  Most health care compliance problems stem from a lack of knowledge of the law and lack of communication with counsel regarding the activities of the clinical practice.

Compliance in healthcare requires a commitment. While ByrdAdatto can prepare a plan or structure an arrangement to navigate compliance obstacles, compliance does not end with the documentation. Rather, health care compliance starts with the documentation and continues with the day to day operation of the practice.

For more information on your state’s laws and regulations, attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

Michael S. Byrd , JD, is a partner with the law firm of ByrdAdatto. With his background as both a litigator and transactional attorney, Michael brings a comprehensive perspective to business and health care issues. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2016) and recognized as a Best Lawyer in Dallas by D Magazine (2013, 2016).

Tags:  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

When Do You Need a Medical Spa Business Attorney?

Posted By Administration, Friday, September 21, 2018

By Michael S. Byrd, Partner, ByrdAdatto

Compliance is cool, but do you have a compliance plan? Are you aware of any state laws that could affect your med spa ownership structure? A common problem among clients is the struggle with this common question: When do you need to hire a business attorney? Consistent with the adage “an ounce of prevention,” our most successful business clients follow the 5/50 rule.

The 5/50 rule is actually a choice we present to our clients when this very question is posed. The choice is whether the client would like to pay $5 now to proactively structure their business, set up compliance protocols, or address legal issues in their business. The alternative choice is to do nothing now and pay $50 to clean up the mess later. Though admittedly we should adjust the rule to realistic dollar comparisons, the 5/50 ratio is realistic. In making the choice more personal by drawing an analogy to one’s personal health, we ask our clients whether they would rather stick to an annual wellness treatment plan and pay the associated costs or go to the doctor and react to a stage 4 cancer diagnosis.

Our clients often then ask how to know whether they are properly using legal counsel to guide their business. A great litmus test is to look at budget and spending for legal counsel for the business. If a business has budgeted or spent under $12,000 in an uneventful year for legal fees, the business is not utilizing legal counsel proactively. Most on-going businesses spend between $18,000-$30,000 per year when using counsel to advise and proactively address the legal needs of the business. Smaller businesses or single-owner physician practices may spend less, but still be in the $12,000 range on the low end.

The first step to change how and when legal counsel is used is to shift thinking in budgeting and shift thinking on utilization. Good attorneys think strategically and creatively and can be a great confidante for new business ideas or issues.  Start calling your business attorney as a sounding board to work through these ideas and issues.  It does not have to be lonely at the top.

ByrdAdatto has created a platform to ease this transition. Specifically, our Access+ monthly retainer program creates a set monthly fee for a defined scope of work suitable for the typical needs of a business. The key to this program is unlimited access by phone and email to the attorneys at ByrdAdatto. The hope is that this will incentivize proactive communication with us to help keep the business on the 5 side of the 5/50 rule.

For more ways to build and run your medical spa practice legally and profitably attend an AmSpa Medical Spa & Aesthetic Boot Camp and be the next med spa success story.

Michael S. Byrd , JD, is a partner with the law firm of ByrdAdatto. With his background as both a litigator and transactional attorney, Michael brings a comprehensive perspective to business and health care issues. He has been named to Texas Rising Stars and Texas Super Lawyers, published by Thompson Reuters, for multiple years (2009-2016) and recognized as a Best Lawyer in Dallas by D Magazine (2013, 2016).

 

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 

Connecticut Allows Private Cause of Action for HIPAA Violations

Posted By Administration, Friday, September 14, 2018

Jay Reyero, JD, Partner, ByrdAdatto

As a medical facility, any med spa must be HIPAA compliant. While HIPAA does not contain a rule or regulation providing an individual a remedy for a breach nor are violations of HIPAA a specific cause of action, HIPAA is increasingly being accepted as the standard of care with respect to handling confidential patient information. 

In a recent Supreme Court decision, Connecticut joined the list of other states recognizing a private cause of action against health care providers for HIPAA violations.

In the case, a healthcare provider received a subpoena requesting production of all the medical records of one of its patient involved in a paternity suit. In response to the subpoena the healthcare provider mailed a copy of the medical records to the court. As a result, the other party of the paternity suit obtained access to the medical records and began harassing the patient. The patient sued on multiple negligence counts and breach of contract.

In its opinion, the Connecticut Supreme Court concluded that “a duty of confidentiality arises from the physician-patient relationship and that unauthorized disclosure of confidential information obtained in the course of that relationship gives rise to a cause of action sounding in tort against the health care provider, unless the disclosure is otherwise allowed by law.” To determine whether disclosure was allowed by law, the Supreme Court pointed to the requirements under HIPAA for responding to a subpoena because:

“to the extent it has become the common practice for Connecticut health care providers to follow the procedures required under HIPAA in rendering services to their patients, HIPAA and its implementing regulations may be utilized to inform the standard of care applicable to such claims arising from allegations of negligence in the disclosure of patients’ medical records pursuant to a subpoena.”

While most healthcare providers think of HIPAA as only an enforcement tool utilized by the Federal Government, this case further demonstrates the increasing use of HIPAA as the standard of care when it comes to common-law causes of action. Regardless of whether HIPAA is applicable to a particular healthcare provider, all healthcare providers need to be cognizant of its rules and regulations, as they may be held to such standards and rules. 

HIPAA isn’t the only standard that could come into play as typically there are other standards such as state law, licensing board rules, and ethical rules. Healthcare providers would be wise to reevaluate their policies and procedures and ensure they are in line with the applicable rules and standards to ensure the proper handling of confidential patient information within their organization. AmSpa members can check their state’s medical aesthetic legal summary to find the laws governing their practice.

For more information on patient privacy requirements in medical spas sign up for AmSpa’s live webinar on the topic, free to AmSpa members.

Jay Reyero, JD, is a partner at the business, healthcare, and aesthetic law firm of ByrdAdatto. He has a background as both a litigator and transactional attorney, bringing a unique and balanced perspective to the firm’s clients. His health care and regulatory expertise involves the counseling and advising of physicians, physician groups, other medical service providers and non-professionals. Specific areas of expertise include Federal and State health care regulations and how they impact investments, transactions and various contractual arrangements, particularly in the areas of Federal and State anti-referral, anti-kickback and HIPAA compliance.

 

Tags:  ByrdAdatto  Med Spa Law 

Share |
PermalinkComments (0)
 
Page 2 of 2
1  |  2
Contact Us

224 N Desplaines, Ste. 600S
 Chicago, IL 60661

Phone: 312-981-0993

Fax: 888-827-8860

Mission

AmSpa provides legal, compliance, and business resources for medical spas and medical aesthetic practices.

Follow Us: