/*Accordion Page Settings*/

legal

86 - Embryo Disposition: Implications and How to Protect Your Clinic, an interview with Igor Brusil

The disposing of embryos has long been a controversial topic in the world of IVF. Clinics can’t afford to keep embryos around when patients have stopped paying their bills. But the ethical and legal implications keep embryo disposition from being a simple decision. Plus, patients aren’t really properly educated on what the limitations of cryopreservation are and clinics aren’t always fully prepared with proper consents and contracts when the time comes to freeze embryos.

On this episode of Inside Reproductive Health, Griffin spoke to Igor Brusil, attorney-at-law and per diem embryologist and legal counsel for the American College of Embryology in Houston, Texas. After working as an embryologist, Igor became interested in the ethical and legal implications of lab procedures, specifically embryo disposition. This led him to pursuing a legal degree and working as counsel for a variety of clients, but his focus remained in healthcare law, risk management, and professional liability.

He brought his unique experience to the show, sharing his thoughts on what clinics can do to protect themselves when it comes to the issue of embryo disposition.

64 - Consents in the Age of COVID-19: Using Digital Solutions to Protect Your Patients and You

“...this is an unprecedented time for everybody. We all have our expertise in different areas and our experience in different areas and now's the time to be talking about our approaches, what we're doing, sharing our ideas, and really, really working together to try to get through this and to put practices and patients in the best positions possible.”

It is business as unusual right now. Patients everywhere have been told that treatments have been put on hold and have been left in limbo. Thankfully, there has been a surge in interest in using digital technology to keep some semblance of normal for patients seeking treatment. Thanks to applications such as Zoom, clinics are able to conduct consults or relay testing results. And thanks to new innovations making consents available online, clinics are able to get patients ready for treatment, while remaining in good legal-standing.

On this special episode of Inside Reproductive Health, Griffin talks to Jeff Issner and Taylor Stein of EngagedMD, a company that has developed an application that not only provides digital consent forms, but also goes the extra mile in patient education. Dr. Steven Katz of REI Protect joins in the discussion, offering his perspective on risk mitigation and ensuring your practice reduces liability in any way it can during these unprecedented times.

This episode was recorded during a live webinar. In the coming weeks, we will continue to provide webinars with updated information on relevant topics. Learn more about our upcoming webinars at FertilityBridge.com.

Please note that all information included in this podcast is not legal advice and is simply to provide fertility clinics with information on the use of digital consents. Before using any advice in this podcast episode, please consult with your legal team.

Find Jeff Issner and Tayor Stein at Engaged MD by visiting Engaged-MD.com.Learn about Dr. Katz and his services at REI Protect at REIProtect.com.

Need help navigating marketing through this unprecedented time? Check out our COVID-19 Toolkit from Fertility Bridge.

63 - Is it Time to Reduce Your Staff? Managing Furloughs, Layoffs, and Financial Support during the COVID-19 Pandemic

Determining when, how, and why you should consider staff reductions can be challenging. During the COVID-19 pandemic, making these decisions can be even harder.

On this special episode of Inside Reproductive Health, I spoke with Sara Mooney, Director of Administration at Seattle Reproductive Medicine and Marianne Kreiner, Chief Human Resources Officer at Shady Grove Fertility. Together, we lay out some details of the CARES Act, the Paycheck Protection Program, and answer questions from fertility leaders in clinics across the country.

We are all in this together. If you need help navigating your business through this pandemic and want to know how to prepare your clinic when it is over, sign up for our Communications and Marketing Toolkit.

To get started on a marketing plan for your company, complete the Goal and Competitive Diagnostic at FertilityBridge.com.

62 - Navigating Telemedicine During the COVID-19 Pandemic, an Interview with Jill Gordon and Sarah Swank

The outbreak of COVID-19 is changing the world, in both the present and in the future. In these uncertain times, hospitals and other healthcare facilities are looking to implement new technologies to continue to provide services, while limiting their face-to-face interaction. But implementing HIPAA-approved telehealth applications in a short amount of time can prove to be a challenge. Thankfully, the federal government is lifting rules and reevaluating their regulations to allow healthcare companies to use other tools to reach their patients in these difficult times. On this episode of Inside Reproductive Health, Griffin talks to Jill Gordon and Sarah Swank, lawyers in the healthcare division of Nixon Peabody. They navigate the changes to HIPAA regulations in the midst of the COVID-19 crisis and how clinics can appropriately implement telehealth to help their patients through their journeys without seeing them in office.

48 - David Wolf, Do Regulatory Restrictions Hinder or Help Innovation in the Fertility Field?

“...I think fighting consolidation is not going to be a winning strategy in the long run. That being said, I think there's still lots of room for creative, innovative, entrepreneurial operators whether they’re at the clinic level or the supplier level and... as the field gets bigger and gets more interesting from a public capital markets perspective, there's going to be a lot more opportunity for funding those exciting innovations.”

Consolidation, IPO, publicly-owned...all words that weren’t a part of the fertility world vocabulary 10 years ago. Now, they are becoming more and more common, which can be both exciting and nerve-wracking to entrepreneurs in the field. On this episode of Inside Reproductive Health, Griffin Jones, founder of Fertility Bridge, talks to David Wolf, President and CEO of Hamilton Thorne. They discuss the implications of consolidation coming into the fertility world as well as the pros and cons of both publicly- and privately-owned clinics and suppliers.

Click here to learn more about David Wolf and Hamilton Thorne.

To get started on a marketing plan for your company, complete the Goal and Competitive Diagnostic at FertilityBridge.com.

47 - Geographical Differences in 3rd Party Reproduction, An Interview with Liz Ellwood

With the introduction of the Assisted Human Reproduction Act in Canada, Canadian clinics and families have been struggling to find quality third-party reproduction partners while remaining in accordance with the law. After going through her own journey and learning the challenges of the process, Liz Ellwood decided to make a difference in the lives of hundreds of Canadian families struggling with infertility by co-founding Fertility Match, an agency that matches families with donors. On this episode of Inside Reproductive Health, Griffin talks to Liz about her story and what she is doing to make the third-party reproductive process easier on families in Canada.

To learn more about Liz Ellwood, Fertile Future, and how you can help, visit www.fertilefuture.ca.

Want to learn more about Fertility Match? Visit them at www.fertilitymatch.ca.

The details of the Canadian Assisted Human Reproduction Act can be found at https://laws-lois.justice.gc.ca/eng/act/a-13.4/

To get started on a marketing plan for your company, complete the Goal and Competitive Diagnostic at FertilityBridge.com.

39 - Can Geographic Location Have An Impact on Fertility Success? An Interview with Dr. Alex Quaas

But think of the differences across the world--it’s hard to fathom! On this episode of Inside Reproductive Health, Griffin Jones and Dr. Alex Quaas give us a glimpse into (literally) the world of fertility. Having practiced in numerous states and countries, Dr. Quaas shares his experiences, diving into the biggest differences in care he witnessed in Europe and here in the USA.

34 - How At Risk Are You as a Physician? Mitigating Liability In Your Practice: An Interview with Dr. Steven Katz

A malpractice case can be the end of an REI practice, and with IVF errors often making it into the news, the pressure to be perfect is high. Thankfully, technology aimed to reduce errors has grown. On this episode, Griffin talks to Dr. Stephen Katz, CEO and Founder of REI Protect, a company formed to provide risk management services and coverage for REI practices across the country. They discuss what can go wrong in an office or IVF lab, and, more importantly, how to protect your practice from errors.

30 - Unpacking Diverse Family Building Paths: An Interview with Dr. Mark Leondires

The world of fertility has grown and changed as the needs of families has changed. And now more than ever before, there are different populations seeking fertility care. In this episode, Griffin talks to Dr. Mark Leondires, a board-certified REI and the founder of Gay Parents-to-Be, about the various paths of family-building and how fertility clinics can provide personalized care to those with differing goals and needs. 

23 - Reducing Third-Party Legal Risk in an Era of Limited Anonymity. An Interview with Melissa Brissman

In this episode, host Griffin Jones speaks to Melissa Brissman, an experienced attorney specializing in reproductive law. In addition to practicing law with a focus on reproduction for the last 21 years, Brissman also acted as her own attorney as she had twin sons and a daughter via gestational carrier. An advisor to a variety of organizations and an experienced keynote speaker, Brissman was the 2017 Advocacy Award recipient from Path to Parenthood. Today, Jones and Brissman discuss the differences between a contract and consent, the changes coming to fruition thanks to recent laws, and more.

How Much Does IVF Really Cost? Why No One Will Tell You The Plain, Ugly Truth

By Griffin Jones

How do people feel about the financial charges associated with IVF? I don't know, you tell me.

  • "Incompetent or possibly fraudulent insurance practices"

  • "Almost a year later I am still unable to officially take care of my billing issues"

  • "They have no problem with asking me for money but pointing out there was a descrepancy [sic] in billing no one would answer"

All of these comments come from real fertility clinic reviews. Is this frustration familiar to you? Financial stress is one of the biggest pain points in dealing with infertility and it sometimes negatively influences your relationship with your fertility clinic. As if infertility didn't already give you enough to deal with, its best medical solution is one of the most expensive endeavors you'll ever face. Some people talk about the cost of IVF in terms of financial infertility, because it is the most common obstacle that prevents couples and individuals from seeking treatment. We frequently see GoFundMe and other crowdfunding campaigns to raise money for IVF. In most U.S. states and Canadian provinces, the expense of IVF is paid out of pocket. Even in the United Kingdom, where the National Health System (NHS) covers most health expenses, there are still many people in the U.K. who don't qualify for the terms of coverage and they too have to pay from their own accounts.

Organizations like RESOLVE advocate for broader and deeper coverage of fertility treatment and you can join them for their 2016 infertility advocacy day on May 11.  Still, even in states like Massachusetts where insurance companies are mandated to offer IVF coverage, you find plenty of complaints about billing and unexpected charges.  At issue, there are many items you can be charged for because needs vary from patient to patient. It's not uncommon to see posts from people who say they've spent over $50,000 on costs associated with IVF. That's a wide leap from the IVF packages listed at $7,500. 

This variance poses a problem to you as you search for information to properly plan your budget. In the spring of 2015, I surveyed a small group of people dealing with infertility who listed cost confusion as one of their three most common pain-points in dealing with their clinics. You want a clear answer.  You want the transparency that you enjoy in almost every sector in which you spend your money. You instantly pay for everything else at fixed prices from Amazon, Priceline, Fandango, and Blue Apron. Why can't you get a straight answer about how much IVF will run you? You need to know what costs you'll incur and how much of it will be covered by insurance in order to budget for your treatment. Why aren't clinics more transparent with you? 

The answer is multi-faceted, so let's dig into it.

Hidden costs in IVF

proven fact: insurance is the devil

Let's start with one of the very few, axiomatic, incontrovertible laws of the universe: insurance is a nightmare. Remember the national debate we had about healthcare coverage just a few years ago? Effectively, the arguments centered around whose solution would make our horrible payer system even more horrible. The problem certainly isn't unique to fertility care; all of healthcare is plagued by the problem of cost uncertainty.  A study conducted by Consumer Reports shows that billing disputes are the third most common complaint Americans have about their doctors. Why can't a provider tell you how much a service will cost before you decide to go through with it? CEO of tech startup, PokitDok, Lisa Maki, says that people "are trapped by a system that requires that they agree to a service with no knowledge of what the outcome or what the consequences might be to them financially". It's a conundrum. Put yourself in the position of the billing manager; they hate it just as much as you do.

does insurance even cover ivf?

Glad you asked. Every U.S. state and Canadian province is different. In the United States, some states have mandated coverage. If you don't know the universal definition of mandated coverage for infertility...it's because there isn't one. It's helpful that RESOLVE grades states based on how much coverage is mandated. Some states like New York and Texas may be considered mandated states, but their coverage varies. In New York, insurance companies are mandated to cover certain treatments like IUI, but not IVF. In Texas, insurance companies are required to offer coverage in plans to employers, but employers do not have to purchase those plans.

IVF cost confusing

Even in states like Massachusetts and Illinois, the law doesn't apply to certain types of employers, such as those who self-insure. What's more, you may live in a mandated state, but if your employer is not based in that state, then your home state's coverage doesn't apply to you. Don't forget about deductibles, either. You may need to spend a certain amount before insurance will pay for anything. Certain tests and medications might be covered and some might not. If you'd like to take a look at your clinic's website to see what insurances they accept, that won't help much. Every person's coverage depends on their individual plan. What might be covered for your co-worker might not be for you.

the ivf package price is not the total cost of treatment

Is your head spinning yet? We'll table the idea of insurance for the moment. Let's approach this as though you're paying entirely out of pocket. What other costs might you incur in addition to the price of the IVF cycle?

  • Tests. Ask your IVF coordinator if your package has a limit on labs or ultrasounds during treatment. If there is a limit, how many labs and ultrasounds are included and how much is each additional?

  • Medications. Which drugs are included in the package and which are not? How much do they cost? Is your doctor able to prescribe generic or other brand labels that might be covered by insurance? Are you allowed to buy them on your own?

  • Labs. Does your clinic have an in-house endocrine lab or are your labs sent out to a third party? Labs will be drawn throughout your treatment that need to be resulted the same day. If your labs are sent to a third party, there may be an additional cost to you.

  • ICSI. Is Introcytoplasmic Sperm Injection included in the package? According to Sher Fertility Institute, ICSI is often required when cases involve the severest degrees of male infertility.

  • Embryo freezing. Some clinics will store your embryos in cryopreservation for six months after your IVF cycle, and some might include it for a year. How many months are included in your IVF package? What is the fee for each additional month of storage?

There are even more potential costs associated with IVF

There are even more potential costs associated with IVF

  • Anesthesia. If the clinic doesn't disclose whether or not anesthesia is included, it is likely that they charge an additional fee.

  • Donor eggs. Donor egg prices are not included in IVF packages unless specifically mentioned in separate pricing. The clinic may have their own donor bank or they may use a third party. If this is a need of yours, it will mean additional costs.

  • Surrogacy. If you have this need, the total cost of surrogacy may be as high as $150,000.

  • PGD. Preimplantation genetic diagnosis can greatly improve pregnancy success rates by carefully selecting embryos. For older women, and women who have suffered early pregnancy loss, PGD may be all but necessary. Rarely do IVF packages include the cost of PGD.

See? Now you understand why it's so hard for clinics to quote one all-encompassing price for IVF, beyond the most basic IVF package. Rachel Gurevich of About Health reports that the total cost of IVF treatment averages around $20,000, as opposed to the $12,000 average cycle price. There are so many moving parts, it's virtually impossible to give you one set price. As far as clinics are concerned, they need to start displaying "sample pricing". As far as you're concerned, it's better to estimate very conservatively.

then why the heck doesn't my clinic just tell me all this?

This is a great question and it's part of the reason I wrote this post. Fertility practices need to get better at educating prospective patients on cost complexity. From my observation as a marketer, some fertility centers aren't good at discussing finances for two main reasons.

  1. Doctors don't like to talk about money. Generally speaking, they find it unbecoming of the conduct of a physician. They hold the patient-physician relationship to be very sacred and they don't want to cause you to think otherwise. They want you to know that they are invested in your care and not the financial arrangement behind it. I see two scenarios play out in online reviews--one that validates physicians'reluctance to talk about money and one that reveals an adverse effect. In the first scenario, the doctor is perceived as "money-grubbing" or trying to "sell" IVF. In the second, people are surprised by a bill and they lash out at their practice for a charge they weren't expecting. Finance isn't an easy subject to bring up, and that's why most physicians leave the discussion to their billing department. The appropriate sales conversation for infertility treatment is content for another post.

  2. Clinics are afraid to be punished for doing the right thing. What happens when a fertility practice tells you to budget $20,000, and you get a quote of $8,000 from one of their competitors? To a degree, this concern is justified. Tests show that, if not supported by the necessary context, pricing can sometimes drive people away. I would know. I am not the cheapest marketer that someone can hire and I never want to be. When I quote someone for a price, I want to include everything they might need. If I tell someone they should budget for a marketing strategy at $6,000/month, I include an advertising budget, graphic design, web development, etc. Someone else might tell them that they charge $600 per month for marketing services. That $600 doesn't do much but it sure sounds better than $6,000. No matter the service, people often ask about price before considering the total value being offered. This creates an undesirable cycle: you won't tell me your pricing until I'm more interested; I'm not interested until I know your pricing. This is very annoying for both parties involved, fertility centers and their patients.

be an educated consumer, and make sure they know it

So why should your  fertility clinic show you detailed sample pricing? Are they trapped in a catch 22? Tests prove that the advantages of publishing prices far outweigh the disadvantages Think of it this way. Do you ever stop shopping before you know what the price is? What is the cost of a ride across town? You won't know until the cab stops and adjusts their meter. So you choose Uber, because you see the price in advance, and peer reviews validate the experience you're looking for. To compete for your selection, fertility clinics need to be more upfront with pricing. Leave that part to me.

For your part, the more educated you are as a patient-consumer, the more information practices will have to provide to you ahead of time. You are now conversational in the basics of infertility financing. You will be fluent by the end of your journey. To start, you have some background knowledge of which costs to investigate. Clinics are reluctant to share more information on pricing, partly because they are concerned that their competitors will get away with cost ambiguity. Don't let competing fertility clinics win by giving you less information. As an educated patient-consumer, you have the power to let transparency rule the day.

 

 

3 Common Things Fertility Practices Do On the Internet that Make HIPAA Lawyers Cringe

"We must all obey the great law of change. It is the most powerful law of nature."--Edmund Burke

In the summer of 2015, I asked my e-mail list of fertility doctors if if they had any questions about the Health Insurance Portability and Accountability Act (HIPAA) as it relates to internet marketing. Except I didn't write HIPAA. I wrote HIPPA. Thankfully, someone who read the e-mail, corrected me. I was a little embarrassed. I knew what the acronym stood for, but I still wrote it incorrectly. Why would I spell it that way?

What Canadian Fertility Centres Need to Know About the Law and Digital Media

By Griffin Jones

A patient’s health information is sacred and a fertility practice’s community of adoring supporters is invaluable. In a world where social media and communication technology develop years ahead of the law, how do we safeguard both privacy and engagement without sacrifice to one or the other? I have interviewed several attorneys regarding the Health Information Portability and Accountability Act (HIPAA) and other regulatory schemes in the United States, but I’ve yet to investigate the law relevant to you, the leaders in reproductive health across Canada.

Dr. Alan West

Dr. Alan West

That is, until now. Dr. Alan West is a physician and a partner at the law firm of Gowling WLG in Toronto. He specializes in healthcare advertising law. Mr. Evan Atwood is a senior associate at the same office who specializes in consumer and healthcare privacy law. You should always consult an attorney for specific legal advice, which Dr. West and Mr. Atwood do not give here, but they offer us some education about how the law can pertain to a Canadian fertility clinic’s internet presence.

Federal and provincial regulations

“We don’t have HIPAA. My head spins when I have to deal with HIPAA.” West clarifies. “We have a mix of federal and provincial laws”. Canada’s PIPEDA (Personal Information Protection and Electronic Documents Act), applies to health information as well as consumer information and applies only in provinces that haven’t passed their own statutes with privacy protections equivalent to those contained in the federal statute. .

Several provinces, including British Columbia and Ontario, have their own health privacy laws. In Ontario, the law is called PHIPA (the Personal Health Information Protection Act).  Atwood explains, “Both fortunately and unfortunately, the law does not explicitly state what information is prohibited from being released without authorization.” Unlike HIPAA in the United States, which has a data set of 18 identifying factors (name, date of birth, license plate number, etc.) for Protected Health Information (PHI), there is no concept of a data set in Canadian privacy law. The principles are much more general.

HIPAA’s 2013 Omnibus rule, adds liability to “business associates”, those who receive and send PHI to “covered entities” (healthcare providers). The obligations of a business associate are explicit. Again, in Canada, the law is not as specific, but the health records custodian (you, the fertility centre) is obliged to see that its vendors only store that data on behalf of the health records custodian, with the same protections in place.  

“The law is always behind the actual practice of medicine.”

Mr. Evan Atwood

Mr. Evan Atwood

In some provinces, medical practices are prohibited from mentioning the brand names of pharmaceuticals and devices in their advertisements. The regulation of marketing falls more on the practices than on the drug companies. “Doctors are allowed to advertise their own services, but they are not supposed to identify or associate themselves with specific products or drugs. Although many do so.” West finds. West and Atwood point to the example of “physician locators”, search engines within pharmaceutical or manufacturer websites, that list nearby physician offices who administer their products. These websites may be impermissibly marketing directly to the consumer, but “I know of no prosecution for using brand names in advertising,” West says.

West offers some insight as to why there is a lack of enforcement of some laws in healthcare advertising. Provincial boards of medical examiners have limited resources, and they spend their attention on investigating serious cases of fraud and malpractice, not on the use of brand names in advertising, which in some instances, have found their way into the public vernacular. In some provinces, there is no obligation to investigate every complaint that is reported to the provincial board. In others, such as Ontario, the board is obliged to investigate every written complaint. They might not take an enforcement action, but the risk is higher because they have to at least open the file.

This is important to know, because what is permissible in one province, may be prohibited by another province’s advertising law. In Ontario for instance, under the Medicine Act, patient testimonials are not permissible. Nonetheless, some medical practices may include testimonials on their websites, including some fertility centres. Whether you use testimonials on your website or not, what about the content posted by a patient to your Facebook or Google Places profile? In that case, it might be advisable not to solicit reviews. “It might not be the intent of the law, but I would rather be the prosecuting attorney than the defendant in such a scenario,” West opines. “As the law is written, I think the doctor has an obligation to police the postings on his or her social media channel”.

“The law has not caught up to reality, to put it mildly”, Atwood adds. “Still, there’s never been a prosecution for what a patient has put on a provider’s social media channel”.

Digital Media and Privacy Law

This wisdom comes with regard to provinces with regulations prohibiting patient testimonials, not with regard to health privacy. Consent is implied when a patient posts his or her own information on a clinic’s blog or social media channel. The doctor can leave it on their site. “Doctors and practices are allowed to respond to reviews and comments because the patient waives his or her right to privacy when they post their own information” West says.

“Implied consent has limits,” Atwood cautions. “You can’t take that content and use it somewhere else”. Failing to obtain the proper consent is a mistake that Atwood and West commonly see. Though Canadian law does not specify six core elements for what is required in an authorization (as in HIPAA), expressed, written consent should be obtained whenever you use patient information outside of what is specified in the law.

West leaves us with a bit of caution. While provincial boards have not yet enforced certain regulations, such as those against the use of brand names in physician advertising, he believes punitive measures could be likely in the future. “Be forewarned of enforcement action. That may be something we see quite a bit more.”

Get specific legal advice

In every country, the technologies and media that people use to communicate develop much more rapidly than the laws that regulate them. We have to engage our online communities in a way that respects patient privacy and also complies with the law. In my opinion, Canada’s laws seem to follow common sense more so than the ambiguity of other regulatory schemes, but I’m not an attorney. I recommend you always consult an attorney about the federal, provincial, and local regulations specific to your area.

Dr. Alan West is a partner in Gowling WLG's Toronto office, practicing primarily in areas of law related to pharmaceuticals and health care.

Mr. Evan Atwood is a senior associate at Gowling WLG’s Toronto office, with experience in guiding clients with advertising compliance issues with Health Canada.

Avoid Common HIPAA Violations: An Interview with George Indest

By Griffin Jones

This is the seventh interview in a series that explores the crossroads of the Health Insurance Portability and Accountability Act (HIPAA) and digital media.

George Indest

George Indest

George Indest practices healthcare law in Florida and across the country. Mr. Indest’s comments don’t provide legal advice, but they do offer us some insight on how the Health Insurance Portability and Accountability Act (HIPAA) impacts digital media for fertility centers. I asked Mr. Indest about some of the more common mistakes that practices have made to lead to a HIPAA breach.

Indest: Very often, breaches are inadvertent disclosures of protected health information (PHI) to people who didn’t have authorization to view it. Unauthorized disclosures may even include the patient’s immediate family members. Unless the patient has signed a HIPAA authorization for their family members to be able to view their information, the provider cannot release those records. There are several inadvertent mistakes that lead to HIPAA breaches, often including unintended recipients of patient information. This can include sending or forwarding an e-mail to the wrong person, replying to all instead of to an individual, or sending a fax to a recipient whose number is only one digit different from the intended recipient.

What happens when a patient releases their own information on a blog, place page, or social media channel operated by the practice?

The patient is free to release whatever information they want. That in no way effects the practice or the covered entity. I know of no legal obligation to take down patient posts. If the channels are open to the public, it’s the patient’s right and decision to disclose that information. That’s not covered by HIPAA. But, if the channels are open to the public, the covered entity needs to make warnings available that the practice does not have control over who can see that information.

What are the implications when the practice responds to the patient? Does a general response disclose a patient-physician relationship?

I don’t think there’s any sort of violation at all in a response that doesn’t contain PHI. Social interactions take place between patients and physicians all the time. There’s no breach of anyone’s confidentiality unless medical information is discussed. With that said, I have read of breaches wherein a practice responded to a patient’s Better Business Bureau (BBB) complaint and disclosed some of their records to refute the complaint. This is an unauthorized disclosure of PHI and a clear HIPAA violation. The patient is free to release whatever information they want, but that doesn’t authorize the practice to do the same. Even if it is a positive review, where the practice wants to share or retweet information that the patient has already made public, it would be on the safe side to get HIPAA authorization.

What should healthcare providers be doing right now to ensure HIPAA compliance?

The Office of Civil Rights (OCR) and the Department of Health and Human Services (HHS) have indicated more HIPAA audits and investigations. There are more law suits and more complaints of breaches than ever before. Personnel need constant training. They need constant reminders of HIPAA risks. Go overboard in your risk assessment and risk management. There are plenty of plaintiff attorneys looking for suits and there are plenty of things that shouldn’t be occurring. Personnel not directly involved in a patient’s care should not be viewing that patient’s records, and it’s a risk that happens far too often. Education and training need to be provided on an ongoing basis.

George Indest is the principal of the Health Law Firm in Altamonte Springs, Florida. The Health Law Firm, concentrates in representing health care providers, exclusively. Their attorneys include those Board Certified in Health Law. If you would like to learn more from George’s legal expertise, you can contact him here.

Preparing for HIPAA Compliance Audits: An Interview with Valerie Breslin Montague

By Griffin Jones

This is the sixth interview in a series exploring the implications of the Health Insurance Portability and Accountability Act (HIPAA) as it relates to digital media.

Valerie Breslin Montague

Valerie Breslin Montague

Valerie Breslin Montague is an attorney who specializes in HIPAA in Chicago, IL. Ms. Montague’s comments do not contain legal advice, but they do educate us about some of the risks that face fertility centers with respect to HIPAA and social media. I started the interview with a topic that we are all very interested in--what are the implications when patients include their own information on a practice’s website, blog, place page, or social media channel?

Montague: Generally, under federal and state privacy laws, when a patient is forthcoming with their own information, that’s not a disclosure by the practice. Anything posted by the patient would be their disclosure. With that said, it would be wise for practices to include that publicly in their social media policy. Patients should know that social media channels and review sites are public places, and anything posted on the internet should be considered permanent. The practice should inform the public that they do not have control over who can see that information, once posted. When responding to patient comments, it would be wise to do so in a general manner (such as “thank you” or “we appreciate that”). I wouldn’t confirm the patient’s visit, or add any new information.

Is there a danger of disclosing the physician-patient relationship even if it’s a basic acknowledgement of the comment?

I don’t think there’s any guidance here, but I don’t believe that’s something that would be enforced as a HIPAA violation. I think the government would have a hard time arguing that was a breach of PHI. If the government wanted to be very overreaching, I suppose they could, but I don’t see a very big risk there. The practice wouldn’t want to do anything to amplify or further share the patient’s message, such as adding a hash tag, tagging another person, or retweeting or sharing the post, without a proper HIPAA authorization.  The practice can directly message or e-mail the commenter, to ask them to complete a HIPAA authorization. Then they can share the posted content for purposes agreed upon in the authorization.

Why don’t the department of Health and Human Services (HHS) and the Office of Civil Rights (OCR) issue guidelines on practice engagement on digital media?

Hopefully OCR will in the near future but its focus now is on enforcement and audits.

Tell us about the pending round of HIPAA compliance audits.

OCR has been warning of a second round of audits for more than a year. The first round of HIPAA compliance audits took place in 2012. This time, the audit will include both covered entities (healthcare providers and health insurers) and their “business associates” (EHR providers, billing companies, etc.) The agency has said they will audit a large scope of entities from large health systems to small practices.

What are common vulnerabilities that might be exposed for healthcare providers during these audits?

 It’s very common to have HIPAA policies in place for privacy obligations. Providers have been doing a pretty good job of keeping up in that respect. Some smaller or newer business associates may need more help. Where I’m concerned that many people may fail to meet compliance is their requirement to do a security risk assessment. They need to check the security of everything that impacts PHI. Once strengths and weaknesses have been analyzed, a risk management plan has to be implemented.

Not having a “business associate” contract in place is also a risk for both the healthcare provider and the business associate. The arrangement, not the agreement, determines if the relationship exists, and both parties are culpable if a signed contract is not in place.

What should healthcare providers be doing right now to ensure HIPAA compliance?

Providers should be prepared for risks before any incidents might occur. It is much easier to correct security weaknesses before an audit or investigation, and much more difficult to do so in the midst of one. Our firm (Nixon Peabody) works with providers and their vendors to review HIPAA compliance programs and implement any necessary updates before issues arise. OCR will definitely investigate any mass breach that involves over five hundred people and they may investigate smaller breaches and complaints, especially if it is a high profile case.

 It’s important to be proactive to determine where your practice stands, relative to compliance, before a complaint or breach requires it.

Valerie Breslin Montague focuses her practice on regulatory compliance, nonprofit governance and tax exemption, and HIPAA/health information privacy and security. She is a partner at the firm, Nixon Peabody, in Chicago. If you would like to learn more about HIPAA compliance and risk management, you can contact her here.


Start With The Law: An Interview on HIPAA and Social Media with Paul Hales

Paul Hales

Paul Hales

This is the fourth interview in a series exploring the implications of the Health Insurance Portability and Accountability Act (HIPAA) as it relates to digital media.

Paul Hales is an attorney from St. Louis, who specializes entirely in HIPAA law. Mr. Hales’ comments do not contain legal advice, but they do educate us about some of the risks that face fertility centers with respect to HIPAA and social media. Mr. Hales gives us some background on the Act.

Hales: We have to start with the law. My focus is on enabling practitioners to make use of social media and comply with the law. HIPAA was passed in 1996 with two objectives;

  1. To be able to keep insurance when switching from one provider to another.

  2. To have a uniform code for information and payment

It has had further additions since.

  • The privacy regulations were added in 2003.

  • The HIPAA security rule was added in 2005

  • HITECH was passed in 2009.

  • In 2013, the Omnibus rule was added to HIPAA to extend liability to “business associates”.

What is a business associate?

A “business associate” is a person or entity that performs certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to, a covered entity.

What are common areas in which covered entities and businesses associates fail to meet HIPAA compliance?

  • Protected Health Information (PHI) is made up of 18 identifiers, including but not limited to name, e-mail address, full face photos, and date of birth.

  • Under HIPAA, every health care practice or organization must designate a privacy officer. The privacy officer must perform a risk-analysis.

  • Health plans and covered health care providers are required to develop and distribute a notice that provides a clear explanation of privacy rights and practices with respect to patients’ personal health information.

What about when a patient posts their own information on a blog, social media channel, or place page operated by the practice?

It’s important to look at how HIPAA defines a website, which is any site that provides information about a covered entity’s services or benefits. Therefore, if a patient posts their own information to a site that’s owned by the practice, that is unauthorized PHI on the practice’s site. The practice has to obtain HIPAA authorization before allowing any patient content to be published to its sites.

What is necessary in a HIPAA authorization?

HIPAA Authorizations have six core elements:

  1. A specific and meaningful description of the information to be used or disclosed.

  2. The name or other specific identification of the person(s), or class of persons, authorized to make the requested use or disclosure.

  3. The name or other specific identification of the persons(s), or class of persons, to whom the covered entity may make the requested use or disclosure (i.e., the intended recipients).

  4. Description of each purpose of the requested use or disclosure.

  5. Must contain an expiration date or an expiration event.

  6. The signature of the individual and the date.

 

A HIPAA authorization must also include three statements.

  1. Individual’s right to revoke the Authorization.

  2. Clarification that the covered entity is not permitted to condition the provision of treatment on the execution of a valid Authorization.

  3. Explanation that there is a potential that the information may be re-disclosed by the recipient of the information and that the recipient may not be required to comply with the Privacy Rule.

What should fertility practices be conscious of right now to minimize risk of HIPAA violations?

Recently, there has been more enforcement, and soon there will be audits. On February 16, 2016 the Office of Civil Rights (OCR) settled an enforcement action against Complete P.T., Pool & Land Physical Therapy, Inc. for impermissibly disclosing patient information in the form of testimonials on their website. HIPAA is a very extensive law. There is a lot of information on the internet that is simply wrong. HIPAA regulations are very demanding and products cannot ensure compliance. No product can be HIPAA compliant. It’s how a covered entity uses a product that makes it compliant or not.

Paul Hales is an attorney who provides legal services and consultation regarding HIPAA compliance. His software, the HIPAA e-tool helps covered entities and business associates with a complete HIPAA compliance solution. If you’re interested in an educational webinar with Mr. Hales, you can register here.

Legal Considerations When Responding to Online Patient Reviews: An Interview with Eric Goldman

Eric Goldman

Eric Goldman

This is the third interview in a series which explores digital media and the law, including questions about HIPAA and online engagement.  Eric Goldman is a professor at Santa Clara University School of Law. While Mr. Goldman's answers don't provide us with legal advice, they do give us some insight into how fertility practices might consider the law when responding to patient reviews online.

Jones: Should physicians respond to reviews written about them online? Why or why not?

Goldman: In most circumstances, physicians either should not respond to online reviews or respond generically by thanking the reviewer and indicating that the physician appreciates and carefully considers online feedback. It rarely makes sense to get into substantive discussions with reviewers online. Not only could such discussions implicate HIPAA, but physicians often look thin-skinned and petty when they attempt to debate fact matters online. Furthermore, increasing the number of comments to a review may actually cause search engines to rank the content higher (a counterproductive result if the review is negative). If the physician chooses to engage a negative review about the facts (which is rarely if ever advisable), the response should discuss the office’s general practices and not discuss how those practices were applied in the reviewer’s specific situation.

J: What information should physicians never include in their responses to reviews?

G: Given the boundaries of HIPAA, there are few circumstances where a physician can discuss any individual facts about the reviewer. Indeed, it is potentially problematic to even acknowledge that the reviewer is a patient.

J: Are there different implications for responding to patients when their identities are public (ex. Facebook) vs. when they are anonymous (ex. RateMDs)?

G: I couldn’t think of any.

J: Are responses to reviews considered protected health information (PHI) if the patient posted the information?

G: It’s a risky practice for physicians to confirm information that a patient or family member voluntarily publicly disclosed.

J: What should physicians and practices always be wary of regarding online reviews and their public reputation?

G:

  1. Prospective patients are increasingly looking at other patients’ reviews when selecting physicians. I know many physicians wish this weren’t true, but there’s no point pining for an alternative universe.

  2. Prospective patients are savvy enough to discount outlier reviews. If one negative review is surrounded by multiple positive reviews, it will have minimal effect on the physician’s reputation.

  3. Patients’ reviews of their physicians are overwhelmingly positive, i.e., in some cases 90%+ of patients’ reviews are positive.

  4. If a physician deals with dozens or hundreds of patients, inevitably there will be a few unhappy patients who will vent online.For these reasons, physicians should be actively encouraging their patients to review them online. This will better inform future prospective patients, and it usually will help create a base of positive reviews that will insulate the physician from the occasional negative reviews that inevitably will come.

G: A final thought: getting negative feedback never feels good, but it can provide a candid insight into the patient’s experiences. If the physician can overcome the emotional sting of a negative review, there may be valuable customer feedback that can help physicians do a better job meeting their patients’ needs.

If you would like to read a short essay by Mr. Goldman which explores how doctors and other healthcare professionals have responded to patient reviews of their services and addresses how they should deal with patient reviews in the future, you can find it here.

Every Fertility Center Needs a HIPAA Compliant Social Media Strategy: An interview with Mike Bossenbroek

By Griffin Jones

This was the first interview that I did in a series exploring the Health Insurance Portability and Accountability Act (HIPAA) and its implications regarding digital media. I originally recorded this interview in August of 2015,  before the Fertility Bridge blog was active in its current form. Per usual, my video intro is corny, and very crudely edited, but the content is very valuable because practices should educate themselves about HIPAA considerations in social media as much as they can.

Michael Bossenbroek practices healthcare law in Michigan. Of course, Mr. Bossenbroek's comments are NOT legal advice, but they give us important information to consider about how fertility centers should approach social media and patient engagement. In this interview, we address

  • What are some things that a HIPAA compliant social media policy should include?

  • Where should a fertility practice's social media policy be visible?

  • What else should fertility practices consider when deciding their activity on social media?

Michael Bossenbroek is a partner at Wachler & Associates, P.C.  in Royal Oaks Michgian. Mr. Bossenbroek practices in all areas of health care law, including representing clients in matters relating to HIPAA compliance. If you'd like to learn more about HIPAA compliance from Mike, you can contact him here.