Genetic Testing HIPAA Warning: Legal Considerations

genetic testing hipaaBy: Jacqueline Bain

You might have recently received a holiday gift of a direct-to-consumer genetic testing kit from Ancestry.com or 23andMe.com (or any other number of companies). So exciting! In our melting pot society, one can’t help but be curious about where they come from and if they are more likely than any other person to be subject to any number of ailments.

Not so fast though! Before you swab yourself and send away your genes for testing, you might consider what you’re exposing yourself to. Direct-to-consumer genetic testing companies, which provide genetic testing directly to consumers without any intervening healthcare provider, are not bound by HIPAA. They are not considered “covered entities”, and therefore not required to use the same protections for genetic information the way a hospital or your doctor would.Continue reading

Fall 2014 HIPAA Audits: Is Your Business Ready?

hipaa-audits-imageFile-3-a-7296

hipaa-audits-imageFile-3-a-7296By: Jackie Bain

Section 13411 of the HITECH Act authorizes and requires the Department of Health & Human Services Office for Civil Rights (“OCR”) to provide for periodic audits to ensure that covered entities and business associates comply with the HIPAA Privacy and Security Rules. OCR conducted its first round of those audits in 2011 and 2012, and has announced that it will begin a second phase.  Unlike the first phase of audits, which were limited to covered entities, both covered entities and business associates are intended to be audited during this second phase.

How will audited businesses be selected?

This fall, OCR will deliver pre-audit surveys to between 550 and 800 covered entities.  OCR is attempting to obtain a fair snapshot of all covered entities, so these pre-audit surveys will be sent to health care providers, health plans, and health clearinghouses. Moreover, the audits will span the gamut of business sizes, from large corporations to solo practitioners. After pre-audit surveys are returned, OCR will randomly select 350 of those covered entities for a full audit.  As a part of these full audits, covered entities will be asked to identify their business associates.  OCR will then select 50 business associates to participate.Continue reading

Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication

gavelThe Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records.  The underlined portions below are the new standards required for medical records as it relates to compounded medications.  These standards are effective September 9, 2013.Continue reading

Marketing: Boldly Going Where No Practice Has Gone Before

By now, every physician has learned about ACOs, Super Groups, IPAs and the like. Virtually every “new” acronym and idea has revealed itself as a retread old one, so at least physicians are getting more comfortable with the new language of healthcare reform. And they are accepting that no one really knows what’s going to happen and how medical practice will ultimately be years from now.
Nearly every physician has asked in the past year or so “What do I do now?” And they have heard responses from every vendor which translates into “Buy my stuff.” Ask an IT person what to do…”Buy my stuff.” Ask an EMR person what to do…”Buy my stuff.” Ask a lawyer….ok enough.

What to do and when to do it in light of feared changes in healthcare is anyone’s guess. There is, however, one remarkably overlooked area of business which physicians have traditionally neglected and which they must focus on now more than ever—marketing.

Do you have a website? Do you know what SEO is and how it works? Do you believe that patients buy what you do and not just who you are? In the internet age when people buy mattresses online, sight unseen, physicians have to begin to learn about marketing.

Though years ago, practicing medicine was clearly a profession, it is now big business. And physicians who thrive will be those who embrace business practices, including marketing. This takes a huge shift in perception since most physicians look at marketing as an expense, not as a good investment.

If you were told that every dollar invested in marketing will yield five dollars in new business would you spend the money? If you were told that buying a stock will result in a five-fold yield over twelve months, would you invest? Physicians have to look as marketing as a good investment rather than simply as a cost. And those that do will likely grow and thrive.


2010 Has Already Been a Huge Year in Healthcare

             Healthcare reform alone is enough of a Rubik’s Cube, but CMS and the OIG has been especially well-staffed these days, enough so that their offices are turning out new laws and interpretations at an alarming rate.  Though it may seem overwhelming, physicians need to work harder than ever to stay on top of the changes.

Health Information Technology (HIT)

            The physician incentive payments/penalty provisions that piggybacked their way onto the federal healthcare reform law have physicians concerned and scrambling.  IT vendors and advisors are drawn to the opportunities the new law has created; and physicians need to be educated and wise. 

             The so called “HITECH” provisions of the federal healthcare reform law create a pot of about $34 Billion worth of incentive payments for eligible professionals and hospitals that attain meaningful use of certified electronic healthcare records (EHR) technology.  To obtain any money, eligible parties will have to demonstrate full compliance no later than 2015, and earlier (2011!) if they want the full benefit.  Medicare has allocated roughly $44K worth of incentives for each compliant physician; and Medicaid offers another $20K roughly, but the real incentive is not the money; it’s the fact that financial penalties apply if you don’t comply by 2015.

             Financial incentives are available for eligible professionals who use certified HIT which satisfies the “meaningful use” regulations, which were issued August 2010. They are complex and limited by time lines which industry insiders claim to be unreachable. Vendors are, nevertheless, selling and physicians are buying software and solutions in hopes they will qualify for the incentive payments.  Physicians should make sure that their contracts with such vendors protect them by requiring the solutions to be certified and meet the meaningful use guidelines. 

Healthcare Reform

            Though everyone is scared about how healthcare reform will unfold, remembering the past may help.  The fact is the concepts in the Act are not new.  For instance, IPAs, PHOs, capitation and the like are the cornerstone of the reform.  Physicians have seen these before, though not on a government mandated basis.  Moreover, where those models were once purely financial, there is a heavy clinical outcome component woven into the regulations. 

            No matter how one views it, the Act creates huge opportunities for physicians and others.  Risk based compensated Accountable Care Organizations (ACOs) are slated to be the new platform for healthcare delivery.  Good news for PCPs:  regulators and think tankers think that physicians, especially primary care physicians, are the best positioned to lead the ACO development charge.  That said, the form the ACOs will take is completely unclear and is expected to unfold over a period of ten years.  Like technology vendors, physicians have to be wary of anyone who has something to sell at this time.  One size does not fit all!  IPAs might be a great vehicle to start.  Capitated models are familiar, but a bundled payment methodology may work better in some circumstances.  One thing that is certain:  whatever business model a physician explores ought to be able to bear financial risk (e.g. capitation or bundled payments) and measure clinical outcomes, because both elements will form the basis of payments of the future.  Though specifics about the future of healthcare are unavailable, the following is a fair list of what’s likely:

  1. Movement away from fee for service payment to risk based compensation;
  2. The prevalence of IT & EMR;
  3. The need to demonstrate clinical effectiveness;
  4. An expanded role of primary care physicians;
  5. Expansion of concierge type services;
  6. Employment of physicians by hospitals;
  7. The development of larger medical practices;
  8. More patients (through insurance mandates and expansion of Medicaid     eligibility);
  9. Expanded use of “physician extenders” (as the PCP shortage worsens); and
  10. Increased enforcement in the area of healthcare fraud (civil & criminal).

OIG and CMS Pronouncements

            May was a busy month for healthcare regulators.  SMS issues the Ambulatory Surgery Center Waiting Area Separation Requirements, which has had the effect of preventing creative business opportunities between ACSs and other healthcare businesses.

            Additionally, the OIG recently issued an Advisory Opinion which makes it very difficult for imaging centers to do prior authorizations for referring physicians.

Fraud and Abuse

            If the first 2/3 of 2010 are any indication of the future in healthcare law, healthcare business professionals have a lot to keep up with. Enforcement by the Justice Department and the Office of Inspector General is in full swing. Already, for instance, nearly $2 million has been repaid as the result of employing a person who has been excluded from a federal healthcare program. Examples include:

Read On at www.FloridaHealthcareLawFirm.com