OCR updates its website to show enforcement statistics
Posted by: Robert Markette
May 13, 2008
Topic: HIPAA - Privacy

The Department of Health and Human Services Office of Civil Rights (“OCR”) has added a new page to its website.  (Or at least updated an existing page.)  Interested people can now look up enforcement statistics at OCR’s website here.   Statistics they are tracking include number of complaints by year, number of complaints by state, a break down of resolutions each year, and the top 5 issues investigated each year.

One interesting fact from the website, not surprisingly, the number of complaints has gone up each year since HIPAA went into effect.  Last year, the number of complaints hit an all time high of 8,132 complaints.  That is up 800 from the year before.  The only bigger jump is between 2003 and 2004, of course you would expect to see a big jump there, because 2003 was a partial year.

It is interesting to look at these statistics, especially as Congress is considering major changes to HIPAA.   (The Health Information Privacy and Security Act is currently winding its way through Congress.)  Part of the motivation to amend HIPAA is a mistaken belief that HIPAA does not provide enough protection to individuals.  This is a result of the major security breaches that are reported on the news about once a quarter or so.

However, OCR’s statistics show a much larger number of complaints investigated and resolved without the need for corrective action.  On average, the charts (which do not contain a great deal of explanation) appear to say that corrective action was pursued in about 20% of the cases.  That would indicate that in 80% of the complaints, the providers were not doing anything wrong.  Within the 20% of cases where corrective action was obtained, it does not indicate how severe the violations were or how expansive the corrective action was. 

This would be interesting to know, because if the majority of the violations were not severe this would combine with the large number of complaints in which no violations was found to indicate that Congress does not need to overhaul HIPAA to provide more stringent protections and steeper penalties.  If the providers are complying under the current regime, why create a bigger stick to threaten them with. 

It is also interesting to note that the statistics show no fines or other penalties have been assessed against providers for violations.  At least for now, getting providers into compliance instead of punishing them appears to be OCR’s enforcement policy.  (A policy which I think makes a lot more sense.)

Admittedly, the data reported is relatively Spartan, but if you are interested in what OCR has been doing with HIPAA the last few years, this is an interesting site.

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New legislation in Florida
Posted by: Robert Markette
May 08, 2008
Topic: Home Care and Hospice Regulations

Well, the Florida legislature just passed a major revision to the Florida home health licensure statutes.  As many of you know, home health fraud has been rampant in Florida.  The abuses in Miami have been widely reported and are probably well known to anyone reading this blog.  A number of law enforcement agencies have been investigating these abuses.

It seems that the Florida legislature has decided additional action is necessary.  They have enacted a number of anti-fraud provisions into the Florida home health licensure statute.  The statute gives the Florida Agency for Health Care Administration the authority to impose fines for certain violations.  A number of new violations have been added that appear to mirror federal anti-kickback and/or stark laws. 

I recall that a few years ago the Florida Supreme Court struck down Florida’s fraud and abuse statutes as being preempted by Federal law.  Having the fraud and abuse enforcement be a matter of administrative proceedings may avoid that issue, but it seems to create a whole other host of problems.  For example, it would seem that the burden of proof is less than the beyond a reasonable doubt standard that would be necessary for an anti-kickback case.  For a stark type violation, you would be able to appeal to an ALJ, but you would not have the right to a trial by jury, because this is an “administrative” matter.

One of the new penalty provisions calls for fines if the agency identifies a “pattern” of falsifying training documents.  Although a pattern is defined as three entries, no time frame is provided.  Is this a three strikes and your out type rule, meaning three such entries over the life of your agency or is it three mistakes in a single survey (which would mean two mistakes per survey are “freebies”).  I say mistakes, because if these “fraudulent entries” are identified by surveyors, a mistaken entry may be treated as a fraudulent entry.  Other offenses involving patterns of conduct include a time frame and they range from three per quarter to three a year.

Another provision allows for a $5,000 fine for failure to provide a service as outlined in the care plan or service agreement. If you have ever been cited for failure to follow a care plan, this should at least give you pause.

None of the remuneration provisions provide a minimum value exception which the federal fraud and abuse laws do.  Will it be a defense in Florida that you have complied with the minimal value exceptions in Stark and the CMP statute?

I may seem a bit alarmist in my initial reaction to this change, but making fraud and abuse issues licensure matters handled by surveyors and ALJs severely erodes the procedural protections available to an agency in the midst of a fraud investigation.  In this day and age, with the emphasis on fraud enforcement, removing protections from providers is likely to cause more harm than good.  There may be other unforeseen consequences as well. 

Perhaps Florida felt they needed to do this because of the ruling a few years ago from the Florida supreme court, but wouldn’t it have made more sense, been simpler, and more cost effective to simply give the agency the authority to penalize the provider upon conviction of a violation of the applicable federal fraud and abuse laws?  Or perhaps, given the federal emphasis on state enforcement, a new state level fraud and abuse code could have been enacted and survived a court challenge, because there is lots of evidence from the feds they want state level enforcement.  Heck, the DRA called for state level false claims act statutes, even though there is a federal one as well.

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The future of private duty regulations (beware what follows is pure speculation)
Posted by: Robert Markette
April 09, 2008
Topic: Home Care and Hospice Regulations

I was out in San Diego for the NPDA convention.  One of the recurring themes of the convention was the attendees concern about where the regulation of the industry was heading.  For those of you who don?t know, NPDA is the National Private Duty Association.  Its members are the private duty home care providers, also known as the non-medical home care or personal care industry.

Private duty providers around the country are split.  Some feel that licensure will improve the industry?s reputation and should be sought after.  Others feel that licensure will lead to a heavier burden on providers and should be avoided.

Personally, as an attorney who spends a lot of time helping clients deal with  regulators and regulations, I tend to agree with the providers who are opposed to regulating private duty.  (although more regulation does tend to lead to more business for me.) Unfortunately, I do not think that is very likely to happen.  

I think the regulation of the private duty industry is probably inevitable, because of a number of factors.  First, the industry is growing rapidly.  As more and more providers serve more and more clients, the industry will become more visible to state regulators.  (State regulators are already aware of private duty, but as the industry grows the regulators will become more interested in regulating them.)  As it becomes more visible, the likelihood of regulation increases.

Second, the industry serves populations traditionally considered ?vulnerable?- the elderly, children, and the disabled.  Because of the patient population served by the industry, legislators will feel compelled to take action to regulate the industry as a means to protect this population.  (This move will be more rapid if a member of a vulnerable population is harmed, neglected, or taken advantage of.)

Third, private duty ?looks like? home health care.  State agencies look at private duty agencies and see an entity sending employees into a patient?s home to provide care.  Because of this similarity to home health care, the reaction is that it needs to be regulated.  

Although I think these factors make the eventual licensure of private duty inevitable (at least in any state the licenses home health), I am not suggesting that it ought to be regulated or that the industry should simply accept it.  I think the private duty industry needs to be aware that this may be the future and act accordingly.  To the extent you can prevent it, the industry will likely be better relying upon accreditation, industry standards, etc.

However, the industry needs to remain vigilant, because if licensure or other regulation looks to be heading your way, the providers and their trade associations need to educate lawmakers.  Lawmakers need to see why private duty should not be regulated like home health.  For example, doctor?s orders should not be necessary for most private duty care.  Regulators need to know what care the industry provides, how they provide it, etc.  They need to know that less regulation is appropriate.

It will fall to the providers in each state to be aware of how its state regulators ?view? the industry and be ready to take action.  They need to be part of the process of developing licensure statutes, licensure standards etc.  Indiana?s providers were very successful in this effort and the state personal services licensure regime address private duty in a very different way and restricted the use of regulations by the licensing agency.

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IAHHC has another legislative success
Posted by: Robert Markette
March 14, 2008
Topic: Home Care and Hospice Regulations

Congratulations to my friends at the Indiana Association for Home and Hospice Care (?IAHHC?).  After a great deal of effort, IAHHC has succeeded in getting legislation passed that temporarily suspends the national criminal background check for home health and personal service companies.  As many of you know, I (and many others) felt the national criminal background check (?NCIC?) as conceived in the statute did not make a lot of sense, because the statute did not allow providers to receive a copy of the NCIC, but only allowed them to receive a determination from the Indiana state police.

This determination was to be a letter from the state police that was issued after the police compared the NCIC to the Indiana list of disqualifying convictions.  The problem with that procedure was two fold, first the NCIC would not show any convictions that were not already on the individual?s limited criminal history.  Second, home health and personal services agencies would routinely disqualify someone for having convictions for crimes other than those listed in the statute.

This second point is important, because the state of Indiana only disqualifies homecare workers for a few convictions.  Home health and personal services agencies use a much broader list of convictions, because they are very concerned about patient safety.  They realize the importance of their position in protecting their patients.

Requiring agencies to pay more and then not allowing them to see the report and make their own determination would actually allow more individuals with criminal histories to go into homes and provide home care.  (Not a situation most home care providers looked forward to.)  In addition, there were other technical problems that led to serious delays in getting the determination.  During these delays, the employee was free to keep working, another potential problem.

Because the statute was not actually helpful (not surprising since neither IAHHC nor ISDH were contacted prior to its passage), IAHHC focused on getting the national criminal background check statute repealed.  Ultimately, the legislature would only pass a one year ?partial roll back?. (And even that was only due to IAHHC?s extensive efforts this session, thank you Mary Ann Maroon)  Indiana home health and personal services agencies have until July 1, 2009 to continue to perform limited criminal history checks.  There is one exception:  If you think an employee lived out of state in the previous two years, you will still have to do a national criminal check.  

As things currently stand, the national criminal history statute goes back into effect on July 1, 2009.  Hopefully, between now and then either CMS will take some action based upon its current background check pilot program or IAHHC will be able to get the legislature to fix the national criminal background check statute so that starting in July 2009, the agencies will have the opportunity to see the history information and make their own, more particular determinations about an employee?s suitability to work in their patients homes.  There could be other solutions as well, but in my opinion simply allowing the original statute to go back into effect as is on July 1, 2009 will not be good for homecare providers or for patients.  Before next year, a better solution needs to be found.

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Dealing with Assisted Living Facilities
Posted by: Robert Markette
March 12, 2008
Topic: Fraud and Abuse, Self Referral, False Claims

I read an interesting article in this weeks home health line.  It was a follow up to a recent pre-conference HHL sponsored. The subject of the article was renting space from ALFs.  Because ALFs are an excellent source of referrals, rental arrangements are definitely an area that can be abused.  (Of course renting space from any potential referral source can be a source for abuse.)  I thought the article made some good points, but it failed to address some other potential risk areas for fraud and abuse with assisted living facilities.

One arrangement I have seen is the ALF that has a related therapy company (perhaps an outpatient therapy company conveniently located to the facility).  The ALF will ?suggest? the agency contract with its therapy company for therapists to provide services to patients in the ALF.  Contracting for therapists in and of itself is not a problem, in fact, many agencies need to, because they are unable to find enough therapists to hire.  However, contracting for therapists with a company that is part of or owned by the ALF can create problems.  

The question I always ask clients is, do you need therapists?  In other words, could you staff the patients in the facility without the contract?  If you can, you will have a hard time justifying your relationship with the ALF's "sister company."  Contracting for unnecessary staff almost guarantees the arrangement is not fair market value.  If it is not fair market value, you are outside of the safe harbor and may end up being asked a lot of uncomfortable questions.

 Another question I have asked when a "therapy contract" is offered is, can you use these therapists to staff your patients outside the facility?  Often, the answer to that question is no.  In these cases, the government is likely to consider the "staffing contract" simply a quid pro quo to the facility.  You get the home health business, but they get a piece of the action for their therapists.

 This can become even more complicated if you add in the facility's offer to make the HHA a "preferred provider."  Now, a preferred provider agreement, if done properly can be acceptable.  (Disclaimer: You should always discuss this kind of arrangement with knowledgeable legal counsel.)  But when a lease or therapy contract is involved along with a preferred provider agreement, it may appear that the contract was a quid pro quo for the designation, because everyone knows being the preferred provider is usually good for business.

 Home health is very competitive and providers are willing to try many angles to increase business.  However, when looking at ways to increase referrals from ALFs, providers should be wary of offers to rent space or staff.  Rewarding a referral source with an unnecessary or inflated contract may improve business, but it is also likely to land you in jail.  Remember the anti-kickback statute is a felony.

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