Category Archives: Laboratory Services

Do the Anti-Kickback and Stark Laws Apply to Private Payors?

Good question.

Anti-Kickback statutes (AKS) and Stark law are extremely important issues in health care. Violations of these laws yield harsh penalties. Yet, many healthcare professionals have little to no knowledge on the details of these two legal beasts.

The most common question I get regarding AKS and Stark is: Do AKS and Stark apply to private payers? Health care professionals believe, if I don’t accept Medicare or Medicaid, then I don’t need to worry about AKS and Stark. Are they correct??

The general and overly broad response is that the Stark Law, 42 USC § 1395nn, only applies to Medicare and Medicaid. The AKS, 42 USC § 1320a-7b(b)),applies to any federal healthcare program.

Is there a difference between AKS and Stark?

Answer: Yes. As discussed above, the first difference is that AKS applies to all federal healthcare programs. This stark difference (pun intended) makes the simple decision to not accept Medicare and Medicaid, thus allowing you to never worry about AKS, infinitely more difficult.

Let’s take a step back… What are AKS and Stark laws and what do these laws prohibit? When you Google AKS and Stark, a bunch of legal blogs pop up and attempt to explain, in legalese, what two, extremely esoteric laws purport to say, using words like “renumeration,” “knowing and willful,” and “federal healthcare program.” You need a law license to decipher the deciphering of AKS and Stark. The truth is – it ain’t rocket science.

The AKS is a criminal law; if you violate the AKS, you can be prosecuted as a criminal. The criminal offense is getting something of value for referrals. You cannot refer patients to other health care professionals in exchange for money, reduced rent, use of laboratory equipment, referrals to you, health services for your mother, marketing, weekly meals at Ruth’s Chris, weekly meals at McDonalds, oil changes, discounted theater tickets, Uber rides, Costco coupons, cooking lessons, or…anything of value, regardless the value. 

Safe harbors (exceptions to AKS) exist. But those exceptions better fit squarely into the definition of the exceptions. Because there are no exceptions beyond the enumerated exceptions.

AKS is much more broad in scope than Stark. Other than Medicare and Medicaid, AKS applies to any health care plan that utilizes any amount of federal funds. For example, AKS applies to Veterans Health Care, State Children’s Health Programs (CHIP), Federal Employees Health Benefit Program, and many other programs with federal funding. Even if you opt to not accept Medicare and Medicaid, you may still be liable under AKS.

Stark law, on the other hand, is more narrow and only applies to Medicare and Medicaid. I find the following “cheat sheet” created by a subdivision of the Office of Inspector General to be helpful in understanding AKS and Stark and the differences between the two:

One other important aspect of Stark is that is considered “strict liability,” whereas AKS requires a proving of a “knowing and willful” action.

Feel free to print off the above chart for your reference. However, see that little asterisk at the bottom of the chart? It applies here as well.

Step Right Up! CMS Announces New Medicare-Medicaid ACO Model

Come one! Come all! Step right up to be one of the first 6 states to test the new Medicare-Medicaid Affordable Care Act (ACO) pilot program.

experiment

Let your elderly population be the guinea pigs for the Center for Medicare and Medicaid Services (CMS). Let your most needy population be the lab rats for CMS.

On December 15, 2016, CMS announced its intent to create Medicare/caid ACOs. Currently, Medicare ACOs exist, and if your physician has opted to participate in a Medicare ACO, then, most likely, you understand Medicare ACOs. Medicare ACOs are basically groups of physicians – of different service types – who voluntarily decide (but only after intense scrutiny by their lawyers of the ACO contract) to collaborate care with the intent of higher quality and lower cost care.  For example, if your primary care physician participates in a Medicare ACO and you suffer intestinal issues, your primary care doctor would coordinate with a GI specialist within the Medicare ACO to get you an appointment. Then the GI specialist and your physician would share medical records, including test results and medication management. The thought is that the coordination of care will decrease duplicative tests, ensure appointments are made and kept, and prevent losing medical records or reviewing older, moot records.

Importantly, the Medicare beneficiary retains all benefits of “normal” Medicare and can choose to see any physician who accepts Medicare. The ACO model is a shift from “fee-for-service” to a risk-based, capitated amount in which quality of care is rewarded.

On the federal level, there have not been ACOs specially created for dual-eligible recipients; i.e., those who qualify for both Medicare and Medicaid…until now.

The CMS is requesting states to volunteer to participate in a pilot program instituting Medicare/Medicaid ACOs. CMS is looking for 6 brave states to participate. States may choose from three options for when the first 12-month performance period for the Medicare-Medicaid ACO Model will begin for ACOs in the state: January 1, 2018; January 1, 2019; or January 1, 2020.

Any state is eligible to apply, including the District of Columbia. But if the state wants to participate in the first round of pilot programs, intended to begin 2018, then that state must submit its letter of intent to participate by tomorrow by 11:59pm. See below.

dual-acos

I tried to research which states have applied, but was unsuccessful. If anyone has the information, I would appreciate it if you could forward it to me.

Participating in an ACO, whether it is only Medicare and Medicare/caid, can create a increase in revenue for your practices. Since you bear some risk, you also reap some benefit if you able to control costs. But, the decision to participate in an ACO should not be taken lightly. Federal law yields harsh penalties for violations of Anti-Kickback and Stark laws (which, on a very general level, prohibits referrals among physicians for any benefit). However, there are safe harbor laws and regulations specific to ACOs that allow exceptions. Regardless, do not ever sign a contract to participate in an ACO without an attorney reviewing it. 

Food for thought – CMS’ Medicare/caid ACO Model may exist only “here in this [Obama] world. Here may be the last ever to be seen of [healthcare.gov] and their [employee mandates]. Look for it only in [history] books, for it may be no more than a [Obamacare] remembered, a [health care policy] gone with the wind…”

As, tomorrow (January 20, 2017) is the presidential inauguration. The winds may be a’changing…

Look into My Crystal Ball: Who Is Going to Be Audited by the Government in 2017?

Happy New Year, readers!!! A whole new year means a whole new investigation plan for the government…

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) publishes what is called a “Work Plan” every year, usually around November of each year. 2017 was no different. These Work Plans offer rare insight into the upcoming plans of Medicare investigations, which is important to all health care providers who accept Medicare and Medicaid.

For those of you who do not know, OIG is an agency of the federal government that is charged with protecting the integrity of HHS, basically, investigating Medicare and Medicaid fraud, waste, and abuse.

So let me look into my crystal ball and let you know which health care professionals may be audited by the federal government…

crystal-ball

The 2017 Work Plan contains a multitude of new and revised topics related to durable medical equipment (DME), hospitals, nursing homes, hospice, laboratories.

For providers who accept Medicare Parts A and B, the following are areas of interest for 2017:

  • Hyperbaric oxygen therapy services: provider reimbursement
  • Inpatient psychiatric facilities: outlier payments
  • Skilled nursing facilities: reimbursements
  • Inpatient rehabilitation hospital patients not suited for intensive therapy
  • Skilled nursing facilities: adverse event planning
  • Skilled nursing facilities: unreported incidents of abuse and neglect
  • Hospice: Medicare compliance
  • DME at nursing facilities
  • Hospice home care: frequency of on-site nurse visits to assess quality of care and services
  • Clinical Diagnostic Laboratories: Medicare payments
  • Chronic pain management: Medicare payments
  • Ambulance services: Compliance with Medicare

For providers who accept Medicare Parts C and D, the following are areas of interest for 2017:

  • Medicare Part C payments for individuals after the date of death
  • Denied care in Medicare Advantage
  • Compounded topical drugs: questionable billing
  • Rebates related to drugs dispensed by 340B pharmacies

For providers who accept Medicaid, the following are areas of interest for 2017:

  • States’ MCO Medicaid drug claims
  • Personal Care Services: compliance with Medicaid
  • Medicaid managed care organizations (MCO): compliance with hold harmless requirement
  • Hospice: compliance with Medicaid
  • Medicaid overpayment reporting and collections: all providers
  • Medicaid-only provider types: states’ risk assignments
  • Accountable care

Caveat: The above-referenced areas of interest represent the published list. Do not think that if your service type is not included on the list that you are safe from government audits. If we have learned nothing else over the past years, we do know that the government can audit anyone anytime.

If you are audited, contact an attorney as soon as you receive notice of the audit. Because regardless the outcome of an audit – you have appeal rights!!! And remember, government auditors are more wrong than right (in my experience).

All Medicare/Caid Health Care Professionals: Start Contracting with Qualified Translators to Comply with Section 1557 of the ACA!!

Being a health care professional who accepts Medicare and/ or Medicaid can sometimes feel like you are Sisyphus pushing the massive boulder up a hill, only to watch it roll down, over and over, with the same sequence continuing for eternity. Similarly, sometimes it can feel as though the government is the princess sleeping on 20 mattresses and you are the pea that is so small and insignificant, yet so annoying and disruptive to her sleep.

Well, effective immediately – that boulder has enlarged. And the princess has become even more sensitive.

boulder

On May 18, 2016, the Department of Health and Human Services (HHS) published a Final Rule to implement Section 1557 of the Affordable Care Act (ACA). Section 1557 of the ACA has been on the books since the ACA’s inception in 2010. However, not until 6 years later, did HSD finally implement regulations regarding Section 1557. 81 Fed. Reg. 31376.

The Final Rule became effective July 18, 2016. You are expected to be compliant with the rule’s notice requirements, specifically the posting of a nondiscrimination notice and statement and taglines within 90 days of the Final Rule – October 16, 2016. So you better giddy-up!!

First, what is Section 1557?

Section 1557 of the ACA provides that an individual shall not, on the basis of race, color, national origin, sex, age, or disability, be

  • excluded from participation in,
  • denied the benefits of, or
  • subjected to discrimination under

all health programs and activities that receive federal financial assistance through HHS, including Medicaid, most Medicare, student health plans, Basic Health Program, and CHIP funds; meaningful use payments (which sunset in 2018); the advance premium tax credits; and many other programs.

Section 1557 is extremely broad in scope. Because it is a federal regulation, it applies to all states and health care providers in all specialties, regardless the size of the practice and regardless the percentage of Medicare/caid the agency accepts.

HHS estimates that Section 1557 applies to approximately 900,000 physicians. HHS also estimates that the rule will cover 133,343 facilities, such as hospitals, home health agencies and nursing homes; 445,657 clinical laboratories; 1300 community health centers; 40 health professional training programs; Medicaid agencies in each state; and, at least, 180 insurers that offer qualified health plans.

So now that we understand Section 1557 is already effective and that it applies to almost all health care providers who accept Medicare/caid, what exactly is the burden placed on the providers? Not discriminating does not seem so hard a burden.

Section 1557 requires much more than simply not discriminating against your clients.

Section 1557 mandates that you will provide appropriate aids and services without charge and in a timely manner, including qualified interpreters, for people with disabilities and that you will provide language assistance including translated documents and oral interpretation free of charge and in a timely manner.

In other words, you have to provide written materials to your clients in their spoken language. To ease the burden of translating materials, you can find a sample notice and taglines for 64 languages on HHS’ website. See here. The other requirement is that you provide, for no cost to the client, a translator in a timely manner for your client’s spoken language.

In other words, you must have qualified translators “on call” for the most common 15, non-English languages in your state. You cannot rely on friends, family, or staff. You also cannot allow the child of your client to act as the interpreter. The clients in need of the interpreters are not expected to provide their own translators – the burden is on the provider. The language assistance must be provided in a “timely  manner. “Further, these “on call” translators must be “qualified,” as defined by the ACA.

I remember an English teacher in high school telling the class that there were two languages in North Carolina: English and bad English. Even if that were true back in 19XX, it is not true now.

Here is a chart depicting the number of non-English speakers in North Carolina in 1980 versus 2009-2011:

languages

As you can see, North Carolina has become infinitely more diverse in the last three decades.

And translators aren’t free. According to Costhelper Small Business,

Typical costs:
  • Interpreting may take place in person, over the phone or via video phone.
  • In-person interpreters typically cost $50-$145 per hour. For example, American Language Services offers interpreters starting at $100 per hour (or $125 for sign language) and a two-hour minimum is required.
  • Phone interpreters typically cost $1.25-$3 per minute. Language Translation, Inc. offers a flat fee of $1.88 per minute for phone interpreting, for example.
  • Video interpreters typically range from $1.75 to $7 per minute. For instance, LifeLinks offers video interpreting from $2.25 per minute for any language and $2.95 for sign language. A 15-minute minimum is common for phone or video interpreting.

It seems likely that telehealth may be the best option for health care providers considering the cost of in-person translations. Of course, you need to calculate the cost of the telehealth equipment and the savings you project over time to determine whether the investment in telehealth equipment is financially smart.

In addition to agencies having access to qualified translators, agencies with over 15 employees must designate a single employee who will be responsible for Section 1557 compliance and to adopt a grievance procedure for clients. Sometimes this may mean hiring a new employee to comply.

The Office of Civil Rights (“OCR”) at HHS is the enforcer of Section 1557. OCR has been enforcing Section 1557 since its inception in 2010 – to an extent.

However, expect a whole new policing of Section 1557 now that we have the Final Rule from HHS.

What is the Stark Law? And Why Is It Important to You?

It seems apropos that a US Congressman was named Pete Stark who first sponsored what came to be known as the Stark law, because the Stark law mandates stark penalties for financially driven physician referrals. Get it? Cheesy, I know.

The Stark law (42 U.S.C. 1395nn) prohibits physician referrals of designated health services (DHR) for Medicare and Medicaid if the physician has a financial interest with the “referred to” agency.

For example, Dr. Goneril is an internist. As an investment, he and his partner, Dr. Regan open a local laboratory “Gloucester” and hire Mr. Lear to run Gloucester. Drs. Goneril and Regan are silent partners. Dr. Goneril orders blood work on Patient Cordelia and refers her to Gloucester.

The above example would be a direct violation of the Stark law.

The penalties are severe. If caught, Dr. Goneril would have to repay all money received for services in which he referred Cordelia to Gloucester. In addition, he could be penalized $15,000 for every time he improperly referred Cordelia, plus three times the amount of improper payment he received from the Medicare/caid program, possible termination from the Medicare/caid program, and penalties of up to $100,000 for every time he tried to circumvent the Stark law.

On the federal level, the Department of Justice, the Center for Medicare and Medicaid Services (CMS), and the Department of Health and Human Services (DHHS) are tasked with enforcing the Stark law.

Recent years have seen the most Stark law violations since its inception and it is only being enforced more and more.

On June 9, 2015, the Office of Inspector General (OIG) issued a fraud alert regarding the Stark law. Investigations since June 2015 has risen significantly.

Here are some recent Stark settlements (for you to understand the severity):

  • Adventist Health System agreed to pay $118.7 million to the federal government and to multiple states.
  • Columbus Regional Healthcare System is paying $25 million.
  • Citizens Medical Center in Victoria, Texas, agreed to pay $21.75 million.

“O, reason not the need! Our basest beggars / Are in the poorest thing superfluous. / Allow not nature more than nature needs, / Man’s life’s as cheap as beast’s.” (King Lear, II, iv).

How do you defend yourself if you are accused of a Stark violation?

First and foremost, hire a qualified health care attorney. There are exceptions to the Stark law which, hopefully, you fall within. Furthermore, there are multiple legal arguments that can abate penalties. You do not always want to settle.There have been a number of agencies, that recently, decided to never settle. Oddly enough, the number of their audits decreased. Maybe the government targets easy money.

“Red Rover, Red Rover, Send Lab Services Right Over!” And How To Self Audit

Medicare is the largest payor of clinical lab services in the nation. Clinical lab services include everything from blood counts to urinalyses, and every letter of the alphabet in between. Lab services are performed by hospitals, independent labs, physicians, or other institutions.

Medicare Part B (which covers lab services) has had increased enrollment over the past few years, but the amount billed to Part B over the past few years has increased at a much higher rate. In other words, the amount of lab services billed to Part B has increased disproportionately to the increase in enrollment. Any number of factors could contribute to this: defensive practice of medicine, more reliance on laboratory testing, more labs…

Regardless, the higher billing amounts in lab services has now won the prestigious award of “Increased CMS Scrutiny!” (sarcasm, people). And the crowd goes wild!!!!

Mid-2014, the U.S. Office of Inspector General (OIG) published a study entitled, “Questionable Billing for Medicare Part B Clinical Laboratory Services.” OIG determined that Medicare allowed $1.5 billion to be paid for claims with questionable billing. It recommended that CMS: (1) review the labs identified with questionable billing and take appropriate action; (2) review program integrity strategies and determine whether such strategies are adequate; and (3) ensure that claims with invalid and ineligible ordering-physician numbers are not being paid.

In normal and expectant government time frames, the “dinosauric beast” has now determined, a little over a year later, that laboratory service claims warrant enhanced scrutiny. And a little over 85 years after its discovery, we finally determine that Pluto isn’t a planet.

CMS zoomed in their lens of scrutiny on lab services multiple times over a decade ago. Each “CMS zoom” resulted in millions and millions of money given to the federal government, which perpetuates the feds to zoom more and more…it’s easy money.

For example, in 2000, OIG issued Project LabScam, which resulted in substantial settlements against Laboratory Corporation of America Holdings, SmithKline Beecham, Met/Path, Damon, Roche, and Allied.

In 2002, OIG found that Medicare incorrectly paid $7.4 million for lab services with invalid ordering UPINs and $15.3 million for lab service claims with inactive ordering UPINs.

What does this mean to providers of lab services today?

It means you need to be prepared for an audit.

When I was young, one of my favorite games was “Red Rover.” Children would grasp arms and form a straight line facing the other team, which was doing the same. I would yell, “Red River, Red Rover, send Holly right over!” At which time, little Holly would be released from her line and prepare to run, full speed, into my line of little kids’ arms. Inevitably, once we saw where Holly was running, we would tighten up our grasps on one another’s arms to prepare for the impact.

Similarly, in preparation for upcoming audits, lab service providers need to tighten up.

How?

The best way to be certain of your risks in a potential audit is to hire a professional consultant or an experienced attorney to review a large sample of your documents. This allows an outsider to provide an unbiased opinion as to your risk. You may have the best billing manager in the world, but, when it comes to a self audit, he or she already believes that his or her documentation is stellar and that the organization of such documents is self evident. Having an outsider audit your records is worth its weight in gold and the best way to tighten up pre-audit.

The second best way to be certain of your risks in a potential audit is to self audit. Even if you hire a consultant or an attorney for a one time, third-party audit, you still want to self-audit multiple times a year. Every now and then you need to kick the old tires.

How do you self audit?

FYI: My general explanation of how to self audit will be appropriate for all health care service provider types. I will describe some more detailed ways to self audit that will be specific to lab services.

In order to self audit, I teach the IAKA method, not to be confused with IKEA.

  • Identify common risks
  • Audit a sample of your documents
  • Keep record of each step of your audit, including findings
  • Act on the findings.

Identify

What are the common red flags in your industry?

For lab services, common red flags may be high average allowed amounts per ordering physician, high percentage of claims with ineligible ordering-physician numbers, high percentage of claims with compromised beneficiary numbers, and high percentage of duplicate lab tests.

Here’s an area to look into that you may not otherwise consider in a self audit: what percentage of your lab clients live outside 100 miles? This may sound hoaky, but I had a lab service client flagged because 92% of the clients resided over 150 miles away. There was a perfectly reasonable explanation for such anomaly, the lab was located in a large, prestigious hospital in a rural area and people came from miles away to the hospital, but the statistic still flagged it.

Another specific item to review is, on average, how much does each physician bill in the laboratory? Do you have 4 physicians who bill, on average, $60,000+ per ordering physician? Because, for an independent lab, that would be very high.

Audit

For the actual self audit, you want to break up the audit into two categories: standards and procedures and document compliance.

For standards and procedures, you are reviewing whether you are properly orienting new hires, the specific training you implement, your criminal background check procedures, HIPAA training, your license renewal processes, your certification renewal processes, etc.

For document compliance, you are reviewing for physician signatures and dates.

NOTE: It is not required, but it is extremely prudent to print the name of the signator underneath all signatures. I have seen auditors ding providers on “physicians not being licensed/credentialed” because the auditor could not read the name of the physician. 

You are also reviewing for medical necessity, eligible ordering-physician numbers, distance the client is to the lab, amount prescribed to that particular client, amount prescribed by that particular physician, whether that test prescribed for the same client within a 12 month period, coding compliance, etc.

Keep Record

It is imperative that you keep meticulous records while you conducting the audits. You want to be able to show an auditor that you caught a mistake and that you implemented a plan of correction to remedy the mistake going forward. And that, in actuality, you remedied the mistake going forward. This documentation is essential for possible defenses to alleged potential overpayments, false claims, and, even, alleged criminal actions. Your documentation skills could be the difference between paying millions in penalties, or, in the extreme case, jail.

Act

I got ahead of myself in the prior section by saying that you need to document the way in which you fix the mistake. But I cannot emphasize it enough. Acting on your findings is important, obviously, but documenting the actions is more important. Ever hear the saying, “If it isn’t documented, it didn’t happen?” Take that as gospel.

Be prepared. Be proactive. Be ready. Tighten up!

Extrapolated Medicaid Audits Continue: Be Proactive! (Or Move to West Virginia)

Extrapolated audits are no fun, unless you work for a recovery audit contractor (RAC).  You get a Tentative Notice of Overpayment (TNO) that says the auditor reviewed 100 dates of service (DOS), found an overpayment of $1,000, so you owe $1 million dollars.  Oh, and please pay within 30 days or interest will accrue…

North Carolina’s 2nd recovery audit contractor (RAC) is ramping up.  HMS had a slower start than Public Consulting Group (PCG); the Division of Medical Assistance originally announced that HMS would be conducting post-payment reviews last October 2012 in its Medicaid Bulletin.  NC’s 1st RAC, PCG came charging out the gate.  HMS has been a bit slower, but HMS is active now.

HMS is performing post-pay audits on inpatient and outpatient hospital claims, laboratory, specialized outpatient therapy, x-ray and long-term care claims reviews.

According to the December 2013 Medicaid Bulletin, the findings for the first group of automated lab reviews were released in early November 2013.  Additional lab reviews are expected to be completed and findings released by late December 2013.  The post-payment reviews are targeting excessive drug screening.

And specialized therapy service providers, you are next on the list!

How will the providers know the results of an HMS post-payment review? Same way as with PCG.  You will receive a Tentative Notice of Overpayment (TNO) in the mail with some crazy, huge extrapolated amount that you supposedly owe back to the state.

If you receive a TNO, do not panic (too much), take a deep breath and read my blog: “You Received a Tentative Notice of Overpayment, Now What?”

Or “The Exageration of the Tentative Notices of Overpayments.”

Remember, most of the post-payment reviews that I have seen have numerous auditing mistakes on the part of the auditor, such as the auditor applying the more recent clinical coverage policies rather than the clinical coverage policy that was applicable to dates of services audited.

DMA Clinical Policy 1S-4 “Cytogenetic Studies“, for example, was recently revised February 1, 2013.  Obviously, an auditor should not apply the February 1, 2013, policy to a service provided in 2012…but you would not believe how often that happens!

So what can you do to be prepared?  Well, realistically, you cannot be prepared for audit ineptness.

But you can be proactive.  Contact your insurance policy to determine whether your liability insurance covers attorneys’ fees for regulatory audits.  It is important to be proactive and determine whether your insurance company will cover attorneys’ fees prior to undergoing an audit.  Because if you find out that your liability insurance does not cover attorneys’ fees, then you can upgrade your insurance to cover attorneys’ fees.  I promise, it is way better to pay additional premiums than get hit with $25,000+ bill of attorneys’ fees.  Plus, if you wait until you are audited to determine whether your liability insurance covers attorneys’ fees and you realize it does not, then the insurance company may not allow you to upgrade your insurance.  The audit may be considered a pre-existing condition.

So…proactiveness  is imperative.  But you can always move to West Virginia…

In a survey of 18 states conducted by the National Conference of State Legislatures (NCSL) and published August 29, 2013, NCSL determined that 10 states use extrapolations with the RAC audits, 7 do not and 1 intends to use extrapolations in the future. (No idea why NCSL did not survey all 50 states).

Delaware, Maryland, New Hampshire, Pennsylvania, Vermont, West Virginia, and Wisconsin do not use extrapolations in Medicaid RAC audits.

So moving to West Virginia is an option too…