Sixth Circuit Upholds Constitutionality of Reform Law

In what is being hailed by some as a big victory for the Obama administration, the U.S. Court of Appeals for the Sixth Circuit June 29th delcared the Patient Protection and Affordable Care Act’s individual mandate provision a valid exercise of congressional authority under the commerce clause (Thomas More Law Center v. Obama, 6th Cir., No. 10-2388, 6/29/11).

The ruling upheld a decision by the U.S. District Court for the Eastern District of Michigan, which refused to enjoin implementation of PPACA after finding the mandate constitutional. The plaintiffs in the case included the Thomas More Law Center, a public interest law firm.

“Today’s ruling is a huge victory for the millions of Americans who are already benefitting from the Affordable Care Act and the millions more who will in the coming years,” according to Eddie Vale, communications director for advocacy group Protect Your Care.

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Haven’t Thought Much About Compliance Lately? The Government Has


It is estimated that health care fraud is a $60 billion a year business fueled by illegal conduct such submitting false claims and paying kickbacks to physicians and suppliers. Until recently, if large health care organizations were the targets of fraud investigations, these companies, as their penance, typically wrote a big check to the government and continued business as usual. Things have changed.

While indicting and convicting health care executives is not a new practice, officials at the Department of Health and Human Services (“DHHS”) and the Department of Justice (“DOJ”) are said to be frustrated with the frequent occurrence of repeat violations and they are ramping up their strategy. Lately there have been aggressive new initiatives rolling out to combat rampant health care fraud and the government is increasingly bringing criminal charges against executives even if they were not complicit in the fraud scheme, but could have stopped it if they had known.

What’s more striking is that in addition to civil monetary penalties and criminal indictments, the government is taking great efforts to exclude convicted executives from being involved in companies that do business with federal health programs. A recent bill introduced to Congress under the name of the “Strengthening Medicare Anti-Fraud Measures Act of 2011 (the “Act”), increases DHHS’ existing powers and allows them to seek to exclude owners, officers and mangers of companies that are convicted of health care fraud from federal healthcare programs even if they left the company prior to any conviction of the entity.

In addition to the expansion of the permissive exclusion afforded by the Act to DHHS, regulators and law enforcement officials are going to be increasingly utilizing current permissive exclusion remedies. DHHS’ bold move appears to be based on the rationale that the permissive authority of Secretary of DHHS or the Office of the Inspector General of DHHS to exclude individuals is a much easier process than criminal proceedings.

The impact of this aggressive new government strategy will likely have even further reaching consequences for convicted healthcare business owners and executives. For instance, an exclusion from being part of a business that works with federal health care programs would be a career ending blow for most executives. It should also be emphasized that smaller organizations are not in any way immune from enforcement activity. In fact, with newly increased enforcement budgets, authorities have the means and the time to target organizations of all sizes.

Law makers and regulators are hopeful that by ramping up the enforcement of existing laws and expanding the scope of DHHS’ power, it will act as a powerful deterrent against overt acts and will compel corporate executives to take proactive steps in preventing fraudulent activities and affirmatively addressing fraudulent practices when discovered. It is vitally important now more than ever, to have an active compliance program in place. A strong compliance program can not only detect and prevent fraudulent or negligent activities but also will typically be considered as a mitigating factor if an organization is culpable of fraudulent activity. The Florida Healthcare Law Firm works with health care organizations of all sizes to assist in the audit, development and implementation of effective compliance programs.


ACOs: The Interview We Want to See

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ACOs are S.T.U.P.I.D

We have probably never seen so much enthusiasm and spending on anything in our history as we are on healthcare reform. The point is to slow spending and improve quality by incentivizing cost-saving, quality-enhancing behavior. And the Accountable Care Organization is the new healthcare delivery model designed to save us from our greedy, over-utilizing selves. Here’s how it works:

First, you take a lot of primary care physicians and tell them they will get more money by (1) taking an expanded role in taking care of patients, and (2) reducing the expenses associated with that care. Then you tell them two really special things: first, you tell them “Uh, since we’re afraid that you will improperly reduce the amount of care the patients need, we won’t tell you which patients are in an ACO and which are not.” Second, you tell them “We really mean it when we tell you that we intend for you to make more money, but we won’t tell you exactly how we’re gonna do that. Trust us, ok?”

Second, you empower physicians to lead the charge. After all, they’re the only participants in ACOs that smart people think can control costs and quality. And you do this by telling them to (1) shell out about $26 Million to form an ACO, (2) go to Wharton and get an MBA, (3) educate themselves about all the intricacies of information technology and work out the kinks involved in implementing electronic medical records, and (4) keep taking care of those patients while you do all this. Finally, you keep the identity of patients secret from the physicians so there is no way to prepare care plans that take into account the diseases faced by the patients. No problem.

Third, you let patients run amok. They can go into an ACO…or not. They can go in and out of ACOs. They’re like kids that way, but they’re responsible for reading the 397 pages of ACO regs and then deciding whether they like the idea of not. Oh, and they have absolutely no incentive to sign up for ACO care. And why would they? “Hey, how about you go with this ACO, which will get more money if they spend less on you. How’s that sound?” How could this possibly be sold to Medicare patients? “This ACO will get paid for getting you well! Your primary care doctor that you’ve trusted for 20 years and who helps you get and stay healthy…that person doesn’t have the same incentive to get you well.” NOT.

Simplicity. There is none. Never before in our history have we seen something so simple (patient rationing) become so complicated (rationing = less expensive care). And so many acronyms and governmental departments and positions too! There are one sided models, two sided models and now a Pioneer model, for those who are especially adventurous. And did I mention that the basis for healthcare reform, the one that only the state of Washington has the courage to articulate, is really just rationing?

Troubling to pretty much everyone. Yes. Except for policy makers, there has yet to be any significant support for anything other than the IDEA that healthcare should cost less and be more outcome oriented. Even the Mayo, Geisinger and Cleveland systems have all politely declined at this point.

Unlimited flexibility. Yes, this is true, especially as it relates to patients. See, patients can be in a cost saving ACO or not. They can go in and out of them and the ACO will bear the cost. That’s right: patients can go in and out of them—ACO, non-ACO, and yet only the ACO will be penalized for cost increases. Let’s see, the ACO model is the cost saving model. And the plan is to allow patients to choose for society to save money or not. And the patients have zero incentives for participating in an ACO. And who is responsible for the behavior of these patients? Uh, well, we all are.

Patient accountability. This is completely lacking in the ACO model. There is absolutely nothing to incentivize patients for making healthy decisions and to punish them for making unhealthy ones. Also primary care driven. Not really. There aren’t enough to go around, but some guy who knows a doctor is free to see you now. Oh, also pro competitive, meaning everyone will wanna be an ACO, so that will create competition in the market and a tremendous drive to drive costs down and quality up. Ok, not really, but wouldn’t it be nice if that COULD happen. In fact, healthcare reform is functioning to do one sure thing—reduce competition, since only the biggest, strongest organizations can afford to compete or to be one.

Inexpensive. Nah. While the initial cost projections suggested about a $2 Million price tag for forming one, they are now up in the $12 to 26 Million range.

Direct and demonstrative. NOT. The entire healthcare reform delivery plan is like pushing a mouse through a maze by its tail.

Healthcare reform is like Alice in Wonderland at its best. It only makes sense on mind-altering drugs. Moreover, the shizo message from our policymakers on the whole issue is dumbfounding. “We are committed to lowering healthcare costs. ACOs will do this. Patients can be in them…or not.” Some legislators think they’ve created a panacea with ACOs, but then don’t want to compel them. It’s just political nonsense.

Look, slowing healthcare cost creep and quality enhancement are good things. We all (patients included) ought to be outcome driven and focused so that the end result is actually healthcare. ACOs just don’t and won’t do that, which may have something to do with the recent announcement by Mayo, Cleveland and Geisinger that they’re really not that interested in playing with them.


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