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Wiley Rein's Kirk Nahra Comments on Top Health Care Law Issues for 2011
Health Care Practice co-chair Kirk Nahra discussed the top health law issues for 2011 in a January 6 BNA article. Among the issues facing the industry this year are fraud enforcement, antitrust, health plan regulation and health information. The Patient and Protection and Accountable Care Act (PPACA), which some say could change before the end of 2011, is another issue facing the health care arena. "The health care industry has devoted an enormous amount of resources to understanding and preparing to implement PPACA's substantial new set of programs and policies, but even before most of these programs have begun and their effects felt, there is a possibility that some (or all or most) will be revised or eliminated. So, we are continuing to impose change and new cost (both in dollars and in compliance obligations) without giving these programs any time to evolve or demonstrate if they are working," Mr. Nahra said. "While it is clear that the PPACA efforts will not 'solve' the health care crisis, the question over the next few years is whether we are going to improve the system in any meaningful way or whether we will simply add to the problem by imposing new costs and challenges without waiting to see if there are any benefits," he added.
According to BNA's Health Law Reporter advisory board members, fraud and abuse top the list of health law issues with Mr. Nahra saying that "shifting perspectives on fraud enforcement have created substantial new pressures to generate enormous anti-fraud recoveries, creating significant conflicts of interest in the government, with the need to generate fraud recoveries almost regardless of the basis for these recoveries. This threatens to create a fundamentally unfair approach in the anti-fraud area, where the government's position and leverage-already incredibly strong-are increased significantly while the government's appropriate discretion is challenged by the pressure to generate recoveries." Mr. Nahra cautioned that "economic pressure for fraud recoveries at a time of massive new regulations demanding fundamental change may create an inappropriate pressure to move forward with enforcement even before the kinks have been worked out in the system."
Second on the list for 2011 was antitrust, due in part to an increased emphasis on government enforcement. Mr. Nahra said that antitrust enforcement will be "a real wild card for 2011" and called the government's action against BCBSM a "shot across the bow on health insurer practices." He noted that antitrust policy is "a key consideration in achieving some of the potential benefits of some of the important health care reform ideas, such as ACOs. Therefore, how much antitrust policy evolves over the next year or two will be an important overall component in the health care industry."
Also affecting the health care industry will be health plan regulation. Mr. Nahra noted that health plans "are at the epicenter of the ongoing debate about health care reform and that, while there are challenges facing everyone in the health care industry, the health plan community is facing a full scale attack on its entire way of doing business, a monumental set of new challenges created by PPACA, and the very real possibility that-despite the millions and millions of dollars spent on getting ready for these changes-the system will change yet again because of the political shifts in Washington." He added that "through the 'back door' of the medical loss ratio rules, the health plan industry is facing a new set of aggressive oversight policies that delve into critical details of every aspect of their operations. With new regulation at both the state and federal level, ongoing and perhaps unprecedented change and a less than positive reputation in the public, the health plan industry is facing challenge like none before."
Industry experts have predicted that health information technology such as electronic health records that support the use of health information exchanges (HIEs) will also play a big role in the health care industry for 2011. Mr. Nahra said that health information technology likely is "one of the few possibilities for a 'win-win' in the health care reform debate. Technology can significantly improve overall care, while decreasing costs at the same time." He added that the "goals of using health information technology to improve care and reduce costs will be achieved only if the new electronic exchange systems are built wisely…To date, there is a real concern that the costs of the system are substantially higher than anticipated, progress is much slower, and the emerging regulatory framework threatens to eliminate (or at least reduce dramatically) the possibilities of these benefits actually coming to fruition." Mr. Nahra noted that the "traditional HIPAA framework is evolving, although this evolution so far has been slow and incremental rather than dramatic. While there is no evidence to support the idea that the HIPAA enforcement approach will be significantly different, the government has the tools available to it to engage in substantial enforcement of these rules." "Companies facing HIPAA regulation-particularly business associates who have not previously been subject to regulation-need to understand that the risks in this area are substantial and that it is critical to engage in aggressive overall compliance activities to meet these challenges," he concluded.