¶ … appease the allegation that medical errors beset the healthcare industry and generate major risk to patients. As with any matter posing a potentially significant impact on a population, the government has a sizable interest. Lately, the government decided to take action toward enacting quality of care and patient protection regulation. In an optimal setting, this would appear easy to execute, but reality indicates such top-down regulatory answers to health care quality and patient safety lead to negative domino effects, including increased health care costs, unforeseen conflicts with pre-existing regulation, and decline of provider self-governance. Regulation carries its weight in gold through its function ratio of benefits to costs. In regards to the cost side of the equation, it includes costs to the government, consumers, and regulated entities. A study conducted in 2002 to assist research in understanding the estimated comprehensive value of health care regulation found the figures led to a net cost of $169 billion as of 2002. "Of that total, the study projected quality-related governmental oversight ran an estimated $51.6 billion but only returned an estimated benefit of $30.1 billion -- thereby contributing a projected $21.5 billion, or 13%, to the overall net fiscal burden of health care regulation" (Mekel, 2010, p. xx-xx ). In regards to how net cost was determined: "the questions concern compliance costs in relation to benefits obtained, transaction costs associated with regulatory administration and enforcement, and unanticipated or unwanted responses on the part of the regulated industry"(Mekel, 2010, p. xx-xx) .

Regulation in an already heavily regulated area only leads to higher costs as shown by the data represented in the study. Regulations sometimes lead to high individual adherence costs, particularly organization attempt to comply with existing regulations that conflict with new ones. This conflict often results in one preventing the other from achieving their intended benefit. So instead of better compliance with the previous and current regulations, additional regulation only leads to conflict of compliance, reduction in compliance,...

Health care is a field where compliance failures and regulatory inflation exist due to the "fragmented jurisdiction among federal, state, and local governments" (Ellig, 2012, p. xx-xx) . In fact, constant additions of convoluted regulations produce regulatory overburden and uneven enforcement. Lack of research on effectiveness of such regulations leads to an inability to improve the current state of certain areas in healthcare such as Medicare Home-Based Care programs.
As stated by American Association for Homecare (2011), one of the most ineffective Medicare regulations for home-based care is the controversial Medicare "competitive" bidding program. Its implementation began January 1, 2011 in 9 large metropolitan-based regions: Charlotte, Cincinnati, Cleveland, Dallas-Fort Worth, Kansas City, Miami, Orlando, Pittsburgh, and Riverside, California. An additional 91 regions were applied later that year. As the letter states: "The bidding program will affect millions of Medicare beneficiaries who require oxygen therapy, enteral nutrients (tube feeding), continuous positive air pressure (CPAP) and respiratory assistive devices, power wheelchairs, walkers, hospital beds and support surfaces, and mail-order diabetic supplies"(Teichert, 2013, p. xx-xx) . The Medicare Program led to the severe restriction of which companies could provide the equipment and services subject to bidding. Since the bidding program began everyone within the bidding sphere, clinicians, patients, etc., have had trouble acquiring providers for equipment and supplies.

The case of American Associates for Homecare v. Kathleen Sebelius, case number 1:13-cv-00922, in the U.S. District Court for the District of Columbia addresses the problems faced in the Medicare bidding program and demonstrates the difficulties such regulations put on the healthcare field. The program led the company to non-compliance as they received contracts from companies that failed to meet licensing requirements. "U.S. District Judge Beryl A. Howell denied the American Association for…