IN THIS ISSUE...


FDA OKS FIRST OTC HOME USE HIV TEST KIT

On July 3rd, the Food and Drug Administration (FDA) gave approval to the first over-the-counter (OTC) test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). Developed by OraSure Technologies, the kit allows an individual to collect an oral fluid sample, place it into a vial, and obtain test results within 20-40 minutes. The FDA recommends that tests be confirmed in a medical setting. The Centers for Disease Control and Prevention (CDC) believes that 20 percent of the estimated 1.2 million individuals infected with HIV in the United States are not aware of their condition. For more information regarding the OraSure test, please click here.

URBAN INSTITUTE REPORT INDICATES MANY POOR MAY NOT GET HEALTH INSURANCE

The Urban Institute, a Washington DC think tank, recently issued an analysis of the Supreme Court’s decision regarding the Medicaid expansion provision in the Affordable Care Act (ACA). Under the law, states are required to expand their Medicaid programs to all individuals with incomes up to 133 percent of the poverty level. The federal government then would pay 100 percent of the additional costs for the first three years, gradually reducing the federal-state cost share agreement to a 90-10 split.

Although the federal subsidies are generous, many states have complained about the long-term costs of this change. Under ACA, if they fail to comply with the directive, they lose all Medicaid funding. The Supreme Court found the coercive nature of this provision unconstitutional, and gave states the option of expanding their programs, or not expanding. Five states (affecting more than four million people), Iowa, Florida, Louisiana, Texas and Wisconsin have already stated that they will not participate in the expanded program.

The repeal of the expansion provision has exposed a flaw in ACA, i.e. the health care law does not provide federal subsidies to individuals under the poverty level to purchase insurance. Therefore, those individuals who do not receive Medicaid will have to purchase insurance using only their own funds. The Urban Institute reports that nearly 18 million individuals, classified as poor, fall into this gap. The Urban Institute’s state-by-state analysis is available on its Web site.

PRESIDENT SIGNS USER FEE LAW

On July 9th, President Obama signed into law the Food and Drug Administration Safety and Innovation Act, extending, for another five years, the medical device user fee which helps fund the agency’s review of medical device submissions. The agreement, supported by AdvaMed, also includes a number of innovations, particularly streamlining the de novo process. A copy of the law will soon be available on the Government Printing Office Web site. In the interim, if you want to see the final text, go to the congressional Web site, THOMAS, here, and search for S.3817.

HOUSE VOTES TO REPEAL HEALTH CARE REFORM…AGAIN

On July 11th, the House of Representatives passed legislation, H.R.6709, to repeal the 2010 Affordable Care Act (ACA), extending health care coverage to 30 million Americans. The vote of 244-185 was largely partisan with all Republicans and five Democrats supporting the repeal. Speaker John Boehner (R-OH) urged passage of the bill arguing that the law “is making our economy worse, driving up costs and making it harder for small businesses to hire new workers.” The Republicans passed a similar initiative in January, 2011. According to House Republicans, the recent vote was the party’s 33rd effort to repeal all or part of the law. The Senate is not expected to take up the legislation. For a copy of the legislation, please go to the Web site, THOMAS here.

PFS PROPOSED RULE RELEASED

The Centers for Medicare and Medicaid Services recently released its annual proposed rule suggesting changes to the physician fee schedule (PFS). This year, the proposal addresses the placement of the new molecular pathology codes intended to the replace the ‘stacking’ codes in 2013. CMS prefers to assign all of the molecular codes to either the PFS or clinical laboratory fee schedule (CLSF) rather than splitting them between the two.

According to CMS, it is “concerned that establishing different prices for comparable laboratory services across two different payment systems would create a financial incentive to choose one test over another simply because of its fee schedule placement.” Thus, the agency prefers all tests on a single fee schedule. However, earlier CMS solicitations of the medical and laboratory communities indicated a lack of consensus regarding this approach, since the AMA “concluded that 79 of 101 new molecular pathology codes include work furnished by a physician,” while ACLA indicated that only 32 of the 101 new molecular codes required physician interpretation.

A copy of the PFS proposed rule should be available shortly in the Federal Register Web site here.