Patient Access to Lab Results

HHS released proposed regulations that would modify the restrictions under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the PPACA and allow patients or their representatives to have direct access to laboratory test results.  Comments are due in 60 days.

MA Rates for 2012

Refuting critics that the PPACA reductions in payments to Medicare Advantage plans will lead to disruption, CMS announced that MA enrollment for 2012 is expected to increase by 10% and that monthly premiums are expected to decline by an average of 4%.

Grants to Community Health Centers for IT

HHS announced it has awarded nearly $8.5 million in PPACA grants to 85 community health center programs for use in adopting information technologies.

Notice on Use of Identifiable Patient Data in ACO Program

CMS issued notice that it is establishing a new system of records that will contain personally identifiable information (PII) about individuals who participate in or whose information is used to determine eligibility of an Accountable Care Organization to receive enhanced payments under the Medicare Shared Savings Program.  The new system will come online October 19th.

FDA Issues: Senate HELP Committee Hearing on Imported Drugs

At a Senate HELP Committee hearing, Chairman Tom Harkin committed to acting next year to improve the FDA’s inspection of foreign drug manufacturers and secure the drug supply chain, most likely as part of the reauthorization of the funding for the FDA’s drug review process.  However, he emphasized that any approach to improving the security of the supply chain could not cost too much money.

Recently Introduced Health Legislation

H.R. 2112, making appropriations for Agriculture, Rural Development, Food and Drug Administration, and related agencies programs for the fiscal year ending Sept. 30, 2012, with an amendment in the nature of a substitute. (S. Rept. No. 112-73).

S. 1553 (VETERANS’ HEALTH), to amend the Public Health Service Act to facilitate emergency medical services personnel training and certification curriculums for military veterans; KLOBUCHAR; to the Committee on Health, Education, Labor, and Pensions, Sept. 14.

S. 1560 (LONG-TERM CARE), enhance access to controlled substances for residents of institutional long-term care facilities, and for other purposes; KOHL; to the Committee on the Judiciary, Sept. 14.

H.R. 2925 (MEDICARE), to establish a smart card pilot program under Medicare; GERLACH; jointly, to the committees on Ways and Means and Energy and Commerce, Sept. 14.

H. CON. RES. 78 (DISEASE AWARENESS), supporting the goals and ideals of Sickle Cell Disease Awareness Month; DAVIS of Illinois; to the Committee on Education and the Workforce, Sept. 14.

S. 1573 (APPROPRIATIONS), making appropriations for financial services and general government for the fiscal year ending Sept. 30, 2012, and for other purposes; from the Committee on Appropriations; DURBIN; placed on the calendar, Sept. 15.

H.R. 2939 (DRUGS), to provide for the disposal of drugs pursuant to national pharmaceutical stewardship programs, and for other purposes; SLAUGHTER; jointly, to the committees on Energy and Commerce and Ways and Means, Sept. 15.

H.R. 2951 (STEM CELL RESEARCH), to intensify stem cell research showing evidence of substantial clinical benefit to patients, and for other purposes; FORBES; to the Committee on Energy and Commerce, Sept. 15.

H.R. 2954 (MINORITY HEALTH), to improve the health of minority individuals, and for other purposes; LEE; jointly, to the committees on Energy and Commerce, Ways and Means, Education and the Workforce, the Budget, Veterans’ Affairs, Armed Services, Agriculture, the Judiciary, and Natural Resources, Sept. 15.

H.R. 2960 (DIABETES), to amend the Public Health Service Act to foster more effective implementation and coordination of clinical care for people with pre-diabetes and diabetes; OLSON; to the Committee on Energy and Commerce, Sept. 15.

H.R. 2961 (DEFICIT REDUCTION), to amend the PPACA to have Early Innovator grant funds returned by states apply toward deficit reduction; POMPEO; to the Committee on Energy and Commerce, Sept. 15.

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