PCORI Announces Funding for New CER Studies

The PPACA’s Patient-Centered Outcomes Research Institute (PCORI) announced it is seeking to fund up to eight new or existing Clinical Data Research Networks (CDRNs) to develop the capacity to conduct comparative effectiveness studies in large populations. PCORI will fund the 18-month initiative up to $56 million. The organization will also provide up to $12 million to support up to 18 new or existing Patient-Powered Research Networks (PPRNs) consisting of patients with a single rare or common medical condition who are willing to participate in research and report data that can be shared with other network members. Letters of intent from interested applicants for both programs are due by June 19th.

Vote on CMS Administrator Put on Hold

Although the Senate Finance Committee voice voted the nomination of Marilyn Tavenner to become the Administrator of the Centers for Medicare & Medicaid Services (CMS), Senator Tom Harkin (D-IA) quickly put the nomination on hold pending a conversation with the Administration over the transfer of funds from the PPACA’s Prevention and Public Health Fund to help finance the PPACA navigator program.

Senate HELP Subcommittee Explores Need for More Primary MDs

At a Senate HELP Subcommittee on Primary Health and Aging hearing, a spokesman for the National Association of Community Health Centers (NACHC) testified that the funding for the PPACA’s Teaching Health Centers Graduate Medical Education program (THCGME), which ends in FY 2015, could create a death spiral for the program. He urged that funding be extended for five years or made permanent, or else the primary care residency training programs at community health centers will fall short of being able to support the 2014 class through their graduation. Also, the director of the National Health Service Corps (NHSC) testified that while the number of providers serving in the NHSC is at an all time high, the agency can only fund about 40% of the applications for medical scholarships and loans for primary care physicians, dentists, nurse practitioners and behavioral health providers who agree to practice in underserved areas.

House Hearing on Transparency of Hospital Quality Information

At a House Oversight Subcommittee on Energy Policy, Health Care and Entitlements hearing, the director of surgical quality and safety at the Johns Hopkins Bloomberg School of Public Health testified that runaway costs and the wide variation in medical quality “….calls for measuring hospital performance by tracking patient outcomes.” He referenced an Institute of Medicine (IOM) report that up to 30% of health care spending may be unnecessary and said that making quality information about hospitals more transparent can help improve quality and reduce unnecessary expense. He suggested that making public access a condition of taxpayer funding for over 150 of the existing national outcome registries would be a simple reform that would allow the market to cut waste.

IPPS Payments to Increase in FY 2014

CMS issued a proposed rule under which inpatient prospective payment system (IPPS) payments will increase by 0.8% in FY 2014 for acute hospitals participating in the Hospital Inpatient Quality Reporting (IQR) Program. Non-participating hospitals would receive a 2% reduction in the proposed increase. Of note, the rule said hospital inpatient admissions spanning less than two midnights, less than one Medicare utilization day, would be presumed to be unqualified for payment under Part A (with a possible exception for longer expected stays). In addition a new disproportionate-share hospital (DSH) payment system will be instituted for FY 2014 with only hospitals currently receiving such funding continuing to receive 25% of estimated DSH funding and others being subject to a new formulation based on the amount of uncompensated care incurred.

Rewards for Medicare Fraud Tips

HHS issued a proposed rule under which anyone who discloses information leading to the recovery of Medicare funds would potentially be eligible to receive a reward of 15% of the amount recovered, up to $9.9 million.

CMS Upgrades Emergency Information on Vulnerable Populations

CMS gave notice that eight federal enrollment, long-term care, claims history and Medicare databases will be utilized to help identify medically vulnerable residents during local and national emergencies. Comments are due within 30 days.

HHS Releases Updated Policies to Reduce Health Disparities

The HHS Office of Minority Health released updated voluntary standards to the National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care which include additional policies that relate to socioeconomic status, spirituality, disability, sexual orientation, gender identity and geography.

Senate and House Promote National Drug Tracking Legislation

Senate HELP Committee Chairman Harkin (D-IA), ranking member Alexander (R-TN) and Senators Burr (R-NC) and Bennet (D-CO) announced they will introduce legislation that will “improve patient safety by replacing the patchwork of state product tracing laws with a strong, uniform standard that would ultimately result in electronic, interoperable unit level product tracing for the entire country.” Also, at a House Energy and Commerce Subcommittee on Health hearing which discussed similar track and trace legislation proposed by Reps. Bob Latta (R-OH) and Jim Matheson (D-UT), full committee Chairman Fred Upton (R-MI) said he intends to mark up the legislation in May in an attempt to send final legislation to the President’s desk by the August recess. Democrats raised concerns about federal preemption of existing state regulation of compounding pharmacies and the Director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) testified that the legislation should include requirements to create an interoperable, unit-level drug tracking system which would provide the most protection for patients. Senators Harkin, Alexander and Roberts (R-KS) also released separate draft legislation that sets minimum standards for ingredients used by all compounding pharmacies and that would give the FDA authority to regulate “compounding manufacturers” as pharmacies that produce injectable drugs and ship them across state lines without patient-specific prescriptions from doctors. At a House Appropriations subcommittee hearing, FDA Commissioner Margaret Hamburg said that the FDA needs a stronger, clear regulatory framework for oversight of compounding pharmacies. She also said that the cuts to FDA user fees under sequestration will curtail medical product reviews.

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