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Senators Reveal Parallel, Complementary Efforts To House Cures Bill

Senate health committee chair Lamar Alexander (R-TN) and Sen. Richard Burr (R-NC) on Thursday (Jan. 29) launched the upper chamber's version of the House 21st Century Cures Initiative by unveiling a report identifying areas in need of improvement within FDA and the National Institutes of Health and soliciting feedback from stakeholders on ways to improve drug and medical device development.

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House Republicans plan to reintroduce last year’s Sustainable Growth Rate replacement bill soon, and the House Office of Legislative Counsel is reviewing the bill, Rep. Michael Burgess (R-TX) said Wednesday (Jan. 28) at a Brookings Institution event.

CMS is considering shortening the so-called meaningful use of electronic health record reporting period for 2015, alongside other changes to the program, in a planned proposed rule to update Medicare and Medicaid meaningful use, the agency announced in a blog Thursday (Jan. 29).

Proposals to provide additional resources, including funds for the National Institutes of Health, are still on the table for the House 21st Century Cures draft bill, according to a congressional aide familiar with the issue.

FDA in February will hold the first meeting of its new Pharmacy Compounding Advisory Committee to discuss proposed revisions to the list of drugs that cannot be compounded because they have been found to be unsafe or not effective, as required by the Drug Quality and Security Act.

A federal judge, in a D.C. Circuit Court memorandum opinion unsealed last week, ruled that the Hatch-Waxman Act gives drug makers the right to choose which listed drugs they reference in 505(b)(2) applications but that FDA can look at data on similar drugs without requiring the applicants to reference relevant patents for those drugs.

Senators on both sides of the aisle discussed amendments that would modify provisions of the Affordable Care Act during a Finance Committee markup of the Hire More Heroes Act on Wednesday (Jan. 28), though none were formally added.

Several of the nation’s largest health care systems, insurance plans and employers announced Wednesday (Jan. 28) that they'll put 75 percent of their business into value-based payment arrangements by 2020, which is part of an effort by CMS and the private sector to align the public and private payer systems.

House Energy and Commerce Republicans on Wednesday (Jan. 28) asked HHS to hand over any communications and documents related to potential contingency plans should the Supreme Court rule against the administration in King v. Burwell, a decision that would eliminate subsidies for those who enrolled via Healthcare.gov.