The President and some members of Congress have proposed requiring that prescription drug manufacturers pay rebates to the federal government for drugs dispensed to Medicaid/Medicare dual-eligible beneficiaries and other low-income seniors through the Medicare Part D program. (The required rebates would be in addition to the manufacturer-paid rebates already in the Part D program due to the market-based negotiations between manufacturers and Part D plans).
The United States faces a daunting budgetary outlook. To avert an impending debt crisis, policymakers must tackle the unsustainble growth in entitlments in general, and Medicare spending in particular.
The Patient Protection and Affordable Care Act (PPACA), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biologic products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biologic product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act).
Formed under the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, generic drugs have garnered attention in the health care spotlight. With almost two thirds of all prescriptions filled by generic drugs, the Generic Drug User Fee Act (GDUFA) is slated to be authorized by Congress before the start of fiscal year 2013.
Wednesday evening the House of Representatives voted 267-159 on the Fiscal Responsibility and Retirement Act of 2011 (HR1173), which repealed the Community Living and Assistance Services and Supports (CLASS) Act. The CLASS Act is the program created by the Patient Protection and Affordable Care Act (PPACA) that provides voluntary, long-term care. CLASS was incorporated in PPACA as budgeting trick to make the bill appear fiscally sound and solvent.
Researchers from Indiana University’s Kelley School of Business released a report about the sources of job creation in Indiana entitled “Where the Jobs Are.” The authors found that small businesses, which they define as fewer than 50 employees, are crucial in creating net job gains for the state. Many of these small “homegrown” businesses they studied grew beyond 50 employees but remain relatively small.
One of Sen. Ted Kennedy’s long-standing goals was the establishment of a federal program for long-term care for the infirm and disabled. This goal was – apparently – achieved posthumously when his Community Living Assistance Services and Supports (CLASS) Act was incorporated into the Patient Protection and Affordable Care Act (PPACA).
While most of the public debate on the constitutionality of the health reform law has centered on the “individual mandate” – the requirement to obtain government-approved health insurance or pay a penalty – the Supreme Court has also agreed to consider another, far less discussed issue: whether the law’s expansion of Medicaid eligibility might be an unconstitutional federal infringement on state legislative authority.
