This post was written by Paul Sheives and Areta Kupchyk.

The FDA and CMS have entered into a Memorandum of Understanding (MOU), effective June 25, 2010, to promote collaboration and enhance knowledge and efficiency by sharing information and expertise. In particular, the MOU highlights the agencies’ “common needs for evaluating the safety, efficacy,

CMS has announced that it is not implementing at this time changes that would have automatically rejected certain Medicare claims based on orders, certifications, and referrals made by providers that have not had their PECOS enrollment applications approved by July 6, 2010. Nevertheless, the Affordable Care Act provides that only a Medicare enrolled physician or

The ACA provides a tax-free, one-time $250 check for beneficiaries who reach the Part D coverage gap during 2010 and are not eligible for low-income subsidies. A June 10, 2010 CMS memo to Part D plan sponsors provides additional information on implementation of coverage gap rebate. The memo notes that prompt submission of prescription drug

CMS has issued a series of guidance documents on the Medicare Secondary Payer (MSP) mandatory reporting provisions in section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA). The new guidance documents address: risk management write-offs by providers, physicians, suppliers, and non-provider/supplier entities; reporting health reimbursement arrangements; what entities are MMSEA Section

CMS’s Office of Legislation has released preliminary questions and answers on the ACA’s provisions to encourage the development of Accountable Care Organizations (ACOs) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare beneficiaries and reduce unnecessary costs. Participating ACOs that meet specified quality performance standards will be eligible to

CMS is soliciting state applications for the “Multi-payer Advanced Primary Care Practice Demonstration,” under which Medicare and Medicaid, along with private insurers, will join together in state-based efforts to improve the delivery of primary care and lower health care costs. HHS describes an Advanced Primary Care (APC) practice, also referred to as a patient-centered medical

CMS is hosting a Special Open Door Forum May 19, 2010 to discuss a variety of Medicare provider enrollment issues. Topics to be covered include: CMS’s May 5, 2010 interim final rule on Medicare/Medicaid provider and supplier enrollment, ordering and referring, and documentation requirements; and changes in provider agreements; internet-based Provider Enrollment, Chain and

CMS has issued guidance to State Medicaid Directors on the Medicaid prescription drug rebate provisions of the Patient Protection and Affordable Care Act (PPACA). Specifically, the letter addresses the increased rebate percentages for covered outpatient drugs dispensed to Medicaid patients, the extension of prescription drug rebates to covered outpatient drugs dispensed to enrollees of

On April 26, 2010, HHS published its semiannual regulatory agenda outlining its planned regulatory initiatives in a number of health policy areas. Among other things, the agenda includes listings for Office of the Secretary health information technology rules, a variety of Food and Drug Administration (FDA) regulatory actions involving prescription drugs, and CMS regulations updating Medicare

President Obama has nominated Dr. Donald Berwick to be CMS Administrator. Dr. Berwick currently serves as President and CEO of the Institute for Healthcare Improvement, and is a professor at Harvard Medical School and the Harvard School of Public Health. Among many other appointments, Dr. Berwick has served as Chair of the National Advisory Council

A number of recent Congressional hearings focused on health policy issues, including the following:

  • A Senate Homeland Security and Governmental Affairs Committee hearing on CMS contract management.
  • A Senate Aging Committee hearing on “Aging in Place: The National Broadband Plan and Bringing Health Care Technology Home.”
  • A Senate Health Education Labor and Pensions Committee hearing