The Centers for Medicare and Medicaid Services (CMS) late Thursday decided to abandon a pilot plan that aimed to lower Medicare pharmaceutical spending. The Part B Drug Payment Model , first unveiled in March, would have tested whether alternative drug payment designs will lead to a reduction in Medicare expenditures. CMS said in a statement on Friday to Focus : "After considering comments, CMS will not finalize the Medicare Part B Drug Payment Model during this Adm...

A pilot program intended to reduce the time between clearance and Medicare coverage for innovative medical devices will continue on indefinitely, the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) announced on Friday. The program, known as parallel review, allows device makers to request a simultaneous, overlapping review by the two agencies with the goal of reducing the time between receiving a pre-market approval (PMA) or t...

The US Food and Drug Administration (FDA) on Tuesday released new draft guidance to clarify difficulties in categorizing investigational medical devices for Medicare coverage, just two days before a memorandum of understanding is set to take effect between FDA and the Centers for Medicare and Medicaid Services (CMS). While an agreement has been in place between the two agencies for more than two decades, FDA says it has run into issues with some devices not easily fittin...

Senators Elizabeth Warren (D-MA) and Charles Grassley (R-IA) questioned the Centers for Medicare and Medicaid Services' (CMS) opposition to incorporating the unique device identifier (UDI) for medical devices into insurance claims forms. By not adding UDIs to insurance claims forms, Warren and Grassley warn that Medicare is making it more difficult to monitor device safety, which has resulted in millions of claims that could have been avoided with better monitoring. In ...

Policy solutions to bring down the rising tide of prescription drug prices should be included in next year’s budget, eight senators said in a letter sent to President Barack Obama on Tuesday. Examples of ways Obama could help to lower drug costs include requiring drugmakers to provide rebates on prescriptions for Medicare Part D low-income subsidy enrollees “in the same way that it does already for Medicaid recipients,” the senators said, noting that about $120 billion c...

Rep. Jan Schakowsky (D-IL) on Thursday introduced a new bill that would allow the Department of Health and Human Services (HHS) secretary to negotiate Medicare Part D prices for either sole-source drugs or biologics and are not manufactured by more than two drug companies. Under the bill, drug manufacturers and the secretary would have 90 days to negotiate the price of a drug covered by Medicare Part D. If the two parties fail to reach an agreement after the allotted tim...

Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco. Although the majority of OIG’s work is tied to the oversight of Medicare and Medicaid fu...

The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of its time and resources to investigating several programs run by the US Food and Drug Administration (FDA) during 2013. OIG's plans were revealed on 2 October in the release of its Fiscal Year 2013 Work Plan , a 123-page document detailing the basic outline of its investigati...

A decision by the US Centers for Medicare & Medicaid Services (CMS) to cover transcatheter aortic valve replacement (TAVR) procedures for patients enrolled in Medicare is among the first under an October 2011 memorandum of understanding with the US Food and Drug Administration (FDA). "This decision is particularly important as it highlights cooperative efforts among CMS, FDA, the Agency for Healthcare Research and Quality, medical specialty societies and the medica...

US government officials are looking to clamp down on regulatory violations by the pharmaceutical industry-which has already paid $8 billion in fines over the last decade-by going after individuals within the companies more aggressively, reports USA Today. The US Department of Justice, in particular, is ramping up its use of the Park Doctrine-a legal doctrine that holds individuals within a company responsible for the actions of a company. Senator Chuck Grassley (R-IA) ...

Differences in the regional cost of Medicare Part D plans have long confounded health economists, even if their basic causes are generally known. A new study by the RAND Corporation published in the New England Journal of Medicine claims to have isolated those basic causes and determined their respective effects on price differences . RAND analyzed the Medicare claims data of 4.7 million beneficiaries using three popular drug categories-statins, antidepressants and st...

The Fiscal 2013 federal budget released on 13 February by the Obama administration laid out more than just the proposed spending levels for dozens of federal agencies, including the US Food and Drug Administration (FDA). Buried in the several-hundred page budget document are indications that the Obama administration intends to forcefully move against 'pay-for-delay' settlements that the Federal Trade Commission (FTC) considers to be "anticompetitive," biologic exclusivity...