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CMS Oncology Care Model Updates & FDA Public Meeting to Discuss Off-Label Drug Promotion


IP Blog | Dave Melin | May 10, 2015

BioBlog Weekly oncologyThis week in healthcare, the May 7th deadline passed for Oncology Care Model provider Letters of Intent, and some ACCC members may still be on the fence about participating in OCM.

Oncology Care Model: Updates from CMS

As providers continue through the final stages of the application process for CMS’s new Oncology Care Model program, some questions still remain. Here, ACCC sums up CMS’s answers to three of those questions, dealing with performance benchmarking methodology, payer collaboration, and the financial feasibility of the monthly fee.

FDA to Hold Public Meeting on Off-Label Drug Promotion

As a part of Congress’s 21st Century Cures initiative, the FDA plans to hold a public meeting this summer to “address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech.”

Drugmaker Sues F.D.A. Over Right to Discuss Off-Label Uses

There is much disagreement about whether it is appropriate for drugmakers to discuss potential off-label uses with physicians. In pursuit of this right, Amarin Pharma has lodged a preemptive lawsuit against the FDA, “arguing that it has a constitutional right to share certain information about its product with doctors, even though the agency did not permit the company to do so.”

King v. Burwell: What the Supreme Court Decision Will Mean for Providers

At a recent panel discussion, experts discussed the possible outcomes of the impending Supreme Court decision about federal ACA subsidies. The impacts will depend on which of three options the court chooses: “Either the court will rule the subsidies are legal, they are illegal but there is flexibility, or they are legal and there is no flexibility.”

New Cancer Drugs Are Expensive, But Price Controls Are Misguided

A recent piece on 60 Minutes argued that manufacturers are to blame for high cancer drug costs. But, as this Forbes piece rebuts, “ They allege that the pharmaceutical industry’s claim to innovate is bogus, because its “marketing” expenditures outweigh those for research. They deny the difficulty and expense of drug development and advocated a medieval notion of “just” pricing.”

Insurers Might Lose Millions of Medicaid Members

Although 15 million Americans have gained health care coverage through the ACA, that number may be about to shrink: “Federal law requires that states verify each year whether Medicaid recipients remain eligible for the program, but many have failed to do so,” which means that many recipients may now be ineligible.

Company Creates Bioethics Panel on Trial Drugs

With breakthrough drugs, sometimes there is a supply and demand problem: there are limited spots in the clinical trials for the many people who could potentially benefit from the treatment. To deal with this issue, Johnson & Johnson will convene an ethics panel to decide who will be the first to receive access to their new drugs.

Court Blocks Novartis Copy of Amgen Cancer-Care Drug

The first FDA-approved biosimilar drug is stuck after a court challenge: “A U.S. appeals court has blocked Novartis AG from selling its knockoff version of an Amgen Inc. cancer supportive-care drug in the U.S. until the court resolves a legal fight between the rivals.” Arguments are scheduled for June 3rd.

CMS Finalizes 2016 Payment and Policy Updates For Medicare Health and Drug Plans

CMS has released its final Medicare Advantage (MA) and Part D Prescription Drug program changes for 2016. While the changes will have different effects on different plans, “on average, the expected revenue change is 1.25% without accounting for the expected growth in coding acuity that has typically added another 2%.”

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