The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.
Peter Johnson
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The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.
Topics: Industry Trends, Market Access, Product Release, Data & Analytics
Radar On Market Access: Interoperability Mandate Could Be an Opportunity for Payers
Posted by Peter Johnson on Apr 8, 2021
Payers should look at the looming interoperability mandate as a chance to gain a lasting advantage over their competitors, according to two health care information technology (IT) experts.
In a March 26 webinar hosted by America's Health Insurance Plans (AHIP), IBM Vice President Michael Curry of Watson Health and Jeff Rivkin, research director for payer IT strategies at IDC Insights, said payers should do more than meet the minimum interoperability standards, AIS Health reported.
Topics: Industry Trends, Data & Analytics, Payer
Cigna's Evernorth health services arm announced on Feb. 26 that it had reached an agreement with MDLive to acquire the virtual care provider, according to MDLive's website. MDLive has been available in-network as a primary care option to all members of Cigna's commercial plans since January 2020.
Topics: Industry Trends, Data & Analytics, Payer
Radar On Market Access: PBM Regulation, Rebate Rule Are High on Legislative Agenda
Posted by Peter Johnson on Apr 1, 2021
As a new bill introduced by Sen. Bernie Sanders (I-VT) indicates, Congress is once again looking seriously at tackling drug pricing reform. D.C. insiders say that Democrats could pursue big changes to PBM regulation and Medicare's ability to negotiate drug prices, AIS Health reported.
Also, Congress could repeal the Trump administration’s so-called "rebate rule," which would have removed safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs and Medicare Part D plans.
Topics: Industry Trends, Market Access, Payer
Radar On Market Access: Orphan Drug Act Has Been Overused, A New Study Shows
Posted by Peter Johnson on Mar 18, 2021
A new study published in Health Affairs found that spending in the orphan drug category is overwhelmingly concentrated on so-called partial orphan drugs, which have both orphan and nonorphan indications. The study affirms growing concerns across the health care industry that drugmakers are misusing the orphan drug designation and introducing unwarranted cost into the drug channel, AIS Health reported.
The Orphan Drug Act of 1983 covers diseases that affect fewer than 200,000 people in the U.S., plus diseases that affect more than 200,000 people but are so expensive to treat that companies developing and marketing such therapies are not expected to recover their costs. With the designation, the FDA grants drugmakers expanded intellectual property and commercial rights intended to offset these steep costs.
Topics: Specialty, Industry Trends, Product Release, Data & Analytics
Radar On Market Access: Cigna's Evernorth to Acquire MDLive in Telehealth Expansion
Posted by Peter Johnson on Mar 11, 2021
Health insurers have begun to consolidate their position in the telehealth market, as indicated by a recent move by Cigna Corp. to acquire MDLive Inc. Meanwhile, lawmakers are beginning to consider the future of telehealth regulation and payment, AIS Health reported.
Cigna's Evernorth health services arm announced on Feb. 26 that it had reached an agreement with MDLive to acquire the virtual care provider, according to MDLive's website. MDLive has been available in-network as a primary care option to all members of Cigna's commercial plans since January 2020.
Topics: Industry Trends, Data & Analytics, Payer
The Biden administration will suspend implementation until 2023 of the so-called "rebate rule," a Trump administration regulation that would have revamped the Medicare prescription drug rebate system, and DC insiders expect the regulation will be repealed by Congress before then. Meanwhile, a growing number of PBMs that deal in the commercial market have pitched plan sponsors on a 100% pass-through rebate structure, in which the PBM collects its compensation through a fee or surcharges rather than diverting a share of rebate revenue.
Topics: Industry Trends, Data & Analytics
Radar On Market Access: Pass-Through Rebate Models Need to Demonstrate Value
Posted by Peter Johnson on Feb 18, 2021
With the Trump administration's rebate rule delayed and possibly slated for repeal by Democrats in Congress, major changes in how the PBM industry distributes rebate revenue will have to come from the private sector, AIS Health reported.
The Biden administration will suspend implementation until 2023 of the so-called "rebate rule," a Trump administration regulation that would have revamped the Medicare prescription drug rebate system, and DC insiders expect the regulation will be repealed by Congress before then. Meanwhile, a growing number of PBMs that deal in the commercial market have pitched plan sponsors on a 100% pass-through rebate structure, in which the PBM collects its compensation through a fee or surcharges rather than diverting a share of rebate revenue.
Topics: Industry Trends, Market Access, Payer
Radar On Market Access: Though Care Utilization Rebounds, Insurers Still Face Uncertainty in 2021
Posted by Peter Johnson on Jan 28, 2021
Since the start of the COVID-19 pandemic, the managed care industry has wrestled with how to project utilization of normal care and assess the risk of funding care related to the virus. While insurers generally seem to be in good financial shape, experts say that plans face continuing uncertainty, AIS Health reported.
In the early days of 2021, the U.S. confronted a grim milestone when the tally of Americans who died from COVID-19 reached 400,000.
Topics: Industry Trends, Data & Analytics, Payer
Surprise billing, also known as balance billing, is the practice of charging patients for out-of-network procedures that insurers refuse to pay for in whole or in part. Often, patients incur these balance bills without their knowledge. The new legislation would ban providers from sending such a bill to patients, and would instead require providers to negotiate reimbursement with the patient's insurer or submit the dispute to a binding arbitration process.
Topics: Industry Trends, Provider, Payer