Curbs on pharma
Yet, there's unlikely to be any budget deal without reducing both public and private outlays for US healthcare, and drug prices
and reimbursement are a prime target. Prior to the election, the Obama administration proposed to curb Medicare spending largely
by reducing fraud and abuse and adopting reimbursement models that pay more for quality care. Now there's more talk about
raising the eligibility age to 67, increasing the Part B premium and reducing utilization of new technology. And House Democrats
have pressed for added rebates on drugs purchased by Medicare drug plans for low-income "dual-eligible" seniors, which could
total more than $100 million over 10 years.
Counterfeits and Compounders
Outlays for drugs face challenges on all sides, including proposals to reduce spending on pharmaceuticals by federal employees
and other federal health programs. The White House further proposes to save money by ending "pay-for-delay" generic-brand
patent settlements and by limiting the exclusivity period on data for biotech therapies from 12 years to seven years. Some
pharma critics are pressing for longer expiration dates on drugs to reduce waste and spending. Others champion academic detailing
to disseminate findings from comparative effectiveness studies more objectively to providers. Payers and plans have taken
aim at pharma co-pay coupons as a scheme to build patient demand for new, more costly medicines.
More transparency in drug prices and reimbursement, moreover, could steer providers and patients to less costly medicines,
using tiered co-pays and benefit designs to influence choices. Expensive specialty medicines are a prime target, as seen in
the recent campaign against the price for colorectal cancer treatment Zaltrap by physicians at Memorial Sloan-Kettering Cancer
Center. Sanofi responded with 50 percent discounts for private payers, according to The Cancer Letter, a case that promises to encourage more physician and patient involvement in drug pricing issues.
Budget-cutting also threatens FDA and NIH initiatives. An 8.2 percent cut in the FDA budget, as proposed under the budget
sequestration process, would reduce FDA's 2013 budget by $320 million and prompt the agency to lay off some 1000 employees,
according to consultant Steven Grossman. And proposals to reduce NIH funding, which range from about $2.5 billion under sequestration
to some $4 billion, would eliminate more than 2000 research grants and jeopardize the pace of new drug and biotech discovery,
just as a number of R&D initiatives are helping to fill depleted new drug pipelines.
New payment models
A related concern is that serious budget-cutting will slow ACA implementation and discourage states from building insurance
exchanges and expanding Medicaid programs. HHS has revved up its rule-writing operation to meet multiple deadlines for establishing
exchanges and defining regulations and benefits. Many state governors and legislatures have been reluctant to commit to new
ACA programs amidst political uncertainty. HHS responded by giving states extra time to submit plans for establishing their
own exchanges, and more time to decide whether to "partner" with the feds on this operation. But continued talk about cutting
promised premium subsidies and extra Medicaid funds makes states nervous about future support for new health programs.
The challenge for the second Obama administration is to determine whether Washington can work with states to establish and
operate exchanges, and if this and other initiatives will succeed in extending coverage to millions of uninsured. Pressure
to reduce healthcare expenditures at the same time will require a shift to pay for value vs. volume, notes Paul Keckley of
Deloitte Center for Health Solutions. Pharma and providers will be affected by the emergence of medical homes, accountable
care organizations, bundled payment approaches, and value-based pricing, and will have to adapt to survive.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at