The cornerstone for expanding coverage for the uninsured is the formation of state-based insurance exchanges that will offer
plan options to small businesses and individuals who don't get health benefits from employers or public health programs. Plans
sold through exchanges will have to meet a host of quality criteria defined by the ACA, including coverage of "essential benefits"
for consumers. The good news for pharma marketers is that prescription drugs are on the list of 10 basic benefits that all
plans have to cover. However, instead of establishing a common set of essential benefits for all exchanges across the country,
HHS announced in December 2011 that it is leaving it up to each state to set coverage benchmarks that fit local needs and
preferences. That may be a plus for pharma in states that require coverage of contraceptives, for example, or specifically
authorize reimbursement for off-label drug uses; it could backfire, though, where drug coverage is less generous.
HHS opted for the "flexibility" route largely to deflect charges from health reform critics that Washington is formulating
a one-size-fits-all national healthcare system, but there's strong opposition to this approach. Consumer advocates predict
that some states will scale back coverage requirements too much, while employers and insurers fear state mandates will make
plans too costly. Pharmacy benefit managers are gearing up to oppose state anti-mail-order laws. And everyone will be looking
at new policies governing deductibles and copays, which have a significant impact on utilization of services and medication
ACOs Seek Value
ACA initiatives that shift from pay-for-volume to pay-for-value models also will encourage appropriate drug use. For example,
a new CMS quality reporting system for Medicaid programs calls for providers to check whether adult enrollees take antidepressants
and antipsychotics as prescribed; regularly monitor meds to treat chronic conditions; and track hospital admissions for patients
with diabetes, congestive heart failure, and asthma, which often involve irregular drug use. Similar quality standards apply
to a number of value-based reimbursement programs and new pilots to reduce hospital readmissions and prevent heart attacks.
The poster child for this approach is the accountable care organization (ACO), an entity formed by hospitals and physicians
to share the risk for improving care and reducing costs. While health systems have been establishing ACO-like operations for
some time, the strategy gains support from the ACA provision authorizing a Medicare "shared savings" model: Medicare ACOs
can retain some of the savings generated by more efficient coordinated care approaches, as indicated by 33 quality measures;
those that fail to achieve quality and savings face rate reductions. Along with risk-sharing, the legislation gives ACOs protection
from certain fraud and abuse laws that otherwise curtail hospital/doctor collaborations.
ACOs that assume risk put pressure on pharma marketers to demonstrate how pricey medicines can save money by keeping patients
healthy and reducing inappropriate tests and treatment. Patient compliance with prescribed therapy is key, and analysts are
examining a range of drug-related strategies to enhance care.
Increasingly, "doctors are aware of the total cost of care, including the cost of medicines and their ability to keep patients
out of the hospital," pointed out William Shrank, director of the Rapid-Cycle Evaluation Group at the Center for Medicare
& Medicaid Innovation (CMMI) in CMS. He explained at the December 2011 FDA/CMS Summit in Washington that physicians in ACO
shared savings programs are looking for information on drug effectiveness and innovative strategies for controlling the cost
of care, including formulary arrangements and reduced cost-sharing for more effective medicines. Shrank urged pharma companies
to invest in research that will build the evidence base for medication adherence, and not just for their own products. "Cost
is only one factor," he observed, noting that drug packaging, treatment complexity, cultural issues, and health literacy also
can affect patient behavior.
Medicare ACOs will emerge in coming months, following publication of final regulations in October 2011 that modified initial
reimbursement and reporting policies. Providers had balked at requirements proposed last June, and many health systems with
ACOs signaled they would not participate in the Medicare shared-savings approach. However, CMMI announced in December 2011
that the initiative will get off the ground with 32 healthcare organizations testing the ACO Pioneer program.
More evidence on the value and effectiveness of medications and other clinical treatments is the goal of the ACA-authorized
Patient-Centered Outcomes Research Institute (PCORI), which is moving forward despite continued controversy over the type
of research it will support and how the information will be used. PCORI executive director Joe Selby, who was appointed last
May, insists that the Institute won't do cost-effectiveness analysis, something that pharma companies strongly oppose, but
admits that the term "cost analysis" is vague and that even talking about "value" raises red flags.
Yet PCORI's potential for improving care and cutting costs is spurring a lot of interest, as seen in a whopping 850 applications
to a recent notice announcing grants totaling $26 million for studies on outcomes research methodology. PCORI is slated to
finalize its priorities and research agenda in April, which it posted for comment last month.
Jill Wechsler is Pharmaceutical Executive's Washington correspondent. She can be reached at firstname.lastname@example.org