News: Perspectives Spring/Summer 2010
 

Rx AND HEALTH CARE REFORM

 

One of the biggest questions about the past several decades of US domestic policy has finally been answered: Yes, the Patient Protection and Affordable Care Act will help correct what has become a fundamentally unjust US health care system. By providing coverage to an estimated 32 million uninsured people, this new law marks the beginning of a far more equitable system in which almost all of us will have access to comprehensive health care coverage. We won’t be denied coverage because of pre-existing conditions, nor will it be canceled because of illness. These policy changes usher in a new era of health care that helps pave the way to expanding access to prescription drugs, which we hope will be the safest, most effective, and most affordable medications.

One notable aspect of the new law is the inclusion of the Physician Payment Sunshine provisions to require drug and device companies to disclose gifts and payments they make to physicians and teaching hospitals. In response to the revelation that physicians receive millions of undisclosed dollars for speaking and advisory roles for drug companies—even as they conduct research on drugs made by those companies—the Sunshine provisions will help protect prescribing from the excessive influence of the pharmaceutical industry. At the same time, they empower consumers by making the disclosures available to the public on a searchable website thereby exposing possible conflicts of interest to the light of day.

Another feature of the new law, which is of particular significance to those on Medicare, is the first step toward closing the infamous gap in Part D coverage, known as the “donut hole.” This year, seniors who enter the prescription drug coverage gap will get $250 to help pay for their medications. Going forward, drug-company discounts on brand-name drugs and federal subsidies and discounts for all drugs will gradually reduce the gap, eliminating it by 2020. By that time, seniors, who now pay 100 percent of their drug costs once they hit the gap, will pay 25 percent. And, as has already been the law, once seniors spend a certain amount on medications, they will get “catastrophic” coverage and pay only 5 percent of the cost of their medications.

The new law also provides a 23 percent Medicaid discount (rebate) on new drugs, which may appear to be good news. However, it’s unclear how effective the rebates will be in providing relief since the rebates are based on the price set for the drug by the manufacturers and are usually offered only for the newer, more expensive drugs, which often are no more effective or safer than others on the market. As states and the federal government are pushed to put newer, more expensive drugs on their formularies and preferred drug lists, rebates are held out like carrots in an effort to persuade the inclusion of certain drugs. How the increased rebates for certain drugs affect the ability of consumers to access the most effective and safest prescription drugs they need should be carefully monitored, as should the cost implications as higher priced drugs are used because of the rebates offered.

Of course, the biggest question about the new law is whether the legislation to mend the broken system will break the bank or save the day. The Congressional Budget Office (CBO) estimates that the new law will reduce the federal budget deficit by $143 billion through 2019 and will yield even greater savings in the decades to come. Additionally, there are opportunities to put more cost controls in place.

Prescription drug policy is a great place to start in terms of improving health care quality—especially safety and effectiveness—while containing costs. One opportunity missed in the new law is giving the federal government the authority to negotiate prescription drug prices for the newly insured and the elderly under Medicare Part D. Currently, the private sector reaps billions in revenues by negotiating prices and steering plans (and beneficiaries) toward certain drugs under Part D. Meanwhile, the government obtains lower prices for veterans and Medicaid patients and could achieve huge savings as the nation’s largest drug purchaser for our elderly. There is the potential for great savings through prescription drug price negotiations that could be used to help slow Medicare’s growth and pay for expanded health care coverage. Efforts to strengthen the new law ought to include price negotiations.

In terms of improving health care quality while containing costs, the importance of comparative effectiveness research and evidence-based medicine cannot be underestimated. Emphasis must continue to be placed on providing doctors and consumers with the best information available regarding treatment options, that is, the science showing what works best, is safest, and is most effective. Data from comparative effectiveness research does and will continue to help doctors choose the most effective treatments based on scientific evidence rather than drug industry influence. Likewise, academic detailing programs, also known as prescriber education, in which trained clinicians provide prescribers with unbiased information regarding certain therapeutic areas and drug classes, have proven effective in countering industry influence, improving health care quality, and reducing costs. More often than not, the most effective treatments yield savings in terms of patient health and safety as well as prescription drug costs.

While the inclusion of the Sunshine provisions is a step in the right direction, reporting will not begin until 2012, and not made publicly available until 2013. Furthermore, failure to report will be fined, but such fines are not to exceed $1,000,000 annually. In an industry with annual sales in the hundreds of billions of dollars (in the US alone) paying the fines, instead of disclosing gift and payment information, may end up being the better business strategy for drug companies that already flaunt regulations by aggressively marketing their products for unapproved (off-label) uses and have a history of putting profits before patients.