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12:27pm October 16, 2012

Key Challenges to Affordable Care Act’s Implementation

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By Dr. Gary Puckrein

Several months have passed since the U.S. Supreme Court ruled on the Affordable Care Act’s constitutionality.  Hundreds of thousands of uninsured Americans are now eligible to receive coverage starting in the year 2014.  While this is an extraordinary step in the right direction, meeting the expanded coverage requirement will be difficult and expensive.

Presidential candidate Mitt Romney and President Obama continue to spar over the implementation of the healthcare law – particularly the way to handle the broken Medicare system.  This debate concerns everyone because it will affect the quality of care patients can receive.

The New York Times recently reported that the medical community is concerned it will be understaffed to handle an influx of newly insured patients. While more students than ever are attending medical school, the rate of new doctors entering the health care market is too slow to meet the expanded coverage requirements.  In 2014, the number of patients seeking medical help will outstrip the number of capable and qualified physicians.

To address this looming problem, the Obama administration plans to spend $300 million over 3 ½ years to boost Medicaid payments rates and entice doctors to accept more patients.  But lawmakers will also need to get creative about how best to address expanded coverage.  According to the Times, potential solutions might include more walk-in clinics, expanding nurses’ responsibilities and encouraging doctors to work in teams.

As money is being spent to improve access to healthcare, lawmakers have looked for other ways to offset costs.  The $700 billion cuts to Medicare that have been discussed by President Obama and Vice President hopeful Paul Ryan have received the most attention, but there are smaller yet still enormous cost-saving measures already embedded in the healthcare bill.

One area in which the government plans to save costs is with the approval of copycat versions of biotech medicines, or ‘biosimilars’, which are used to treat cancers, and chronic conditions like rheumatoid arthritis, multiple sclerosis and Crohn’s disease. While generic drugs have been available to patients for nearly three decades, to date there are no biosimilars.  It is estimated by the Congressional Budget Office that the country will be saving $25 billion from the use of biosimilars over 10 years.

The healthcare law included a provision to authorize the U.S. Food and Drug Administration to create a pathway to test and approve biosimilar medicines.  To date, the government has not yet finalized this regulatory pathway and appears to be working judiciously as it recognizes the potential challenges in developing and administering biosimilars.  This is necessary as biotech medicines are much larger and more complex than traditional chemical drugs and can never have identical duplicates or ‘generic’ versions. Additionally, as biologics are made from living cells, DNA and other organic materials, they are the highly complex and small differences in the structure of a biologic and its biosimilar counterparts can have harmful effects in patients.

To ensure widespread adoption of biosimilars and healthcare savings, physicians will have to be convinced that prescribing a biosimilar is safe and effective.  A recent survey conducted by the Alliance for Safe Biologic Medicines revealed that doctors who prescribe biologics want assurances that biosimilars will be safe for patients.  Specifically, they are very concerned about patients being switched from one biologic to another by a pharmacist without physician notification and stated that distinct scientific names for biosimilars will provide the most assurances to physicians.  These are two areas that federal and state regulators and lawmakers can easily address.

The Affordable Care Act promises a healthier future for Americans.  It increases health care coverage and creates more treatment options for medical patients.  By examining all the potential pitfalls of the law and correcting them in advance, we can easily shift to a stronger health care system that will provide immense benefits to the American public.

Dr. Gary Puckrein is President and Chief Executive Officer of the National Minority Quality Forum. Dr. Puckrein also serves as Executive Director of the Alliance of Minority Medical Associations.



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