In a session marked by so much partisan rancor, why are the UFA bills different? What can Congress learn from this process?

House Republicans have bashed the health reform law as the beginning of the end of the employer-sponsored health insurance market, since it would be less expensive for some employers to drop their plans and pay a fine to the federal government. The House Ways and Means committee released a report last week finding 71 of Fortune 100 companies could save $422 billion by simply paying fines for their employees, instead of the insurance plans they offer now.

But Republicans haven't been huge fans of employers dictating health insurance coverage for individuals in the past. Sen. John McCain, R-Ariz., proposed getting rid of the employer-sponsored health insurance tax exclusion in his failed 2008 presidential campaign, which could incentivize people to buy their own plans. Gov. Mitt Romney, the presumptive Republican presidential nominee for 2012, hasn't gone that far yet. But he does want to "equalize" the tax treatment of health insurance, giving individual buyers the same tax breaks that employees get on their employer health insurance.

Should people get their health insurance through their employers? What considerations should lawmakers take into account when writing policies that shape insurance coverage?

The number is well under federal projections from October, which predicted up to 270 groups would sign up to become Medicare accountable care organizations, or ACOs. The ACO program pays bonuses to doctor and hospital groups if they successfully coordinate care and improve health outcomes for certain Medicare patients. The groups can eventually lose money from the federal government if they don't meet those standards.

Does the low turnout mean ACOs are over? Or is the program just off to a slow start? Why?

Several options have been floated-- like auto-enrolling people in health insurance plans or restricting enrollment to certain times of the year--but so far no formal strategy has emerged.

Are there any ways to salvage the health care law that have been missed? What programs do you see surviving if the Supreme Court decides the insurance requirement is unconstitutional?

As the Supreme Court deliberates the constitutionality of the Affordable Care Act, there are several key provisions unrelated to the individual mandate or the commerce clause that hang in the balance. One such provision can be found in the subtitle of the law known as the Biologics Price Competition and Innovation Act or BPCIA. This provision granted the U.S. Food and Drug Administration (FDA) the authority to approve imitative versions of biologic drugs, known as biosimilars,  that would be less costly than the innovator biologic they attempt to replicate.

Generic forms of many standard, chemically produced drugs have been available in the United States for nearly three decades, offering patients less expensive alternatives to name-brand products.  However, due to their complexity, biologics were excluded from the original legislation controlling the production and distribution of generic drugs in the U.S.  

Biologics are a category used to describe medicines made from complex mixtures of proteins, sugars and nucleic acids. They are engineered in living organisms to treat serious illnesses including cancer, Multiple Sclerosis and HIV/AIDs. Unlike generic forms of chemically produced drugs, which are near exact copies of innovator products, a biosimilar can never be identical to its biologic. Any small difference in the structure or make-up of a biosimilar in relation to its innovator counterpart can also affect their safety and efficacy.

Recognizing the immense task ahead, the FDA met with industry, patient groups and researchers in late 2010 and released draft guidelines for biosimilar manufacturers this past February.   The agency is now seeking additional input. The biggest area where input is needed is in ensuring biosimilars are safe and effective. Whereas innovator products are tested thoroughly in Phase 3 clinical trials, biosimilars may not have to go through the same rigorous clinical and analytical assessments. Requiring clinical studies, transparent product labels, unique names and other traceability measures will help put patients’ safety first.

Biosimilars are already available in the European Union and Canada, and we should learn from their experiences. For instance, these drugs are only available as standalone therapies and aren’t interchangeable with a biologic.   They are not considered interchangeable in large part because there is so little known about how they interact with other drugs. While the FDA has the authority to determine a biosimilar “interchangeable” early indications are that it will not take that responsibility lightly and will issue additional guidance to set the parameters for such a determination.

As the Supreme Court deliberates on matters unrelated to biologics, the FDA continues to do what the Affordable Care Act required of it, i.e., help make sure that patients in the U.S. have access to biosimilars that are first and foremost safe but also more affordable. We can only hope that the Supreme Court decision is limited to the provisions that raise constitutional questions and those provisions that are constitutionally sound, good for patients and enjoy overwhelming bi-partisan support remain the law of the land.

If you were implementing the law, what would you have done differently? What would you keep the same? In the battle for public opinion, who is winning: Democrats or Republicans?

The goal of any health care reform legislation should be to expand access, increase quality and lower costs. For the most part, the landmark health reform bill signed into law by President Obama does just that. For example, it contains provisions that prohibit the use of “pre-existing conditions” to deny coverage and create health insurance exchanges that will encourage a more competitive marketplace.  

But at least one part of this law represents serious government overreach and  begs for significant rethinking or perhaps even repeal.

Section 6002, the Physician Payments Sunshine Act, is intended to bring transparency to potential conflicts of interest and, theoretically, reduce pharmaceutical companies’ influence on physicians’ prescribing behavior. This is a fine goal and sounds relatively simple in concept but is actually quite complex in practice, especially, for instance, in the case of payments made for medical research. The complexity of this law caused CMS to miss the statutory deadline for issuing its rule.  The subsequent delayed implementation continues to cause a great amount of regulatory and business uncertainty.  CMS estimates it will cost upwards of $200 million annually to comply, but experts predict the cost will be up to four times that amount.

Arguably, payments for bona fide research should be exempt from the law altogether, as they are in several states that have similar statutes. The public disclosure of payments or “value transfers” (like bagels brought to a physician’s office), and the great potential for misreporting and misinterpretation serves as a major disincentive for physicians to participate in medical research. Given the opportunity, I would remind President Obama that not all medical research takes place within the hallowed halls of the National Institutes of Health or within academia. In fact, the biopharmaceutical industry spends more than double the NIH budget on research and development each year. If the United States is to have a robust, innovative biopharmaceutical industry, private sector research is a must and an activity that should be encouraged rather than tainted with a phony “conflict of interest” label.

Make no mistake, the burden to comply with this law will not fall solely on pharmaceutical companies, but will capture physicians and hospitals as well, effectively distracting doctors from patient care so they can focus on nonsensical accounting and diverting hospital resources from activities like increasing nursing staffs to hiring more compliance officers.  Counting bagels is not healthcare reform and a billion dollars spent on “sunshine” requirements that do not increase access or the quality of care is not progress. On at least this one provision of the healthcare law, we suggest that common sense should prevail.

There really is no excuse for the case now before the Supreme Court on individual mandates. I am not speaking to the legal merits of each side but to the inability of Republicans and Democrats to come together to fix anything.   The individual mandate is really a penalty for not buying insurance. As one of those writing on individual mandates over the years, I had suggested before and during the health reform debate that it be assessed simply as a condition for receiving certain other government benefits. If done that simpler way, there would be no court case. No one disputes the government’s right, even necessity, to set the conditions for receiving various benefits.

Instead, disregarding lessons from tax and welfare systems in the past, the Democrats decided they would rather add on some new, separately enforceable, and cumbersome tax and welfare systems along the way to passing health reform. Many of these new systems do not work well. Meanwhile, Republicans currently seem to be insisting on vitiating all parts of the reform, as if leaving tens of millions of uninsured in a crumbling system is a solution to anything. 

The partisan divide isn’t just about partisanship, it’s about the preference of both sides for a good fight even over compromises that meet objectives of both sides.