The Justices indicated Nov. 14 that they will hear oral arguments in March, which would lead to a ruling on the case in June, just four months prior to the November presidential elections. Whether the Court regards the ACA as an illegal expansion of federal government power – as opponents claim – or a valid way to regulate commerce – will have a profound impact on the national political debate. The decision also is slated to shape the legacy of the Supreme Court under chief justice John Roberts.

If the Supreme Court strikes down the individual mandate, it then has to decide if that also invalidates other portions – or all – of the ACA. The Justices agreed to consider the issue of “severability:” whether the mandate is so closely linked to the rest of the reform law that all of it must be set aside. The Obama administration contends that most of the law should remain intact, but that the mandate would undermine requirements that insurers cover everyone, including individuals with pre-existing conditions.

A ruling that kills the mandate and other policies designed to broaden health care coverage could be disastrous for biopharmaceutical companies. Drug makers, as well as insurers and health care providers, supported the ACA as a way to expand coverage for some 30 million uninsured Americans so that they would have the means to access to health care services and treatments. In addition to penalizing individuals and employers for rejecting coverage, the reform law provides subsidies to help lower-income individuals purchase coverage and expands Medicaid programs to cover more of the uninsured. The promise of a much larger market for prescription drugs was considered a reasonable trade-off for pharmaceutical companies to pay millions in extra fees and to cover much of the cost of closing the Medicare “coverage gap.”

The Justices also will consider arguments from some states that the law’s expansion of Medicaid illegally coerces them to spend additional money. Medicaid supporters are particularly upset about this contention, pointing out that much of the cost of increased Medicaid coverage will be borne by the federal government.

The last topic on the docket is a more technical point:  whether an 1867 law prevents the government from challenging new taxes before they are collected. Although most parties maintain that this law does not apply to the ACA, one appeals court said that judicial review of the tax issue should wait until a fine is assessed, which would first occur in 2015. If the High Court agrees, all parties will be sorely disappointed, as that would delay a ruling on the larger constitutional issues for several years.

The Justices are allowing more than five hours to hear arguments on these issues, a remarkably long amount of time that reflects the national importance of the subject under debate.

The administration “is confident that the law will be upheld as constitutional,” predicted Health and Human Services secretary Kathleen Sebelius at a press briefing Nov. 14, 2011 to announce separate health reform initiatives. Many Supreme Court experts agree, based partly on comments from lower-court conservative jurists on the validity of the law.

The case is before the Supreme Court because several federal Appeals Courts across the country have ruled differently on the mandate and other topics. Most recently, the DC Circuit Court of Appeals declared the mandate constitutional, as it fits the role of Congress under the Commerce Clause to “forge national solutions to national problems” – a term that includes the need to provide affordable, quality health care.

That followed a June decision by the Sixth Circuit Court of Appeals in Michigan also supporting the mandate. Here, a Bush-appointed conservative judge concurred  that “not every intrusive law is an unconstitutionally intrusive law.” Separately, the Fourth Circuit in Virginia dismissed two challenges to the health reform law, one on the basis that it was premature to rule because the mandate and related fees, or taxes, do not go into effect until 2014.

However, the Eleventh Circuit Court in Atlanta declared in August that Congress exceeded its powers to regulate commerce in requiring individuals to buy health insurance. This case, brought by Florida and 25 other states plus the National Federation of Independent Business, provides the basis for the High Court deliberations.

Whatever the High Court decides, the issue will remain at the top of the political agenda through the coming year. In the recent November elections, Ohio voters adopted an amendment to their state constitution opposing the mandate for purchasing health insurance. The vote is largely symbolic, because an individual state cannot ignore a valid federal policy, and the Ohio action becomes moot if the Supreme Court rules against the mandate. But this action reflects widespread public opposition to the insurance purchase requirement and many other reform provisions.

Meanwhile, Republican White House hopefuls continue to rail against Obamacare in general, and the insurance mandate specifically. Every GOP presidential candidate has pledged to repeal PPACA and to enact less intrusive health reform policies. If the Court does not strike down all of PPACA, though, it will be difficult for Congress to kill the current reform program because of its many broadly supported provisions, and due to projections that it will reduce government health care spending.

Most experts consider wholesale repeal of the ACA unlikely. Even if the mandate and broader coverage requirements fall, provisions for establishing biosimilars and to support comparative effectiveness research are expected to remain. The program for establishing state-based exchanges to offer insurance also could survive, along with popular provisions designed to control insurance premiums increases.

One area of agreement by all parties is that speedy resolution of the constitutional issues by the High Court will provide a much-needed sense of predictability about health reform. A number of providers and hospital groups filed briefs asking the Justices to  decide the mandate issue promptly in order to reduce uncertainty among health care providers about how to move forward with major changes in operations and policies.

Because broader insurance coverage and gap closure will expand drug sales and industry revenue, the Obama plan also increases a proposed “assessment” on pharma from $23 billion in the Senate bill to $33 billion, starting in 2011 to avoid tax problems. Medical device makers also would have to pay $20 billion in fees over 10 years, starting in 2013.

Similar to previously approved Senate and House bills, the plan retains a boost in Medicaid drug rebates from 15 to 23% and authorizes discounts on drugs sold to community hospitals. Drug companies would have to fully disclose financial arrangements with doctors, and pharmacy benefit managers would report rebates and discounts on drugs, along with success in boosting generic drug use.

The proposal also seeks to curb “pay-for-delay” deals between brand and generic drug manufacturers; stipulates that effectiveness research would not influence coverage decisions; and supports establishing a pathway for follow-on biologics.

For these and most of the provisions in the White House announcement, there are few specifics or proposals for implementation.

Many key provisions in enacted Democratic legislation are featured in the plan: an insurance exchange to provide coverage options to the uninsured; tax credits to help individuals and small business pay premiums; curbs on insurance industry discriminatory practices; aid to state Medicaid programs; an individual coverage mandate (with low penalties); and cuts in rates for Medicare Advantage plans.

Most notable politically, there’s no govern-run coverage option. And the plan significantly scales back a proposed tax on high-cost “Cadillac” health plans, making up the lost revenue with a tax hike on high-income individuals. Most notable politically, there’s no govern-run coverage option.

Deputy FDA Director Joshua Sharfstein acknowledged in a press briefing that some proprietary information—the formula for making a certain pill, for example—may remain confidential. He also conceded that concerns about patient privacy and other issues may limit full data transparency. But this initiative clearly opens the door to broader disclosure of records that manufacturers regard as private property. Unpublished clinical and preclinical studies, product formulations, and manufacturing data have long been considered trade secrets, and pharmaceutical companies are likely to mount a stiff defense of the rules and laws that protect their rights.

FDA may have more leeway to expand transparency about its own decisions and regulatory actions. The agency currently announces product approvals, but not when it turns down an application. And it’s up to manufacturers to disclose when they file an application or withdraw a submission. Margaret Hamburg, FDA commissioner, told reporters that she wants to address complaints that FDA is a “block box” by clarifying agency processes. Agency decisions often have good explanations, and Hamburg would like to see what information could be made available to avoid confusion and criticism.

FDA will begin its transparency review with a public meeting, and Hamburg expects a report by year’s end that will describe what additional information the agency can release on its own and what changes require new regulations or Congressional action. The pendulum clearly is swinging towards the transparency side, and everyone is watching to see whether it swings too far.

Pharmaceutical Technology has added FDA’s transparency blog to its own blogroll.

In a sharp break with Washington tradition, Rep. Henry Waxman (D-Calif) unseated long-time top Democrat on the House Energy & Commerce Committee, John Dingell (D-Mich), to become the panel’s new chairman. The House Democratic caucus backed Waxman for the job after a hotly contested campaign in which Waxman claimed to be better positioned to work with the new Obama administration to enact environmental and health care legislation.

The change puts a long-time critic of the pharmaceutical industry at the helm of this all-important panel. All health care legislation fall under its purview, along with measures affecting the Food and Drug Administration and other federal health agencies. However, Waxman differs with Dingell more notably on environmental and clean air policy and less on health issues, making the change less dramatic for pharma and health care entities. Both Dingell and Waxman have long championed universal healthcare, and a top priority for the new chairman will be to pursue health reform legislation vigorously.

Daschle’s familiarity with health policy issues is evident in the book he co-authored earlier this year:  “Critical:  What We Can Do about the Health-Care Crisis.”  But with less administrative experience than the governors who preceded him, Daschle will need capable deputies to oversee key HHS agencies, including the Food and Drug Administration, the National Institutes of Health and Medicare and Medicaid.

The former Senator from South Dakota lost his seat in a hard-fought battle in 2004. He was criticized then as too much of a Washington insider, and his nomination provoked similar comments from some parties. But most observers regard the appointment as realistic assessment that consummate political skill is needed to reform the nation’s healthcare system.