Final Bill Research Articles

Corporate Law Reform and Political Environment: An Empirical Analysis Employing Public Comment Procedure Data

Corporate law shapes the fundamental business environment and affects various stakeholders such as shareholders, managers, employees, and creditors. Each stakeholder has an incentive to influence the reform process of corporate law. The many corporate law reforms in Japan reflect its rapidly changing business environment. It is possible to determine the behaviour of various stakeholders by examining the politics of the reform process of corporate law.In order to understand the corporate law reform process, this paper uses the notice-and-comment procedure (`public comment procedure'), which was introduced by the Administrative Procedure Act in 1993. The Administrative Procedure Act requires every law reform or order proposed by a government agency to undergo a public comment procedure. Under this procedure, people submit comments to the Ministry of Justice; some of these comments are reflected in the final bill, whereas others are not. The paper performs a quantitative analysis of a hand-collected dataset from two recent public comment procedures on corporate law reform. By analysing the comments with respect to the issues, we can understand the mechanism of the corporate law reform process, particularly the relative political power of various interest groups.The results showed that the bureaucrats are rigid and not willing to take public comments seriously. However, on some technical issues, legal academics and legal professionals, such as courts and law firms, influence the behaviour of the bureaucrats. The results showed that the bureaucrats employed these comments to honour the technical views of professionals. In other cases, corporate managers significantly influence the reform process. The results did not support Croley's (2007) independence hypothesis about government agencies.

Party Politics and Enactment of “Obamacare”: A Policy-Centered Analysis of Minority Party Involvement

The Patient Protection and Affordable Care Act of 2010 (ACA) passed with no Republican votes and was accompanied by intense criticism that the reform was "rammed through" the legislative process by the majority party. By contrast, many Democrats emphasized the extensive yearlong debate over health care reform and argued that the final bill represented a compromise of good ideas from both parties. We undertake a policy-centered analysis to help reconcile these conflicting reports of this legislative episode. Drawing on real-time accounts published in the Capitol Hill newspaper Roll Call, we compare the success of Democratic and Republican Parties' policy proposals in terms of centrality to the policy agenda and inclusion in the enacted legislation. Our findings indicate that Republican-backed proposals were more present on the policy agenda than in the final legislation--although both were dominated by Democratic policy proposals. In this case, the major limit on majority party power seemed to be intraparty conflict, rather than opposition from the minority party.

Identification of reservation capacity in critical peak pricing electricity demand response program for sustainable manufacturing systems

SUMMARY Electricity demand response is considered an effective approach to balance the electricity demand and supply with existing infrastructure of generation, transmission, and distribution. A majority of existing literature on the electricity demand response has mainly centered on the commercial and residential building sectors while the application for the industrial sector is largely neglected. This paper presents a methodology for the application of a typical demand response program, Critical Peak Pricing (CPP) program, for the manufacturing enterprises. The configuration of the reservation capacity (in kilowatt, kW) in the CPP program, which plays a critical role in the cost of the final bill charge, will be identified by optimal production scheduling for the typical manufacturing systems with multiple machines and buffers. Mixed Integer Nonlinear Programming formulation is used to establish the mathematical model with the objective to minimize the electricity bill cost as well as the potential penalty cost due to the non-fulfillment of the target production. An approximate technique is introduced to find a near optimal solution, and a numerical case study is used to illustrate the effectiveness of the proposed method. Copyright © 2013 John Wiley & Sons, Ltd.

Addressing Shortfalls in Traditional Legal Education: UT's Concentrations and Capstones and Waller Lansden's Schola2juris Program

Law school’s traditional educational model needs to be revamped. The traditional law firm’s summer associate model needs restructuring. Some might say they are both broken. Across the country, educators, and commentators are talking about legal education reforms and leading law firms are confronting how to improve the age-old mechanism for recruiting law students. In the recent past, the legal employment landscape provided no incentive for law firms to question their traditional recruiting practices. The traditional law-firm recruitment model — the summer-associate program — is often little more than a glorified summer camp for some of the most highly educated — and debt-ridden — law students of our time. This summer-long social event often fails to provide students with a true depiction of life inside the law firm. Instead, the experience introduces the summer associate to isolated but “glamorous” aspects of legal matters, rather than assigning the students to perform necessary, but perhaps mundane, billable hours. Even in firms whose clients continue to allow them to bill for work performed by summer associates, a seasoned associate is often required to rework the majority of the student’s work or reduce or delete time spent by the student from the final bill. The traditional summer-associate program historically emphasizes entertainment over providing the summer associate with a realistic experience of life inside a law firm. Law students and law schools are realizing that the apprentice stage of legal education should provide a more valuable, tangible experience. The students recently voiced their discontent in The American Lawyer’s 2012 Summer Associate Survey, which reveals the students’ desire to engage in legal work and to experience professional mentoring, while decreasing the number of over-the-top social events that are the norm. The problem of wasted summer work opportunities is compounded by another phenomenon, discussed by Dean Daniel Rodriguez of Northwestern Law School, who has openly questioned the value of the third year of law school. Rodriguez asserts that law schools must do more to provide substantive experiences and exposure to real life legal matters to prepare their students for legal careers. Some law schools are catching on, while others have long integrated skills-based courses in their curriculums.This article addresses the University of Tennessee’s Concentrations in Advocacy and Business and related programs, which seek to bring practice experience into law school, and Waller Lansden’s Schola2Juris program, which seeks to bring teaching about law and practice into its recruiting program. Both are coming at the same set of shortfalls of traditional legal education with substantially similar solutions, but from different ends of the legal job market.

Costs of unnecessary admissions and treatments for “threatened preterm labor”

Cervical length (CL) of 3 cm or greater has been shown to have a 97-99% negative predictive value for preterm delivery in women with threatened preterm labor. Consequently, hospitalization and treatment are not indicated in these patients. We analyzed how often patients with a CL of 3 cm or greater are still being admitted and treated for preterm labor and how much this contributes to the economic burden of preterm labor hospitalizations. Twelve month hospitalizations for preterm labor at less than 34 weeks at a single institution were reviewed and patients with a CL of 3 cm or greater were identified. We chose to use patients' hospital charges as a surrogate for health care costs, recognizing that charges are not synonymous with the final patient bill and also do not reflect additional costs such as the cost of treatment at the referring facility, transportation, physician fees, and other such costs as lost wages, need for additional child care, etc. Between July 2009 and June 2010, 139 patients were admitted and treated for preterm labor at our level III center. Fifty of these patients (36%) had a CL of 3 cm or greater. None of them delivered preterm. Total hospital charges for the management of these patients were $1,018 589 (mean, $20,372; median, $14,444). Unnecessary admissions and treatments for threatened preterm labor are part of clinical practice and contribute to exploding health care costs. Using currently available diagnostics, these costs could be lowered significantly without jeopardizing outcome.

Medical Device Excise Tax: Implications for Interventional Radiologists

The Affordable Care Act of 2010 represents the most sweeping health care reform in the past 50 years, extending health insurance coverage to 33 million uninsured Americans. The final bill included numerous changes in the tax code to help fund its central tenets, including one of the largest ever expansions of Medicaid and federal health insurance subsidies for low-income families. One such change is the Medical Device Excise Tax, a new 2.3% tax levied on the sale price of any medical device as defined by the Food and Drug Administration, which went into effect January 1, 2013 (1). Products subject to the tax include surgical drapes, catheters, wires, stents, and advanced imaging equipment, all of which interventional radiologists routinely use to do their work. Although the Medical Device Excise Tax is paid by the medical device manufacturer or importer, it may nonetheless have important implications for hospitals, interventional radiologists, and their patients. The medical device industry has been thriving in the United States, with estimated sales of as much as $116 billion per year and encompassing as many as 460 public and 1,247 venture capital–backed companies (1,2). It is estimated that the 10 largest medical device makers will pay 86% of the revenue collected from the Medical Device Excise Tax (2). The tax is projected to generate $29 billion over the next 10 years, and large companies such as Cook and Stryker are expected to shoulder additional tax burdens of as much as $30 million and $150 million per year, respectively (2–4). Companies with annual revenues of less than $5 million are exempt from the tax (5). However, as many small and startup medical device companies will not achieve profitability until they reach at least $100–$150 million in sales, this exemption threshold remains too low to protect these vulnerable companies (1). For example, based on 2009 revenues, NxStage would have paid an

A wafer-based monocrystalline silicon photovoltaics road map: Utilizing known technology improvement opportunities for further reductions in manufacturing costs

As an initial investigation into the current and potential economics of one of today's most widely deployed photovoltaic technologies, we have engaged in a detailed analysis of manufacturing costs for each step within the wafer-based monocrystalline silicon (c-Si) PV module supply chain. At each step we find several pathways that could lead to further reductions in manufacturing costs. After aggregating the performance and cost considerations for a series of known technical improvement opportunities, we project a pathway for commercial-production c-Si modules to have typical sunlight power conversion efficiencies of 19–23%, and we calculate that they might be sustainably sold at ex-factory gate prices of $0.60–$0.70 per peak Watt (DC power, current U.S. dollars).This may not be the lower bound to the cost curve for c-Si, however, because the roadmap described in this paper is constrained by the boundary conditions set by the wire sawing of wafers and their incorporation into manufacturing equipment that is currently being developed for commercial-scale production. Within these boundary conditions, we find that the benefit of reducing the wafer thickness from today's standard 180μm to the handling limit of 80μm could be around $0.05 per peak Watt (Wp), when the calculation is run at minimum sustainable polysilicon prices (which we calculate to be around $23/kg). At that minimum sustainable polysilicon price, we also calculate that the benefit of completely eliminating or completely recycling kerf loss could be up to $0.08/Wp.These downward adjustments to the long run wafer price are used within the cost projections for three advanced cell architectures beyond today's standard c-Si solar cell. Presumably, the higher efficiency cells that are profiled must be built upon a foundation of higher quality starting wafers. The prevailing conventional wisdom is that this should add cost at the ingot and wafering step—either due to lower production yields when having to sell wafers that are doped with an alternative element other than the standard choice of boron, or in additional capital equipment costs associated with removing problematic boron–oxygen pairs. However, from our survey it appears that there does not necessarily need to be an assumption of a higher wafer price if cell manufacturers should wish to use n-type wafers derived from the phosphorus dopant. And as for making p-type wafers with the traditional boron dopant, the potential price premium for higher lifetimes via the magnetic Czochralski approach is calculated to be very small, and can ostensibly be offset by the higher expected cell efficiencies that would result from using the higher quality wafers. With this final consideration, the projected minimum sustainable price requirements for three advanced c-Si solar cells are incorporated into a final bill of materials for a polysilicon-to-module manufacturing facility located within the United States.

773: Costs of unnecessary admissions and treatments for “threatened preterm labor”

Cervical length (CL) of ≥ 3 cm has been shown to have a 97-99% negative predictive value for preterm delivery in women with “threatened preterm labor”. Consequently, hospitalization and treatment are not indicated in these patients. We analyzed how often patients with CL ≥ 3 cm are still being admitted and treated for preterm labor and how much this contributes to the economic burden of preterm labor hospitalizations. Twelve-month hospitalizations for preterm labor at less than 34 weeks at a single institution were reviewed and patients with CL ≥ 3 cm were identified. We chose to use patient's hospital charges as a surrogate for healthcare costs recognizing that charges are not synonymous with the final patient bill, and also do not reflect additional costs such as the cost of treatment at the referring facility, transportation, physician fees and other such costs as lost wages, need for additional child care etc. Between July 2009 and June 2010, 139 patients were admitted and treated for preterm labor at our level-III center. 50 (36%) of these patients had a CL ≥ 3 cm. None of them delivered preterm. Total hospital charges for the management of these patients were $ 1 018 589 (mean $ 20 372, median 14 444). Unnecessary admissions and treatments for “threatened preterm labor” are part of clinical practice and contribute to exploding healthcare costs. Using currently available diagnostics these costs could be lowered significantly without jeopardizing outcome.

Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences (review)

Reviewed by: Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences Scott H. Podolsky Dominique A. Tobbell. Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences. California/Milbank Books on Health and the Public. Berkeley: University of California Press/New York: Milbank Memorial Fund, 2012. xv + 294 pp. $26.95 (978-0-520-27114-2). Today, concerns regarding the incentivizing of the pharmaceutical industry, the affordability of medicines, and the “capture” of the medical profession by industry reverberate throughout both academic and congressional debate. Yet as Dominique Tobbell relates, these are not new concerns. Daniel Carpenter has recently analyzed in detail the means by which the FDA enlarged its scope of regulation throughout the latter half of the twentieth century to become arguably the most important regulatory agency in the world. Yet the federal government could have gone still further. And Tobbell, in this well-researched and skillfully argued volume, explores how the pharmaceutical industry and its allies in the medical profession forestalled still more aggressive reform in the second half of the twentieth century, setting the stage for the ongoing debate and reform efforts of the twenty-first century. The 1938 Federal Food, Drug and Cosmetic Act, as Carpenter has written, mandated that drugs be determined safe prior to their release for interstate sale, necessitating increased investment in the testing of drugs. Expanding upon the work of John Swann and Nicolas Rasmussen, Tobbell begins by examining how the drug industry and academic medicine expanded their mutually beneficial relationships in the post–World War II era partly to meet this need. For an increasingly research-oriented drug industry, relationships with medical schools and their faculty not only provided access to leading scientists but also helped to enable the training of the emerging cadre of “clinical pharmacologists” who could evaluate their products. For academia, industry funding provided the support required by their faculty, independent of government direction or oversight. Such relationships would be put to the test by the end of the 1950s. As concerns regarding the prices of the wonder drugs escalated, the leading research-oriented pharmaceutical firms banded together. They could not, however, fend off Senator Estes Kefauver’s muckraking investigation and congressional hearings into the drug industry beginning in 1959, as lines were drawn between reformers in Congress and academic medicine on the one hand, and the pharmaceutical industry, the American Medical Association, and cultivated allies from academic medicine on the other. Industry and its allies invoked Cold War rhetoric regarding the need for an unshackled wonder-drug-producing industry both for the health of the American people and for a potential worldwide battle against communist pharmaceutical purveyors. And while the Kefauver–Harris Amendments of 1962 mandated the formal proof of drug efficacy and introduced the phased system of drug review existing today, more radical measures attending to patents were successfully kept out of the final bill. The 1962 amendments still entailed a significant expansion of FDA oversight. Yet as Tobbell explains, industry and its academic allies, recognizing the degree to which the FDA’s increased powers seemingly outstripped its personnel, formed [End Page 486] a Commission on Drug Safety as an advisory body to the FDA. The commission evolved into the Drug Research Board (DRB), under the auspices of the National Academy of Sciences–National Research Council, but still well represented by industry representatives and their academic allies. The DRB, from the mid-1960s through the mid-1970s, would serve to counter FDA attempts to control a national drug compendium and blocked federal efforts to mandate the substitution of generic for brand-name drugs (which would instead occur in piecemeal fashion at the state level). Years of alliance building had apparently borne fruit and would again in the Hatch–Waxman Act in 1984 (which extended patent durations even as it supported the expansion of the generic drug industry), the Medicare Prescription Drug Improvement and Modernization Act in 2003, and even the Patient Protection and Affordable Care Act in 2010. My only quibble with Tobbell’s analysis is that notions of medical “capture” by industry run the risk of being overly simplistic (as Tobbell...

Mortgaging the Future of Medical Research

Mortgaging the Future of Medical Research

Necessary Improvements to the Australian Privacy Principles (Annex)

Part I of this article is a Submission to the Australian Senate’s Finance and Public Administration Committee on the Exposure Draft of the Privacy Amendment Legislation submitted by the government to Parliament in 2010. The general thrust of the Submission is that the proposed Australian Privacy Principles (APPs) in the Exposure Draft Bill are weaker than the Australian Law Reform Commissson’s (ALRC’s) proposed UPPs and the current Information Privacy Principles (IPPs) for the public sector and National Privacy Principles (NPPs) for the private sector. Unless significantly improved during the Parliamentary process, this proposed Bill will lead to an overall reduction in privacy protection. The government has gone backwards instead of forwards in terms of modernising the principles, and seems to have been unduly influenced by both business and agency interests, to the detriment of the interests of the citizens and consumers who the Privacy Act is intended to protect. In the case of government agencies, a raft of changes have been ‘slipped in’ at the last minute to avoid some agencies having to rigorously apply well-designed existing exceptions. Such lazy drafting and special pleading should be rejected. There are a few improvements to the ALRC proposals in the government’s draft Bill, but in many cases proposed changes to the language of the principles which appear minor and superficially innocuous in fact have very significant adverse effects. In particular, the cross-border disclosure principle, which has an ever-increasing importance in the context of borderless networks and ‘cloud’ computing, is seriously inadequate. There are a few improvements to the ALRC proposals in the government’s draft Bill, but in many cases proposed changes to the language of the principles which appear minor and superficially innocuous in fact have very significant adverse effects. In particular, the cross-border disclosure principle, which has an ever-increasing importance in the context of borderless networks and ‘cloud’ computing, is seriously inadequate. Part II of this article is the ‘Improved Exposure Draft’ annexed to the Submission, which contains the detail of our recommended changes. Our proposed additions to and deletions from the Exposure Draft are visible from the change tracking to the document. It is unfortunate that the government has released an Exposure draft of the APPs without drafts of other provisions relating to compliance and enforcement, and some coverage, exemption and definition matters not yet addressed. We understand the rationale for a staged release, and this is acceptable in relation to the specific credit reporting and health privacy rules. But a complete judgement as to the effect of changes to the principles can only be made in the context of the Information and Privacy Commissioners’ functions and powers, and other parts of the Act, which may or may not change in the final amendment Bill. [Postscript: As of March 2012, a Bill to change the privacy principles has not been submitted to Parliament. It is expected that such a Bill will be submitted during 2012, but whether it will be any different from the Exposure Draft is unknown.]

The Tale of a Licensing State

The Tale of a Licensing State

CONGRESS MOVES ON BUDGET

AT NEARLY two months into the federal government’s 2012 fiscal year, Congress is just now expected to clear its first appropriations measure. The package, known as a minibus, combines three appropriations bills and includes funding for several key science agencies. The package on the table now “represents significant progress in the budgetary work of Congress, and will put us one step ahead as we strive towards swift completion of all fiscal-year 2012 appropriations bills,” House of Representatives Appropriations Committee Chairman Harold (Hal) D. Rogers (R-Ky.) said in a statement. The final bill (H. Rept. 112-284) was set to clear Congress at C&EN’s press time on Nov. 17. It includes 2012 budgets for NSF, NASA, NIST, NOAA, and FDA. Under the measure, NSF will be funded at $7.0 billion, up 2.5% from 2011 levels. The $751 million budget set for NIST will include $33 million, a 6.5% increase, over 2011 funding for its core scientific ...

‘Too Wild to Succeed’: The Occasional Conformity Bills and the Attempts by the House of Lords to Outlaw the Tack in the Reign of Anne*

By the late 17th century it had been largely established as a part of the ‘constitution’ that the house of commons played the leading role in proposing financial legislation and that the house of lords by convention could not amend such bills, but only accept or reject them. From the late 1670s, the practice developed of the Commons ‘tacking’ money or supply bills to other, controversial legislation, to try to ensure that the Lords would pass the whole bill. This underhand proceeding sometimes worked, but at other times the Lords amended the non-monetary parts in such a way as to render the bill unacceptable to the Commons, but such actions sometimes resulted in the loss of financial legislation necessary for the king's government. From the 1690s, the whig-dominated Lords attempted to ‘outlaw’ tory-backed tacking by protesting at its unparliamentary nature. This culminated in a formal declaration by the House in 1702 of the unconstitutionality of tacking. The last major attempt at tacking took place over the Occasional Conformity Bills of 1702–4. The final bill of 1704 essentially failed, however, because of the party strengths in the Lords when the tories were outvoted by the whigs. The Lords, however, continued to condemn tacking until at least 1709.

Acquisition of expanded indications for intravenous cyclophosphamide in the management of childhood rheumatic disease in general

We created the final bill of "Intravenous cyclophosphamide (IVCY) for the treatment of rheumatic disease of children in general" in order to get approval for the off-label use of IVCY from the Study Group on Pediatric Drug Therapy. As a result, this study group approved IVCY's off-label use in children via public applications. We could create IVCY regimen specific for Japanese children independently of the efficacy, dosage, and administration applied in Germany, which at the time of application was the only country in Europe and the USA where IVCY was approved. Later, its use in adults was given approval through public applications after being fully reviewed by the Study Group on Unapproved and Off-label Drugs of High Medical Need. Consequently, IVCY is now available for the treatment of both childhood and adult rheumatic diseases in general.

Minimum alcohol pricing in Scotland

The Scottish Parliament recently passed the Alcohol etc (Scotland) Bill following a long debate regarding minimum pricing. This article considers the arguments that ensued and some of the evidence that was produced. While minimum pricing was removed from the final bill, the author argues this will not be the end of the debate on price in Scotland.

The Patient Protection and Affordable Care Act, Cost Control, and the Battle for Health Care Reform

For many social workers, March 2010 enactment of Patient Protection and Affordable Care Act (PPACA) (EL. 111-148)--later amended to include EL. 111-152, Health Care and Education Reconciliation Act of 2010--was bittersweet moment. Bitter because was less than many of us had wanted. For years, NASW had advocated single-payer system, which president and congressional leaders rejected from beginning. During debate over reform, NASW supported strong public option, which was not included in final legislation. Yet, despite this, bill's enactment was, as NASW (2010b) put (in response to enactment of House bills, H.R. 3590 and H.R. 4872), a monumental legislative achievement of our time and a significant step toward comprehensive and universal care system for our nation. Although this battle was successful, war over care reform is far from over (Aaron & Reischauer, 2010). Polls have found mixed support for legislation and confusion about its content and potential effects on various groups (Kaiser Family Foundation, 2010a). In several states, legislators have introduced bills challenging aspects of legislation, particularly mandate requiring individuals to buy insurance, and others have scheduled ballot referendums to determine whether citizens can refuse to comply with legislation (Cauchi, 2010). In addition, several state attorneys general have brought suit against law (Lazarus & Morrison, 2010). Opponents of reform pledged to and the procedures used to enact it an issue in 2010 elections (Aaron & Reischauer, 2010). Supporters of reform hoped that once legislation became law, opposition would dissipate; however, middle of May 2010, this had not happened (Pollster.com, 2010). The complexity of law, critical role of states in carrying out, and legislation's implementation schedule make likely that reform will be an arduous process (Aaron & Reischauer, 2010). Aaron and Reischauer (2010) warned that unless supporters of reform face up to challenges, health care reform could go way of Medicare Catastrophic Coverage Act of 1988, which was enacted with almost self-congratulatory enthusiasm but, due to strong opposition from consumers, was repealed year and half later (p. 1260). A critical issue facing supporters of PPACA is whether can succeed in reducing care inflation. Although latter has slowed in recent years, remains serious concern. Between 1999 and 2009, employer-based insurance premiums increased 131 percent, more than three times worker wages and four times general inflation (Kaiser Family Foundation, 2009). Health care inflation, in form of increased Medicare expenditures, also lies at root of our much discussed budget and crisis (Orszag, 2009). Opponents of PPACA argue that will worsen care inflation. At President Obama's summit, Representative Paul Ryan (R-WI), ranking Republican on House Budget Committee, warned that Senate bill, which was similar to final version, failed to control costs or [the] deficit and engaged in double-counting and other gimmicks (Rep. Paul Ryan on Health Inflation, 2010). After enactment of final bill, Ryan stated that these bills would exacerbate our fiscal crisis adding trillions of dollars to our debt burden (Ryan: 'This Heavy-Handed Overhaul', 2010). What is reality? The Congressional Budget Office (CBO) and staff of Senate's Joint Committee on Taxation estimated that health-related sections of bill (the legislation also included education provisions) would reduce budget $124 billion between 2010 and 2019 and by ... around one-half percent of gross domestic product during following decade (Elmendorf, 2010b). …

Healthcare reform legislation signed into law

After nearly nine months of con-gressional committee hearings, contentious town hall meetings, and a bipartisan summit hosted by the White House, President Obama signed the primary healthcare reform legisla-tion into law on March 23, 2010 and the change package into law on March 30, giving the President a huge victory on his top domestic priority. When Congress returned to Washington, D.C. in January to begin the Second Session of the 111th Congress, many thought the House and Senate were close to a compromise on the content of health-care reform legislation. However, negoti-ations on a final bill were stalled when, on January 19, Republican Scott Brown was elected to the Massachusetts Senate seat vacated by the death of Senator Edward Kennedy. Brown's election effectively took away the Senate Democratic leader-ship's 60th vote in support of healthcare reform legislation. Without the fi libuster-proof 60 votes in the Senate, Democrats would not have been able to overcome the procedural hurdles to passing a fi nal House-Senate compromise bill without Republican votes. As a result, pressure mounted on Speaker Nancy Pelosi (D-Calif.) for the House to take up and pass the Senate-approved healthcare reform bill, the Patient Protection and Affordable Care Act, H.R. 3590. However, Speaker Pelosi and the House Democratic lead-ership did not have the votes needed to pass H.R. 3590 without changes. Thus, the House and Senate Democratic lead-ership began to pursue the budget rec-onciliation process to move healthcare reform legislation through Congress in two pieces. The White House and House and Senate Democratic leadership agreed on a two-step process in which the House would pass the Senate-approved healthcare reform bill and then vote on a pack-age of changes to the bill negotiated by Democrats in both chambers. Under budget reconciliation, the Senate would be able pass the package of changes with a simple majority vote. The provisions do not preclude CMS from including oral drugs without an injectable equivalent in the bundled payment system in 2011. With the Senate's commitment to pass the package of changes, the House approved H.R. 3590 by a vote of 219 to 212 on March 21. President Obama signed the Patient Protection and Affordable Care Act into law on March 23. Subsequent to President Obama signing H.R. 3590 into law, the House approved the reconciliation bill amend-ing H.R. 3590 by a vote of 220 to 211, sending the package of changes to the Senate. The Senate then voted 56 to 43, approving the reconciliation bill. However, before passing the bill, it omitted two provisions in the student loan section that were ruled non-germane by the Parliamentarian. The leg-islation had to be returned to the House for final approval before being sent to President Obama for his signature. The House cast the final vote on health-care reform legislation, 220 to 207, and approved the amended reconciliation bill. President Obama signed the recon-ciliation bill into law on March 30. With the President's signature, the end-stage renal disease (ESRD) provisions in the Senate bill became law. Under the new law, the one percent reduction to the ESRD market basket is eliminated and replaced by a productivity adjustment. The law also requires a Government Accountability Office (GAO) study of including oral drugs in the bundled pay-ment system and a report on Medicare beneficiary access to high-quality dialy-sis services. The study will include analysis of a provider's ability to furnish specified oral drugs, defined as a drug or biologic for which there is no injectable equivalent, or to arrange for the provi-sion of oral drugs and a provider's abil-ity to comply with State laws in order to furnish specifi ed oral drugs. The study will also evaluate wheth-er appropriate quality measures exist to protect beneficiary access to speci-fied oral drugs and other areas to be determined by the Comptroller General. The GAO report is required no later than March 23, 2011, one year from the enactment of healthcare reform. It is important for the kidney-care commu-nity to note that the healthcare reform provisions do not preclude the Centers for Medicare and Medicaid Services (CMS) from including oral drugs with-out an injectable equivalent in the bun-dled payment system in 2011. The final rule on the ESRD pro-spective payment system (PPS) has not been released. It is expected that CMS will issue a final regulation this spring, since the bundled payment system will replace the current payment system on January 1, 2011. The full impact of the bundled PPS on patients and providers is still unknown, and only time will tell if CMS agrees to delay the oral drug provisions until after the completion of the GAO study. The authors are with the Prime Policy Group based in Washington, DC.

A Vote for Health Care Reform

Health care reform legislation has languished in political purgatory for the past 2 months, teetering between historic enactment and epic collapse. The House of Representatives and the Senate both passed health care legislation at the end of 2009. After a year of tumultuous debate, agreement seemed near on a final compromise bill that would represent both a substantial advance in health care coverage and a major political triumph for the Obama administration. But the stunning victory of Republican Scott Brown in Massachusetts' special Senate election in January sent health care reform into a tailspin. Democrats lost their 60-vote, filibuster-proof Senate . . .

Reform, Reform Everywhere and Not a Primary Care Dollar to Drink

Reform, Reform Everywhere and Not a Primary Care Dollar to Drink