Healthcare Reform Center

With new federal healthcare legislation now in place, Holland & Knight is prepared to help you effectively navigate through the most substantial changes to the industry since the inception of Medicare. Our Healthcare Reform Center is an informational hub to provide up-to-date content and resources regarding the new Health Reform Bill, including its impact on specific industry sectors and employers. Let us help you evaluate the opportunities and challenges this legislation presents.

Healthcare Providers | Health Plans and Insurance |
Pharmaceutical & Medical Device Industry | Employers |
Funding & Grant Opportunities | Accountable Care Organizations | Holland & Knight Analyses |

Essential Resources

• President Obama Signs Health Care Reform Legislation
• Timeline of Key Provision Implementation Dates and Interactive Timeline
• Patient Protection and Affordable Care Act of 2010 as Amended by Health Care and Education Reconciliation Act of 2010
• Kaiser Health News: Legal Questions and Answers that Will Decide the Health Law's Fate (Chart) (November 18, 2011)
• Secretary Sebelius Issues Letter to Congress on Progress of Health Care Reforms Enacted by Patient Protection and Affordable Care Act (January 5, 2011)
• Department of Health and Human Services issues Initial Guidance to States regarding the establishment of Health Insurance Exchanges. (December 2010)
• Office of Consumer Information and Insurance Oversight releases Federal Support and Standards for Medicaid and Exchange Information Technology Systems to help States develop consumer-oriented information technology systems. (November 3, 2010)
• Department of Health and Human Services issues Frequently Asked Questions pertaining to the implementation of the Patient Protection and Affordable Care Act (October 12, 2010)
• Summary of MedPAC Commissioners Meeting held October 7-8, 2010 (October 8, 2010)
• Office of Inspector General releases recordings and transcripts of October 5, 2010 workshop regarding Accountable Care Organizations, and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback, and Civil Monetary Penalty (CMP) Laws. (October 5, 2010)
• Summary of MedPAC Commissioners Meeting held September 13-14, 2010
• Secretary Sebelius Issues Letter to Congress Regarding Implementation of the Affordable Care Act (May 10, 2010)
• Federal Government provides guidance and information about how residents of each State can apply for Pre-Existing Condition Insurance Plan (July 1, 2010)
• Holland & Knight Summary of Health Insurance Reforms in Affordable Care Act (August 5, 2010)
• Department of Health and Human Services releases report which examines selected cost-saving provisions that CMS has already implemented or will be implementing very soon as a result of the Patient Protection and Affordable Care Act (August 5, 2010)

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Healthcare Providers

• HHS makes available $1 billion for innovative healthcare hiring with Health Care Innovation Challenge; Health Care Innovation Press Release & Fact Sheet (November 14, 2011)
• CMS announces Bundled Payments for Care Improvement initiative and invites providers to apply to help test and develop four different models of bundling payments. (August 23, 2011)
• CMS releases state-by-state list of high readmission rate hospitals as part of its Community-Based Care Transitions Program (December 28, 2010)
• Holland & Knight Health Law Alert: CMS Releases Final Rule on Physician-Owned Hospitals (November 23, 2010)
• Centers for Medicare and Medicaid Services issue guidance regarding Health Homes for Medicaid Enrollees with Chronic Conditions. (November 16, 2010)
• Centers for Disease Control and Prevention seeks public comment on the development of guidance concerning Health Risk Assessment (HRAs). (November 16, 2010)
• Department of Health and Human Services issues Frequently Asked Questions pertaining to the implementation of the Patient Protection and Affordable Care Act (October 12, 2010)
• Office of Inspector General releases recordings and transcripts of October 5, 2010 workshop regarding Accountable Care Organizations, and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback, and Civil Monetary Penalty (CMP) Laws. (October 5, 2010)
• Holland & Knight Health Law Alert: Medicare ACO Rules Under Development: Many Unanswered Questions Remain (September 13, 2010)
• CMS issues guidance to states as to how Medicaid programs can qualify for a 90% federal match for administrative expenses associated with the incentive program for providers to adopt, implement, and meaningfully use certified electronic health record (EHR) technology. (August 17, 2010)
• Holland & Knight Health Law Alert: Analysis of final Regulations setting standards for EHR, Meaningful Use and Technology Certification under the HITECH Act (August 12, 2010)
• Centers for Medicare and Medicaid Services issues fact sheet summarizing findings of annual Medicare Board of Trustees Report (August 5, 2010)
• Department of Health and Human Services awards $159.1 Million to support Health Care Workforce Training (August 5, 2010)
• Department of Health and Human Services issues a request for comment asking states, consumer advocates, employers, insurers, and other interested stakeholders to provide input as to the rules and standards which Health Insurance Exchanges should be required to meet. (August 3, 2010)
• Holland & Knight Health Law Alert: Analysis of Newly Released Proposed Rule on Physician-Owned Hospitals (July 27, 2010)
• CMS releases proposed rule on Physician-Owned Hospitals (July 27, 2010)
• Department of Health and Human Services proposes rules that will modify HIPAA Privacy, Security, and Enforcement Rules under the HITECH Act of 2009 (July 14, 2010)
• CMS issues regulations regarding expanded Medicare coverage under Part B to include an Annual Wellness Visit Providing Personalized Prevention Plan Services. (July 13, 2010)
• Department of Health and Human Services Releases Final Rule on "Meaningful Use" of an Electronic Health Record and Standards, Implementation Specifications, and Certification Criteria for Electronic Health Records (July 13, 2010)
• Holland & Knight Health Law Alert: IRS Seeks Comments on the New Requirements for Tax-Exempt Hospitals Under the Patient Protection and Affordable Care Act (July 8, 2010)
• Department of Health and Human Services issues Announcement of Availability of Funds for Support for Pregnant and Parenting Teens and Women (July 2, 2010)
• The Office of the National Coordinator for Health Information Technology ONC Final Rule regarding Electronic Health Records Technology (June 24, 2010)
• Holland & Knight Summary of CMS Call on Accountable Care Organizations (June 24, 2010)
• Holland & Knight Health Law Alert: Key Provisions of the New Federal Health Reform Law Impacting Providers (June 22, 2010)
• Internal Revenue Service issues announcement on expanded tax benefit to health professionals working in underserved areas (June 16, 2010)
• Department of Health and Human Services issues Fact Sheet regarding increasing the number of health care providers and strengthening the primary care workforce (June 16, 2010)
• Holland & Knight Presentation: Health Care Reform: The Impact on Hospitals & Health Systems Webinar (June 7, 2010)
• Holland & Knight Presentation: Healthcare Reform Legislation: What Does it Mean for Exempt Organizations? (April 28, 2010)
• Holland & Knight Health Law Alert: Medicare Payment Advisory Commission (MedPAC) (April 15, 2010)
• Holland & Knight Health Law Alert: Healthcare Reform Requires All Providers and Suppliers to Establish Compliance Programs (April 6, 2010)
• The Centers for Medicare & Medicaid Services issues Preliminary Questions & Answers regarding Medicare “Accountable Care Organizations” Shared Savings Program

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Accountable Care Organizations

• Accountable Care Organizations: Medicare Shared Savings Program Application 2012. The application seeks information on the legal and governance structure of accountable care organizations, provider participation agreements, data sharing, and quality improvement and patient engagement efforts. (November 10, 2011)
• Regulatory Advisory, The Medicare Shared Savings Program Accountable Care Organizations: The Final Rule, At a Glance (November 8, 2011)
  Published by the American Hospital Association
• Accountable Care Organizations: Medicare Program; Final Waivers in Connection with the Shared Savings Program (November 2, 2011)
• Accountable Care Organizations: FTC/DOJ; Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (November 2, 2011)
• Accountable Care Organizations: Final Rule, 42 CFR Part 425 (October 20, 2011)
• Brief Summary of Accountable Care Organizations, Final Rule, 42 CFR Part 425 (October 20, 2011)
• Accountable Care Organizations: IRS Fact Sheet FS 2011-11: Tax-Exempt Organizations Participating in the Medicare Shared Savings Program through Accountable Care Organizations (October 20, 2011)
• CMS announces Bundled Payments for Care Improvement initiative and invites providers to apply to help test and develop four different models of bundling payments. (August 23, 2011)
• American Hospital Association provides comments to CMS regarding the proposed rules for ACO Program (June 1, 2011)
• American Medical Association provides comments to the Federal Trade Commission and the Department of Justice (DOJ) on the proposed Statement of Antitrust Enforcement Policy regarding ACOs (May 26, 2011)
• American Medical Association provides draft comments to CMS regarding the proposed rules for ACO Program (May 26, 2011)
• CMS Issues Request for Applications for Pioneer ACOs (May 15, 2011)
• Congressional Research Service Issues Memorandum on ACOs and Medicare Shared Savings Program (April 25, 2011)
• Holland & Knight Health Law Alert: Medicare Shared Savings Program: Accountable Care Organizations (April 6, 2011)
• CMS Launches Dedicated Web Page for Medicare Shared Savings Program (March 31, 2011)
• CMS Issues Proposed Rule for ACOs (March 31, 2011)
• CMS Issues Fact Sheet Addressing Legal Issues regarding ACOs (March 31, 2011)
• CMS Issues Summary of Proposed Rule Provisions for ACOs (March 31, 2011)
• CMS Issues Guidance on "What Providers Need to Know" about ACOs (March 31, 2011)
• CMS Issues Guidance on "What Patients Need to Know" about ACOs (March 31, 2011)
• CMS Issues Fact Sheet Describing Proposals for Measuring Quality and Scoring Performance of ACOs (March 31, 2011)
• CMS Issues Frequently Asked Questions (FAQs) regarding ACOs and Medicare Shared Savings Program (March 31, 2011)
• Transcript of Speech Given by Mr. Donald Berwick, Administrator for the Centers for Medicare and Medicaid Services, at the Engelberg Center for Health Care Reform at the Brookings Institution (January 31, 2011)
• American Medical Association's views and recommendations on ACOs. (December 2, 2010)
• Medicare Payment Advisory Commission's comments and recommendations on ACOs (November 22, 2010)
• American Hospital Association's comments and recommendations on ACO development and implementation. (November 17, 2010)
• Association of American Medical Colleges issues Statement on ACOs and Healthcare Innovation Zones. (October 5, 2010)
• Office of Inspector General releases recordings and transcripts of October 5, 2010 workshop regarding Accountable Care Organizations, and Implications Regarding Antitrust, Physician Self-Referral, Anti-Kickback, and Civil Monetary Penalty (CMP) Laws. (October 5, 2010)

Morning Session	Afternoon Session
Audio of Opening Comments and FTC Pannels (MP3)	Audio of HHS Panel and Listening Session (MP3)
Transcript of Comments and FTC Pannels (PDF)	HHS Pannel and Listening Session (PDF)

• Holland & Knight Health Law Alert: Medicare ACO Rules Under Development: Many Unanswered Questions Remain (September 13, 2010)
• Holland & Knight Summary of CMS Call on Accountable Care Organizations (June 24, 2010)
• The Centers for Medicare & Medicaid Services issues Preliminary Questions & Answers regarding Medicare “Accountable Care Organizations” Shared Savings Program
• Healthcare Transactions in a Post-Reform World: Creating the Next Generation U.S. Healthcare Delivery System (September 23, 2010)

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Health Plans and Insurance

• Departments of Health and Human Services, Labor, and Treasury issue proposed rules requiring health insurers and group plans to provide consumers upon request or before they buy coverage an easy to understand Summary of Benefits and Coverage and a uniform glossary of commonly used health insurance terms. (August 22, 2011)
• Department of Health and Human Services issues Initial Guidance to States regarding the establishment of Health Insurance Exchanges. (December 2010)
• Department of Health and Human Services issues Amendment to Interim Final Rules for Group Health Plans and Health Insurance Coverage relating to status as a Grandfathered Health Plan. (November 17, 2010)
• Department of Health and Human Services issues Frequently Asked Questions pertaining to the implementation of the Patient Protection and Affordable Care Act (October 12, 2010)
• CMS issues guidance to states as to how Medicaid programs can qualify for a 90% federal match for administrative expenses associated with the incentive program for providers to adopt, implement, and meaningfully use certified electronic health record (EHR) technology. (August 17, 2010)
• Department of Health and Human Services awards $46 million in grants to 45 States and the District of Columbia to improve the oversight of proposed health insurance premium increases, take action against insurers seeking unreasonable rate hikes and ensure consumers receive value for their premium dollars. Click here for a list of States’ current health insurance rate review practices and a summary of their intended use of the grant money awarded to them. (August 16, 2010)
• Holland & Knight Health Law Alert: Analysis of final Regulations setting standards for EHR, Meaningful Use and Technology Certification under the HITECH Act (August 12, 2010)
• CMS issues fact sheet summarizing findings of annual Medicare Board of Trustees Report (August 5, 2010)
• Holland & Knight Health Law Alert: Health Insurance for High Risk People: Interim Final Rule Establishes Coverage Guidelines (August 4, 2010)
• Department of Health and Human Services issues a request for comment asking states, consumer advocates, employers, insurers, and other interested stakeholders to provide input as to the rules and standards which Health Insurance Exchanges should be required to meet. (August 3, 2010)
• Interim final regulations implementing Pre-Existing Condition Insurance Plan Program. (July 30, 2010)
• Department of Health and Human Services announces availability of $51 million in resources for states to build new competitive Health Insurance Marketplace. (July 29, 2010)
• Interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets. (July 23, 2010)
• Department of Health and Human Services issues Fact Sheet discussing new regulations governing internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets. (July 23, 2010)
• Letter from the Congressional Budget Office providing a financial analysis of the public plan option that is proposed to be available through the health insurance exchanges that will be established in 2014 (July 22, 2010)
• Interim final regulations implementing the rules for group health plans and health insurance coverage in the group and individual markets regarding preventive health services. (July 19, 2010)
• Department of Health and Human Services proposes rules that will modify HIPAA Privacy, Security, and Enforcement Rules under the HITECH Act of 2009 (July 14, 2010)
• CMS issues regulations regarding expanded Medicare coverage under Part B to include an Annual Wellness Visit Providing Personalized Prevention Plan Services. (July 13, 2010)
• Department of Health and Human Services announces the creation of the Pre-Existing Condition Insurance Plan ("PCIP") (July 1, 2010)
• Federal Government provides guidance and information about how residents of each State can apply for Pre-Existing Condition Insurance Plan (July 1, 2010)
• Department of Health and Human Services announces that it will begin accepting applications for participation in the Early Retiree Reinsurance Program (June 29, 2010)
• Department of Health and Human Services issues Fact Sheet and Questions & Answers regarding coverage for dependants who have not reached the age of 26
• Interim Final Regulation implementing rules for group health plans and health insurance coverage in the group and individual markets regarding preexisting condition exclusions, lifetime and annual dollar limits, rescissions and patient protections. (June 28, 2010)
• Holland & Knight Health Law Alert: Patient Protection and Affordable Care Act: American Health Benefit Exchanges and CO-OPs – Competition and Coverage (June 22, 2010)
• Letter from the Congressional Budget Office discussing High-Risk Insurance Pools Under the Patient Protection and Affordable Care Act Information About High-Risk Insurance Pools Under the Patient Protection and Affordable Care Act (June 21, 2010)
• Interim Rule on “Grandfathered” Health Plans under the Patient Protection and Affordable Care Act (June 17, 2010)
• Department of Health and Human Services issues Fact Sheet and Questions & Answers regarding how the Patient Protection and Affordable Care Act and the "grandfather" rule will affect individuals, employers, and insurers going forward. (June 14, 2010)
• Department of Health and Human Services announces Patient Protection and Affordable Care Act grants to innovate, improve, and enhance health insurance premium rate review (June 7, 2010)
• Department of Health and Human Services issues interim final regulations implementing the requirements for group health plans and health insurance issuers in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding dependent coverage of children who have not attained age 26. (May 13, 2010)
• Department of Health and Human Services issues Interim Final Rule implementing Early Retiree Reinsurance Program. (May 5, 2010)
• Department of Health and Human Services issues interim final rule establishing requirements and rules for Health Care Reform Insurance Web Portal created by the Patient Protection and Affordable Care Act. (May 3, 2010)
• Department of Health and Human Services issues Fact Sheet on High Risk Pool Program and State Allocations (April 23, 2010)
• Department of Health and Human Services establishes Office of Consumer Information and Insurance Oversight (April 14, 2010)
• Department of Health and Human Services, Labor and Treasury invite public comment on medical loss ratios (April 14, 2010)
• Department of Health and Human Services requests public comment on premium review process (April 14, 2010)
• Department of Health and Human Services Secretary Kathleen Sebelius Requests feedback from Governors and Insurance Commissioners on High Risk Pools (April 2, 2010)

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Pharmaceutical & Medical Device Industry

• CMS issues fact sheet summarizing findings of annual Medicare Board of Trustees Report (August 5, 2010)
• Department of Health and Human Services proposes rules that will modify HIPAA Privacy, Security, and Enforcement Rules under the HITECH Act of 2009 (July 14, 2010)
• Holland & Knight Health Law Alert: Little-Known Health Reform Provision Could Have Big Impact on Medical Research (April 6, 2010)
• Holland & Knight Health Law Alert: Health Care Reform: New Challenges and Opportunities for Life Sciences Companies (March 29, 2010)

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Employers

• Department of Health and Human Services issues Frequently Asked Questions pertaining to the implementation of the Patient Protection and Affordable Care Act (October 12, 2010)
• IRS Delays Reporting Requirements for Employers regarding Costs of Supplying Healthcare Coverage to Employees (October 12, 2010)
• Holland & Knight Presentation: Impact of Healthcare Reform on Labor Relations (September 25, 2010)
• Holland & Knight Health Law Alert: Analysis of final Regulations setting standards for EHR, Meaningful Use and Technology Certification under the HITECH Act (August 12, 2010)
• Holland & Knight Health Law Alert: Health Insurance for High Risk People: Interim Final Rule Establishes Coverage Guidelines (August 4, 2010)
• Department of Health and Human Services issues a request for comment asking states, consumer advocates, employers, insurers, and other interested stakeholders to provide input as to the rules and standards which Health Insurance Exchanges should be required to meet. (August 3, 2010)
• Department of Health and Human Services proposes rules that will modify HIPAA Privacy, Security, and Enforcement Rules under the HITECH Act of 2009 (July 14, 2010)
• Federal Government provides guidance and information about how residents of each State can apply for Pre-Existing Condition Insurance Plan (July 1, 2010)
• Department of Health and Human Services announces that it will begin accepting applications for participation in the Early Retiree Reinsurance Program (June 29, 2010)
• Internal Revenue Service issues announcement on expanded tax benefit to health professionals working in underserved areas (June 16, 2010)
• U.S. Department of Labor announces more than $14 million in health care career grants supported by Patient Protection and Affordable Care Act (June 16, 2010)

• Department of Health and Human Services announces Patient Protection and Affordable Care Act grants to innovate, improve, and enhance health insurance premium rate review (June 7, 2010)
• Internal Revenue Service issues Notice 2010-44 and examples to help small employers determine whether they qualify for the Small Business Health Care Tax Credit (May 17, 2010)
• Department of Health and Human Services issues interim final regulations implementing the requirements for group health plans and health insurance issuers in the group and individual markets under provisions of the Patient Protection and Affordable Care Act regarding dependent coverage of children who have not attained age 26 (May 13, 2010)
• Statement of Assistant Secretary of Labor Phyllis C. Borzi calling on employers and benefit plans to make young adult coverage available immediately. (May 11, 2010)
• Department of Health and Human Services issues Interim Final Rule implementing Early Retiree Reinsurance Program (May 5, 2010)
• Holland & Knight Health Law Alert: Healthcare Reform: What It Means for Employers (April 26, 2010)
• Internal Revenue Service issues tax tips, guide and answers to frequently asked questions regarding Small Business Health Care Tax Credit for Small Employers (April 1, 2010)
• Internal Revenue Service issues Notice 2010-38 which provides guidance on the tax treatment of health coverage for children up to age 27 under the Patient Protection and Affordable Care Act (April 1, 2010)

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Funding & Grant Opportunities

• Federal Grants Web site: http://www.grants.gov
• State by state breakdown on grants which have been awarded for healthcare workforce professionals
• Department of Health and Human Services awards $46 million in grants to 45 States and the District of Columbia to improve the oversight of proposed health insurance premium increases, take action against insurers seeking unreasonable rate hikes and ensure consumers receive value for their premium dollars. Click here for a list of States’ current health insurance rate review practices and a summary of their intended use of the grant money awarded to them. (August 16, 2010)
• Department of Health and Human Services announces availability of up to $250 million in grants for New Access Points for the delivery of primary health care services for underserved and vulnerable populations under the Health Center Program (August 9, 2010)
• Department of Health and Human Services awards $159.1 Million to support Health Care Workforce Training (August 5, 2010)
• Department of Health and Human Services announces availability of $51 million in resources for states to build new competitive Health Insurance Marketplace. (July 29, 2010)
• Department of Health and Human Services issues Announcement of Availability of Funds for Support for Pregnant and Parenting Teens and Women (July 2, 2010)
• U.S. Department of Labor announces more than $14 million in health care career grants supported by Patient Protection and Affordable Care Act (June 16, 2010)
• Department of Health and Human Services announces Patient Protection and Affordable Care Act grants to innovate, improve, and enhance health insurance premium rate review (June 7, 2010)

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Holland & Knight Analyses

Health Law Alerts

• CMS Releases Final Rule Implementing Accountable Care Organizations under the Medicare Shared Savings Program Alert (November 22, 2011)
• HIPAA Update: new Proposed HIPAA Accounting Rules and KPMG Audits Alert (July 8, 2011)
• CMS Announces Three New ACO Initiatives Alert (May 25, 2011)
• Regulatory Implications of FDA's New MDDS Final Rule for Hospital Systems Alert (April 12, 2011)
• Medicare Shared Savings Program: Accountable Care Organizations (April 6, 2011)
• Home Medical Equipment Call Center Complications in Florida Alert (March 24, 2011)
• OFCCP Issues New Directive on Coverage of Healthcare Providers and Insurers Alert (February 24, 2011)
• FDA Releases Much Anticipated 510(k) Action Plan Alert (January 20, 2011)
• CMS Opens EHR Incentive Program Registration for Eligible Hospitals and Professionals Alert (January 12, 2011)
• CMS Releases Final Rule on Physician-Owned Hospitals (November 23, 2010)
• Medicare ACO Rules Under Development: Many Unanswered Questions Remain (September 13, 2010)
• Analysis of final Regulations setting standards for EHR, Meaningful Use and Technology Certification under the HITECH Act (August 12, 2010)
• Health Insurance for High Risk People: Interim Final Rule Establishes Coverage Guidelines (August 4, 2010)
• Analysis of Newly Released Proposed Rule on Physician-Owned Hospitals (July 27, 2010)
• IRS Seeks Comments on the New Requirements for Tax-Exempt Hospitals Under the Patient Protection and Affordable Care Act (July 8, 2010)
• Patient Protection and Affordable Care Act: American Health Benefit Exchanges and CO-OPs – Competition and Coverage (June 22, 2010)
• Key Provisions of the New Federal Health Reform Law Impacting Providers (June 22, 2010)
• Healthcare Reform: What It Means for Employers (April 26, 2010)
• Medicare Payment Advisory Commission (MedPAC) (April 15, 2010)
• Healthcare Reform Requires All Providers and Suppliers to Establish Compliance Programs (April 6, 2010)
• Little-Known Health Reform Provision Could Have Big Impact on Medical Research (April 6, 2010)
• Health Care Reform: New Challenges and Opportunities for Life Sciences Companies (March 29, 2010)

Presentations

• Impact of Healthcare Reform on Labor Relations (September 25, 2010)
• Healthcare Transactions in a Post-Reform World: Creating the Next Generation U.S. Healthcare Delivery System September 23, 2010
• Summary of MedPAC Commissioners Meeting held September 13-14, 2010
• Health Care Reform: The Impact on Hospitals & Health Systems Webinar (June 7, 2010)
• Healthcare Reform Legislation: What Does it Mean for Exempt Organizations? (April 28, 2010)

Charts & Summaries

• Summary of MedPAC Commissioners Meeting held October 7-8, 2010 (October 8, 2010)
• Summary of Health Insurance Reforms in Affordable Care Act (August 5, 2010)
• Summary of CMS Call on Accountable Care Organizations (June 24, 2010)

We encourage you to check the Healthcare Reform Center regularly for updated information.