OIG Proposes Amendment of Health Care Program Civil Monetary Penalty Regulations

The Office of Inspector General (OIG) of the Department of Health and Human Services has issued a proposed rule that would institute several changes to the health care program civil monetary penalty (CMP) regulations. Under the proposed rule, which is analyzed in a client alert prepared by Reed Smith lawyers Paul Pitts, Joe Metro, and Susan Edwards, the OIG would have the expanded authority to enforce significant CMPs on providers and suppliers in a variety of scenarios.

In addition, the rule proposes a reorganization and clarification of current CMP regulations, including the methods used to determine when and how a CMP should be issued and how a CMP should be calculated. The OIG estimates that enforcement of the proposed rule would result in an increase in CMP collections by the government. Comments on the rule are due by July 11, 2014.

China Life Sciences and Health Industry Client Briefing - August 2012 (September 18, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during August include:

  • New Regulations Concerning Hospital Procurement of Class-A Large-Scale Medical Equipment
  • MOH to Investigate Infection Events in Hospitals
  • Wenzhou Develops New Plans to Attract Private Medical Investors
  • Notice Concerning Public Hospital Reform in 2012
  • MOH to Establish EDLs for Secondary and Tertiary Hospitals
  • Pricing Developments for Drugs of Foreign Companies
  • Revised Regulations on Criminal Prosecutions for Leaks of Confidential Patient Information
  • State Council to Release Regulation Permitting Local Governments to Buy Commercial Insurance on for Serious Illnesses

To read the full briefing by Reed Smith China team members, click here.

China Life Sciences and Health Industry Client Briefing - July 2012 (August 8, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Katherine Yang, May Wong and Gordon B. Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries

Some important developments during July include:

  • Counterfeit Drug Crackdown in China
  • China Agencies Drafting Policies to Accelerate Development of Medical Devices
  • Mindray Medical Completes Acquisition of Dragonbio's Orthopedics Business
  • Multinational Medical Device Companies Focus on Grassroots Market
  • J&J Plans Training Center in China
  • New Round of Drug Price Cuts Expected
  • MOH Enhances Planning of Private Medical Institutions and Further Relaxes Threshold for Private Investors

To read the full briefing by Reed Smith China team members, click here.

Life Sciences Health Industry China Briefing - June 2012 (July 20, 2012)

This post was written by John Tan, Jay J. Yan, Mao Rong, Katherine Yang, and Gordon B. Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Pharmaceuticals, Medical Devices, Health Care & Life Sciences 


  • China's Compulsory License Rule Has Drug Companies On Edge (Law360 2012-06 12) — June 14, 2012

China's new patent regulations allowing the government to force drug companies to grant compulsory licenses for generic versions of their products if it is deemed to be in the "public interest" has the pharmaceutical industry worried about where China will draw the line, attorneys said. The new regulations issued by China's State Intellectual Property Office last month say the government can order compulsory licenses for generic drugs when there is a "national emergency or any extraordinary circumstances, or for public interest purposes." What constitutes the public interest is very much open to interpretation and appears to give the Chinese government broad leeway to order drug companies to allow generic versions of drugs that are still covered by patents.

  • Beijing to Carry out Pilot Project of Separation of Dispensing from Prescription: Medical Service Fee up to 100 Yuan (Caixin Media 2012-05-19) — June 20, 2012
Following Shenzhen and Shanghai, Beijing will initiate the pilot project to cut off the relationship between the income of hospitals and drug sales. Beijing plans to cancel the price addition to lower drug price, and to cancel the registration fee and diagnosis fee, which will be replaced by the medical service fee. The medical service fee will be divided into four levels:  42 yuan for ordinary physicians, 60 yuan for deputy chief physicians, 80 yuan for chief physicians and 100 yuan for expert physicians. The medical insurance will reimburse 40 yuan for the medical service fee. In addition, Beijing Friendship Hospital, Beijing Chaoyang Hospital, and Beijing Children's Hospital will carry out the legal person governance mechanism in order to provide experiences for the further reform of public hospitals in Beijing.
  • Drug Company to Acquire Controlling Stake (China Daily 2012-06-28) — June 29, 2012
China Pharmaceutical Group Ltd, which derives almost half of its sales from antibiotics, will buy a maker of finished drugs from its controlling shareholder for HK$8.98 billion ($1.2 billion) worth of new stock and convertible bonds. The purchase of Robust Sun Holdings Ltd will reduce the company's reliance on drug intermediaries, bulk antibiotics, and vitamin C, which now account for 66 percent of its sales.
  • Investors Eye Chances in High-End Healthcare (Shanghai Daily  2012-06-19) — June 19, 2012
As demand for high-quality health care rises in China, venture capital and private equity companies are taking advantage of ample investment opportunities in the nation's private and specialized hospitals. There were 158 investment deals in the medical and health care sector last year, worth $4.14 billion, around the same amount as the total deals in the sector from 2006 to 2010, according to a report from the Zero2IPO research center. The report said 28 medical and health care companies were listed last year, raising $5.33 billion, and 12 of them were backed with VC or PE investment.  The State Council passed a medical reform plan in 2009 that promised to spend 850 billion yuan ($123 billion) by last year to provide universal medical services to the country's 1.3 billion people. "We treat private medical institutions equally (with public ones), and they can be included in the scope of basic medical insurance under certain conditions," said Li Jinghu, deputy director of the Institute of Social Security at the Ministry of Human Resources and Social Security. In April, the State Council issued a statement on deepening the medical system reform, which states that local governments are required to issue detailed regulations to encourage private capital into this industry, and to guide the restructuring of certain public hospitals. A total of 300 county-level hospitals will take part in a pilot program that will see them undergo reforms in finance, management and human resources, according to guidelines published on the central government's website in June.
  • CIRC Encourages Insurance Companies to Establish Medical Institutions to Expand Business (Caijing 2012-06-20) — June 21, 2012
China Insurance Regulatory Commission (CIRC) issued a Notice concerning Fulfillment of the Programs on Deepening the Medical Reform during the 12th Five-Year Period. According to the Notice, CIRC will conduct research on the feasibility and the effective way for insurance companies to establish medical institutions and become involved in the restructuring of public hospitals. In fact, the encouragement on insurance companies to invest in hospitals has been mentioned in the Opinions of State Council on Reform and Development in the Insurance Industry in 2006. Accordingly, China PingAn Insurance signed an agreement with the Longgang District Government of Shenzhen to establish a Chinese medicine hospital in Longgang last year as a pilot.
  • MOH and Medical Reform Office under State Council Respond to Questions on Opinions of Comprehensive Reform Pilot Project of Public Hospitals at County Level (National Development and Reform Commission 2012-06-15) — June 15, 2012
The State Council recently issued the Opinions concerning the Comprehensive Reform Pilot Project of Public Hospitals at County Level. The Opinions aim to ease the difficulties and the problems of expensive medical charges in the medical treatment for rural residents. The comprehensive system for the medical cost through drug-selling profits shall be eradicated. The pilot public hospitals at county level will be compensated through service charges and government subsidy. Each county (city) shall have one to two hospitals (including Chinese medicine hospital) at county level. The county (city) with more than 300,000 population shall have at least one Grade 2A hospital. Remote consultation, remote diagnosis, and distance education will be realized among hospitals at county level. In addition, excellent professionals will practice at county level hospitals through nurturing and offering preferential treatment.
  • 311 Counties to Pilot China's Hospital Reform (Xinhua News Agency 2012-06-27) — June 27, 2012
China has nominated 311 counties or county-level cities in a program to pilot reform of the country's public health care facilities, the Ministry of Health announced Tuesday. The national initiative includes 83 counties or county-level cities in East China, 136 in Central China, and 92 in West China, according to the ministry. The 311 counties or county-level cities are expected to undergo reforms in finance, management and human resources by 2015 to enhance their capacity.
  • First Wholly Taiwan-funded Hospital Opens (Shanghai Daily 2012-06-27) — June 27, 2012
The Chinese mainland's first wholly Taiwan-funded hospital opened in Shanghai yesterday. It is the first solely invested Taiwan hospital to receive the green light on the mainland after the Economic Cooperation Framework Agreement, or ECFA, was signed between the mainland and Taiwan authorities in 2010. Established by the Taipei-based Landseed International Medical Group, the Shanghai Landseed International Hospital, with a 150 million yuan (US$23.81 million) investment, is mainly aimed at Taiwanese, expatriates living in Shanghai, and locals with high-end health demands, hospital officials said.
  • Smiling Angel Children's Hospital To Go into Operation (Caixin Media 2012-06-24) — June 25, 2012
Beijing Smiling Angel Children's Hospital, the first private charity children’s hospital run by film star Li Yapeng, will go into operation July 1. The hospital will operate in nonprofit mode based on the Smile Angel Foundation. Given the current shortage of pediatricians, the hospital will provide medical services through the multi-site practice of the pediatricians from the public hospitals. Apart from the children from poor families, the hospital will also be opened to ordinary families. Some high-quality services will be charged highly accordingly. All the income will be used to develop the hospital in sectors including R&D and medical assistance, and there will not be dividends to the shareholders. The operation cost will be mainly from the social donations through charity dinners, small donations and other manners. 
  • China Medical Services Market to Hit $500B (Agencies 2012-06-25) — June 25, 2012
China needs to bolster its medical services and investors are ready to help, Bloomberg reported. The latest is Carlyle Group LP-backed Concord Medical Services Holdings Ltd, which last week completed a deal for a 52 percent stake in Chang'an Hospital, a 1,000-bed facility at the eastern end of the Silk Road, according to Bloomberg. China's medical services market is growing 18 percent annually and is projected to reach 3.16 trillion yuan ($500 billion) in 2015, Bloomberg reported, citing accountancy firm Deloitte China.

Life Sciences Health Industry China Briefing - May 2012 (June 14, 2012)

This post was written by John Tan, Jay J. Yan, Mao Rong, Katherine Yang, and Gordon B. Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during May include:

  • Introduction of Administrative Measures on Clinical Application of Antimicrobial Drugs
  • Two Agencies Crack Down on Violent Crime Against Medical Personnel
  • Medical Insurance Reimbursement for Hospitalization to Reach 75% of Total Expenses During 12th Five-Year Plan
  • Foreign Medical Workers to Receive TCM Training in Shanxi 
  • MOH Requires Class B and Higher Hospitals to Establish Security Offices
  • China to Expand Medical Payment Reform
  • SFDA Campaign to Regulate TCM Raw Material Market
To read the full briefing by Reed Smith China team members, click here.


Life Sciences Health Industry China Briefing - April 2012 (May 21, 2012)

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.  Some developments during April include:

  • Chinese Government to Review Drug Pricing Differences Between Ex-factory and Bid Prices
  • Heightened Attention to Hospital Mark-ups of Drug Prices
  • State Council to Cancel Drug Price Addition and Raise Medical and Surgery Fees
  • Cessation Drugs to be Included in Medical Insurance: Multinational Pharmaceutical Companies Play a Large Role in Government Procurement
  • 13 Products of 9 Pharmaceutical Companies Using Capsules Suspected of Excessive Chromium Contamination
  • Growth in Home Care Medical Devices

To read the full briefing by Reed Smith China team members, click here.

Life Sciences Health Industry China Briefing - March 2012 (April 13, 2012)

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.  Some developments during March include:

  • American Medical Device Maker Accused of Bribery to Doctors in China and other Countries
  • Qiagen Inks HPV Screening Deal with China's KingMed Diagnostics
  • Medical Care Administration to Improve through Health Cards
  • Cuts in Drug Prices
  • Notice Concerning Registration after Adjustment of Classification of Medical Devices
  • MOH Encourages Private Capital into Medical Rehabilitation Services

To read the full briefing by Reed Smith China team members, click here.

Life Sciences Health Industry China Briefing - February 2012 (March 13, 2012)

This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during February include:

  • Release of the 12th Five-Year Plan on Drug Safety and Standards
  • SFDA: Concentrated Rectification Action in National Drug Manufacturing and Distribution Sectors
  • Twelve Ministries: Crackdown on Serious Illegal Advertisement Broadcasting
  • SFDA: Electronic Drug Supervision Plan from 2011 – 2015
  • MOH: Administrative Measures on Health Card for Residents (for Trial Implementation)
  • MOH: Revised Diseases Classification and Code

To read the full briefing by Reed Smith China team members, click here.

Life Sciences Health Industry China Briefing - December 2011 (January 12, 2012)

This post was written by Jay Yan, Mao Rong, Zack Dong, Gordon Schatz, and Katherine Yang.

Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.

Some important developments during December include:

  • SFDA Issues Catalogue of Class II Medical Devices Exempted from Submitting Clinical Trial Materials
  • SFDA Issues Notice Concerning Circulation of Guiding Principles of Phase I Clinical Trial Management of Drugs
  • SFDA Issues Notice on Soliciting Comments on Revisions of the Good Supply Practice for Pharmaceutical Products
  • China Adopts Drug Safety Plan: All Drugs to be Qualified by 2015
  • NDRC Issues Rules on Drug Price Parity to Prevent Disguised Price Hikes
  • Guangdong Issues Drug Price Adjustment Program: 307 Western Drugs’ Price have a 22 percent Reduction in Average
  • Shenzhen Public Hospitals to Revoke Drug Price Addition by the End of 2012

To read the full briefing by Reed Smith China team members, click here.

HRSA Publishes Proposed Rule Regarding the Exclusion of Orphan Drugs for Certain 340B Covered Entities

This post was written by Joseph W. Metro and Vicky G. Gormanly.

On May 19, 2011, the Health Resources and Services Administration (“HRSA”) released a proposed rule concerning the exclusion of orphan drugs for certain covered entities under the 340B Program. The 340B Program, enacted pursuant to the Veterans Health Care Act of 1992 (“VHCA”), limits the prices that participating manufacturers may charge for outpatient drugs purchased by certain “covered entities” that act as “safety net” providers of services to low-income individuals.

Health care reform included significant changes for the 340B program, including expanding the types of covered entities eligible to participate in the Program. New classes of covered entities include certain freestanding cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children’s hospitals. However, under the amendments, 340B prices are not available for “orphan drugs” purchased by freestanding cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals. This limitation applies to protect financial incentives for manufacturers to bring to market such drugs.

Under the proposed rule, however, such covered entities may in fact purchase orphan drugs at the 340B price so long as the drug is not transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the orphan drug was designated. In other words, covered entities can purchase the drugs for approved non-orphan uses, as well as potentially unapproved, off-label uses. This proposal potentially “guts” the ineligibility provisions of the statute, as the rule provides no guidance as to how manufacturers can determine what indications (or non-indicated off-label uses) their orphan drugs are used for, and emphasizes that manufacturers may not condition the offer of 340B pricing upon an entity’s assurance that the drug will be used for its orphan indication.

The proposed rule is also somewhat unusual in its specificity, in that HRSA has not previously issue a rule that more generally governs the 340B program. Thus, manufacturers may wish to consider whether it is appropriate to comment on some of the general defined terms (e.g., “covered entity,” “covered outpatient drug”) contained in the proposed rule.

The proposed rule may be viewed here.  Comments are due July 19, 2011.

Pharmaceutical Package: Safe, Innovative and Accessible Medicines and A Renewed Vision For the Pharmaceutical Sector

This post was written by Paule Droualt-Gardrat, Juliette Peterka and Julie Gottenberg.

On December 10, 2008, the European Commission published a series of political measures and legislative proposals, the so-called “Pharmaceutical Package.” This series included the “Communication on a renewed vision for the pharmaceutical sector,” which reflected on ways to improve market access and develop initiatives to boost European Union (“EU”) pharmaceutical research. Through the Pharmaceutical Package, the European Commission aims to make pricing and reimbursement more transparent, increase the development of pharmaceutical research within the EU, improve the safety of medicines worldwide, and reinforce cooperation with international partners.

The European Commission has published three separate sets of proposals amending Directive 2001/83/EC on the Community Code of medicinal products and Regulation 726/2004 on medicinal products obtained through centralized procedures:

1.  A proposal amending Directive 2001/83 as “regards information to the general public on medicinal products subject to medical prescription” (Information to patient);
2.  A proposal amending Directive 2001/83 and a proposal amending Regulation 726/2004 as “regards pharmacovigilance” (The EU pharmacovigilance system); and,
3.  A proposal amending Directive 2001/83 as “regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source” (Counterfeit Medicines).

Read Reed Smith's full alert outlining proposed amendments to Directive 2001/83/EC and Regulation 726/2004.

Ninth Circuit Allows Section 340B Covered Entity Pricing Lawsuit Against Pharmaceutical Manufacturers

In a significant--and likely to be controversial--decision, the Ninth Circuit yesterday reinstated a putative class action filed by Santa Clara County, Calif., against more than 10 pharmaceutical manufacturers for allegedly overcharging hospitals for their medications. 

In County of Santa Clara v. Astra USA, Inc., __ F.3d __, 2008 WL 3916268 (9th Cir. Aug. 27, 2008), the question addressed was whether "Section 340B covered entities"--certain federally funded medical clinics--were intended direct beneficiaries of drug discount pricing agreements between the federal government and manufacturers. Section 602 of the Veterans Health Care Act of 1992, Pub. L. No. 102-585, 106 Stat. 4943, 4967, entitled “Limitations on Prices of Drugs Purchased by Covered Entities,” directs the Secretary of Health and Human Services to enter agreements with pharmaceutical manufacturers capping the price at the "average manufacturer price," as defined. 42 U.S.C. § 256b(a)(1). Pursuant to that statute, the Secretary entered into a standard Pharmaceutical Pricing Agreement ("PPA") with several manufacturers. The putative class action alleged, under federal contract law, that the County and several of its federally funded medical clinics were charged more than the PPAs allowed. The Ninth Circuit panel concluded that Section 340B covered entities are intended third-party beneficiaries of the PPAs with enforceable rights (even in the absence of a contractual right to sue, and the absence of a statutory private right of action), and rejected the argument that the primary jurisdiction doctrine required referral of the matter to the Secretary for agency resolution.

The Medicare Improvements for Patients and Providers Act of 2008

This post was written by Debra A. McCurdyRobert J. Hill, Jacqueline B. PenrodCatherine Durkin, Jamie L. Schreiber, and Nancy A. Sheliga.

I.  Introduction

On July 15, 2008, the House and Senate overrode President Bush’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (“MIPPA”). [1] MIPPA rescinds a 10.6 percent cut in Medicare physician payments, delays a controversial medical equipment competitive bidding program, and makes numerous other Medicare and Medicaid policy changes. Highlights of the new law include the following:

  • Physician Fee Schedule: MIPPA repeals a 10.6 percent cut in Medicare physician fee schedule rates that was briefly triggered on July 1, 2008, and provides a 1.1 percent increase for 2009 (rather than the forecasted 5.4 percent cut). The law also expands the Physician Quality Reporting Initiative (“PQRI”), promotes electronic prescribing, and requires non-hospital advanced imaging providers to be accredited by 2012.
  • DMEPOS Competitive Bidding. MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (“CMS”) competitive bidding program for certain categories of durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”). The delay is financed by cutting fee schedule payments for items included in round one by 9.5 percent nationwide beginning January 1, 2009, followed by a 2 percent increase in 2014 (with certain exceptions).
  • Therapy Caps Exception Process. MIPPA extends through December 31, 2009 the exceptions process relative to the annual per-beneficiary limitations on outpatient therapy services.
  • Clinical Laboratory Services. The act repeals the competitive bidding demonstration project for clinical laboratory services and instead reduces the fee schedule update for lab services by 0.5 percent in each of the next five years.
  • Medicare Advantage (“MA”) Provisions. MIPPA makes a series of payment and policy changes affecting MA plans, including a $1.8 billion cut in the MA stabilization fund for regional preferred provider organizations in 2012 and a phase-out of the adjustment for indirect medical education.
  • Medicare Part D Drug Plans. MIPPA establishes timeframes for plan payments to pharmacies and long-term care pharmacy submission of claims; codifies coverage of certain “protected classes” of drugs; limits certain sales and marketing activities; and makes other Part D reforms.
  • End-Stage Renal Disease Provisions. The law provides a 1.0 percent update to the composite rate for renal dialysis services for 2009 and 2010, requires the establishment of a fully-bundled ESRD payment system by January 1, 2011, and establishes a quality incentive payment program for ESRD providers.
  • Medicaid Drug Reimbursement.  MIPPA delays the adoption of Medicaid payment based on average manufacturer price (“AMP”) for multiple source drugs and prevents publication of AMP data until October 1, 2009.

The following is a summary of the major provisions of the new law.  We would be pleased to provide additional information upon request.


A.  Beneficiary Improvements

1.  Preventive Services

MIPPA authorizes the Secretary of the Department of Health and Human Services (“the Secretary”) to expand Medicare coverage to additional preventive services that (1) identify medical conditions or risk factors classified as grade A or B by the United States Preventive Services Task Force, (2) are reasonable and necessary for prevention or early detection, and (3) are appropriate for Medicare beneficiaries. The Secretary is required to use the national coverage determination (“NCD”) process to make such coverage decisions, and the NCD process may consider the relationship between predicted outcomes and expenses for a service. 

In addition, MIPPA updates the list of services covered under the Medicare initial preventative physical exam to include body mass index and end-of-life planning (defined as verbal or written information regarding an individual’s ability to prepare an advance directive and whether the physician is willing to follow the advance directive). Moreover, the provision waives the beneficiary deductible for the initial screening exam and extending the eligibility period for this service from six months to one year after Medicare part B enrollment. 

These changes are effective January 1, 2009.

2.  Copayment Rates for Medicare Outpatient Psychiatric Services

MIPPA reduces the coinsurance amounts that Medicare beneficiaries must pay for outpatient treatment of mental, psychoneurotic, and personality disorders beginning in 2010. Under this provision, outpatient psychiatric service copayments gradually will be reduced over six years so that they will achieve parity with copayment levels for other outpatient medical care by 2014. Brief office visits for the sole purpose of monitoring or changing drug prescriptions and partial hospitalization services not directly provided by a physician are not included under this provision. 

3.  Medicare Advantage/Part D Drug Plan Sales and Marketing Activities

Effective for plan years beginning on or after January 1, 2009, MIPPA prohibits various sales and marketing activities by Medicare Advantage (“MA”) and Part D drug plans (“PDPs”). Specifically, MIPPA prohibits: unsolicited direct contact (such as door-to-door sales and outbound telemarketing calls); cross selling of non-health-related products (such as annuities and life insurance); free meals; and activities conducted at educational events or in areas where health care is delivered to individuals (such as doctor offices and pharmacies) except when conducted in common areas. 

In addition, by November 15, 2008, the Secretary must establish limits on: the scope of MA and PDP marketing appointments with prospective enrollees; the use of co-branding; the offering of gifts and promotional items; the use of certain types of compensation; and the use of agents, brokers, or other representatives who have not completed specified training and testing. 

MIPPA also requires that for plan years beginning on or after January 1, 2010, the name of any MA or PDP plan must include the plan type. Finally, in an effort to strengthen states’ abilities to address fraudulent or inappropriate marketing of plans, effective for plan years beginning on or after January 1, 2009, MIPPA requires plans to: use only agents and brokers licensed under state law; abide by state appointment laws; report any agent terminations to the state; and comply with state requests for information regarding the performance of agents, brokers, and other third parties representing the plans. 

4.  Improvements to the Medigap Program

MIPPA directs the Secretary to implement the changes to the Medigap program found in the National Association of Insurance Commissioners’ Model Regulation #651, including eliminating certain redundant Medigap plans, modernizing Medigap plan benefits, and adding two new plans with new cost-sharing structures. MIPPA also clarifies existing requirements that supplemental policies for MA and private fee-for-service plans offered to Medicare beneficiaries must meet Medigap standards. 

5.   Part D Low-Income Subsidy Program and Low-Income Assistance Provisions

The low-income subsidy (“LIS”) program provides Medicare/Medicaid dual eligibles and other Medicare beneficiaries who have limited income and resources with subsidized Part D prescription drug coverage if they meet certain eligibility criteria. MIPPA includes a number of reforms intended to improve LIS-eligible beneficiaries’ access to the Medicare Part D prescription drug benefit. First, MIPPA provides that LIS-eligible beneficiaries will not be subject to late enrollment penalties. Second, MIPPA exempts the value of life insurance policies and certain “in-kind” support and maintenance (i.e., assistance from a family member or church) from the definition of income for the purpose of the LIS asset requirements. Third, MIPPA provides for judicial review of LIS denials. 

MIPPA also extends funding through 2009 for the Qualifying Individual program, through which Medicaid programs subsidizes Medicare Part B premiums for low-income individuals. The law also authorizes funding for State Health Insurance Assistance Programs (“SHIPs”) and Area Agencies on Aging to provide outreach to individuals who may be eligible for low-income assistance programs and to provide information regarding Medicare benefits. Moreover, effective January 1, 2010, MIPPA: 

  • Increases the level of savings that Medicare Savings Program (“MSP”) applicants may have and still qualify for help with Medicare out-of-pocket costs, excludes the value of life insurance policies from consideration of resources, and requires CMS to translate the MSP application form into the most frequently-used languages;
  • Requires the Commissioner of Social Security to assist MSP and LIS applicants with obtaining and completing applications and transmitting application data to state Medicaid agencies; and
  • Modifies estate recovery rules to prohibit states from recovering amounts paid for Medicare cost-sharing on behalf of Medicare/Medicaid dual eligibles.

B.  Rural Hospitals and Other Part A Provisions

MIPPA extends the Medicare Rural Hospital Flexibility (“FLEX”) Program through fiscal year (“FY”) 2010. It also expands the FLEX program to provide grants to states increase access to mental health services for veterans and other residents of rural areas, and provides grants to assist eligible critical access hospitals (“CAHs”) transitioning to skilled nursing facility (“SNF”) or assisted living facility status. Moreover, MIPPA: rebases Medicare payments for sole community hospitals for cost reporting periods beginning on or after January 1, 2009; authorizes a demonstration project to test ways to better integrate the delivery of acute care, extended care, and other health care services in rural areas; and extends through September 30, 2009 a number of expiring provisions related to wage index reclassification of certain hospitals. 

MIPPA also ends the unique statutory authority of the Joint Commission on Accreditation of Hospitals to deem hospitals in compliance with the Medicare conditions of participation (although the Joint Commission may be recognized as a national accreditation body in accordance with terms established by the Secretary).

C.   Part B Provisions

1.   Physicians’ Services

a)  Fee Schedule Revisions

The driving force behind enactment of MIPPA was a 10.6 percent cut in Medicare physician fee schedule payments that briefly went info effect July 1, 2008 as a result of the expiration of a temporary boost provided in the Medicare, Medicaid, and SCHIP Extension Act of 2007 (“MMSEA”). 

By way of background, under the statutory “sustainable growth rate” (“SGR”) formula, CMS must adjust the Medicare physician fee schedule update depending on how actual expenditures compare to a target for Medicare spending growth. In recent years, this would have resulted in a series of negative updates, but Congress has repeatedly overridden the formula by specifying separate update factors to avoid payment cuts. In the absence of a change to the SGR formula, negative physician payment updates are forecast into the next decade. MMSEA temporarily replaced the 10.1 percent cut with a 0.5 percent increase, effective for services provided from January 1 through June 30, 2008. During this period, the conversion factor was $38.0870, compared to the conversion factor of $34.0682 applicable to services provided from July 1 through December 31, 2008 in the absence of further statutory change.

MIPPA maintains physician payment rates for 2008 at the boosted levels applicable for the first half of 2008, thus retroactively canceling the 10.6 percent cut that was triggered on July 1, 2008. [2] Moreover, MIPPA provides a 1.1 percent increase for 2009, rather than the 5.4 percent cut that CMS has estimated would result from the SGR formula. The law does not amend the underlying SGR formula or modify payments for years after 2009. The Congressional Budget Office estimates, however, that the current law will necessitate a 21 percent reduction in payment rates under the physician fee schedule in 2010 in the absence of further legislative action. [3]

b)  Physician Quality Reporting Initiative

MIPPA extends and modifies the Physician Quality Reporting Initiative (“PQRI”), under which eligible professionals who satisfactorily report on certain quality measures as specified by the Secretary are eligible for an incentive payment equaling a percentage of their total allowed charges for physician fee schedule-covered professional services furnished during the same period. [4] 

Specifically, MIPPA extends the PQRI program through 2010 and increases the PQRI bonus from 1.5 percent to 2.0 percent for 2009 and 2010. MIPPA also modifies the standards for selection of quality measures. The Secretary is directed to select measures endorsed by a consensus-based entity, such as the National Quality Forum, under contract with the Secretary to review performance measures (as authorized under a separate provision of MIPPA). To the extent the contracted entity has not endorsed a measure for a specified area, the Secretary must give “due consideration” to measures that have been endorsed by another consensus organization. In either case, the Secretary must ensure that eligible professionals have the opportunity to provide input on the selection of PQRI measures. 

Moreover, MIPPA requires the Secretary to establish an alternative process allowing group practices to report on measures targeting high-cost, chronic conditions and preventive care using a statistical sampling methodology (in lieu of payments that otherwise would be made under the PQRI). The Secretary is authorized to revise the criteria for satisfactorily submitting data on quality measures and the reporting periods for years after 2009. MIPPA also directs the Secretary to post on its internet site a list of eligible professionals who successfully report quality measures and who are successful electronic prescribers. In addition, MIPPA includes qualified audiologists in the PQRI program, beginning with 2009.

MIPPA also includes a requirement for the Secretary to establish a “Physician Feedback Program,” under which the Secretary will use Medicare claims data to provide physicians with confidential reports regarding their resource use in treating Medicare patients. The program must be implemented by January 1, 2009. The Secretary may focus the program on specific areas, such as: high-cost specialties; physicians who treat high-cost or high-volume conditions; physicians who use a high amount of resources compared to other physicians; physicians practicing in certain geographic areas; or physicians who treat a minimum number of Medicare patients. To the extent possible, the data should be adjusted to account for variations in health status and other patient characteristics. The Government Accountability Office (“GAO”) must study the implementation of the program and offer recommendations as appropriate.

Finally, MIPPA requires the Secretary to submit a plan to Congress by May 1, 2010 regarding transition to a value-based purchasing program for Medicare physician services.

c)  Electronic Prescribing

MIPPA includes a combination of incentives and penalties to promote the adoption of electronic prescribing (“e-prescribing”). First, the law provides positive incentives for practitioners who are “successful electronic prescribers” in 2009 through 2013. The bonus payment for electronic prescribing will be 2.0 percent of allowed charges for all covered professional services furnished by the physician or eligible group practice, dropping to 1.0 percent for 2011 and 2012 and 0.5 percent for 2013. A “successful electronic prescriber” is to be defined by the Secretary as a physician who: (1) reports any applicable electronic prescribing quality measures in at least 50 percent of cases, or (2) electronically submits a sufficient number of prescriptions under Medicare Part D (as determined by the Secretary). In determining eligibility for bonus payments, MIPPA directs the Secretary to consider to the extent possible whether professionals use e-prescribing systems that comply with federal standards.

Beginning in 2012, Medicare physician fee schedule payments to physicians who are not successful prescribers will be reduced by up to 2 percent. Specifically, payments will be reduced by 1 percent in 2012, by 1.5 percent in 2013, and by 2 percent thereafter.  MIPPA provides a “significant hardship exception” from the e-prescribing mandate, such as in cases where a rural professional does not have sufficient internet access to comply.

The GAO must report to Congress by September 1, 2012 on implementation of the e-prescribing program.

d)   Imaging Provisions

MIPPA requires non-hospital advanced diagnostic imaging providers to be accredited by an accreditation organization designated by the Secretary by January 1, 2012, or Medicare will not make a payment for the technical component of the service under the physician fee schedule. Advanced diagnostic imaging services covered by the provision include: diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography), and other diagnostic imaging services (excluding X-ray, ultrasound, and fluoroscopy) specified by the Secretary in consultation with physician specialty organizations and other stakeholders. 

The Secretary must designate the accreditation organizations by January 1, 2010 based on a number of factors enumerated in the law. The accreditation organizations must evaluate the supplier of the technical component of advanced diagnostic imaging services based on criteria established by the Secretary that is specific to each imaging modality. Such criteria must include standards for: 

  • Qualifications of non-physician medical personnel who furnish the technical component of advanced diagnostic imaging services;
  • Qualifications and responsibilities of medical directors and supervising physicians, including standards that recognize whether the medical director or supervising physician in a particular specialty: receives training in advanced diagnostic imaging services in a residency program; has the experience necessary to be a medical director or a supervising physician; or has completed any continuing medical education courses relating to such services;
  • Procedures to ensure that advanced diagnostic imaging services equipment meets performance specifications;
  • Ensuring that advanced diagnostic imaging services supplier have safety procedures in place;
  • The establishment and maintenance of a quality assurance and quality control program that is adequate to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by such supplier; and
  •  Any other standards or procedures the Secretary determines to be appropriate.

In a related provision, MIPPA requires the Secretary to establish, by January 1, 2010, a two-year, voluntary demonstration program to test the use of appropriateness criteria for advanced diagnostic imaging services. The Secretary may provide “reasonable incentives” to physicians to encourage participation, and physicians will be reimbursed for reasonable administrative costs. The demonstration could be limited to imaging services that account for high Medicare expenditures, fast-growing services, or those for which appropriateness criteria exists. The Secretary is directed to consult with medical specialty societies and other stakeholders to select appropriate criteria, which must developed or endorsed by a medical specialty society and developed in adherence with principles developed by a consensus organization. MIPPA specifies the models that the Secretary must use to collect data regarding physician compliance with the appropriateness criteria, and prevents the use of prior authorization to collect data under the demonstration. Participating physicians will receive feedback reports on their compliance compared to their peers. The Secretary is required to evaluate the demonstration and report to Congress on its findings, including its assessment of whether the use of appropriateness criteria should be expanded. MIPPA provides $10 million to fund the demonstration. 

MIPPA also requires the GAO to conduct a study on the impact of accreditation and other issues related to access to and the value of advanced diagnostic imaging services.

e)    Other Physician Services Provisions

MIPPA includes a variety of other physician payment policy changes. Among other things, MIPPA:

  • Increases funding for the Medicare Medical Home Demonstration Project established in the TRHCA, which provides targeted, coordinated, family-centered care to high-need populations, and authorizes expansion of the program if quality and savings targets are met.
  • Applies the budget neutrality adjustment to the conversion factor, rather than to work relative value units, effective January 1, 2009.
  • Extends through December 31, 2009 the 1.0 floor on the Medicare work geographic adjustment, which has the effect of increasing physician payments in certain rural areas.
  • Extends through December 31, 2009 a provision allowing independent laboratories to bill directly for the technical component of certain physician pathology services provided to hospitals. [5]
  • Makes permanent a current exception to the 60-day limit on Medicare reciprocal billing arrangements between two physicians during periods in which one of the physicians is ordered to active duty as a member of a reserve component of the Armed Forces. 
  • Increases Medicare physician fee schedule payments for certain psychotherapy services by 5 percent for the period of July 1, 2008 through December 31, 2009.
  • Provides full (rather that 50 percent) payment for teaching anesthesiologists involved in the training of physician residents in a single anesthesia case or two concurrent anesthesia cases and provides payment parity for certified registered nurse anesthetists, effective for services furnished on or after January 1, 2010.

2.  Therapy Cap Exceptions Process

The Balanced Budget Act of 1997 (“BBA”) established two types of annual per-beneficiary limitations on outpatient therapy services: (1) a $1,500 cap for all outpatient physical therapy (“PT”) services and speech language pathology (“SLP”) services; and (2) a $1,500 cap for all outpatient occupational therapy (“OT”) services, with both of these amounts indexed for inflation. Although enforcement of the caps has been suspended periodically, the caps are currently in place. In 2008, the cap amount is $1,810 for PT and SLP services combined, and a separate $1,810 cap for OT services.

The Deficit Reduction Act of 2005 (“DRA”) required CMS to implement an exceptions process for therapy expenses incurred in 2006. Under this process, a Medicare enrollee (or person acting on behalf of the enrollee) could request an exception from the therapy caps. The individual could obtain an exception if the provision of services was determined medically necessary; CMS established an automatic process to facilitate exceptions. The Tax Relief and Health Care Act of 2006 (“TRHCA”) extended the therapy cap exceptions process through 2007, and the MMSEA further extended the exceptions process through June 30, 2008. MIPPA extends the therapy cap exception process through December 31, 2009.

3.   Speech Language Pathology Services

MIPPA establishes a statutory definition for outpatient speech-language pathology services, separate from the definition of outpatient physical therapy services. The law also allows outpatient speech-language pathologists to bill Medicare directly for their services subject to the same conditions as physical therapists, beginning July 1, 2009. MIPPA specifies that this provision may not be construed to affect existing CMS regulations or policies that require physician oversight of care as a condition of Medicare Part B payment for speech-language pathology services.

4.   Brachytherapy and Therapeutic Radiopharmaceuticals

MIPPA extends current policy basing Medicare payment for brachytherapy devices/sources in the hospital outpatient setting on hospital charges reduced to cost until December 31, 2009. It also continues the hospital charges reduced to costs methodology for therapeutic radiopharmaceuticals under the hospital outpatient prospective payment system (“OPPS”) until December 31, 2009.

5.   Chronic Obstructive Pulmonary Disease Coverage/Oxygen Ownership

MIPPA provides Medicare coverage of certain items and services furnished under an intensive cardiac rehabilitation program or pulmonary rehabilitation program meeting specified criteria, effective January 1, 2010. Covered services include, among other things: physician-prescribed exercise; education; psychosocial assessment; outcomes assessment; and other reasonable and necessary items identified by the Secretary. The services must be part of a physician-supervised program and meet certain performance standards. The law sets forth specific criteria for intensive cardiac rehabilitation services, including beneficiary eligibility standards, authorization of a total of 72 one-hour sessions, and payment under the physician fee schedule based on the OPPS payment for certain cardiac rehabilitation codes.

In addition, the new law repeals a provision of the DRA that required medical equipment suppliers to transfer the title for oxygen equipment to the beneficiary after 36 months of rental. While the supplier retains the title to the equipment, the supplier must continue to furnish the equipment to the beneficiary during the period of medical need for the remainder of the reasonable useful life of the equipment. As under the DRA, separate rental payments still will be made for the oxygen contents, and maintenance and servicing payments will be made if determined by the Secretary to be reasonable and necessary and not otherwise covered under warranty. This provision is effective January 1, 2009. 

6.   Clinical Laboratory Tests

The MMA required the Secretary to institute a competitive bidding demonstration program for Medicare Part B clinical laboratory services. In October 2007, CMS announced that it intended to launch the first Medicare clinical laboratory demonstration in the San Diego-Carlsbad-San Marcos, California metropolitan statistical area in early 2008. Implementation initially was blocked by a court injunction, however. MIPPA repeals the statutory authority for the Secretary to conduct the clinical laboratory competitive bidding demonstration project. Instead, MIPPA reduces the Medicare fee schedule update for clinical lab services by 0.5 percent in 2009 through 2013.

Separately, MIPPA clarifies that clinical diagnostic laboratory services furnished by a CAH will be treated as being furnished as part of outpatient critical access service (and reimbursed based on reasonable cost), regardless of whether the beneficiary is physically present in the CAH or in a CAH-operated SNF or clinic at the time the specimen is collected. This provision is effective for services furnished on or after July 1, 2009.

7.   Ambulance Services

MIPPA provides increased Medicare add-on payments for ground ambulance services. Specifically, payments are increased by 3 percent in rural areas and 2 percent in other areas for services furnished on or after July 1, 2008 and before January 1, 2010. The law also provides an 18-month hold harmless payment provision for air ambulance regions recently reclassified from rural to urban, and it clarifies the medical review standard for air ambulance services.

8.   OPPS Hold Harmless Provision

MIPPA extends through December 31, 2009, a statutory provision allowing certain small rural hospitals to receive additional Medicare payments if their OPPS payments are less than under the prior reimbursement system. In 2008 and 2009, these hospitals will receive 85 percent of the difference between the payment under OPPS and under the prior reimbursement system. MIPPA also extends this provision to sole community hospitals with fewer than 100 beds.

9.   Telehealth Services

MIPPA provides that additional types of entities can be considered as originating sites for Medicare payment of telehealth services. Specifically, hospital-based or CAH-based renal dialysis facilities, SNFs, and community mental health centers are added to the list of sites where Medicare beneficiaries can receive telehealth services, effective January 1, 2009. 

10.   Chronic Care Demonstration Programs

MIPPA requires the Medicare Payment Advisory Commission (“MedPAC”) to report to Congress by June 15, 2009 on the possibility of using a standing network of providers to test new approaches to care coordination and other chronic care delivered to Medicare patients. In conducting the study, MedPAC is directed to consider the results of the Medicare Coordinated Care Demonstration and Medicare Health Support pilot program. 

11.  Federally-Qualified Health Center Payments

MIPPA increases the per visit cap on Medicare payments to federally-qualified health centers (“FQHCs”) by $5 in 2010 and by an inflation update in subsequent years. The GAO also is directed to study whether the payment structure for FQHC services is adequate.

12.  Kidney Disease Education and Awareness

MIPPA requires the Secretary to establish pilot projects in at least three states to increase public/medical community awareness of chronic kidney disease (“CKD”), focusing on increasing CKD awareness, screening, and surveillance systems. The projects must begin by January 1, 2009 and can last for up to five years. 

In addition, MIPPA expands Medicare coverage to include up to six sessions of kidney disease education services, effective January 1, 2010. Services must be furnished to beneficiaries with stage IV CKD who have been identified as requiring dialysis or a kidney transplant. The services must be designed to help beneficiaries manage comorbidities to delay dialysis, prevent uremic complications, and understand treatment options. In establishing the standards for the education content under this benefit, the Secretary is directed to consult with stakeholders who have not received funding from drug manufacturers or dialysis facilities to the extent possible. This benefit may be furnished by a physician, physician assistant, nurse practitioner, clinical nurse specialist, or rural providers, but not other hospital-based dialysis providers or renal dialysis facilities. Payment to providers will be made under the physician fee schedule.

13.   Renal Dialysis Provisions

MIPPA makes a series of significant changes to Medicare end-stage renal disease (“ESRD”) payment policy. First, the law provides a 1.0 percent update to the composite rate for renal dialysis services for each of 2009 and 2010. It also provides for a “site-neutral,” composite rate for dialysis services under which payment to hospital-based facilities will be the same as payment to independent dialysis facilities, effective January 1, 2009. Likewise, any area wage adjustments for hospital-based facilities must be based on the area wage adjustment for independent facilities.

More significant changes will go into effect by January 1, 2011, when the Secretary is required to establish a fully-bundled ESRD payment system under which a single payment will be made to ESRD providers for renal dialysis services (the Secretary will determine the unit of payment). The single payment must include the following items and services: items and services currently included in the composite rate; erythropoiesis stimulating agents (“ESAs”); drugs and biologicals that are now separately-payable and their oral equivalents; and (4) laboratory tests and other items and services that are currently paid for that are furnished for the treatment of ESRD. Vaccines are not included in the bundle. The Secretary must adjust payments under the new system for such factors as case mix, exceptionally high-cost patients, and low-volume providers (which will receive a temporary add-on payment of at least 10 percent).

The new system must be phased in over four years, with full implementation by January 1, 2014, although providers may elect to forego the phase-in period. Estimated payments under the new system for 2011 must equal 98 percent of payments that would have been made under the current system (including the drug add-on payment), using the lowest patient utilization data from 2007 through 2009. Beginning in 2012, an annual inflation update will be provided equaling the increase in ESRD market basket minus 1.0 percentage point. The GAO must report to Congress by March 1, 2013 on the implementation of the bundled ESRD payment system. 

In addition, MIPPA establishes a quality incentive payment program for ESRD providers. Medicare payments to providers that do not meet the quality standards will be reduced by up to 2.0 percent, as determined by the Secretary, beginning January 1, 2012. Any payment reduction will apply only to one year of payments and will have no impact on reimbursement in subsequent years. The quality measures must address anemia management, patient satisfaction, and other measures at the Secretary’s discretion, with preference given to measures endorsed by a consensus-based entity, and they must address the unique needs of children and young adults. The methodology for assessing each ESRD provider’s quality performance should be weighed to reflect the Secretary’s quality improvement priorities, and the level of payment reductions for not meeting the quality threshold should vary based on performance score. The Secretary must make the ESRD performance scores public, including through an internet site. 

14.   Medicare DMEPOS Competitive Acquisition Program

The MMA required the Secretary to implement competitive acquisition programs for DMEPOS, under which only suppliers who are successful bidders in specified regions and who meet program standards will be eligible to furnish certain categories of DMEPOS to Medicare beneficiaries. Under competitive bidding, successful bidders are paid based on the median of the winning suppliers’ bids for each of the selected items in the region, rather than the Medicare fee schedule or supplier bid amount.

The initial round of the program had gone into effect in the following 10 geographic areas on July 1, 2008: (1) Charlotte-Gastonia-Concord, NC-SC; (2) Cincinnati-Middletown, OH-KY-IN; (3) Cleveland-Elyria-Mentor, OH; (4) Dallas-Fort Worth-Arlington, TX; (5) Kansas City, MO-KS; (6) Miami-Fort Lauderdale-Miami Beach, FL; (7) Orlando-Kissimmee, FL; (8) Pittsburgh, PA; (9) Riverside-San Bernardino-Ontario, CA; and (10) San Juan-Caguas-Guaynabo, PR. Ten categories of DMEPOS were included in phase one: (1) Oxygen Supplies and Equipment; (2) Standard Power Wheelchairs, Scooters, and Related Accessories; (3) Complex Rehabilitative Power Wheelchairs and Related Accessories; (4) Mail-Order Diabetic Supplies; (5) Enteral Nutrients, Equipment, and Supplies; (6) Continuous Positive Airway Pressure Devices, Respiratory Assist Devices, and Related Supplies and Accessories; (7) Hospital Beds and Related Accessories; (8) Negative Pressure Wound Therapy Pumps and Related Supplies and Accessories; (9) Walkers and Related Accessories; and (10) Support Surfaces (Group 2 mattresses and overlays), although this category was subject to bidding only in Miami-Fort Lauderdale-Miami Beach, FL and San Juan-Caguas-Guaynabo, Puerto Rico. Competitive bidding was slated to expand to 70 additional geographic areas next year. 

There were widespread concerns about the way CMS handled the first round of the DMEPOS competitive bidding program, including confusing and contradictory guidance provided to suppliers during the bidding process, the questionable disqualification of numerous suppliers due to allegedly missing financial data, the awarding of contracts to suppliers without established businesses in the particular geographic region (since technically a supplier did not have to be located in the CBA to submit a bid), the adequacy of beneficiary and supplier education efforts, and the potential negative impact of the program on beneficiary access to DMEPOS. These concerns prompted Congress to intervene to delay implementation of the first round of the program and make a series of changes to improve the process in the future. Specifically, MIPPA:

  • Terminates contracts awarded under round one, requires CMS to rebid those areas in 2009, and delays bidding for round two until 2011;
  • Finances the delay by cutting fee schedule payments for all items covered by round one of the bidding program by 9.5 percent nationwide beginning January 1, 2009, followed by a 2 percent increase (in addition to regular inflation updates) in 2014, except where bidding is in effect or CMS has otherwise adjusted rates;
  • Adds a series of procedural improvements to the bidding process, including a requirement that CMS notify bidders in the case of certain missing financial documentation; and
  • Addresses quality by, among other things: requiring subcontractor accreditation; excluding complex rehabilitation wheelchairs and negative pressure wound therapy from bidding; exempting certain rural and low-population areas from bidding; and requiring CMS to issue regulations before using its authority to adjust prices in non-bid areas.  

A detailed Reed Smith analysis of the MIPPA DMEPOS competitive bidding provisions is available at reedsmith.com.

15.   Cost-Sharing for Clinical Trials

In order to encourage beneficiary participation in clinical trials, MIPPA allows the Secretary to develop alternative methods of payment for items and services provided under clinical trials and comparative effectiveness studies that are sponsored or supported by an HHS agency. Such alternative payment methods are authorized if necessary to preserve the scientific validity of the trials or studies, such as in randomized controlled trials. 

16.   Performance Measures and Clinical Effectiveness

MIPPA requires the Secretary to enter into a contract with a private, nonprofit consensus-based standards setting organization to conduct certain performance measurement activities. The organization is tasked with compiling evidence and working with stakeholders to develop recommendations on an integrated national strategy and priorities for health care performance measurement in all applicable settings. The entity also will endorse standardized health care performance quality measures, which must be updated as new evidence is developed, and will promote the development and use of electronic health records containing performance measurement information. The entity must report to Congress and the Secretary annually, and the GAO must conduct two studies and report on the entity’s performance and costs. MIPPA provides $10 million for each of FYs 2009 through 2012 for the program. 

Separately, MIPPA requires the Secretary to contract with the Institute of Medicine (“IOM”) to conduct a study to identify methodological standards for conducting systematic reviews of clinical effectiveness research. In addition, the Secretary must contract with the IOM to review best practices in setting clinical decision-making protocols.

D.   Provisions Relating to Part C

1.   Phase-out of Indirect Medical Education from Capitation Payments

Payments for indirect medical education (“IME”) are presently included as a cost in the calculation of capitation payments for Medicare Advantage (“MA”) plans. However, there is no requirement that an MA organization pass-through the IME portion of the capitation payment in its payments to teaching hospitals. Because teaching hospitals already receive IME payments when a beneficiary is admitted, inclusion of these per capita costs in capitation payments has long been considered a “double payment.”

Over time, MIPPA eliminates the inclusion of IME in payments to MA plans. Beginning in 2010, the calculation that incorporates IME into the capitation rate calculation must be gradually adjusted to exclude these costs. The exclusion is in the form of a phased reduction that applies a maximum decrease of 0.6 percentage points for each year. Capitation rates applicable to the Program of All Inclusive Care for the Elderly (“PACE”) will, however, be unaffected by this change.

2.   MA Private Fee-for Service Plans – Network Requirements

MIPPA imposes significant changes for MA Private Fee-For-Service (“MA PFFS”) plans. Presently, MA PFFS plans are not required to develop a provider network through contracting, but are only required to establish uniform payment rates for all providers, whether they were contracted or “deemed” to be contracted. A non-contracted provider is “deemed” to participate in the MA PFFS plan (and required to accept the plan payment rates) if the provider furnished services other than emergency services to an MA PFFS enrollee, as long as the services were covered by Medicare and the provider was informed about the enrollee’s membership in the plan and was informed or “given a reasonable opportunity to obtain information” about the terms and conditions of payment under the plan. The present MA regulations also exempt MA PFFS plans from developing a defined quality improvement program (discussed below). The absence of these requirements for MA PFFS plans, along with a variety of other concerns about MA PFFS and a rapid rise in enrollment in these types of plans, began to raise concerns that the form and structure may be difficult for patients and providers to understand. The modifications imposed by MIPPA attempt to address these concerns and bring MA PFFS plan requirements into alignment with requirements for other MA plans.

Beginning in 2011 and applying to all subsequent years, most MA PFFS plans will be required to meet MA access standards only through written contracts with providers in order to meet the general access standards for MA plans. The amendment applies to MA PFFS plans sponsored by an employer, a labor organization or by trustees of a fund established by one or more employer. It also applies to plans operating in a “network area,” which is defined as an area identified by the Secretary to have at least two network-based plans with enrollment “as of the first day of the year in which such announcement is made.” A “network based plan” includes coordinated care MA plans, such as HMOs (with or without a point-of-service option), Provider Sponsored Organization plans, and regional or local Preferred Provider Organization plans. The only MA PFFS plans that are exempt from this requirement are those that operate in a network area in which there are not at least two operational network-based plans and those that have previously met access adequacy standards by obtaining prior CMS approval to use methods other than written agreements.

3.  Revised Requirements for MA Quality Improvement Programs

MA PFFS and Medical Savings Account (“MSA”) plans are presently exempt from the requirement that MA plans establish Quality Improvement programs, whereby MA PFFS and MSA plans implement a system to measure quality outcomes and then report such outcomes. MIPPA extends the requirement to have “an ongoing quality improvement program” to these plans, and also imposes requirements “to provide for the collection, analysis, and reporting of data” that will allow for measuring health outcomes and other quality of care indicators. This requirement applies to such plans beginning on or after January 1, 2010.

4.  MA Plans Designed for Special Needs Individuals

MMSEA allowed specialized Medicare Advantage plans for special needs individuals (“Special Needs Plans” or “SNPs”) to limit enrollment to certain populations until January 1, 2010. MIPPA extends this authority to restrict enrollment for an additional year, until 2011. MIPPA also places a one-year moratorium on the Secretary’s authority, granted under the MMSEA, to designate other plans as SNP plans and prohibits service area expansion from January 1, 2010 through December 31, 2010 for SNP plans providing services to members who are dually-eligible for Medicare and Medicaid.

MIPPA also amends several other SNP Plan requirements. These include: (i) requiring independent assessment by a state or other independent entity that a special needs individual living in the community is in need of an institutional level of care; (ii) requiring written disclosure requirements about the benefits and cost-sharing protections to which a beneficiary may be entitled under the state Medicaid program and which of these benefits are covered under the SNP Plan; (iii) imposing care management requirements, including an evidence-based model of care with appropriate networks of providers and specialists; (iv) conducting assessments of enrolled individuals and establishing case-based care plans; and (v) requiring that these plans collect and report data that may be used to measure health outcomes. These modifications generally apply on or after January 1, 2010.

Finally, MIPPA provides some financial protection for dual eligible and qualified Medicare beneficiaries by disallowing any cost-sharing for these enrollees if the amount would exceed the amount of cost-sharing permitted under the traditional Medicaid or Medicare program and the enrollee was not a member of the Medicare SNP. This provision applies to plan years beginning on or after January 1, 2010.

5.   Adjustment to the MA Stabilization Fund

The Medicare Advantage Stabilization Fund was designed to provide incentives to have an MA plan offered in each region and to retain plans in certain MA regions that had market penetration at less than the national average. The Fund, which was established by the MMA, originally included authorization to spend $10 billion between 2007 and 2013. This initial sum was reduced by $6.5 billion by the TRHCA, which also prohibited spending the remainder of the funds until 2012, with $1.6 billion to be made available that year and $1.79 billion to be made available in 2013. The MMSEA further reduced these amounts, eliminating those that were to be available in 2012, reducing the amount of the fund to $1.79 billion and extending the accessibility to the funds until 2013.

MIPPA again reduces the amounts available from the Fund and again extends the time frame as to when the funds will be accessible. Under MIPPA, the funds available will be reduced to $1 billion, and they will not become available until 2014.

6.  Access to Medicare Reasonable Cost Contract Plans

Medicare cost contract plans are reimbursed based on the reasonable cost of providing services to enrollees. Organizations seeking to enter into a cost, rather than risk, contract with CMS may be allowed to do so if the organization is found to be unable to bear the risk of potential losses under a risk-sharing contract or if the eligible organization elects or has an insufficient number of members to be eligible to enter into a risk-sharing contract.

In an effort to reduce the number of cost contract plans, the MMSEA prohibited reasonable cost reimbursement contracts from being extended or renewed after January 1, 2009 if there were two or more MA regional or local plans offered that met certain minimum enrollment requirements for the service area. MIPPA extends that time frame until January 1, 2010. The law also provides that the prerequisite of offering two or more plans in a service area will not apply if both plans are offered by the same MA organization. MIPPA also revises the plan requirements that are applied to determine whether the renewal/extension prohibition is applicable and directs the GAO to study the reasons, if any, why reasonable cost contracts are unable to become MA plans.

7.  Medicare Payment Advisory Commission Studies

MIPPA directs MedPAC to conduct two studies relating to the MA program. These studies focus on developing measurements and benchmarks relating to quality of health care for Medicare beneficiaries and the measurement of costs to provide care to MA enrollees.

The first study is to focus on whether comparable measures of performance and patient experience can be collected and reported so that the quality of care for beneficiaries enrolled in a MA plan can be compared with that for beneficiaries who receive care under original Medicare fee-for-service arrangements.

The second study requires an analysis of the correlation between the costs that MA organizations incur in providing coverage for items and services covered under the original Medicare fee-for-service program and county-level spending under the original Medicare program on a per capita basis. The results of this study may be used to determine appropriate alternate approaches to payment for Medicare beneficiaries enrolled in MA plans other than through county-level payment area equivalents, and to assess the accuracy and completeness of county-level estimates of per capita spending under the original Medicare fee-for-service program.

Both study reports are expected to be produced by March 31, 2010.

E.   Provisions Relating to Part D

1.   Prompt Payment Provisions

MIPPA requires prescription drug plans (“PDPs”) and Medicare Advantage Prescription Drug (“MA-PD”) plans to pay pharmacies for Part D drug claims within 14 days of receipt of “clean claims” submitted electronically, and within 30 days of receipt of clean claims submitted otherwise. A claim is considered to have been received on the date on which the claim is transferred (for claims submitted electronically), and on the fifth day after the postmark date or time stamp date (for claims submitted otherwise). This provision is effective for plan years beginning on or after January 1, 2010.

The term “clean claim” means a claim that has no defect, impropriety, or particular circumstance requiring special treatment that prevents timely payment of the claim. A claim is deemed to be a “clean claim” if the PDP sponsor does not provide notice to the pharmacy of any deficiency in the claim within 10 days of receipt of a clean claim submitted electronically, and within 15 days of receipt of a clean claim submitted otherwise. If a PDP sponsor determines that a claim is not a clean claim, it must notify the pharmacy of such determination, specify all defects or improprieties in the claim, and list the information or documents required for proper processing of the claim. Once additional information or documents are supplied, then a claim is deemed to be a clean claim if the PDP sponsor does not provide notice of any remaining defect or impropriety within 10 days.

If payment according to this section is not made on a timely basis, a PDP sponsor will be required to pay interest to the pharmacy. The Secretary of HHS may exempt a PDP sponsor from paying interest if there are exigent circumstances, such as natural disasters or other unique and unexpected events that prevent timely processing of claims.

Note that these time frames do not apply to mail order pharmacies or pharmacies that are located in, or contract with, a long-term care (“LTC”) facility. MIPPA contains a separate provision which requires pharmacies that are located in, or that contract with, LTC facilities to have not less than 30 days, or more than 90 days, to submit claims to a PDP sponsor or MA-PD plan. 

These requirements apply to plan years beginning on or after January 1, 2010.

2.   Regular Update of Prescription Drug Pricing Standard

MIPPA requires PDPs and MA-PD plans that base reimbursement of pharmacies on the cost of a drug to update their drug pricing standards (e.g., average wholesale prices) at least weekly, with an initial update on January 1 of each year. This amendment applies to plan years beginning on or after January 1, 2009, and its intent is for plans to accurately reflect the market price of acquiring the drugs.

3.   Inclusion of Barbiturates and Benzodiazepines as Covered Part D Drugs

MIPPA expands the definition of “covered Part D drug” to include barbiturates (if used in the treatment of epilepsy, cancer, or a chronic mental health disorder) and benzodiazepines. This provision applies to prescriptions dispensed on or after January 1, 2013.

4.   Formulary Requirements for Certain Categories or Classes of Drugs

The Part D statute generally requires PDPs and MA-PD plans to include drugs within each therapeutic category and class of covered Part D drugs, but not necessarily all drugs within the category or classes. Since the inception of the Part D program, however, CMS has issued subregulatory guidance requiring Part D plans cover all or substantially all drugs in certain “protected” classes due to concerns that interruption of therapy in these categories could cause significant negative outcomes to beneficiaries. The protected classes identified by CMS are: antineoplastics, antidepressants, antipsychotics, antiretrovirals, anticonvulsants and immunosuppressants.

MIPPA includes a provision which supporters describe as “codifying” the CMS protected class policy, although Administration officials has argued that the policy actually expands the Secretary’s authority in a way that could result in additional formulary mandates that eventually drive up prices. Specifically, beginning with plan year 2010, MIPPA requires the Secretary to identify categories and classes of drugs for which both of the following criteria are met:

  • Restricted access to drugs in the category or class would have major or life threatening clinical consequences for individuals who have a disease or disorder treated by the drugs in such category or class, and
  • There is significant clinical need for access to multiple drugs within a category or class due to unique chemical actions and pharmacological effects of the drugs within the category or class, such as drugs used in the treatment of cancer.

PDP sponsors will be required to include all covered Part D drugs in the categories and classes that the Secretary identifies. The Secretary may establish exceptions to this requirement, however, through a rulemaking process that (1) ensures that any exception is based on scientific evidence and medical standards of practice (with more specific guidelines for antiretroviral medications), and (2) includes a public notice and comment period.

5.   Use of Part D Data

MIPPA clarifies that Part D data provided to the Secretary as part of a PDP or MA-PD plan’s contract with the Secretary may be used for research on the utilization, safety, effectiveness, quality, and efficiency of health care services, as well as for other purposes. This section also requires the Secretary to release Part D claims data to authorized Congressional support agencies for the purposes of conducting Congressional oversight, monitoring, making recommendations, and other analysis.

6.  Revision of Definition of Medically Accepted Indication for Drugs

MIPPA extends the Medicare Part B standard for determining medically-accepted indications of anti-cancer drugs to the Part D program, effective for plan years beginning on or after January 1, 2009. The Secretary is required to revise the list of Part D compendia as appropriate using the process under Part B. 

In addition, MIPPA provides that no compendium may be included on the list of approved compendia for determining medically-accepted indications of anti-cancer drugs under Parts B or D unless it has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interest, effective January 1, 2010. 

Finally, MIPPA adds the DRUGDEX Information System to the list of authorized compendia under both Medicare Parts B and D effective January 1 2009, but this designation will apply on or after January 1, 2010 only if this compendia meets the new conflict-of-interest criteria.


1.  Medicaid Pharmacy Reimbursement

By way of background, the DRA mandated a number of revisions to Medicaid drug pricing policy, including a adoption of new federal upper limit (“FUL”) calculation for multiple source drugs based on 250 percent of the lowest average manufacturer price (“AMP”) in a drug class, and requiring CMS to promote transparency in drug pricing by posting AMP amounts on the CMS web site. CMS issued a final rule to implement these provisions on July 17, 2007, but implementation subsequently was blocked by a court order. 

MIPPA delays the establishment of Medicaid payment limits using AMP for multiple source drugs through September 30, 2009. Moreover, CMS is blocked from disclosing AMP data until October 1, 2009. 

2.   Other Medicaid Provisions

MIPPA includes several other provisions impacting Medicaid policy. Specifically, MIPPA: 

  • Extends the Transitional Medical Assistance program and abstinence-only education program through June 30, 2009;
  • Extends the special Medicaid disproportionate share hospital allotment for Tennessee and Hawaii through December 31, 2009;
  • Establishes statutory timelines and procedures for administrative review in cases where the Secretary disallows a state’s claim for federal financial participation under Medicaid; and
  • Increases the percentage of enrollees who may enroll in county Medicaid health insuring organizations in California and adds two new counties to the program.


Finally, MIPPA addresses a number of other health policy issues. Among other things, the new law:

  • Requires the Secretary to study and report to Congress on ways to improve the collection and evaluation of data on disparities in health care services and performance on the basis of race, ethnicity, and gender.
  • Requires the Secretary to establish a demonstration project focused on determining the greatest needs and most effective methods of outreach to previously-uninsured Medicare beneficiaries. The demonstration must be established within one year, last for two years, occur at 10 or more sites, and include SHIPs, community health centers, community-based organizations, community health workers, and other service providers. 
  • Directs the OIG to report to Congress on the extent to which Medicare providers and plans are adhering to non-discrimination requirements with respect to limited speakers of English and the Culturally and Linguistically Appropriate Services (“CLAS”) standards in health care. The report also must discuss the financial impact of providing language services and make recommendations to improve compliance with and enforcement of CLAS standards. Within one year of this report, HHS must institute changes to remedy any identified deficiencies.
  • Replaces the current Physician Assistance and Quality Initiative Fund with a new “Medicare Improvement Fund” to be used to improve the fee-for-service program for Medicare beneficiaries. Funding is available during FYs 2014 through 2017.
  • Directs CMS to participate in the Federal Payment Levy and Administrative Offset Program (“FPLP”), which authorizes the Internal Revenue Service to collect overdue taxes through a levy on federal payments made to delinquent taxpayers. By September 30, 2011, all Medicare Part A and Part B payments must be processed through the FPLP. 
  • Extends the Temporary Assistance for Needy Families supplemental grants through FY 2009.
  • Modifies the Federal Medical Assistance Percentage for District of Columbia foster care and adoption programs.
  • Extends the Special Diabetes Grants Program and provides funding for diabetes research, treatment, and prevention programs for Native Americans and Alaska Natives.

* * *

Please contact our Senior Health Policy Analyst Debra A. McCurdy (703/641-4283, ) or any other member of the Reed Smith health care group with whom you work if you would like additional information or if you have any questions. For continuing news regarding major health policy legislative and regulatory developments, please visit Reed Smith’s Health Industry Washington Watch

The contents of this Memorandum are for informational purposes only and do not constitute legal advice.

[1]          Pub. L. No. 110-275 (July 15, 2008). Additional details regarding the legislation are available on the House Ways and Means Committee web site.

[2]          CMS has issued guidance to physicians regarding claims processing issues arising from the revise fee schedule rates. In addition, the HHS Office of Inspector General (“OIG”) has issued guidance assuring suppliers and providers that they will not be subject to OIG administrative sanctions if they waive retroactive beneficiary cost-sharing amounts attributable to the increased payment rates under MIPPA (subject to certain conditions). Note, however, that suppliers and providers are not required to waive retroactive beneficiary liability, and they may instead choose to bill beneficiaries for any additional copayment obligation. 

[3]          See cbo.gov.  

[4]          For more information about implementation about the PQRI, click here.

[5]          For CMS guidance on this provision, see cms.hhs.gov.  

A Media Campaign Questions the French Monopolistic Sale of Pharmaceutical Products

This post was written by Paule Drouault-Gardrat and Julie Gottenberg.

Under French Law, pharmacies benefit from a monopoly on the sale of medicinal products. This monopoly covers reimbursed and non-reimbursed pharmaceutical products. Once they are de-reimbursed, the price setting is free. This is indeed a very important market for the approximately 23,000 French pharmacies, as the current government follows a policy of dereimbursement.

In addition, the French Public Health Code still prohibits a pharmacist from possessing more than one pharmacy and requests the owner of a pharmacy to be a pharmacist who must personally practice the profession, thus preventing large companies from entering the market.

In this legal context, the distribution group run by Michel Edouard Leclerc[1] (“MEL”) launched a media campaign last April asking for the right for hypermarkets to sell non-reimbursed pharmaceutical products. MEL argued that this would result in a price drop of approximately 25 percent.

The widespread commercials showed a woman’s chest decorated with a necklace made of pills and capsules and bearing the comment “with the price increase of drugs, treating a cough will soon be luxury.” This picture and similar slogans were displayed through various media (TV, website, newspapers). 

This campaign asking for the break of the monopoly on the non-reimbursed pharmaceutical products has been challenged in a summary proceeding filed by French pharmacists’ representatives[2] before a French Court. 

Whereas in the first instance, the French Court (“Tribunal de Grande Instance de Colmar”) granted an order requesting the cessation of the campaign[3], the Court of Appeal (“Cour d’appel de Colmar”) totally reversed the decision[4] in its holding dated 7 May 2008.

Beyond the political and business underlying background, the Court of Appeal’s ruling is interesting for its assessment of the claims related to misleading advertising and denigration.

I.   No Misleading Advertising

The pharmacists’ representatives claimed that the campaign launched by MEL was misleading and confusing since the commercials did not make any clear distinction between reimbursed pharmaceutical products and non-reimbursed ones, on the one hand, and between products sold in pharmacies and those sold in parapharmacies, on the other hand. 

The claimants also argued that the challenged campaign tempted to make the pharmacists globally responsible for the rising price of the medicines.

This argument was favorably accepted by the Court of First Instance but was rejected by the Court of Appeal. 

The latter asserted that a claim for misleading advertising can only apply to commercial practices and accordingly to goods or services that are actually sold on the market. However, in France, because of the above-mentioned legal context, hypermarkets are prohibited from selling pharmaceutical products.

The Court of Appeal rather defined this campaign as “propaganda in favor of a legislation change.”

Said court also observed that the possible consequence of the end of the pharmacists’ monopoly (the alleged price drop) is an open question secured by the free speech provision included in Article 10 of the European Convention on Human Rights.

According to the Court of Appeal, the message broadcasted by MEL “indirectly enhanced the image of Leclerc supermarkets’ activities in the parapharmacy sector,” but did “not include any misleading element.”

II.  No Denigration

The pharmacists’ representatives claimed that the media campaign was of a smear nature.

The Court of First Instance held that the commercials constituted unfair competition practices taking the form of a collective denigration of the entire profession.

On the contrary, the Court of Appeal considered that the unfair competition claim had no ground in the context since “there is precisely no competition” given the monopoly, hereby reminding that in order for a claim based on unfair competition to succeed, several cumulative conditions must be fulfilled, in particular a competitive relationship.

Furthermore, the Appellate Judges must certainly have been more sensitive to humor than the First Instance Judges.

Indeed, whereas the latter held that “no ironical interpretation” of the commercials was possible, the Court of Appeal ruled that MEL’s campaign did not exceed what is permitted as far as humoristic terms are concerned.

More generally, considering that the French Court’s duty is to stop practices that contradict the law in a manifest way and not “to abstractly arbitrate an ideological debate,” the Court of Appeal rejected all the pharmacists’ claims.

* * *

The pharmacists’ representatives eventually failed in demonstrating an obvious breach of the law as required in such summary proceedings. Yet, whatever the legal arguments that may prevail on the merits in a possible future case, this campaign had the effect of informing the general public of the monopolistic situation of the French pharmacists.

With this case, MEL has above all set the cat among the pigeons at a moment when the Health Minister, Mrs. Roselyne Bachelot, has just authorized the “over-the-counter” selling of 217 medicines (“Decret” n° 2008-641 of June 30, 2008), and whereas France is pressed, urged by the European Commission, to open the capital of French pharmacies to non-pharmacists.

[1] Chairman & CEO of the hypermarkets chain LECLERC.

[2] Union Nationale des Pharmacies de France, Union des Syndicats de Pharmaciens d’Officine, Directlabo SA, Univers Pharmacie SAS.

[3] Ex parte order n° 08/00030 of April, 21st 2008, Tribunal de Grande Instance de Colmar.

[4] Decision n° 08/02047 of Mai, 7th 2008, Colmar Court of Appeal, 1ère Ch. Civ., Section B.

Medicare, Medicaid, and SCHIP Extension Act of 2007 Enacted into Law

President Bush has signed into law S. 2499, the “Medicare, Medicaid, and SCHIP Extension Act of 2007." Most notably, the legislation postpones for six months a 10.1% across-the-board cut in Medicare physician payments that was scheduled to go into effect January 1, 2008.

Other policy changes include, among many others:

• Changes in Medicare long-term care hospital (“LTCH”) policy, including a new statutory definition of an LTCH with facility criteria, relief from certain payment policies for three years, a three-year moratorium on the development of new LTCHs and LTCH beds, no payment update for the last quarter of rate year 2008, and new medical necessity reviews by Medicare contractors;

• Revisions to inpatient rehabilitation facility (“IRF”) qualifications and payment policy, including a permanent freeze in the patient classification criteria compliance threshold at 60% (with comorbid conditions counting toward this threshold) and a payment freeze from April 1, 2008 through September 30, 2009;

• An extension of the therapy cap exception process through June 30, 2008;

• A provision to require the Centers for Medicare & Medicaid Services (“CMS”) to adjust Part B drug average sales price (“ASP”) calculations to use volumeweighted ASPs based on actual sales volume;

• Elimination of Medicare Advantage (“MA”) stabilization funding for regional preferred provider organizations in 2012, an extension of authority for specialized MA plans for special needs individuals, and a moratorium on new special needs plans and expanded service areas through December 31, 2009;

• A 6-month delay in CMS rules on Medicaid payment for school-based and rehabilitation services; and 1 Pub. L. No. 110-173 (December 29, 2007). The text of the Act is available by clicking here.

• An extension of the authorization and funding of the State Children’s Health Insurance Program (“SCHIP”) through March 31, 2009.

To read Reed Smith's summary of the major provisions of the Act, please download the PDF here.