HHS Announces Relief for State Part D Drug Cost Expenses

On February 18, 2010, the Department of Health and Human Services (HHS) announced that it will be providing states with an additional $4.3 billion in federal funding to offset the cost of Medicare Part D prescription drug coverage for individuals eligible for both Medicare and Medicaid. The increased aid results from HHS applying the temporary enhanced Federal Medical Assistance Percentage (FMAP) payments authorized by the American Recovery and Reinvestment Act (ARRA) to state “clawback” payments (state payments designed to offset the added expense to Medicare Part D for assuming drug costs for dual eligibles). The temporary adjustment in the clawback payments will apply for the period of October 1, 2008 through December 31, 2010. 

FMAP Rates for First Quarter 2010.

HHS published a notice February 2, 2010 announcing the adjusted Federal Medical Assistance Percentage (FMAP) rates, as provided under the ARRA, for the first quarter of FY 2010 (which began October 1, 2009).

CMS Projects Rising Health Spending Growth in 2009

On February 4, 2010, the Centers for Medicare & Medicaid Services (CMS) released its health spending projections for 2009, estimating that growth in U.S. national health expenditures (NHE) increased 5.7%, compared to 4.4% in 2008. This 2009 growth rate exceeded the growth in the gross domestic product (-1.1%) and brought total national health spending to $2.5 trillion, or 17.3% of the GDP (compared to 16.2% in 2008). The increasing rate of spending is attributable in part to faster growth in Medicaid spending (9.9% compared to 4.7% in 2008), as the recession resulted in increased Medicaid enrollment.  According to CMS, the NHE growth is expected to decelerate in 2010 to 3.9%, but much of this projected slowdown is attributable to the 21.2% reduction in Medicare physician payment rates scheduled to go into effect in March 2010 -- but which Congress is expected to mitigate through legislation (as discussed above). If, on the other hand, physician payment rates are held at 2009 levels, total health spending is projected to grow 4.7%. By 2019, national health spending is expected to reach $4.5 trillion and comprise 19.3% of GDP. 

OIG Medicaid Drug Payment Reports

The OIG has released two reports analyzing Medicaid payments for prescription drugs. The first report, ”Comparison of Medicaid Federal Upper Limit Amounts to Acquisition Costs, Medicare Payment Amounts, and Retail Prices,” concludes that the current method for setting federal upper limit (FUL) amounts results in “substantially inflated Medicaid payments for many drugs” compared to other prices in the marketplace, potentially costing the Medicaid program hundreds of millions of dollars per year. While the Deficit Reduction Act of 2005 (DRA) required that FULs be based on average manufacturer price (AMP), implementation of this policy was blocked by a federal injunction. Based on the OIG’s calculations, AMP-based FULs calculated under the DRA would significantly lessen the gap between FUL amounts and other prices. While the OIG notes that CMS’s options are limited by the injunction and legislative policy, the OIG nevertheless recommends that CMS continue to work with Congress to identify strategies that would lower “inflated” Medicaid payments for multiple-source drugs.  A second OIG report, “Outlier Average Manufacturer Prices in the Federal Upper Limit Program,” reviews CMS’s FUL outlier policy, under which CMS generally will exclude the lowest AMP from the FUL calculation if it is more than 60% below the second-lowest AMP. T he OIG examined 242 FUL drugs with AMPs that would have met CMS’s outlier criterion if the changes enacted by the DRA had been in effect for January 2008. The OIG identified potential problems with some of these outlier AMPs, including discrepancies in the unit of AMP submission, inaccuracies in reporting, and the inclusion of discontinued drug products. The report includes several recommendations for improving the accuracy of the outlier policy in future FUL calculations.

Medicaid/CHIP Children's Healthcare Quality Measures

CMS has published a notice soliciting comments on an initial set of children's health care quality measures for voluntary use by state Medicaid and Children’s Health Insurance Program (CHIP) and health insurance issuers and managed care entities that contract with these programs, and providers of Medicaid and CHIP services. The notice also seeks input on how to facilitate the voluntary use of the children's health care quality measures. The comment deadline is March 1, 2010.

GAO Report on Medicaid Drug Pricing

The Government Accountability Office (GAO) has released a report entitled “Medicaid Outpatient Prescription Drugs: Second Quarter 2008 Federal Upper Limits (FULs) for Reimbursement Compared with Average Retail Pharmacy Acquisition Costs.” The report examines the relationship between FULs based on average manufacturer price (AMP) — as required under the Deficit Reduction Act of 2005 (DRA) but which has been delayed by judicial and legislative action — and pharmacies’ average acquisition costs. Among other things, the GAO concludes that if AMP-based FULs had been in place in the second quarter of 2008, they would have been lower than average retail pharmacy acquisition costs, in general, for most of the 83 drugs in the GAO sample and in the national aggregate (although the GAO notes that its calculations do not account for rebates and discounts that pharmacies may receive from wholesalers or manufacturers). Overall, the FULs would have been 17% lower than acquisition costs, although there was significant variation by state.

Uncompensated Hospital Care Costs

The GAO has issued a report entitled "Medicaid: Ongoing Federal Oversight of Payments to Offset Uncompensated Hospital Care Costs Is Warranted." The GAO’s review found that, among other things, certain states with large supplemental payments for uncompensated care costs did not calculate correctly the hospital-specific disproportionate share hospital (DSH) payment limits. In the report, the GAO recommends that CMS ensure that states account for all Medicaid payments, including non-DSH supplemental payments, when calculating payment limits.

House Approves Temporary Medicaid Funding Increase

The House has approved a temporary extension of enhanced Medicaid matching funds as part of legislation designed to spur job creation. H.R. 2847, passed on December 16, 2009, would provide $23.5 billion to extend higher federal Medicaid matching fund levels under the American Recovery and Reinvestment Act of 2009 (ARRA) through June 2011. The bill also would provide $12.3 billion to extend from nine to 15 months the 65% COBRA health insurance subsidy for individuals who have lost their jobs. The bill, the “Jobs For Main Street Act of 2010,” now moves to the Senate, where the outlook is questionable given that chamber’s current focus on health reform legislation. 

Federal Medical Assistance Percentages (FMAP) Under ARRA

HHS has published a notice finalizing the methodology for calculating the higher FMAP amounts available to states under the ARRA. The adjusted FMAPs are applicable to the third and fourth quarters of FY 2009.

HHS Semiannual Regulatory Agenda Posted

On December 7, 2009, HHS published its semiannual regulatory agenda outlining the Obama Administration's planned regulatory initiatives in a number of health policy areas.  Note that discussions of certain major regulatory initiatives (health information technology, drug and device reporting requirements, and Medicare physician, inpatient hospital, and outpatient hospital rules, among others) are highlighted in an introduction to the regulatory plan
 

CMS Withdraws Medicaid Rehabilitation Coverage Rule, Further Delays Medicaid Benefit/Cost Sharing Flexibility Rules

CMS published a notice on November 23, 2009 withdrawing a controversial August 2007 proposed rule that would have amended the definition of Medicaid “rehabilitative services.” Separately, on November 30, 2009, CMS published a final rule further delaying two rules regarding Medicaid benefit packages and beneficiary cost-sharing. Specifically, CMS is again delaying the effective date of its December 3, 2008 final rule that provides states with increased flexibility to define the scope of covered Medicaid services, along with a November 25, 2008 final rule designed to enhance state flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. The new effective date of the rules is July 1, 2010. 

Federal Medical Assistance Percentages (FMAP) for FY 2011

The Department of Health and Human Services (HHS) has announced the FMAP and Enhanced FMAP amounts for FY 2011, which begins October 1, 2010. These rates will be used by HHS in determining the amount of federal matching for state Medicaid, Children's Health Insurance Program, and other HHS program payments.  

Improper Medicare/Medicaid Payments; Executive Order on Waste/Fraud/Abuse

CMS has released its 2009 Medicare and Medicaid improper payment rates, reflecting a more complete accounting methodology and Medicare claims review process which has resulted in higher overall reported Medicare improper payment rates. Specifically, CMS is reporting a 2009 Medicare fee-for-service error rate of 7.8%, compared to 3.6% in 2008. The baseline composite Medicare Advantage error rate, based on payment year 2007, is 15.4 percent. The composite Medicaid error rate is 8.7%, compared to 10.5% the prior year. Separately, on November 23, President Obama issued an Executive Order on “Reducing Improper Payments and Eliminating Waste in Federal Programs.” The order directs various agencies and departments to intensify efforts to eliminate payment error, waste, fraud, and abuse in the major federal programs through a series of steps, including greater transparency in reporting significant payment errors; a focus on identifying and eliminating the highest improper payments; accountability for reducing improper payments among executive branch agencies and officials; and coordinated federal, state, and local government action in identifying and eliminating improper payments.

CMS Proposes Further Delay of Medicaid Benefit Package, Cost-Sharing Rules

CMS published a proposed rule on October 30, 2009 that would further delay two rules regarding Medicaid benefit packages and beneficiary cost-sharing. Specifically, the rule would again delay the effective date of CMS’s December 3, 2008 final rule that provides states with increased flexibility to define the scope of covered Medicaid services, along with a November 25, 2008 final rule designed to enhance state flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. Upon review of legislation enacted this year and public comments received on previous notices delaying enforcement of the regulations, CMS believes "it is necessary to revise a substantial portion" of these rules. Because it may take several months, CMS is soliciting comments on delaying the effective date of the final rules from December 31, 2009 until July 1, 2010. Comments on the proposal will be accepted until November 19, 2009.

October Congressional Hearings

A number of Congressional committees have held hearings recently on health policy issues, including the following:

In addition, several hearings are scheduled for October 15.  The Senate Small Business Committee is holding a hearing on "Sensible Health Care Solutions for America's Small Businesses." The Senate HELP Committee will examine health care equality for women.  The Energy and Commerce Oversight Subcommittee is holding a hearing on the problem of underinsurance.

OIG Report on Medicaid Fraud Data Usefulness

The HHS Office of Inspector General (OIG) has issued a report on the Medicaid Statistical Information System (MSIS) that concludes that MSIS data -- the only source of nationwide Medicaid claims and beneficiary eligibility information -- were not timely, accurate, or comprehensive for fraud, waste, and abuse detection. The OIG notes opportunities to improve and expand Medicaid data collection and reporting to further assist in fraud, waste, and abuse detection.  

FY 2009 Federal Medical Assistance Percentage Rates

On August 4, 2009, HHS published a notice with comment period describing the methodology for calculating the higher federal matching funds available under the American Recovery and Reinvestment Act of 2009 (ARRA). Specifically, the ARRA provides for temporary increases in the Federal Medical Assistance Percentage (FMAP) rates to provide fiscal relief to states and to protect and maintain state Medicaid programs in a period of economic downturn. The increased FMAP rates apply during a recession adjustment period (October 1, 2008 through December 31, 2010). The percentages listed in the rule are for the third quarter of FY 2009, beginning April 1, 2009 and ending June 30, 2009. HHS will accept comments on the rule through August 19, 2009. 

CMS Issues Guidance to State Survey Agencies, Medicaid Directors

CMS has recently issued guidance to state survey agencies on a number of issues, including: Interpretive Guidelines for Long-Term Care Facilities (infection control programs); Surveying Facilities That Use Electronic Health Records; EMTALA Requirements and Options for Hospitals in a Disaster; Clarification of Ambulatory Surgical Center Interpretive Guidelines; Initial Surveys of CAH Distinct Part Units Changed to Tier 4 Priority Status; and Priority Order of Quality Indicator Survey National Implementation in States. In addition, CMS has issued guidance to State Medicaid Directors on the ARRA “prompt pay” requirements.

State Medicaid Fraud Control Units

The HHS Office of Inspector General (OIG) has issued it Annual Report on the State Medicaid Fraud Control Units (MFCU) for FY 2008. During this period, MFCUs: recovered more than $1.3 billion in court-ordered restitution, fines, civil settlements, and penalties; obtained 1,314 convictions; and reported 971 civil settlements and/or judgments. 

Improper Medicaid/CHIP Payments

The Centers for Medicare & Medicaid Services (CMS) has issued a proposed rule to implement provisions from the Children's Health Insurance Program Reauthorization Act of 2009 with regard to the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs. The rule also would also codify several procedural aspects of the process for estimating improper payments in Medicaid and the Children's Health Insurance Program (CHIP). CMS is accepting comments on the proposed rule until August 14, 2009. 

Medicaid Integrity Program Provider Audit Program Call: July 15

On July 15, 2009, CMS is hosting a Special Open Door Forum (ODF) on the Medicaid Integrity Program (MIP) Provider Audit Program.   The primary audience for this Special ODF is provider groups.  The call will take place from 1pm-2:30pm ET; to participate, dial 1-800-837-1935 and reference Conference ID# 17763217.

Medicaid Provider Tax Rule Delay

On June 30, 2009, CMS published a final rule delaying enforcement of a portion of a February 22, 2008 Medicaid provider tax rule that clarifies the standard for determining the existence of a “hold harmless” arrangement. This provision was already subject to a Congressional moratorium on enforcement until July 1, 2009; the final rule extends the delay in enforcement until June 30, 2010. 

CMS Rescinds Three Bush Administration Medicaid Rules

On June 30, 2009, CMS published a final rule rescinding three controversial Bush Administration Medicaid rules that also had been blocked by Congress. Specifically, CMS is withdrawing: a December 28, 2007 final rule regarding Medicaid payment for the costs of certain school-based administrative and transportation activities; a November 7, 2008 final rule clarifying the definition of Medicaid outpatient hospital services; and certain provisions of a December 4, 2007 interim final rule with comment period on optional state case management services. In rescinding the rules, CMS cites concerns about “the potential restrictions on services available to beneficiaries and the lack of clear evidence demonstrating that the approaches taken in the regulations are warranted.” The rule is effective July 1, 2009.  

Medicaid Home and Community-Based Services Waivers

On June 22, 2009, the Centers for Medicare & Medicaid Services (CMS) published an advance notice of proposed rulemaking announcing its intention to amend its regulations implementing Medicaid home and community-based services waivers under section 1915(c) of the Social Security Act. The notice solicits advance public comments on the merits of providing states the option to combine or eliminate the existing three permitted waiver targeting groups (i.e., aged or disabled, or both; mentally retarded or developmentally disabled, or both; and mentally ill). Comments also are solicited on the most effective means to define home and community. Comments will be accepted until August 21, 2009.  

CMS Issues Guidance to States on ARRA Medicaid/CHIP Provisions

On June 17, 2009, CMS issued guidance to state Medicaid directors on implementation of the American Recovery and Reinvestment Act of 2009 (ARRA) Medicaid and Children’s Health Insurance Program provisions, including details on payments that should not be counted for purposes of eligibility for federal programs. 

Unannounced State Surveys

CMS has issued a memo to state survey agencies reiterating current policy that all surveys must be unannounced for all providers and suppliers, except for standard Clinical Laboratory Improvement Amendments surveys of laboratories and other limited exceptions. 

OIG Audit of ARRA Funding/FMAP Amounts

A Department of Health and Human Services (HHS) Office of Inspector General (OIG) audit found that HHS correctly calculated temporary increases in Medicaid’s Federal Medical Assistance Percentages (FMAP) in accordance with Recovery Act requirements.

State Medicaid Nonemergency Medical Transportation Services (NEMT)

The OIG has released a report summarizing state fraud and abuse safeguard activities related to Medicaid NEMT. According to the OIG, such safeguard activities include screening providers, requiring prior approval for services, and other methods to prevent and detect improper payments. OIG also found that state Medicaid fraud control units investigated a total of 509 NEMT fraud and abuse cases from 2004 to 2006, with the most common types involving billing for services not rendered, unspecified overbilling, and upcoding.

HHS ARRA Implementation Plans Released

HHS has released a series of American Recovery and Reinvestment Act (ARRA) Implementation Plans, detailing how the department is addressing key aspects of the legislation. Specifically, the plans highlight the following areas: Improving and Preserving Health Care (including increases in the Medicaid Federal Medical Assistance Percentage); Accelerating the Adoption of Health Information Technology; Strengthening Scientific Research and Facilities; Improving Children and Community Services; Strengthening Community Healthcare Services; Supporting Comparative Effectiveness Research; Promoting Prevention and Wellness; and Improving Accountability and Information Technology Security. The updates include funding tables and discussions of objectives and planned activities, among other features.

Medicaid Provider Tax Rule Delay

On May 6, 2009, CMS published a proposed rule further delaying enforcement of certain provisions of a February 22, 2008 Medicaid provider tax rule already subject to a Congressional moratorium. Specifically, CMS is delaying until June 30, 2010 enforcement of the rule’s provision clarifying the standard for determining the existence of a “hold harmless” arrangement. The current Congressional moratorium on enforcement of this provision expires July 1, 2009. CMS is accepting comments on the delay through June 1, 2009.

CMS Proposes to Rescind Three Medicaid Rules Blocked by Congress

On May 6, 2009, CMS published a proposed rule that would rescind three controversial Bush Administration Medicaid rules that have been blocked by Congress. Specifically, the rule would withdraw: a December 28, 2007 final rule regarding Medicaid payment for the costs of certain school-based administrative and transportation activities; a November 7, 2008 final rule clarifying the definition of Medicaid outpatient hospital services; and certain provisions of a December 4, 2007 interim final rule with comment period on optional state case management services. In proposing to rescind the rules, CMS cited concerns about “the potential restrictions on services available to beneficiaries, potential deleterious effect on state partners in the economic downturn, and the lack of clear evidence demonstrating that the approaches taken in the regulations are warranted.” CMS is accepting comments on the rulemaking through June 1, 2009, including comments on, among other things, problems that could result from rescission of the rules and whether the objectives of the rules might also be accomplished through alternative approaches, such as program guidance and technical support. 

Federal Medicaid Matching Shares

HHS has recalculated the Federal Medical Assistance Percentages (FMAPs) for the first two quarters of fiscal year (FY) 2009 pursuant to the American Recovery and Reinvestment Act (ARRA). The new percentages are effective from October 1, 2008 through March 31, 2009.

Medicaid Benefit Package Flexibility Rule Delayed

On April 3, 2009, CMS published a notice delaying for the second time the effective date of its December 3, 2008 final rule that provides states with increased flexibility to define the scope of covered Medicaid services. Specifically, CMS is delaying the effective date until December 31, 2009, and the agency is reopening the comment period through May 4, 2009. The Obama Administration had previously solicited comments on the Medicaid benefits package rule. Based on comments received in response to that solicitation, along with new provisions of the Children’s Health Insurance Program Reauthorization Act (CHIPRA) of 2009 enacted on February 4, 2009, the Administration believes that it “may be necessary to revise a substantial portion of the December 3, 2008 final rule. 

Medicaid Premiums and Cost Sharing Rule Delayed

In January 2009, CMS published a notice delaying for 60 days the effective date of a November 25, 2008 final rule designed to provide state Medicaid agencies with increased flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. On March 27, 2009, CMS further delayed the effective date until December 31, 2009. In addition, CMS reopened the comment period on the November rule until April 27, 2009. CMS is especially interested in comments on the effect of certain provisions of the American Recovery and Reinvestment Act of 2009 (ARRA or Recovery Act) involving premiums and cost sharing on the CMS policy. 

State Survey System Weaknesses

The GAO has issued a report entitled “Medicare and Medicaid Participating Facilities: CMS Needs to Reexamine Its Approach for Funding State Oversight of Health Care Facilities.” The GAO identified a number of weaknesses in the health facility survey system, including state funding inequities, limited data on the impact of funding on facility oversight, and limited oversight of state spending. The GAO recommends that CMS broadly reexamine its current approach to funding and conducting surveys, and makes a number of specific suggestions for addressing identified these weaknesses. CMS concurred with most of the GAO’s recommendations.

Part D/Medicaid Pharmacy Reimbursement

The has OIG issued a report entitled "Comparing Pharmacy Reimbursement: Medicare Part D to Medicaid." The OIG found that Part D and nationwide Medicaid pharmacy reimbursement amounts for most of the single-source drugs that the OIG reviewed were similar; however, Medicaid reimbursement amounts for the multiple-source drugs reviewed were typically higher than the Part D amounts. The OIG notes that it compared only the amount reimbursed to pharmacies by Part D and Medicaid; the OIG did not compare total program expenditures or examine the impact of rebates or post-point-of-sale price concessions. Moreover, in a review of five states, the OIG found that Medicaid and Part D ingredient cost reimbursement amounts were similar for single-source drugs, but the average Medicaid ingredient costs exceeded the average Part D ingredient costs for most multiple-source drugs under review. In addition, Medicaid dispensing fees were substantially higher than average Part D dispensing fees for both the single-source and multiple-source drugs under review.

Economic Stimulus Package/Health Provisions

On February 13, 2009, the House and Senate approved the conference report to accompany H.R. 1, the American Recovery and Reinvestment Act.  President Obama signed the bill into law on February 17, 2009.  The $790 billion economic stimulus package includes a number of health care policy provisions.  Among other things, the final agreement includes:

  • $19 billion to accelerate the adoption of health information technology systems;
  • Strengthened federal privacy and security provisions to protect personally-identifiable health information;
  • Approximately $87 billion in additional federal matching funds over two years to help states maintain their Medicaid programs in the face of state budget shortfalls;
  • $1.1 billion to support comparative effectiveness research;
  • $1 billion for a new Prevention and Wellness Fund; and
  • Provisions to help unemployed workers maintain health insurance coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA) law.
  • A provision blocking a fiscal year 2009 reduction in Medicare payments to teaching hospitals related to capital payments for indirect medical education;
  • A provision blocking a fiscal year 2009 Medicare payment cut to hospice providers related to a wage index payment add-on;
  • Technical corrections to the Medicare, Medicaid, and SCHIP Extension Act of 2007 related to Medicare payments for long-term care hospitals;
  • A temporary increase in states’ annual disproportionate share hospital allotments;
  • An extension of moratoria on Medicaid regulations for targeted case management, provider taxes, and school-based administration and transportation services through June 30, 2009, and a new moratorium on a Medicaid regulation related to hospital outpatient services through June 30, 2009;
  • An extension of Transitional Medical Assistance and the Qualified Individual program; and
  • Medicaid prompt payment requirements for nursing facilities and hospitals.

Information on the versions of the measure approved earlier by the House and Senate is available here.    

Update:  On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the “ARRA”).  Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.

 

Economic Stimulus Package/Health Provisions

The House and Senate currently are drafting major economic stimulus legislation that include a number of health care provisions. Although the details of the House and Senate versions vary, both the House and Senate packages would provide, on a temporary basis, approximately $87 billion additional federal matching funds to help states maintain their Medicaid programs during the economic downturn. Both plans also would expand federal health information technology efforts, including providing increased Medicare and Medicaid payments to certain providers using certified health information technology and establishing new privacy and security protections for health information, and increase federal funding of comparative effectiveness research, among many other things. The House of Representatives is set to vote on the bill this week. Senate panels are currently marking up various titles of the Senate package. Details on the Senate Finance Committee’s health-related provisions are available here

High-Risk Programs (Medicare, Medicaid, FDA)

The Government Accountability Office (GAO) has issued a report entitled “High-Risk Series: An Update,” which identifies areas where federal programs are at risk of fraud, waste, abuse, and mismanagement. This biennial report highlights areas of continuing concern, including Medicare and Medicaid program management.  While the GAO points to certain improvements in Medicare program operations, it recommends further actions, such as monitoring beneficiary grievances; eliminating inappropriate payment incentives; safeguarding the program from payment errors; and addressing deficiencies in oversight of care quality in nursing homes and hospitals. The GAO also identified continued weaknesses in oversight of state Medicaid claims and supplemental payments, review of the budget neutrality of Medicaid demonstrations prior to approval, and the overall level of improper Medicaid payments. The GAO also adds a new high risk area this year focusing on the FDA’s ability to ensure the safety and efficacy of drugs, biologics, and medical devices. The GAO recommendations in this area address, among other things, foreign drug inspections, review of promotional materials, and presentation of clinical trial results by drug sponsors.

Obama Regulatory Review Plan

On January 20, 2009, Rahm Emanuel, Assistant to the President and Chief of Staff, sent a memo to all federal department and agency heads announcing that all regulations approved or pending at the end of the Bush Administration must be reviewed by the Obama Administration before being implemented. Specifically, except in cases of emergency situations, such as urgent health, safety, environmental, financial, or national security matters, no proposed or final regulation should be sent to the Office of the Federal Register for publication unless reviewed and approved by an department or agency head appointed or designated by President Obama, and pending Bush Administration regulations not yet published in the Federal Register must be withdrawn for review. Moreover, agencies are directed to consider extending for 60 days the effective date of Bush Administration rules that have been published but not yet taken effect, with a reopening of the public comment period. Although the Administration has not released a complete listing of regulations subject to this review, the Centers for Medicare & Medicaid Services (CMS) published a notice January 27, 2009 delaying for 60 days the effective date of a November 25, 2008 final rule designed to provide state Medicaid agencies with increased flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. The new effective date is March 27, 2009, and the comment period has been reopened until February 26, 2009. Additional Department of Health and Human Services (HHS) rules also may be affected by the regulatory review.

OPPS, DSH Correction Notices

On January 26, 2009, CMS published a notice correcting technical errors in the November 18, 2008 final Medicare hospital outpatient prospective payment system (OPPS) rule addressing the status indicator for new drug code. Also on January 26, CMS published corrections to its December 19, 2008 notice on Medicaid disproportionate share hospital allotments

Medicaid Provider Screening for Excluded Persons

On January 20, 2009, CMS issued a letter to State Medicaid Directors advising states of their obligation to direct Medicaid providers to screen their employees and contractors for excluded persons.

Town Hall Forum on Dental Care for Medicaid-Eligible Children (April 6, 2009)

On April 6, 2009, CMS is hosting a town hall forum to discuss access to dental care for Medicaid eligible children. Beneficiaries, providers, dentists, industry representatives, and other interested parties are invited to this meeting to present their views and recommendations related to oral health issues. 

HHS Management Challenges

The HHS Office of Inspector General (OIG) has issued a report on the top management and performance challenges facing the HHS. Key areas identified by the OIG include: Medicare Part D oversight (including drug pricing and rebates, fraud and abuse safeguards, and access to accurate information); Medicare integrity (including DME fraud and competitive bidding); Medicare Advantage; Medicaid and State Children’s Health Insurance program integrity (including prescription drug fraud and pharmacy reimbursement); quality of care (including pay-for-performance, “never events,” and transparency of ownership and performance); emergency preparedness and response; oversight of food, drugs, and medical devices (including food safety and security, drug and medical device safety, and transparency of provider financial interests); grants management; integrity of information systems and the implementation of health information technology; and ethics program oversight and enforcement.

Medicaid Disproportionate Share Hospital Payments

On December 19, 2008, the Centers for Medicare & Medicaid Services (CMS) published a final rule implementing provisions of the Medicare Modernization Act of 2003 related to state auditing and reporting of Medicaid disproportionate share hospital (DSH) payments, effective January 19, 2009. CMS also published a separate notice announcing the final federal share DSH allotments for federal fiscal year (FY) 2007 and the preliminary federal share DSH allotments for FY 2009. The notice also announces the final FY 2007 and the preliminary FY 2009 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. 

Medicaid Non-Emergency Medical Transportation Program

CMS published a final rule on December 19, 2008 that implements a provision of the Deficit Reduction Act of 2005 that provides states with additional flexibility to establish a non-emergency medical transportation brokerage program, and to receive the federal medical assistance percentage matching rate. The rule is effective January 20, 2009.

Congressional Budget Office Reports on Health Care Budget Options, Insurance Reform

On December 18, 2008, the Congressional Budget Office (CBO) released a major report entitled Budget Options, Volume 1: Health Care,” which sets forth 115 policy options for Congress to consider as it addresses health care system reform. The CBO points out that Medicare is expected to grow from 2.8 percent of gross domestic product (GDP) in 2008 to nearly 9 percent of GDP in 2050. This spending growth will be fueled primarily by growth in per capita medical costs, according to the CBO, with the aging of the population playing a secondary role. In light of these trends, the CBO offers specific options addressing such areas as: health insurance (market reforms, tax treatment, access to federal programs); health care quality and efficiency; geographic variation in Medicare spending; paying for Medicare services (including hospital, physician, imaging, and post-acute care, and Medicare Advantage plan services, among others); financing and paying for services in Medicaid (including drug payment revisions) and SCHIP; premiums and cost sharing in federal health programs; long-term care; health behavior and health promotion; and closing the gap between Medicare’s spending and receipts.  The CBO also issued a separate report focusing on insurance reform, “Key Issues in Analyzing Major Health Insurance Proposals.” The CBO warns that without changes in policy, a substantial and growing number of nonelderly people are likely to be without health insurance. This issue cannot be addressed without making major changes in the financing or provision of health insurance and health care, which will involve "difficult trade-offs between the objectives of expanding insurance coverage and controlling both federal and total costs for health care." The report describes the assumptions that CBO would use in estimating the effects of key elements of proposals to modify the health insurance system on federal costs, insurance coverage, and other outcomes. In particular, it considers the types of issues that would arise in estimating the effects of proposals to: provide tax credits or other types of subsidies to make insurance less expensive to the purchaser; require individuals to purchase health insurance; require firms to offer health insurance to their workers or pay into a fund that subsidizes insurance purchases; replace employment-based coverage with new purchasing arrangements or provide strong incentives for people to shift toward individually purchased coverage; and provide individuals with coverage under, or access to, existing insurance plans such as the Medicare program, either as an additional option or under a “Medicare-for-all” single-payer arrangement.

Federal Financial Participation Matching Amounts

HHS has published the federal medical assistance percentages and enhanced federal medical assistance percentages for fiscal year (FY) 2010. The percentages in this notice apply to state expenditures for most medical services and medical insurance services, and assistance payments for certain social services. 

State Flexibility for Medicaid Benefit Packages

On December 3, 2008, the Centers for Medicare & Medicaid Services (CMS) published a final rule to provide states with increased flexibility under an approved state plan to define the scope of covered Medicaid benefits, as authorized by the Deficit Reduction Act of 2005 (DRA). Under the rule, states may offer coverage of the following benchmark or benchmark-equivalent benefit packages to certain Medicaid recipients:  the standard Blue Cross/Blue Shield preferred provider option service benefit plan under the Federal Employees Health Benefit Plan; state employee coverage; coverage offered by the state’s largest commercial health maintenance organization; or coverage approved by the Secretary of the Department of Health and Human Services (HHS). The rule is effective February 2, 2009. Note that CMS characterizes the rule as a codification of guidance CMS issued on March 31, 2006 to state Medicaid directors, and the agency points out that states have already begun implementing this provision in advance of this final rule. 

Final Rule on Medicaid Premiums and Cost Sharing

On November 25, 2008, CMS published a final rule on Medicaid premiums and cost sharing to implement requirements of the Deficit Reduction Act of 2005 and the Tax Relief and Health Care Act of 2006. Among other things, the legislation provided state Medicaid agencies with increased flexibility to impose premium and cost sharing requirements on certain Medicaid recipients, including drug cost sharing requirements designed to encourage the use of preferred drugs and to allow higher cost-sharing for non-emergency care furnished in a hospital emergency department. The rule is effective 60 days after publication.

Improper Payment Rates for Medicare, Medicaid, SCHIP

On November 17, 2008, CMS reported that the improper payment rate for the Medicare, Medicaid and SCHIP programs fell from 3.9% in FY 2007 to 3.6% percent in FY 2008. For the Medicare fee-for-service program, most improper payments were due to claims for services that were medically unnecessary or incorrectly coded, while the vast majority of Medicaid and SCHIP errors are due to inadequate documentation. CMS also reported the Medicare Advantage improper payment rate for the first time; that rate was 10.6% in 2006, primarily reflecting health plan errors in documenting members’ diagnoses. CMS also is developing methodologies to report the Medicare Part D error rate in the future.

Final Medicaid Outpatient Hospital/Clinic Rule

On November 7, 2008, CMS published a final rule clarifying the definition of outpatient hospital services under Medicaid to align it more closely with the Medicare definition of such services. CMS stresses that the regulation does not eliminate any Medicaid benefit category, place reimbursement restrictions on those categories, or alter the qualifications that must be met to provide a Medicaid covered service. Note that while the proposed version of the rule, published September 28, 2007, included provisions regarding methods for demonstrating compliance with the upper payment limit (UPL), in consideration of the Congressional moratorium on a separate proposed rule on UPLs published January 18, 2007, CMS is reserving action on the proposed provisions related to outpatient hospital UPLs. CMS may consider publication of the UPL guidance at a future date. The rule is is effective December 8, 2008.

State False Claims Act Recoveries

On October 28, 2008, CMS informed state health officials of CMS policy regarding the refunding of the federal share of Medicaid overpayments, damages, fines, penalties, and any other component of a legal judgment or settlement when a state recovers pursuant to legal action under its state False Claims Act (FCA). CMS notes that many states have enacted their own FCA statutes modeled on the Federal False Claims Act, and numerous questions have arisen regarding Medicaid overpayment identification, investigation, and refunds of the federal share when that overpayment is attributable to fraud and abuse. Additionally, the letter explains what amounts must be returned to the federal government on any recovery, the proper accounting of the relator’s share and litigation expenses, and the time frame for refunding the federal share of any state FCA recovery.

Medicaid Spending Increasing Rapidly

Medicaid spending is projected to total $339 billion in 2008, up 7.3% from 2007 levels, according to figures released by CMS October 17, 2008. Medicaid spending is expected to continue increasing by 7.9% on average over the next 10 years, reaching $674 billion by 2017, far exceeding the 4.8% projected growth rate for the general economy and pointing to continued strains on state budgets in the coming years. Additional spending details are contained in the CMS Office of the Actuary’s first annual fiscal report on Medicaid.

Congressional Hearings

On October 21, 2008, the Senate Finance Committee held a field hearing in Montana on "High Health Care Costs: A State Perspective." 

Excessive Medicaid Personal Care Services

The HHS Office of Inspector General (OIG) has issued a report entitled “Medicaid-Funded Personal Care Services in Excess of 24 Hours per Day.” Based on a sampling of cases in five states, the OIG found 871 instances in which states paid claims for Medicaid reimbursement for personal care services (such as assistance with activities of daily living) in excess of 24 hours per day, and many other cases in which services totaled close to 24 hours a day. The OIG suggested that CMS inform states regarding vulnerabilities in this area, including problems associated with allowing providers to submit such claims in date ranges that include days on which no services were provided.

Medicaid Self-Directed Personal Assistance Services Final Rule

On October 3, 2008, CMS published a final rule to provides guidance to states that seek to administer self-directed personal assistance services through their state plans, as authorized by the Deficit Reduction Act of 2005. The state plan option allows beneficiaries, through an approved self-directed services plan and budget, to purchase personal assistance services, rather than have those services directed by an agency.   Beneficiaries could hire qualified family members to perform certain personal assistance (but not medical) services.   Allotments also could be used to purchase items that promote independence, such as a wheelchair ramp. The rule provides guidance to ensure beneficiary health and welfare and financial accountability of the state plan option. To request state plan change, the state must have an existing personal care services benefit or be operating a home or community-based services waiver program.   Beneficiary enrollment would be voluntary, and the state also must provide traditional agency-delivered services if the beneficiary wishes to discontinue self-directed care. The rule is effective November 3, 2008. 

Final Rule on Medicaid Definition of Multiple Source Drug

On October 7, 2008, CMS pubished a final rule revising the definition of "multiple source drug" under the Medicaid program. The rule also responds to public comments received on the March 14, 2008 interim final rule with comment period. The final rule adopts the March 2008 interim final rule with the following change: in §447.205, paragraph (3)(i) of the definition of multiple source drug, the term "covered outpatient drug" is revised to read "drug product" and "listed product" respectively to reflect the statutory language. As noted in the interim final rule with comment period, to the extent that this rule may affect Medicaid reimbursement rates for retail pharmacies, it is subject to the injunction issued by the United States District Court for the District of Columbia in National Association of Chain Drug Stores et al. v. Health and Human Services. The rule is effective is effective November 6, 2008. 

OIG FY 2009 Work Plan Released

On October 1, 2008, the HHS Office of Inspector General (OIG) released its FY 2009 Work Plan, which discusses planned OIG audit, inspection, and investigative initiatives affecting virtually every type of health care provider and supplier.

Congressional Hearings

Numerous recent Congressional committee hearings have focused on health policy issues, including the following:

  • On September 24, 2008, the Senate Aging Committee examined "ways to respect Americans' choices at the end of life.” The panel also held a hearing September 17 on direct-to-consumer medical device advertising.
  • House Ways and Means Health Subcommittee held a hearing September 23, 2008 on problems in the private health insurance market, with a focus on the need for reforms in the non-group or individual market. The panel also met September 11 to examine on Medicare physician payment policy reform. 
  • On September 23, 2008, the House Oversight and Government Reform Domestic Policy Subcommittee held a hearing on Medicaid pediatric dental care reform. The full Committee also held a hearing September 16 on HIV prevention.
  • The House Energy and Commerce Subcommittee on Health held a hearing September 18, 2008 on health reform, as did the House Small Business Committee.
  • The Senate Finance Committee held a hearing September 16, 2008, on health care delivery system reform, focusing on creating a patient-centered model of care and supporting primary care. On September 23, 2008, the Committee held a hearing on insurance market reform, highlighting health insurance exchanges that connect individuals, small businesses and those eligible for premium subsidies to available health insurance plans.
  • The Senate Special Committee on Aging held a hearing September 11, 2008 on Medicare information issues

State Long-Term Care Partnership Program

On September 2, 2008, the Department of Health and Human Services (HHS) published a notice with comment period regarding State Long-Term Care Partnership Program reciprocity agreements. By way of background, the Deficit Reduction Act of 2005 (DRA) allows states to provide asset disregards and related estate recovery offsets for Medicaid applicants who receive benefits under qualified long term care insurance policies (Partnership policies) that were purchased in the same state. This notice establishes standards for states that choose to enter into a DRA reciprocity agreement under which they agree to provide the same disregards and offsets for qualified Partnership policies that a Medicaid applicant purchased in another state that participates in the reciprocity agreement.

Voluntary Moratorium on Medicaid Rule Implementation

The Department of Health and Human Services (HHS) has announced that it is voluntarily extending until August 1, 2008 the current statutory moratorium on the implementation of two Medicaid rules (the current moratorium expired May 25, 2008). The two rules in question pertain to Graduate Medical Education (published on May 23, 2007) and Cost Limit for Providers Operated by Units of Government and Provisions to Ensure the Integrity of Federal-State Financial Partnership (May 29, 2007). HHS wants to use this time to address Congressional concerns about the impact of the regulations in light of pending legislation to extend the current moratorium.

Medicaid Regulations Moratoria/Physician Ownership Restrictions Advance

On May 22, 2008, the Senate approved a version of the fiscal year (FY) 2008 emergency supplemental appropriations bill, H.R. 2642. The Senate bill would extend a current moratorium on implementation of certain Medicaid regulations and block additional rules through April 1, 2009. The rules affected by the legislation involve: payments to public safety net institutions; coverage of rehabilitation services for people with disabilities; outreach and enrollment in schools and specialized medical transportation to school for children covered by Medicaid; graduate medical education payments; coverage of hospital clinic services; case management services; state provider tax laws; and appeals filed through HHS. In addition, the bill would eliminate, for new hospitals with physician ownership, the "whole hospital" exception to the Stark law's referral prohibition, and would add, for existing hospitals with physician ownership, significant additional conditions to that exception. The version of the measure approved by the House does not include specialty hospital provisions. The two versions will need to be reconciled before being sent to the President, who has threatened to veto both the House and Senate versions. 

Medicaid Regulations Moratoria/Physician Ownership Restrictions Advance

On May 15, the House of Representatives approved an supplemental spending bill (H.R. 2642)  that would extend a current moratorium on implementation of certain Medicaid regulations and block additional rules through April 1, 2009. The rules affected by the legislation involve: payments to public safety net institutions; coverage of rehabilitation services for people with disabilities; outreach and enrollment in schools and specialized medical transportation to school for children covered by Medicaid; graduate medical education payments; coverage of hospital clinic services; case management services; state provider tax laws; and appeals filed through HHS. The bill also would provide $25 million annually to fund Medicaid anti-fraud activities. To finance the legislation, the bill would extend an electronic asset verification demonstration for Medicaid applicants and beneficiaries, and temporarily borrow money from the Physician Assistance and Quality Improvement (PAQI) Fund. The Senate Appropriations Committee also has approved a version of supplemental spending legislation that would likewise block the various Medicaid rules, and in addition would eliminate, for new hospitals with physician ownership, the "whole hospital" exception to the Stark law's referral prohibition, and would add, for existing hospitals with physician ownership, significant additional conditions to that exception.  The full Senate is expected to consider a revised version of the legislation this week; the two versions of the bill would need to be reconciled before being sent to the President, who has expressed opposition to the House version of the bill.