CMS Finalizes MIPPA Medicare Advantage/Part D Drug Plan Rule

On September 1, 2011, CMS published a final rule implementing certain provisions of the Medicare Improvements to Patients and Providers Act (MIPPA) of 2008 that revise Medicare Advantage (MA) and Medicare Part D prescription drug benefit regulations (note that these provisions were addressed previously through a series of interim final rules in 2008 and a final rule with comment period in 2009). Among other things, the final rule strengthens MA and Part D plan marketing requirements, including limits on agent/broker commissions; finalizes requirements that Private Fee-for-Service plans contract with a sufficient number and range of providers to meet access and availability standards; and clarifies various standards for Medicare Special Needs Plans. Except as otherwise specified, these regulations are effective on October 31, 2011.

IOM Issues Comparative Effectiveness Standards Reports

The Institute of Medicine has issued two reports mandated by the Medicare Improvement for Patients and Providers Act that are designed to enhance the quality and reliability of clinical practice guidelines and systematic reviews of the evidence base for health care services. In “Clinical Practice Guidelines We Can Trust,” the IOM recommends eight standards intended to ensure the objective, transparent development of trustworthy clinical practice guidelines. In “Finding What Works in Health Care: Standards for Systematic Reviews,” the IOM recommends 21 standards to ensure scientifically-valid, high-quality systematic reviews of the comparative effectiveness of medical or surgical interventions. The goal of the reports is to improve health quality and outcomes by improving the information available on which to base health-related decisions.

OIG Report on Mail Order Diabetic Testing Strips

The HHS Office of Inspector General (OIG) has issued a report entitled "Medicare Market Shares of Mail Order Diabetic Testing Strips," as mandated by the Medicare Improvements for Patients and Providers Act (MIPPA). The report is intended to assist in implementation of a requirement for future rounds of the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program that contracts for mail order diabetic testing strips be awarded to suppliers who provide at least 50%, by volume, of all types of mail order diabetic testing strips. According to the OIG, suppliers submitted Medicare claims for at least 75 types of mail order diabetic testing strips for the 3-month period ending December 2009.  Based on a sample of 1,210 claims, two types of diabetic testing strips accounted for approximately 26% of the Medicare mail order market share, with seven types of strips making up about half of the Medicare mail order market share and 19 types accounting for approximately 81% of market share. 

CMS Issues Final Rule on Medicare ESRD Bundled Payment System, Proposed Rule on ESRD Quality Program

On August 12, 2010, the Centers for Medicare & Medicaid Services (CMS) is publishing a final rule implementing a prospective payment system (PPS) for Medicare end-stage renal disease (ESRD) services, as mandated by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). The final ESRD PPS rule provides a single bundled payment to dialysis facilities covering services such as dialysis treatments and supplies, certain ESRD-related drugs, and ESRD-related clinical laboratory tests. Notably, while CMS has finalized its policy to include in the definition of renal dialysis services ESRD-related oral drugs without injectable equivalents (so-called “oral-only” drugs), CMS is now postponing payment for such drugs under the ESRD PPS until 2014 (although all other ESRD-related former Part D drugs and biologicals are included in the bundled payment effective January 1, 2011). Under the final rule, dialysis providers will receive a per-treatment base rate of $229.63 (compared to the proposed $198.64 rate) for all services related to a dialysis session. This amount is subject to patient-specific and facility-specific adjustments, including adjustments for case mix and comorbidities, geographic cost differences, low-volume facilities, and certain outlier cases. In response to comments, CMS has added payment adjustment of $33.38 for home dialysis training when clinically appropriate. As required by MIPPA, total ESRD PPS payments are estimated to equal 98% of payments that would have been made absent the statutory changes. The ESRD PPS is effective January 1, 2011, with a four-year phase in-period (facilities may elect to be paid entirely under the new system beginning January 1, 2011). CMS will apply a “transition budget neutrality adjustment factor” of -3.1% to all payments during the phase-in. The rule also adopts three quality measures pertaining to hemodialysis adequacy and anemia management to be uses for the ESRD Quality Incentive Program (QIP), under which ESRD payments will be reduced by up to 2.0% for dialysis providers that do not meet performance standards. Also on August 12, CMS is publishing a related proposed rule that would establish performance standards and a scoring methodology for the ESRD Quality Incentive Program; CMS will accept comments on the proposed rule until September 24, 2010.

CMS Solicits Proposals for Medicare Imaging Demonstration

CMS is seeking up to six "conveners" to apply to participate in the MIPPA Medicare Imaging Demonstration (MID). The MID will test whether the use of decision support systems (DSSs) can improve quality of care and reduce unnecessary radiation exposure and utilization by promoting appropriate ordering of advanced diagnostic imaging services. Conveners will recruit participating physician practices to use an advanced diagnostic imaging DSS, which will be used to collect data on physician ordering of specified services and test results, and provide feedback to physicians on ordering appropriateness. The convener also will distribute incentive payments. CMS notes that certain arrangements under the MID could raise possible fraud and abuse concerns, CMS will consider waivers of relevant statutes on a case-by-case basis. Proposals are due September 21, 2010.

Medicare Advantage Marketing Practices

The OIG recently issued a report entitled “Beneficiaries Remain Vulnerable to Sales Agents’ Marketing of Medicare Advantage Plans.” The report assesses MA plan sponsor compliance with CMS regulations implementing the marketing activity restrictions enacted in the Medicare Improvements for Patient and Providers Act of 2008. Each of six selected plan sponsors reviewed by the OIG did not follow at least one of the marketing regulations concerning sales agent compensation and qualifications. For instance, five of the plan sponsors employing independent sales agents had compensation practices that resulted in inappropriate financial incentives for sales agents and field marketing organizations, and five of the plans did not ensure that all of their sales agents were qualified under CMS’s regulations. The OIG made a series of recommendations, including following-up on noncompliance documented by the OIG, auditing plan sponsors, and strengthening regulatory requirements and CMS guidance in this area. 

CMS Manual Transmittal on Authorized Compendia for Off-Label Uses of Cancer Drugs

On January 30, CMS issued a Medicare Benefit Policy Manual transmittal entitled "Revision of Definition of Compendia as Authoritative Source for Use in the Determination of a Medically-Accepted Indication of Drugs/Biologicals Used Off-label in Anti-Cancer Chemotherapeutic Regimens." The transmittal makes changes to conform to the MIPPA compendia requirement that provides that effective January 1, 2010, no compendia may be included on the list of authorized compendia unless it has a publicly-transparent process for evaluating therapies and for identifying potential conflicts of interests.

ESRD Bundled Payment System

The Government Accountability Office (GAO) has issued a report entitled End-Stage Renal Disease: CMS Should Monitor Effect of Bundled Payment on Home Dialysis Utilization Rates.” According to the GAO, the Medicare bundled payment system for ESRD services, which must be implemented by January 1, 2011 under the Medicare Improvements for Patients and Providers Act, could end up encouraging or discouraging home dialysis depending on how the bundle is structured. The GAO recommend that CMS establish formal plans to monitor the impact of bundled payments on access to home dialysis services; CMS concurred.

CMS Forum on Appropriate Use of Imaging Services (May 27, 2009)

On May 27, 2009, CMS is holding a Special Open Door Forum on the MIPPA Medicare Imaging Demonstration Project on Appropriate Use of Imaging Services.  CMS is seeking input regarding the design and development of the demonstration project.  Interested parties can attend the event in person or by phone.  CMS priority topics for the forum are listed after the jump. 

CMS is particularly interested in the following topic areas:

1. Demonstration Framework:

  • Given that prior authorization is excluded from the demonstration by legislative mandate, how can we best design the demonstration to test both point of order (POO) and point of service (POS) systems?
  • How could CMS assess the impact of POO and POS systems through randomized designs or other comparative models?
  • What will motivate physician participation in the demonstration? How should physicians be recruited? What is the role of economic and non-economic incentives in encouraging participation?

2. Point of Order (POO) and Point of Service Systems (POS):

  • What are the major characteristics of POO and POS? How are they similar and how are they different in their assessments of appropriateness? How are these systems currently used by providers and payers?
  • What data are captured by the systems and what is the comparability in data elements across systems? Are there distinctions in how appropriateness of individual procedures is assessed between these two systems?
  • Does use of POO versus POS systems vary systematically by type of service, service setting, type of physician, and/or geography? How common is the use of these systems by specialists, primary care physicians and performing physicians?
  • How do ordering and performing physicians interface with the POO or POS systems? Do individual physicians or group practices use of more than one system?

3. Imaging Procedures:

  • Specific procedures being considered for inclusion in the demonstration are likely to be high in volume, high in growth, exhibit geographic variation, and have consensus around clinical guidelines. Are there other criteria we should consider when selecting procedures for inclusion in the demonstration?
  • What procedures that have the characteristics described above have been incorporated into POO and POS?
  • Should the demonstration focus on applying a decision support system for only specific types of imaging procedure use (e.g., MRI for Lumbar Spine, rather than all MRIs)? Might a focus on only specific types of procedures cause confusion for physicians or increase burden on physicians?

MedPAC Meeting -- March 12-13, 2009

On March 12-13, 2009, MedPAC is meeting to discuss a number of health policy issues, including: accountable care organizations; physician resource use measurement; MIPPA Medicare Advantage payment report; improving Medicare’s chronic care demonstration programs; the effects of secondary coverage on Medicare spending; medical education; and follow-on biologics.

DMEPOS Competitive Bidding

On January 16, 2009, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period to implement the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA)Among other things, the rule codifies MIPPA provisions: delaying implementation of bidding and requiring CMS to conduct a second Round 1 competition in 2009; establishing a process to provide feedback to suppliers on missing financial documentation; requiring bidders to disclose information regarding subcontractors; and exempting certain DMEPOS items from bidding. CMS also notes that it intends to require one, rather than three, years of financial records to be submitted with future bids. In addition, CMS invites comments on alternatives for diabetic supplies bidding, which will be the subject of future rulemaking. The rule is effective February 17, 2009, but CMS will accept comments on the rule until March 17, 2009. A Reed Smith analysis of the MIPPA DMEPOS competitive bidding provisions is available here. In a related development, CMS announced the appointment of new members of the Program Advisory and Oversight Committee (PAOC), which advises the agency on the competitive bidding program.

MIPPA Part D Drug Benefit Revisions

On January 16, 2009, CMS published an interim final rule with comment period to implement MIPPA provisions regarding protected classes of drugs under the Medicare Part D prescription drug benefit. For 2010, CMS is continuing to require Part D sponsors to include all or substantially all Part D drugs in the antidepressant, antipsychotic, anticonvulsant, immunosuppressant, antiretroviral, and antineoplastic classes for 2010. For contract years 2011 and beyond, any CMS modifications to the protected categories and classes will be made through rulemaking. CMS notes that to identify appropriate drug categories and classes for future revisions, it is beginning an extensive examination of widely-used drug treatment guidelines, analyzing Part D data, and planning validation review with input from an expert panel of physicians and pharmacists. The rule is effective January 16, 2009, and comments will be accepted until March 17, 2009. 

Medicare Inpatient Hospital Payments/Wage Index Changes & Reclassifications

On December 3, 2008, CMS issued FY 2009 hospital wage index changes to implement Section 124 of the Medicare Improvement for Patients and Providers Act of 2008 (MIPPA). The notice contains revised final wage indices and hospital reclassifications for 27 hospitals and are applicable for discharges beginning October 1, 2008. 

2009 Medicare DMEPOS Fee Schedule Released

CMS has released the 2009 Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule. The update reflects payment changes mandated by the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. Specifically, MIPPA reduces the nationwide fee schedule amount of most items included in Round 1 of the DMEPOS competitive bidding program by 9.5% for 2009 (six oxygen codes included in Round 1 will receive a 0% update rather than the 9.5% reduction). Non-competitive bid items will receive a 5.0% update for 2009. 

Part D/MA Correction Notice

On November 21, 2008, CMS published a notice correcting technical and typographical errors identified in the September 18, 2008 interim final rule with comment period that revises the regulations governing the Medicare Advantage program, the Part D prescription drug benefit program, and section 1876 cost plans to conform with provisions of the Medicare Improvements for Patients and Providers Act (MIPPA). The correcting amendment is effective November 21, 2008, and is applicable on September 18, 2008. 

AHRQ Kidney Disease Education Meeting - Dec. 16, 2008

On December 16, 2008, the Agency for Healthcare Research and Quality (AHRQ) is hosting a "Stakeholders’ Meeting" to solicit feedback regarding a provision of MIPPA that provides Medicare coverage for kidney disease patient education services for individuals with Stage IV chronic kidney disease. The registration deadline is December 8, or when capacity is reached. 

E-Prescribing Special Open Door Forum, Nov. 19, 2008

CMS is hosting a Special Open Door Forum November 19 on electronic prescribing under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). At the forum, CMS staff will present information on the following topics: Overview of Part D E-Prescribing Standards, E-Prescribing Resources, E-Prescribing Incentives and E-Prescribing Measures. The forum will take place from 3:30pm-5pm eastern time. The call-in number is 1-800-837-1935; reference conference ID 71918357.

Medicare Coverage of Kidney Disease Patient Education Services

On November 6, 2008, CMS will host a Special Open Door Forum to discuss a Medicare Improvements for Patients and Providers Act provision that provides coverage for Kidney Disease Patient Education Services for individuals with Stage IV chronic kidney disease (CKD).  Among other things, CMS is seeking comments on: specific competencies for referring clinicians and the qualified individual providing the education services; accepted clinical criteria for diagnosing someone with Stage IV CKD; information needed for informed patient decisionmaking; and appropriate modalities of education.

Final Rules on MIPPA Medicare Part D Drug Plan/Medicare Advantage Plan Provisions

On September 18, 2008, the Centers for Medicare & Medicaid Services (CMS) published two final rules modifying Medicare Advantage (MA) and Part D Prescription Drug Plan (PDP) marketing and other requirements. 

  • The first rule implements certain MA and PDP marketing provisions and a requirement related to the disclosure and dissemination of Part D information included in a May 16, 2008 proposed rule and subsequently enacted into statute by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Specifically, the rule: prohibits plans from providing meals to prospective enrollees at promotional events; prohibits unsolicited contact with potential enrollees (e.g., door-to-door solicitation); prohibits plans from cross-selling non-health care related products during Medicare marketing activities; restricts marketing activities in provider offices (except in certain common areas); prohibits plans from conducting marking activities at educational events; requires that only state-licensed representatives conduct marketing activities; requires plans to disclose certain beneficiary information at the time of enrollment and 15 days before the annual coordinated election period; and defines certain terms related to marketing activities. The rule is effective September 18, 2008 and applies to the 2009 benefit year marketing campaign, beginning October 1, 2008.  
  • The second rule, which addresses a variety of other MIPPA MA and Part D provisions, is subject to a public comment period until November 17, 2008. With regard to Part D and MA marketing, the rule, among other things: codifies the $15 limit on nominal gifts to prospective enrollees; codifies restrictions on co-branding; limits marketing appointments to the scope of healthcare-related products agreed upon by the beneficiary in advance; restricts agent/broker compensation arrangements to reduce financial incentives to move a beneficiary from one plan to another; and establishes requirements for agent/broker training and testing and the reporting of terminated agents/brokers. The rule also includes provisions regarding special needs plans (SNP), including: an extension of the authority for SNPs through 2010; state contracting requirements for new and expanding dual eligible SNP applicants; model of care requirements covering scope of provider networks, individual assessments, outcomes measures, and interdisciplinary care management; cost-sharing limitations; disclosure requirements; and quality measure reporting. The rule also includes new access and quality improvement requirements for private fee-for-service plans, codifies the waiver of the late enrollment penalty for low-income subsidy enrollees; implements requirements regarding the prompt payment of clean claims; clarifies claims submission timeframes for long term care pharmacies; modifies cost plan contracts, phases out indirect costs for medical education from MA capitation rates; revises the use of certain Part D data; updates the prescription drug pricing standard; and makes exemptions to the income and resource requirements for Part D low-income subsidy eligibility determination.  The provisions of the rule generally apply beginning October 1, 2008, with certain exceptions.  CMS published a notice correcting technical and typographical errors identified in this rule on November 21, 2008. 

Separately, on September 26, 2008, CMS published a notice correcting a number of technical and typographical errors in its December 5, 2007 final rule regarding Medicare Advantage (MA) and Part D drug plan contract determination and compliance issues.

CMS E-Prescribing Conference

CMS is sponsoring a conference on October 6 and 7, 2008 in Boston to educate stakeholders about the new electronic-prescribing (“e-prescribing”) initiatives included in MIPPA. Pre-registration is required. 

DMEPOS Supplier Accreditation

The Centers for Medicare & Medicaid Services (CMS) has posted a fact sheet on the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), including the provisions related to exemption of certain providers from the accreditation requirements. MIPPA section 154(b) exempts certain professionals from the accreditation requirement unless CMS determines the quality standards are specifically designed to apply to such professionals. Under this provision, CMS is exempting the following professionals: physicians; physical therapists; occupational therapists; qualified speech-language pathologists; physician assistants; nurse practitioners; clinical nurse specialists; certified registered nurse anesthetists; certified nurse-midwives; clinical social workers; clinical psychologists; registered dietitians; nutritional professionals; orthotists; prosthetists; opticians; and audiologists. In addition, MIPPA mandates that all existing non-exempt DMEPOS suppliers be accredited as meeting DMEPOS quality standards by September 30, 2009 (new suppliers have been required to be accredited before applying for enrollment since March 1, 2008). To ensure time for accreditation organizations to process the applications, CMS is directing suppliers to submit a complete accreditation application to an approved accreditation organization by January 31, 2009.  On October 14, 2008, CMS is hosting an on-site conference at CMS headquarters in Baltimore for non-accredited DMEPOS suppliers to provide technical guidance on how to comply with the DMEPOS quality standards.   In a related development, CMS announced on a September 3, 2008 Open Door Forum that it intends to issue a proposed rule next year establishing new supplier standards for Medicare providers of orthotics and prosthetics.

Medicare Advantage Special Needs Plan Chronic Condition Panel

CMS has announced it is convening a Special Needs Plan Chronic Condition Panel to determine the conditions that meet the definition of severe or disabling chronic conditions under MIPPA. CMS will accept comments until October 8, 2008 on the criteria the panel could use for selecting conditions. CMS held a special open door forum to discuss the Panel on September 10, 2008; an audio recording of the event will be available for 30 days beginning September 17. 

MedPAC Meeting

MedPAC met on September 4 and 5, 2008 to discuss a range of Medicare policy issues, including physician financial relationships, MIPPA provisions on DME bidding and ESRD payment, imaging policy, Medicare Advantage, and Part D.  Details regarding the meeting, including a transcript, are available at the MedPAC web site

Medicare Advantage Special Needs Plan Chronic Condition Panel

On September 10, 2008, CMS is hosting an open door forum to announce the convening of the Special Needs Plan Chronic Condition Panel. The panel will determine the conditions that meet the definition of severe or disabling chronic conditions in accordance with the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). CMS also will accept comments from September 10 through October 8, 2008 on the criteria the panel could use for selecting conditions. 

DMEPOS Accreditation

On September 3, 2008, CMS is hosting a Special Open Door Forum to provide guidance to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) providers on the supplier accreditation provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).  MIPPA states that eligible professionals and other persons are exempt from meeting the September 30, 2009 accreditation deadline until CMS determines that the quality standards are specifically designed to apply to such professionals and other persons.  MIPPA also states that CMS may exempt such professionals and persons from the quality standards based on their licensing, accreditation or other mandatory quality requirements that may apply.  The call will take place from 2 pm-3:30 pm Eastern Daylight Time. To participate, dial: 1-800-837-1935 and Reference Conference ID: 61231070. 

Medicare IPPS Final Rule

On August 18, 2008, the Centers for Medicare & Medicaid Services (CMS) published its final Medicare hospital inpatient prospective payment system (IPPS) rule for fiscal year (FY) 2009, which begins October 1, 2008. CMS estimates that the rate updates and other policies in the rule will increase Medicare payments to acute care hospitals by almost $4.75 billion in FY 2009, although the impact on particular procedures varies.  The following are highlights of the sweeping regulation.

  • Rate Update – The final rule includes a 3.6% market basket increase, although hospitals that do not report the quality measures will receive an update of market basket minus 2 percentage points, for a 1.6% update. This update will be partially offset by a 0.9% reduction designed to compensate for changes in documentation and coding practices that do not reflect real changes in case mix.  In FY 2009, CMS will complete the transition to cost-based relative weights, with relative weights based 100% on costs.
  • Value-Based Purchasing Program – CMS is expanding the Hospital-Acquired Conditions policy, under which Medicare will not make higher payments to hospitals for care associated with certain reasonably-preventable conditions unless the condition were reported as present on admission.  CMS has added three new conditions for FY 2009: certain manifestations of poor glycemic control; surgical site infections following certain orthopedic surgeries and bariatric surgery for obesity; and deep vein thrombosis or pulmonary embolism following total knee replacement and hip replacement procedures. In addition, CMS is adding 13 new quality measures for which hospitals will have to report data in FY 2009 in order to receive the full Medicare IPPS market basket update in FY 2010 (down from 43 new measures in the proposed rule) and retiring one previous measure (pneumonia/oxygenation assessment).  Both initiatives are designed to further CMS's Value-Driven Health Care agenda.
  • Charge Compression/Cost Centers – CMS is establishing separate cost centers for (1) medical supplies and (2) implantable devices. CMS is adopting this change to help address “charge compression," or the practice of hospitals applying a higher percentage charge markup over costs to lower-cost items and services and a lower-percentage charge markup over costs to higher cost items and services.
  • New Technology Payments – Under the final rule, CMS will only consider for new technology add-on payments for a particular fiscal year, an application for which the new medical service or technology has received Food and Drug Administration (FDA) approval or clearance by July 1 prior to the particular fiscal year.
  • Hospital Ownership/Physician Self-Referrals – The final rule includes significant revisions to hospital ownership and the physician self-referral provisions (also referred to as the "Stark Law").  Among other things, the final rule prohibits the use of “per-click” leases for office space or equipment when the lease is entered into between a referring physician or physician organization and an entity that furnishes designated health services (DHS). The rule also prohibits the use of a percentage-based compensation formula for determining the rental charges for the lease of office space or equipment (but does not apply to management agreements, billing services arrangements, and gainsharing arrangements). The final rule also revises the definition of an “entity” to include both the entity that bills Medicare for DHS as well as the entity that fully performs the DHS. These provisions are effective October 1, 2009.  Moreover, the rule modifies the “stand in the shoes” provisions in the Stark Act definition of indirect compensation arrangement. Specifically, a physician owner of (or investor in) a physician organization stands in the shoes of the physician organization for the Stark purposes if the physician has the ability or right to receive financial benefits of the ownership or investment.  However, a merely titular owner is not required to (but may select to) stand in the shoes of his or her physician organization.  CMS also is finalizing its proposed revisions to the definitions of “physician” and “physician organization,” and clarifying the period of time for which a physician would be prohibited from referring Medicare patients to an entity for DHS and for which the DHS entity would be prohibited from billing for such DHS where a financial relationship failed to satisfy a Stark Act exception.  The final rule also requires a physician-owned hospital to furnish to patients, on request, a list of physicians or immediate family members who own or invest in the hospital. Moreover, a physician-owned hospital must require all physician owners or investors who are also active members of the hospital's medical staff to disclose in writing their ownership or investment interests in the hospital to all patients they refer to the hospital.  CMS can terminate the Medicare provider agreement of a physician-owned hospital if it fails to comply with these disclosure provisions or with the requirement that a hospital disclose in writing to all patients whether there is a physician on-site at the hospital 24 hours per day, 7 days per week. Reed Smith is preparing a client memo analyzing these provisions; it will be available on our web site, reedsmith.com.
  • Emergency Medical Treatment and Labor Act (EMTALA) – Under the final rule, if an individual with an unstable emergency medical condition presents to a participating hospital and is admitted, the admitting hospital has satisfied its EMTALA obligation.  If the patient is subsequently transferred to a hospital with capabilities for specialized care, that hospital does not have an EMTALA obligation to accept the individual. CMS invites ongoing public comment on whether this policy results in unintended consequences, such refusals by hospitals with specialized capabilities to accept the transfer inpatients whose emergency medical condition remains unstabilized.
  • Other Policies – Among many other things, the rule: makes limited revisions to the classifications of cases to Medicare severity diagnosis-related groups (MS-DRGs) and Medicare severity long-term care diagnosis-related groups (MS-LTC-DRGs); updates the rate-of-increase limits for certain hospitals and hospital units excluded from the IPPS that are paid based on reasonable cost; implements wage index and geographic reclassification changes; reduces by 50% capital Indirect Graduate Medical Education payments; and implements provisions in the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) rebasing sole community hospital payment rates and extending certain geographic reclassifications and special exceptions. The rule also requires Medicare Advantage plans to provide encounter-level data to CMS to be used for risk adjustment, disproportionate share hospital calculations, and Medicare coverage tracking purposes. CMS did not adopt its proposal to expandthe postacute care transfer policy to transfers to home for the furnishing of home health services within 7 days (rather than 3 days) of hospital discharge. 

CMS E-Prescribing Conference

CMS is sponsoring a conference on October 6 and 7, 2008 in Boston, Massachusetts, to educate stakeholders about the new eprescribing initiatives included in the Medicare Improvements for Patients and Providers Act of 2008 (“MIPPA”).    While there is no registration fee, space is limited.  For questions, please call 1-888-883-3734 x 820, or send an e-mail to registrar@e-prescribeconference.com. 
 

Featured keynote speakers include: 

  • Mike Leavitt, Secretary of Health and Human Services
  • Kerry Weems, Acting Administrator, Centers for Medicare & Medicaid Services
  • David J. Brailer, MD, PhD, Chairman, Health Evolution Partners, Former National Coordinator for Health Information Technology

Conference registration is now open.

 

Medicare Physician Payment/DMEPOS Bidding Delay Legislation Enacted

On July 15, 2008, the House and Senate overrode the President's veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (MIPPA).  The law rescinds a 10.6% cut in physician payments and delays a controversial medical equipment competitive bidding program, both of which temporarily went into effect July 1, 2008, and makes numerous other Medicare and Medicaid policy changes.  Highlights of the law include the following:

  • Physician Payments: MIPPA cancels a 10.6% Medicare physician fee schedule cut that was triggered on July 1, 2008 and provides a 1.1% increase for 2009 (rather than the forecasted 5.4% cut).  The law also expands the Physician Quality Reporting Initiative, 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).  H.R. 6331 terminates contracts awarded under round one, rebids those areas in 2009, and delays round two bidding until 2011.  The delay is financed by cutting fee schedule payments for round one items by 9.5% nationwide beginning January 1, 2009.  MIPPA also includes a series of procedural improvements to the bidding process. A detailed Reed Smith analysis of the MIPPA DMEPOS bidding provisions is available on our website.
  • Therapy Caps Exception Process.  MIPPA extends through December 31, 2009 the outpatient therapy service cap exceptions process.
  • Clinical Laboratory Services.  The act repeals the clinical lab competitive bidding demonstration project and reduces the clinical lab fee schedule update by 0.5% in each of the next 5 years.
  • Medicare Advantage (MA) Provisions.  MIPPA makes a series of MA payment and policy changes, including a $1.8 billion cut in the regional MA stabilization fund in 2012 and a phase-out of the adjustment for indirect medical education. 
  • Medicare Part D Drug Plans.  MIPPA sets timeframes for plan payments to pharmacies and long-term care pharmacy submission of claims; mandates coverage of certain classes of drugs; clarifies the use of Part D drug data; limits certain sales and marketing activities; and makes other Part D reforms. 
  • End-Stage Renal Disease (ESRD) Provisions.  The law updates the ESRD composite rate by 1.0% for 2009 and 2010, and mandates a fully-bundled ESRD payment system and quality incentive program by January 1, 2011.
  • 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.

Reed Smith is preparing a client memo analyzing the new law, which will be available on our web site.  

CMS Guidance on MIPPA Implementation.

When MIPPA was enacted July 15, 2008, it included a number of retroactive Medicare policy provisions. CMS has begun providing guidance on implementation of these provisions, including the positive update in the physician fee schedule, the reinstatement of the therapy cap exception process, and the ability of all suppliers to furnish items in the first round DMEPOS competitive bidding areas (CBAs) at fee schedule rates. Likewise, CMS has announced that as a result of MIPPA enactment, the special accreditation deadlines previously established for the second round of the DMEPOS competitive bidding program have been cancelled, although the September 30, 2009 deadline for accreditation of all DMEPOS suppliers still is in effect. 

OIG Guidance on MIPPA/Waiver of Copayments

Certain retroactive payment increase provisions in MIPPA result in increased beneficiary copayment amounts for certain items and services furnished from July 1 through July 14, 2009. As a result, beneficiaries who already paid or were billed for cost-sharing amounts based on lower prices temporarily in effect are liable for additional cost-sharing amounts. On July 24, 2008, the OIG issued a policy statement assuring suppliers and providers affected by retroactive rate increases that they will not be subject to OIG administrative sanctions if they waive retroactive beneficiary cost-sharing amounts attributable to those increased payment rates (subject to certain conditions). The policy impacts the following types of items and services: physician fee schedule services; certain DMEPOS in the initial bidding areas; brachytherapy sources and therapeutic radiopharmaceuticals under the outpatient prospective payment system; and ambulance services. Note, however, that suppliers and providers are not required to waive retroactive beneficiary liability, and they may instead choose to bill the beneficiary for the additional copayment obligation. 

PQRI Update

On August 13, 2008, CMS is holding a national provider conference call on the 2008 Physician Quality Reporting Initiative (PQRI). The call will provide information on the PQRI provisions in MIPPA, the e-prescribing measure for 2008 PQRI and proposed measures for 2009 PQRI, MIPPA incentives for electronic prescribing, and registry reporting for 2008.  Registration information is available here.

MIPPA: Medicare Physician Payment/DMEPOS Bidding Delay Legislation Enacted

On July 15, 2008, the House and Senate overrode the President's veto of H.R. 6331, the  "Medicare Improvements for Patients and Providers Act of 2008” (MIPPA).  The law rescinds a 10.6% cut in physician payments and delays a controversial medical equipment competitive bidding program, both of which went into effect July 1, 2008, and makes numerous other Medicare and Medicaid policy changes. The vote was 70-26 in the Senate and 383-41 in the House, following the President's veto earlier in the day. 

The following are highlights of the legislation:

  • Physician Fee Schedule: MIPPA maintains physician payment rates for 2008 (rather than implement the 10.6% cut that was triggered on July 1, 2008), and provides a 1.1% increase for 2009 (rather than the forecasted 5.4% cut). The law also extends for two years the Physician Quality Reporting Initiative (PQRI), increases incentive payments for reporting by 2%, and makes other reforms to the program. The act promotes electronic prescribing (e-prescribing) by providing incentive payments for practitioners who use a qualified e-prescribing systems in 2009 through 2013, and reducing payments by 2% for providers practitioners who fail to e-prescribe beginning in 2011 (with limited exceptions). MIPPA also requires non-hospital advanced imaging providers to be accredited by 2012 and establishes a voluntary demonstration program to test the use of appropriateness criteria for advanced diagnostic imaging services.
  • 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 first round of the program went into effect in 10 geographic areas on July 1, 2008. H.R. 6331 terminates contracts awarded under round one and rebids those areas in 2009, with bidding for round two delayed until 2011. The delay is financed by cutting fee schedule payments for all items covered by round one bidding program by 9.5% nationwide beginning January 1, 2009, followed by a 2% increase in 2014 (with certain exceptions). MIPPA also includes a series of procedural improvements to the bidding process, and addresses quality by, among other things, requiring subcontractor accreditation, excluding complex rehabilitation wheelchairs and negative pressure wound therapy from bidding, and exempting of certain rural and low-population areas from bidding. Separately, MIPPA repeals current oxygen equipment transfer of ownership requirements.
  • 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 clinical lab services by 0.5% in each of the next 5 years.
  • Medicare Advantage (MA) Provisions. MIPPA makes a series of payment and policy changes affecting Medicare Advantage 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 current coverage of certain “protected classes” of drugs; clarifies the use of Part D drug data for research and other purposes; limits certain sales and marketing activities; and makes other Part D reforms. 
  • End-Stage Renal Disease Provisions. The law provides a 1.0% update to the composite rate for renal dialysis services for 2009 and 2010, requires the Secretary to establish a fully bundled ESRD payment system by January 1, 2011, and establishes a quality incentive payment program for ESRD providers, effective January 1, 2011.
  • Medicaid Drug Reimbursement. MIPPA delays the adoption of Medicaid payment based on average manufacturer price (AMP) for multiple source drugs and prevent publication of AMP data until October 1, 2009.

Additional details regarding the legislation are available on the House Ways and Means Committee web site.