CMS Delays Application of Imaging MPPR Policy to Physicians in Same Group Practice

In the final 2012 Medicare physician fee schedule rule, CMS adopted a controversial policy to expand its multiple procedure payment reduction (MPPR) policy for advanced imaging services (computed tomography scans, magnetic resonance imaging, and ultrasound), which now applies to only the technical component (TC) of the service, to the professional component (PC) of the service. Effective January 1, 2012, the advance imaging procedures with the highest PC and TC payments will be paid in full, but the PC payment will be reduced by 25% for subsequent procedures furnished to the same patient, by the same physician in the same session on the same day. In the final rule, CMS stated that it would also apply the imaging MPPR to procedures furnished to the same patient in the same session by physicians in the same group practice. CMS recently announced, however, that it will not apply the imaging MPPR to procedures furnished to the same patient in the same session by more than one physician in the same group practice for 2012 due to “operational considerations.”

OIG Report on Portable X-Ray Supplier Billing Patterns

The OIG has identified 20 portable x-ray suppliers -- entities that furnish x-rays at a beneficiary’s location using mobile diagnostic equipment -- with questionable billing patterns in 2008 and 2009. For instance, OIG found that while portable x-rays (unlike other tests) must be ordered only by a licensed physician, they discovered that Medicare paid approximately $6.6 million for such services ordered by nonphysicians such as physician assistants and nurse practitioners (who can order tests in other non-hospital settings). The OIG also identified questionable billing related to return trips to nursing facilities.  In the report, “Questionable Billing Patterns of Portable X-Ray Suppliers,” the OIG recommends that CMS take a series of steps to improve oversight of portable x-ray suppliers, including collecting identified overpayments, establishing a process to periodically identify portable x-ray suppliers that merit greater scrutiny, and establishing controls to limit payment to only portable x-ray services ordered by physicians. CMS concurred with the OIG’s recommendations.

CMS Issues Final Medicare Physician Fee Schedule Rule for 2012

Medicare physician fee schedule (MPFS) payments are scheduled to be cut by 27.4% in 2012 under the Centers for Medicare & Medicaid Services’ (CMS) final rule to be published November 28, 2011. The steep reduction is a result of the statutory Sustainable Growth Rate (SGR) formula. While Congress is widely expected to take action to mitigate the SGR cuts, the scope and timing of any such “fix” is uncertain at this time. If the final rule goes into effect as written, however, the conversion factor for 2012 would be $24.6712, down from the current $33.9764. In addition to updating MPFS rates, the sweeping final rule includes numerous policy provisions impacting many types of providers, including the following: 

  • CMS has adopted a controversial policy to expand its multiple procedure payment reduction (MPPR) policy for advanced imaging services (computed tomography scans, magnetic resonance imaging, and ultrasound), which now applies to only the technical component (TC) of the service, to the professional component (PC) of the service. Effective January 1, 2012, the advance imaging procedures with the highest PC and TC payments will be paid in full, but the PC payment will be reduced by 25% for subsequent procedures furnished to the same patient, by the same physician -- including physicians in the same group practice -- in the same session on the same day (CMS initially had proposed reducing the PC by 50%). The TC payment will continue to be reduced by 50%.   Note that in the proposed rule, CMS indicated it is considering more expansive MPPR policies in 2013 and beyond, which could include applying the MPPR to the all imaging services (not just advanced imaging studies) or to the technical component of all diagnostic tests (e.g., tests associated with radiology, cardiology, audiology, procedures furnished in the same encounter). CMS did not finalize any such broader expansion in the final rule. 
  • CMS is updating certain payment policies for Part B drugs to specify that the average manufacturer price (AMP) substitution policy will apply only when the average sales price (ASP) exceeds the AMP by 5% in two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter. CMS will make an AMP substitution only for those situations in which AMP and ASP comparisons are based on the same set of NDCs for a billing code. CMS also is adopting a number of changes to the manufacturer ASP reporting template. 
  • CMS is updating a number of physician incentive programs, including the Physician Quality Reporting System, the ePrescribing Incentive Program, and the Electronic Health Records Incentive Program. CMS also is adopting performance measures for a new “value-based modifier,” mandated by the Affordable Care Act (ACA), that will reward physicians for providing higher quality and more efficient care. CMS is using 2013 as the initial performance year for purposes of adjusting payments in 2015.
  • CMS is taking a number of steps to address payment for “potentially misvalued codes,” including reviewing the value of high-expenditure codes in each specialty and adopting a new public nomination process under which the public can nominate potentially misvalued codes and submit documentation supporting the need for review. 
  • CMS has formally retracted a widely-criticized policy adopted in the 2011 MPFS rule that required the signature of a physician or qualified nonphysician practitioners on a requisition for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule. In withdrawing the policy, CMS cites stakeholder concerns about the many negative practical effects of the policy on beneficiaries and providers, including potential adverse impacts on timely patient care. 
  • The rule also, among many other things: changes how CMS adjusts payment for geographic variation in practice costs;revises the criteria for updating services available through telehealth; updates the methodology for calculating the productivity adjustment for ambulatory surgical center (ASC), ambulance, clinical laboratory, and durable medical equipment (DME) prosthetics, orthotics, and supplies (DMEPOS) fee schedules; sets the 2012 outpatient therapy cap amount at $1,880; and clarifies the applicability of the “3-day payment window” policy to certain services furnished in a wholly owned or wholly operated physician practice. 

Note that CMS will accept comments on a limited number of provisions in the rule, including the interim final relative value units for new, revised, potentially misvalued codes and the physician self-referral designated health services codes, until January 3, 2012.

MedPAC Offers Medicare SGR Proposal, With Offsetting Medicare Cuts

At a recent meeting, the Medicare Payment Advisory Commission (MedPAC) discussed a recommendation to repeal and replace the statutory sustainable growth rate (SGR) formula for updating the Medicare physician fee schedule (MPFS). In recent years, the SGR formula has produced steep cuts in the MPFS update, which Congress has repeatedly blocked through legislation, For 2012, CMS estimates that the SGR formula would result in an almost 30% MPFS cut in the absence of Congressional action. MedPAC is considering an SGR reform proposal that would repeal the SGR and replace it with 10-years of statutory fee schedule updates. The plan would freeze current Medicare payment levels for primary care services, and all other services would be subject to annual payment reductions of 5.9% for 3 years, followed by a freeze.  MedPAC also has released a list of potential offsetting Medicare cuts that would raise $235 billion over 10 years to finance the reforms.  The proposals include, among others: reduced Medicare payments for many Medicare provider types and services; expanded DMEPOS competitive bidding; various reductions in payments to Medicare Advantage plans; prior authorization for certain imaging services; changes to certain Part D cost sharing; prepayment review of power wheelchairs; drug manufacturer rebates for dual eligibles; bundled payments for hospitals and physicians; payment of hospital outpatient evaluation and management visits at MPFS rates; establishment of least costly alternative authority; expansion of readmissions policies for additional provider types, and validation of physician orders for high cost services.

CMS Seeks Comments on Potential Medicare Coverage Determination Topics

CMS is inviting public comments on potential topics for Medicare national coverage determinations (NCDs) “to use Medicare coverage to help align program incentives with the best available clinical evidence.” While CMS issued a list of potential NCDs in 2008, the agency notes that there have been “significant developments in new technologies and changes to CMS authorities under statute” since that time. CMS now seeks input on items and services that may be inappropriately used (including underused, overused, or misused) or that provide minimal benefit. Such items and services could include surgical procedures, diagnostic tests or procedures, imaging or radiology services, lab tests, durable medical equipment, treatments for diseases, or procedures such as orthopedic or eye procedures. CMS will accept comments until November 27, 2011. After the agency reviews comments based on relevance to the NCD authority and potential impact on the Medicare program, a revised list will be released. 

OIG "Spotlight" on IDTFs

The OIG has created a “spotlight page” on its website that compiles information on previous OIG investigations involving independent diagnostic testing facilities (IDTFs) -- Medicare providers that furnish diagnostic services independent from a physician's office or hospital. According to the OIG, “IDTF services have historically been vulnerable to abuse,” and thus have been a topic of focus for the OIG for more than a decade. The spotlight page includes a review of a variety of OIG audit, inspection, and enforcement actions involving IDTFs. This comes in the wake of two recent OIG reports that anounced CMS's plans to conduct more unannounced site visits of IDTFs nationally.

CMS "Provider Compliance Group Outreach Calls" to Focus on Medicare Vulnerabilities (Aug. 23-25, 2011)

CMS has announced a series of calls on specific Medicare program vulnerabilities identified in HHS Office of Inspector General (OIG) reports. The topics of the calls are as follows: August 23: Inpatient Rehabilitation Facility Documentation, Power Wheelchairs/Power Mobility; August 24: Overview of Reviews, Hospice, and Electronic Submission of Medical Documentation (esMD); August 25: Diagnostic Radiology Services in Emergency Departments; Ambulatory Surgical Center Services and Ambulance Transportation Provided to Beneficiaries in Skilled Nursing Facility Stays. CMS Contractor Medical Directors, OIG representatives and CMS personnel will address compliance with Medicare policy, billing instructions, and medical review guidance related to reducing improper payments for these items and services. The calls will be broadcast over the internet. 

CMS Issues Proposed CY 2012 Physician Fee Schedule Rule

July 19, 2011, the Centers for Medicare & Medicaid Services (CMS) published its proposed update to the Medicare physician fee schedule (MPFS) for calendar year (CY) 2012. Most notably, the proposed rule calls for a negative 29.5% update for 2012 under the statutory sustainable growth rate (SGR) formula. For 2012, CMS projects a conversion factor of $23.9635, compared to the 2011 conversion factor of $33.9764. While Congress is expected to consider legislation to advert the upcoming cut, as it has in previous years, the scope, timing, and outcome of any such legislative “fix” is still speculative. The sweeping proposed rule includes numerous other policy proposals, which are summarized after the jump.

  • CMS has made a proposal that is very controversial in the industry to expand its multiple procedure payment reduction (MPPR) policy for advanced imaging services (computed tomography scans, magnetic resonance imaging, and ultrasound), which now applies to only the technical component of the service, to the professional component (physician interpretation) of the service. If finalized, Medicare would pay 100% of the technical and professional component for highest-paid procedure, while the payments for the technical and professional component of the second and each additional imaging service done on the same patient during the same session would be reduced by 50%. CMS also has requested comments on more expansive reduction policies in 2013 and beyond, which could include applying the MPPR to the all imaging services (not just advanced imaging studies) or to the technical component of all diagnostic tests (e.g., tests associated with radiology, cardiology, audiology, procedures furnished in the same encounter).
  • CMS proposes to updates certain payment policies for Part B drugs to specify that the average manufacturer price (AMP) substitution policy will apply only when the average sales price (ASP) exceeds the AMP by 5 percent in two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter. CMS is also proposing a number of changes to the manufacturer ASP reporting template. 
  • CMS proposes to update a number of physician incentive programs, including the Physician Quality Reporting System, the ePrescribing Incentive Program, and the Electronic Health Records Incentive Program. CMS also proposes quality and cost measures for a new value-based modifier, mandated by the Affordable Care Act (ACA), that would reward physicians for providing higher quality and more efficient care. CMS is proposing to use CY 2013 as the initial performance year for purposes of adjusting payments in CY 2015. Payments under the value-based payment modifier provision will be risk-adjusted and budget-neutral. 
  • Among many other things, CMS identifies a variety of potentially misvalued code and proposes a new public nomination process under which the public could nominate potentially misvalued codes and submit documentation supporting the need for review. CMS also proposes changes in how it adjusts payment for geographic variation in the cost of practice; revisions to how it updates services available through telehealth; updates to the productivity adjustment for ambulatory surgical center (ASC), ambulance, clinical laboratory, and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedules; and clarification of the applicability of the “3-day payment window” policy to certain services furnished in a wholly owned or wholly operated physician practice. CMS also seeks comments on physician activities and the associated resources involved in physician provision of effective care coordination surrounding a hospital discharge.

Comments on the proposed rule will be accepted until August 30, 2011.  A variety of supporting files are posted at www.cms.gov/PhysicianFeeSched/PFSFRN/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=4&sortOrder=descending&itemID=CMS1249142&intNumPerPage=10.

MedPAC Recommends Changes to Medicare Ancillary Services Policies

The Medicare Payment Advisory Commission (MedPAC) has released its June 2011 "Report to the Congress: Medicare and the Health Care Delivery System." Most notably, the report includes a number of recommendations that have generated much controversy to address the growing use of ancillary services, particularly non-hospital diagnostic imaging services. According to the report, MedPAC seeks to “improve payment accuracy to reduce providers’ financial incentives to order more ancillary services, while strengthening clinical support tools to improve appropriate use of these services.” Recommendations in this area include the following: (1) the Secretary should accelerate and expand efforts to package discrete services in the physician fee schedule into larger units for payment; (2) Congress should direct the Secretary to apply a multiple procedure payment reduction to the professional component of diagnostic imaging services provided by the same practitioner in the same session; (3) Congress should direct the Secretary to reduce the physician work component of imaging and other diagnostic tests that are ordered and performed by the same practitioner; and (4) Congress should direct the Secretary to establish a prior authorization program for practitioners who order substantially more advanced diagnostic imaging services than their peers. In addition to the ancillary services recommendations, the report includes chapters examining: the Medicare physician fee schedule Sustainable Growth Rate formula; Medicare's fee-for-service benefit design; enhancing Medicare's technical assistance to and oversight of providers; coordinating care for dual-eligible beneficiaries; federally-qualified health centers; and variation in private-sector payment rates. Note that while MedPAC’s recommendations are not binding, Congress and CMS often take into account MedPAC’s assessments when updating Medicare payment policies.  

CMS Call on Accreditation for Advanced Diagnostic Imaging (ADI) Technical Suppliers (June 23)

On June 23, 2011, CMS is hosting a national provider call on the mandatory accreditation requirement for all suppliers that furnish the technical component of ADI, effective January 1, 2012. The agenda for the call includes an overview of the statutory accreditation requirements, including deadlines and suppliers affected; a discussion of the accreditation and enrollment processes; and a question and answer session. According to a CMS announcement, the agency “will update information previously discussed on Open Door Forums that will streamline the requirements.” Registration for the call will close at 2:30 pm on June 22 or when available space has been filled.

CMS Publishes Final Hospital Telemedicine Credentialing Standards

On May 5, 2011, CMS published a final rule revising the hospital conditions of participation (COP) related to the credentialing and privileging of physicians who provide telemedicine services. CMS includes both teleradiology (non-simultaneous) services and telehealth (simultaneous) services within the definition of telemedicine. In short, the final rule allows the governing body of a hospital or critical access hospital (CAH) to rely upon the credentialing and privileging decisions made by a distant-site hospital or telemedicine entity when making its own decisions on privileges for the individual distant-site physicians and practitioners providing such services. Certain conditions must be met under this rule, including a written agreement with the distant-site hospital or telemedicine entity to ensure that the distant-site entity, acting as a contractor of services, furnishes its services in a manner that enables the hospital or CAH to comply with all applicable COPs and standards for the contracted services, including the credentialing and privileging requirements regarding its physicians and practitioners providing telemedicine services. The rule is effective July 5, 2011.

OIG Examines Medicare Radiology Services in Emergency Departments

The OIG has issued a report entitled Medicare Payments for Diagnostic Radiology Services in Emergency Departments.” According to the OIG, because of insufficient documentation, Medicare erroneously allowed 19% ($29 million) of claims for interpretation and reports for computed tomography and magnetic resonance imaging, along with 14% ($9 million) of claims for interpretation and reports for x-rays in hospital outpatient emergency departments in 2008. Examples of insufficient documentation included missing physicians’ orders and records documenting that interpretation and reports had been performed.  The OIG investigators also measured compliance with reporting guidelines recommended by the American College of Radiology. The report did not address the widespread delivery of preliminary interpretation services in thousands of US hospitals.  The OIG recommended that CMS improve provider education regarding documentation requirements and take appropriate action on the erroneously allowed claims identified by the OIG; CMS concurred with these recommendations. CMS did not agree with a separate OIG recommendation that CMS require that claimed services be contemporaneous or identify circumstances in which noncontemporaneous interpretations may be appropriate; CMS noted that it does not believe that a single billed interpretation must in all cases be contemporaneous with the beneficiary’s diagnosis and treatment to contribute to that diagnosis and treatment.

MedPAC Issues Recommendations on the Use of Diagnostic Services

This post was written by Paul Pitts.

On April 7, 2011, the Medicare Payment Advisory Commission (MedPAC) approved new recommendations to Congress regarding Medicare payment for imaging and other diagnostic tests. The recommendations reflect a shift in MedPAC’s policies from advocating for tighter controls on physician in-office services to addressing what MedPAC views as inaccuracies in payment and inappropriate use of diagnostic imaging. MedPAC approved the following recommendations: (1) the Secretary should accelerate and expand efforts to package discrete services in the physician fee schedule into larger units for payment; (2) the Congress should direct the Secretary to apply a multiple procedure payment reduction to the professional component of diagnostic imaging services provided by the same practitioner in the same session; (3) the Congress should direct the Secretary to reduce the physician work component of imaging and other diagnostic tests that are ordered and performed by the same practitioner; and (4) the Congress should direct the Secretary to establish a prior authorization program for practitioners who order substantially more advanced diagnostic imaging services than their peers. The recommendations will appear in MedPAC’s June report to Congress.

CMS Hosts Forum on Advanced Diagnostic Imaging (ADI) Accreditation

On March 22, 2011, CMS hosted a Listening Session on the accreditation requirements for physician offices that bill Medicare for the technical component (TC) of ADI services, such as diagnostic MRI, CT, and nuclear medicine (including PET), and other diagnostic imaging services (excluding X-ray, ultrasound, and fluoroscopy). The purpose of the call was to: review the statutory requirement for accreditation; discuss who needs to be accredited by January 1, 2012; review the accreditation process and timeline; and highlight the importance of preparing to prevent a disruption in payment. On the call, CMS reminded listeners that the accreditation requirement only applies to the suppliers of the images themselves (not the physician's interpretation service); to entities that submit claims to Medicare; and to entities paid under the MPFS (not hospitals billing under the HOPPS). One notable item highlighted is the new billing requirement that bars "global" billing; the TC code must be billed separately. CMS emphasized that any entity covered by the accreditation mandate needs to start the accreditation process now in order to ensure they will be able to furnish ADI services to Medicare beneficiaries in 2012, since the accreditation process may take up to five months. According to CMS, the average cost of accreditation for one location and one modality is $3,500 every three years. A transcript of the call will be posted for 30 days beginning approximately April 22, 2011. 

CMS Open Door Forum on Advanced Diagnostic Imaging Accreditation (March 22)

On March 22, 2011, CMS is hosting a Special Open Door Forum on Furnishing and Billing for the Technical Component of Advanced Diagnostic Imaging. The purpose of the call is to review the accreditation requirements for all physician offices that bill for the technical component of advanced diagnostic imaging, including the statutory requirements, the accreditation process, and the importance of beginning preparations now in order to prevent a disruption in payment.

GAO Reports on Duplications in HHS and Other Federal Programs

The Government Accountability Office (GAO) has issued a lengthy report entitled Opportunities to Reduce Potential Duplication in Government Programs, Save Tax Dollars, and Enhance Revenue.” The report identifies areas of program duplication and fragmentation and other opportunities for cost savings in federal government programs. Among other things, the GAO focuses on the following health care program areas: potential savings in Medicare’s payments for health care (particularly in the areas of physician payment and practice patterns, imaging services, and home oxygen); better targeting of Medicare claim reviews; preventing Medicaid improper payments, including Medicaid supplemental payments; integration of nationwide public health information systems; and controlling Departments of Veterans Affairs and Defense drug costs.

Medicare Imaging Demonstration Conveners Selected

CMS has announced the five “conveners” for the Medicare Imaging Demonstration, which will test the impact of physician "decision support systems" on the appropriateness and utilization of certain advanced medical imaging services ordered for fee-for-service (FFS) Medicare beneficiaries. 

CMS Meeting on Developing New Imaging Efficiency Measures (Jan. 31, 2011)

CMS is hosting a meeting January 31, 2011 to receive comments regarding the development of additional imaging efficiency measures for use in the Medicare Hospital Outpatient Quality Data Reporting Program. Potential topics for discussion include: imaging procedures that would be appropriate candidates for imaging efficiency measures (in addition to current imaging efficiency measures); data sources appropriate for imaging efficiency measures; other potential settings for imaging efficiency measures besides outpatient hospitals; and development of imaging measures based on diagnosis/condition rather than specific procedures. Measure developers, hospitals, medical specialty societies, medical professionals, and other interested stakeholders are invited to participate either in person or via teleconference. Registration opens January 7, 2011, and written comments will be accepted until February 10, 2011.

CMS Issues Final CY 2011 Physician Fee Schedule Rule

On November 29, 2010, CMS is publishing its final Medicare physician fee schedule (MPFS) rule for 2011.  The rule addresses a wide variety of Medicare Part B policies, including many changes mandated by the ACA, as detailed after the jump.

Among many other things, the final rule:

  • Establishes a 2011 conversion factor of $25.5217, compared to the conversion factor of $36.8728 applicable June 1-November 30, 2010. This steep drop is due primarily to the statutory sustainable growth rate (SGR) formula, which reduces rates by a total of 24.9% from November 2010 to January 2011 (reflecting the December 1, 2010 expiration of a temporary increase established by Congress plus an additional 2.9% cut that goes into effect January 1, 2011). CMS also has adopted a rescaling /budget neutrality adjustment of -8.2%, which is designed to offset rescaled relative value units and a rebased Medicare Economic Index (MEI) for 2011. Congress is expected to once again step in to at least mitigate the SGR cuts, but the timing and scope of any such action is still speculative at this time.
  • Updates several durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program policies, including provisions that: expand Round 2 by adding 21 of the largest metropolitan statistical areas (MSAs); subdivide three of the largest MSAs; implement a national mail order competitive bidding program for diabetic testing supplies and make other refinements related to the furnishing of diabetes supplies; modify the definition of mail-order suppliers; create an appeals process for suppliers considered to be in breach of contract; and modify policies related to off-the-shelf orthotics, oxygen and oxygen equipment, and reimbursement to grandfathered suppliers. In addition, the rule addresses payment policy for power wheelchairs outside of the competitive bidding program.
  • Implements ACA provisions that assign a 75% utilization rate assumption to certain expensive diagnostic imaging equipment used in diagnostic CT and MRI services, and that increase the multiple procedure payment reduction (MPPR) applied to the technical component of certain single session imaging services to contiguous body parts from 25% to 50% for more than one imaging procedure preformed in the same session. CMS also adopted its proposal (not mandated by the ACA) to apply the MPPR policy across imaging families and not limited to contiguous body areas. In addition, the rule implements an ACA requirement that physicians who refer patients to certain imaging services under the in-office ancillary services exception to the physician self-referral prohibition inform patients of their option to receive these services from other area suppliers and to provide a list of at least five alternative suppliers within a 25-mile radius of the physician’s office.
  • Establishes a multiple procedure payment reduction policy applicable to certain Part B outpatient therapy services, under which CMS will apply a 25% payment reduction to the practice expense component of the second and subsequent therapy services for certain multiple therapy services furnished to a single patient in a single day (note that under the proposed rule, CMS would have imposed a 50% reduction).
  • Updates certain payment policies for Part B drugs, including establishing a new “carry over” process to address certain delays in manufacturer reporting of pricing data for multiple-source drugs, and establishing an “intentional overfill” policy under which the Medicare payment limit will based on the amount of product in a vial or container as reflected on the FDA-approved label.
  • Finalizes a proposal to use the annual MPFS rulemaking to consider changes in practice expense (PE) price inputs for supplies and equipment, but CMS deferred adopting its proposal to base PE inputs for supplies $150 or more on the U.S. General Services Administration medical supply schedule while it continues to review this policy.
  • Implements ACA provisions that: establish the methodology for applying the ACA’s “multi-factor productivity” adjustment to the updates for the ASC, ambulance, clinical laboratory and DMEPOS fee schedules; update the Physician Quality Reporting Initiative and Electronic Prescribing Incentive Program; eliminate beneficiary coinsurance for most preventive services and expand coverage of certain preventive services; require the Secretary to identify and make appropriate adjustments to the relative values of misvalued services; and revise the timely filing requirements for Medicare claims.

Guidance on Whether Radioactive Studies Require an Investigational New Drug (IND) Application

This post was written by Paul Sheives and Areta Kupchyk.

FDA has published a guidance document entitled “The Radioactive Drug Research Committee: Human Research Without an Investigational New Drug Application,” which provides information about the use of radioactive drugs for certain research purposes. FDA regulations allow for human research using a radioactive drug or biological product under a Radioactive Drug Research Committee approval only (i.e., without an IND) if it constitutes basic research and is not intended for immediate therapeutic, diagnostic, or similar purposes, or to determine the safety and effectiveness of the radioactive drug or biological product. The document describes what would constitute “basic research,” provides criteria for identifying such studies, and provides a frequently asked questions section on the topic. 
 

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.

CMS Outreach on Advanced Diagnostic Imaging Services Accreditation

CMS has directed Medicare contractors to send a letter to all Medicare-enrolled suppliers (individuals, groups and independent diagnostic testing facilities) that have billed for advanced diagnostic imaging services within the past six months to inform them of the need to become accredited to furnish advanced diagnostic imaging services to Medicare beneficiaries on or after January 1, 2012.

CMS Issues Proposed CY 2011 Physician Fee Schedule Update

On July 13, 2010, CMS is publishing its proposed rule to update the Medicare physician fee schedule (MPFS) for 2011. The proposed rule addresses a wide variety of Medicare Part B policies, including many policy revisions mandated by the ACA. CMS will accept comments on the proposed rule until August 24, 2010. A summary of the rule is available after the jump:

Among many other things, the proposed rule would:

  • Provide a negative 6.1% update for 2011 under the statutory sustainable growth rate (SGR) formula. Coupled with the expiration of a temporary 2.2% boost in MPFS payments on November 30, 2010 (see summary of related legislation below) and the more than 21% cut that goes into effect December 1, 2010, along with a proposed 0.921 “rescaling factor”/ budget neutrality adjustment, the conversion factor will be reduced by approximately 29% in 2011 unless Congress takes further action.
  • Update several durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program policies, including provisions that: expand Round 2 by adding 21 of the largest metropolitan statistical areas (MSAs); implement a national mail order competitive bidding program for diabetic testing supplies and make other refinements related to the furnishing of diabetes supplies, create an appeals process for suppliers considered to be in breach of contract; and modify policies related to off-the-shelf orthotics, oxygen and oxygen equipment, and reimbursement to grandfathered suppliers. In addition, the rule addresses payment policy for power wheelchairs and oxygen and oxygen equipment outside of competitive bidding.
  • Implement ACA provisions that reduce Medicare payments for certain diagnostic imaging equipment, including assigning a 75% utilization rate assumption to certain expensive diagnostic imaging equipment used in diagnostic CT and MRI services and increases the multiple procedure payment reduction applied to the technical component of certain single session imaging services to contiguous body parts from 25% to 50% for more than one imaging procedure preformed in the same session (CMS also is proposing to apply the MPPR policy across imaging families and not limited to contiguous body areas).  CMS estimates that this provision, along with the equipment utilization change, will save Medicare $160 million in 2011.  In addition, CMS discusses how it will implement the ACA requirement that physicians who refer patients to certain imaging services under the in-office ancillary services exception to the physician self-referral prohibition inform patients of their option to receive these services from other area suppliers and to provide a list of alternative suppliers.
  • Establish a multiple procedure payment reduction (MPPR) policy applicable to certain outpatient therapy services reimbursed under Medicare Part B, under which CMS would apply a 50% payment reduction to the practice expense (PE) component of the second and subsequent therapy services for certain multiple therapy services furnished to a single patient in a single day..
  • Update certain payment policies for Part B drugs, including implementing the ACA provision providing for Medicare payment of biosimilar biological products using the ASP methodology.
  • Implement an ACA requirement that the Secretary periodically review and identify potentially misvalued codes and make appropriate adjustments to the relative values of misvalued services.  As part of this effort, CMS has asked the RUC to review services that fall into five categories: high volume/cost items on the RUC's "Multi-Specialty Points of Comparison list of procedures, codes with low work values that are reported with multiple units; codes with high volume and low work RVUs; 23 hour stay services, and procedures that were inpatient and have subsequently migrated to the outpatient setting.
  • Base future PE updates for certain high cost supplies (priced at $150 or more) on the U.S. General Services Administration medical supply schedule.
  • Establish the methodology for applying the ACA’s “multi-factor productivity” adjustment to the updates for the ASC, ambulance, clinical laboratory and DMEPOS fee schedules.
  • Update a variety of policies applicable to payment for renal dialysis services furnished by end stage renal disease facilities.
  • Implement ACA provisions that authorize Physician Quality Reporting Initiative incentive payments through calendar year 2014, with a penalty thereafter for eligible professionals who do not provide satisfactory reports, and make revisions to the Electronic Prescribing Incentive Program and the Physician Feedback Program.
  • Implement ACA provisions that eliminate beneficiary coinsurance for most preventive services and expand coverage of certain preventive services.

 

CMS Transmittal on Physician Supervision Requirements

CMS has issued a transmittal to further clarify CMS policies requiring physician supervision of diagnostic and therapeutic services provided to hospital outpatients. In this update, CMS is clarifying policies regarding supervision of diagnostic tests by non-physician practitioners, and CMS further defines the term immediately available and clarifies the credentials, knowledge, skills, ability, and privileges that the supervisory practitioner must possess in order to be qualified to perform a given service or procedure. Note that the transmittal includes more restrictive language than the final 2010 hospital outpatient PPS rule with regard to the qualifications of the supervising physician of a diagnostic test and the proximity standard for the physician providing direct supervision of a diagnostic test. The transmittal is effective July 1, 2010. CMS has also released a related educational article about the policy. 

CMS Calls on Medicare Provider/Supplier Vulnerabilities (June 7, 8, & 9)

CMS has announced a series of  “outreach listening sessions” to focus on vulnerabilities identified in previously-released OIG reports  pertaining to DME claims, chiropractic services, ultrasound billing, hospice care, nursing home stays, psychiatric facilities, and other providers.

  • The first call is scheduled for Monday, June 7, 2010 and will concentrate on pressure reducing support surfaces, wheelchairs, and negative pressure wound therapy pumps.
  • A June 8 call will address chiropractic services, Medicare Part B billing for ultrasound, and hospice care services.
  • A June 9 call will focus on DME provided in nursing homes, inpatient psychiatric facilities, and physician place of service coding.

On each call, CMS Contractor Medical Directors will identify common themes and billing errors “to educate on ways provider and supplier behaviors can be changed to ensure full compliance with Medicare policy, billing instructions and medical review guidance.”

Medicare/Medicaid Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements, and Changes in Provider Agreements

This post was written by Paul W. Pitts.

CMS published an interim final rule with comment period on May 5, 2010 implementing several enrollment and documentation changes to the Medicare and Medicaid programs as mandated by the PPACA. The rule is effective on July 6, 2010 and comments will be accepted through the effective date. In the final rule, CMS requires providers and suppliers to include their NPI on all Medicare enrollment applications, as well as all claims submitted to the Medicare and Medicaid programs. In addition, Part B services must be ordered or referred by a physician or, when permitted, another eligible professional. The final rule also requires physicians and other eligible professionals who order or refer Part B services for Medicare beneficiaries to be enrolled in the Medicare program or maintain a valid opt-out record. With respect to home health services, the services must be ordered by a physician (not an “eligible professional”). All claims submitted for Part B items or services must contain the legal name and NPI of the physician or eligible professional who ordered or referred the item or service. In addition, the rule requires both the furnishing and ordering provider or supplier of DMEPOS, home health, laboratory, imaging, or specialist services to maintain documentation of the order or referral for 7 years, including the NPI of the ordering or referring physician or eligible professional. The documentation of the order or referral must be supplied to CMS or the Medicare contractor upon request. Failure to comply with the documentation requirements may result in a 1 year revocation of enrollment and billing privileges in the Medicare program. Although much of the final rule was mandated by various sections of the PPACA, CMS is using its discretion to expand ordering and referring requirements to all Part B items and services except prescribed drugs. In the preamble to the final rule, CMS indicates that it “reserves the right” to apply these enrollment and ordering requirements to Part B drugs within the next year. 

Other PPACA Updates

CMS has released several manual updates and other transmittals regarding implementation of PPACA policies, including the following:

CMS Special Open Door Forum on Medicare Enrollment Issues (May 19, 2010)

CMS is hosting a Special Open Door Forum May 19, 2010 to discuss a variety of Medicare provider enrollment issues. Topics to be covered include: CMS’s May 5, 2010 interim final rule on Medicare/Medicaid provider and supplier enrollment, ordering and referring, and documentation requirements; and changes in provider agreements; internet-based Provider Enrollment, Chain and Ownership System (PECOS); pharmacy accreditation issues; advanced diagnostic imaging accreditation; provider and supplier reporting responsibilities; and revalidation efforts.

FDA Meeting on Medical Device Radiation Exposure (June 9-10, 2010)

On June 9-10, 2010, the FDA is holding a public meeting on "Device Improvements to Reduce the Number of Under-doses, Over-doses, and Misaligned Exposures from Therapeutic Radiation." The purpose of this meeting is to discuss steps that could be taken by manufacturers of linear accelerators, radiation therapy treatment planning systems, and radiation therapy simulators to help reduce misadministration and misaligned exposures. FDA is seeking input on this topic and requests comments on a number of related questions.

FDA Realignment of the Office of New Drugs within CDER

Effective March 15, 2010, FDA has realigned certain review divisions in the Center for Drug Evaluation and Research (CDER) to better group similar investigational, new drug, and biologics licensing applications. Included in the realignment are medical imaging applications, which have moved from the Division of Medical Imaging and Hematology Products to the new Division of Medical Imaging Products, while hematology applications are now in the Office of Oncology Drug Products in the new Division of Hematology Products. In addition, rheumatology applications have moved from the Division of Anesthesia, Analgesia, and Rheumatology Products to the new Division of Pulmonary, Allergy, and Rheumatology Products. Applications for products to treat the pain of rheumatological diseases, rather than to treat the underlying disease process, will remain in the Division of Anesthesia and Analgesia Products. The FDA has posted a listing of all current applications that have been reassigned.

Congressional Health Policy Hearings

A number of recent hearings in the House of Representatives have focused on health policy issues, including: 

In addition, today the House Energy and Commerce Health Subcommittee is holding a hearing on medical radiation, and on March 3, the Senate Homeland Security and Governmental Affairs Committee, Federal Financial Management Subcommittee will review oversight challenges in the Medicare Part D prescription drug program.   Two health care fraud hearings have been scheduled for Thursday, March 4. The House Judiciary Subcommittee on Crime, Terrorism and Homeland Security has scheduled a hearing entitled “The Enforcement of the Criminal Laws Against Medicare and Medicaid Fraud,"  and the House Appropriations Labor-HHS Committee is holding a hearing on "Combating Health Care Fraud and Abuse."

FDA Meeting/Comment Opportunity on Reducing Radiation Exposure

This post was written by Paul Sheives.

On March 30-31, FDA is holding a public meeting on “Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging.“ The purpose of the meeting is to seek stakeholder input on how manufacturers of devices used in computed tomography (CT) and in fluoroscopy could alter medical devices or clinical practice to lessen exposure to unnecessary ionizing radiation during these procedures. FDA also is accepting public comment on this issue until April 15, 2010.

FDA Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

This post was written by Paul Sheives.

FDA recently announced an initiative seeking to minimize patient exposure to ionizing radiation associated with computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams. To further this goal, the agency is advocating the universal adoption of two principles of radiation protection: (1) appropriate justification for ordering each procedure, and (2) careful optimization of the radiation dose used during each procedure. FDA states that “each patient should get the right imaging exam, at the right time, with the right radiation dose.” The FDA released a white paper on the initiative along with a question and answer document

CMS Announces Accreditation Organizations for Imaging Suppliers

On January 26, 2010, CMS published a notice announcing its approval of the following three national accreditation organizations to accredit suppliers seeking to furnish the technical component of advanced diagnostic imaging services under Medicare:   the American College of Radiology, the Intersocietal Accreditation Commission, and The Joint Commission.

Final CY 2010 Medicare Physician Fee Schedule Rule Released

The Centers for Medicare & Medicaid Services (CMS) has released its final rule updating the Medicare physician fee schedule (MPFS) for calendar year (CY) 2010. Most notably, the final rule calls for a 21.2% across-the-board cut in MPFS paymentsfor 2010 due to the statutory sustainable growth rate (SGR) formula (CMS had forecast a 21.5% cut in the proposed rule). For 2010, the SGR formula results in a conversion factor of $28.4061, compared to the 2009 conversion factor of $36.0666. [NOTE:  CMS subsequently published a notice correcting the conversion factor; the new conversion factor is $28.3895].   As noted above, Congressional leaders are seeking a legislative solution to block the pending cut, but the outcome of these reform efforts are not certain at this time. CMS did exercise its administrative authority to remove drugs from the definition of “physicians’ services” for purposes of the SGR formula, which CMS expects will reduce the number of future years in which physicians are projected to experience a negative update under the SGR formula, but which does not impact 2010 rates. The sweeping rule affects a wide range of other Medicare policies, as discussed after the jump.

  • CMS is cutting technical component payments for certain non-hospital imaging procedures by changing the imaging equipment usage assumption for equipment priced over $1 million from the current 50% usage rate to a 90% usage rate, which will reduce per procedure practice expense (PE) relative value units (RVUs) -- and thus the per procedure technical component reimbursement -- for services using such imaging equipment).   In the final rule, CMS decided only to apply this change to MRIs and CTs. The payment cut will be transitioned with full implementation not for four years. Beginning 2010, 75% of the practice expense is paid based on the old usage rate with full implementation in 2013. CMS also has adopted provisions to begin implementing the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) provision mandating an accreditation process for entities furnishing the technical component of certain advanced diagnostic testing procedures by January 1, 2012. CMS also is publishing a separate notice inviting independent accreditation organizations to participate in the accreditation program. 
  • The final rule revises the Electronic Prescribing Incentive Program and the Physician Quality Reporting Initiative (PQRI) to, among other things, simplify e-prescribing reporting requirements, provide additional reporting options (including an electronic health record-based reporting mechanism), allow group practices to be considered successful e-prescribers; and expand PQRI quality measures. 
  • CMS is adopting its proposal to refine malpractice RVUs to redirect payment to physicians with the highest malpractice costs.
  • CMS is ending payment for consultation codes and instead requiring use of evaluation and management (E/M) codes. Note that under the final rule, CMS is making an exception to this policy for telehealth consultations and maintaining payment for G-codes used to bill for these consultations. Savings from the discontinuation of consultation codes are being redistributed to increase payments for the existing E/M services and to the payment for the surgical global period.
  • The final rule clarifies the "stand in the shoes" standard for considering compensation arrangements under Stark.
  • CMS is establishing a process for submitting claims for damages caused by the MIPPA provision terminating contracts awarded in 2008 under the durable medical equipment, prosthetic, orthotic and supplies (DMEPOS) competitive bidding program, and making changes in the “grandfathering” rules for noncontract suppliers. CMS is also finalizing policy changes regarding maintenance and servicing of oxygen equipment. 
  • The rule provides that the annual per beneficiary outpatient therapy caps for CY 2010 will be $1860 each for (1) outpatient physical therapy and speech-language pathology services combined, and (2) outpatient occupational therapy services. CMS also notes that its authority to provide for exceptions to therapy caps will expire on December 31, 2009, unless the Congress acts to extend it.
  • The final rule implements a variety of other Part B policies, including provisions that: establish Medicare coverage of cardiac and pulmonary rehabilitation services and chronic kidney disease education; update end-stage renal disease (ESRD) facility rates; require authorized compendia used to determining medically-accepted indications of drugs and biologicals used off-label in anti-cancer chemotherapeutic regimens to have a transparent process to evaluate therapies and identify potential conflicts of interests; revise certain requirements under the Part B drug competitive acquisition program. 

The official version of the rule is scheduled to be published in the Federal Register on November 25, 2009. CMS will accept comments on certain provisions of the final rule until December 29, 2009. Specifically, CMS is accepting comments on the following issues: interim RVUs for selected codes, the physician self-referral designated health services, services for consideration for the Five-Year Review of work RVUs, and whether additional guidance is needed regarding CMS’s policy regarding services provided under arrangement.  

CMS Transmittal on OIG Reports with Medical Review Implications

On October 9, 2009, CMS issued a transmittal to contractors highlighting several HHS Office of Inspector General (OIG) reports with recommendations on addressing Medicare’s vulnerability to questionable claims. In particular, CMS cites OIG reports on Medicare Part B chemotherapy administration payments, nonphysicians who performed Medicare physician services, inappropriate Medicare payments for chiropractic services, and Medicare Part B billing for ultrasound. CMS directs contractors to review claims data for services mentioned in the OIG reports and take appropriate action (e.g., prepayment edits and reviews, postpayment reviews, and physician/supplier education), if the data warrants action. 

Utilization of Physician Services

The GAO has issued a report entitled "Medicare Physician Services: Utilization Trends Indicate Sustained Beneficiary Access with High and Growing Levels of Service in Some Areas of the Nation." According to the GAO, Medicare beneficiaries experienced few problems accessing physician services in 2007 and 2008. The proportion of beneficiaries who received physician services and the number of services per beneficiary increased from April 2000 to April 2008. The GAO identified potentially over-served geographic areas of the country, in which certain physician services, such as advanced imaging and minor procedures, are performed more frequently despite similar beneficiary demographic characteristics.

Medicare Imaging Demonstration Project.

On October 1, 2009, CMS is holding a Special Open Door Forum to share its proposed key design elements of the Medicare Imaging Demonstration Project. Among other things, the call will provide an overview of the demonstration, define advanced imaging procedures, and review the decision support systems and guidelines.  Call-in information is available here.   

Medicare Physician Payments for Services Provided Together

The Government Accountability Office (GAO) has issued a report entitled “Medicare Physician Payments:  Fees Could Better Reflect Efficiencies Achieved When Services Are Provided Together.” The report reviews steps CMS has taken to ensure that physician fees recognize efficiencies that occur when certain services are commonly furnished together, such as the CMS multiple procedure payment reduction (MPPR) policy for certain imaging and surgical services furnished together.  According to the GAO, expanding the MPPR to reflect efficiencies when nonsurgical, nonimaging services are provided together could save approximately one-half billion dollars annually.  Moreover, expanding the MPPR policy to reflect efficiencies in the physician work component of certain imaging services could cut payments by an estimated additional $175 million annually, the GAO notes.

Medicare Part B Billing for Ultrasound Services

The OIG reports that 20 high-use counties with 6% of Medicare beneficiaries accounted for 16% of Part B spending on ultrasound services in 2007. In addition, the OIG believes that 3.2 million ultrasound claims (almost one in five nationwide) might be inappropriate. The OIG recommended that CMS monitor ultrasound claims data to detect and review questionable claims prior to payment, and take certain action when providers bill for high numbers of questionable claims; CMS concurred.

CMS Proposes CY 2010 Medicare Physician Fee Schedule Rule

On July 1, 2009, the Centers for Medicare & Medicaid Services (CMS) released the advance text of its proposed rule with comment period updating the Medicare physician fee schedule (MPFS) for calendar year (CY) 2010. Most notably, the proposed rule calls for a 21.5% across-the-board reduction in physician fee schedule payments under the statutory sustainable growth rate (SGR) formula. Over the past several years, Congress has repeatedly stepped in to block cuts triggered by the SGR formula, and such efforts are underway as part of broader health reform legislation, although the level of relief, if any, that may be provided is uncertain at this time. In the proposed rule, CMS has exercised its regulatory authority to remove drugs from the definition of “physicians’ services” for purposes of the SGR formula. CMS notes that spending on physician-administered drugs has risen faster than all other MPFS services, contributing significantly to the large projected reductions in future MPFS updates under the SGR formula. While this would not mitigate the projected negative 21.5% update for 2010, it would reduce the number of years in which negative updates are expected. In other policy areas the rule would, among many other things:

  • Change the equipment usage assumption for imaging equipment priced over $1 million from the current 50% usage rate to a 90% (which would significantly reduce per procedure practice expense relative value units (RVUs) -- and thus the per procedure technical component reimbursement -- for services using such imaging equipment) and begin to implement the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) provision mandating an accreditation process for entities furnishing certain non-hospital advanced diagnostic testing procedures by January 1, 2012;
  • Expand the measures and measure groups that eligible physicians can report under the Physician Quality Reporting Initiative (PQRI), allow physicians to report data on PQRI measures through a qualified electronic health record product, and establish a new process for group practices to be considered successful electronic prescribers.
  • Refine malpractice RVUs to redirect payment to physicians with the highest malpractice costs;
  • End payments for consultation codes and instead require use of evaluation and management codes;
  • Amend the "stand in the shoes" standard for considering compensation arrangements under Stark;
  • Establish a process for submitting claims for damages caused by the MIPPA provision terminating contracts awarded in 2008 under the durable medical equipment, prosthetic, orthotic and supplies (DMEPOS) competitive bidding program, and make changes in the “grandfathering” rules for noncontract suppliers;
  • Implement MIPPA provisions that provide Medicare coverage of cardiac and pulmonary rehabilitation services and chronic kidney disease (CKD) education;
  • Revise Medicare end stage renal disease facility (ESRD) rates, including updating the drug add-on adjustment (using a refined methodology for projecting growth in drug expenditures), the wage index adjustment, and the ESRD wage index floor;.
  • Make changes to the Part B drug competitive acquisition program designed to better define certain aspects of the program and minimize the administrative burden for participating physicians and vendors; and
  • Require authorized compendia used in determining medically-accepted indications of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen to have a transparent process for evaluating therapies and for identifying potential conflicts of interests.

The official version of the rule will be published in the Federal Register on July 13, 2009, and comments will be accepted until August 31, 2009. 

MedPAC Report on Medicare Payment Policy

MedPAC has issued its June 2009 "Report to the Congress: Improving Incentives in the Medicare Program."   Among other things, the report addresses follow-on biologicals, chronic care management, physician self-referrals involving imaging services, physician resource use measurement, graduate medical education, accountable care organizations, Medicare benefit design, and Medicare Advantage payment policy.

White House proposes $313 billion in additional Medicare/Medicaid cuts

The White House has proposed $313 billion in new Medicare and Medicaid cuts over 10 years, in addition to the provisions included in the Administration's proposed FY 2010 budget. Among other things, the Administration is endorsing: incorporating productivity adjustments into Medicare payment updates; reducing hospital subsidies for treating the uninsured as coverage increases; paying "better" prices for Medicare Part D drugs (including reducing reimbursement for beneficiaries dually eligible for Medicare and Medicaid); increasing the equipment utilization factor for advanced imaging from 50 percent to 95 percent; adopting MedPAC’s recommendations for 2010 payments to skilled nursing facilities, inpatient rehabilitation facilities, and long-term care hospitals; and cutting waste, fraud, and abuse (including prepayment review for physicians in high-risk areas or those that order a high volume of high-risk services such as durable medical equipment, home health, and home infusion services).

The following chart summarizes the Obama Administration's health reform financing proposals released to date:

 
 
Source
Health Care Reserve Fund
($ in billions)
10 years
FY 2010 Budget
-  Medicare and Medicaid Savings
-  Revenues
$635
$309
$326
Additional Medicare and Medicaid Savings
-  Incorporate productivity adjustments into Medicare payment 
    updates
-  Reduce hospital subsidies for treating the uninsured as  
    coverage increases
-  Pay better prices for Medicare Part D drugs

-  Other

$313
$110

 
$106

 
$75
$22
Total
$948

Senate Finance Releases Health Reform Financing Options -- Comments Due May 26, 2009

Today Senate Finance Committee Chairman Max Baucus and Ranking Member Chuck Grassley released a policy paper setting forth options for financing health reform. This is the third and final set of policy options for discussion before the Finance Committee marks up legislation in June. The Finance Committee has scheduled a member "walk through" to discuss the financing policy options on May 20, 2009. The financing options include, among other things: adjusting annual market basket updates and imposing “productivity adjustments” for various Medicare fee-for-service providers; a variety of payment changes impacting hospitals and home health agencies; Part B payment reforms (targeting potentially-overvalued Part B services and utilization of advanced diagnostic imaging services); improvements to promote payment accuracy for durable medical equipment; a variety of reforms pertaining to Medicaid drug rebates; policy options to reduce inappropriate spending variations across and within geographic areas; revisions to beneficiary cost-sharing obligations, including Part D means testing; and a variety of tax code changes involving the exclusion for employer-provided health coverage, changes to the itemized deduction for medical expenses, and excise tax provisions affecting alcohol and sugar-sweetened beverages.  The Finance Committee will accept comments on the health reform financing options through May 26, 2009.

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?

HOPPS Imaging Efficiency Measures

CMS it is holding a Special Open Door Forum conference call on May 20 to discuss the development and implementation of facility-level hospital outpatient imaging efficiency measures.

Finance Committee Releases Health Care Delivery System Reform Options; Comment Opportunity (Due May 15)

Senate Finance Committee Chairman Max Baucus and Ranking Member Chuck Grassley released a lengthy policy paper on April 28, 2009 discussing options for reducing health care costs and improving quality in the health care delivery system, including significant Medicare payment reform proposals. Key areas addressed in the paper include the following:  

  • Promoting Quality Care – Policy options to promote quality in the Medicare program include: establishing value‐based purchasing programs for hospitals, home health, and SNFs by FY 2012; expanding programs leading to value‐based purchasing for doctors, IRFs, and LTCHs; tying Medicare Advantage payments to quality of care; and restricting utilization of diagnostic imaging services.
  • Fostering Care Coordination and Provider Collaboration – Policy options to enhance care management efforts include: establishing Medicare payment incentives for hospitals that reduce preventable hospital readmissions; providing a single bundled Medicare payment for acute and post‐acute episodes of care; establishing Medicare pilot programs of patient‐centered care coordination models for the chronically ill ; making reforms to Medicare physician reimbursement rates.
  • Infrastructure Investments – Potential health delivery infrastructure investments include:  additional efforts to support widespread adoption and meaningful use of health information technology (beyond ARRA provisions); the development of quality measures; the establishment of a independent institute to conduct comparative effectiveness research; and improvements to health care workforce training.
  • Transparency– Policy options to promote transparency include: requiring drug and device manufacturers to report publicly certain payments to physicians; establishing new restrictions on specialty hospitals; and expanding information for consumers on nursing home quality. 
  • Other Health Care Delivery Options – Among other things, the plan calls for various steps to promote primary care (including providing primary care practitioners and targeted general surgeons with a 5% Medicare payment bonus) and expanded efforts to fight Medicare fraud and abuse.

The the deadline for public comments is May 15, 2009. The document is the first of three sets of potential option papers, each covering a different topic area that members will discuss before a bipartisan “Chairman’s Mark” on comprehensive health care reform is developed. Policy option papers on increasing health care coverage and financing health care reform will be released following future roundtable discussions on those topics. Note that the Finance Committee held its roundtable discussion on access to health care coverage on May 5, 2009, so an options paper on that topic should be available in the near future. In addition, on May 12, the Senate Finance Committee is holding its third roundtable discussion, this one focusing on financing comprehensive health care reform.

Upcoming MedPAC Meeting (April 8-9, 2009)

The Medicare Payment Advisory Commission (MedPAC) is meeting April 8-9, 2009 to discuss a variety of Medicare payment and policy issues, including the impact of physician self-referral on use of imaging services, potential Medicare savings associated with follow-on biologics, and Medicare Advantage payments, among others.

Obama Budget Proposal

On February 26, 2009, the Obama Administration released its proposed federal budget for fiscal year (FY) 2010. Most significantly in terms of health policy, the proposal would establish a reserve fund of $633.8 billion over 10 years to finance health reform. While half of the reserve funds would come from tax increases on higher-income individuals, the rest would come from health system savings impacting a wide range of providers, health plans, and manufacturers. While additional details are expected to be released in the coming weeks, the following are highlights of the information released to date: 

  • Medicare Advantage (MA) Payments. The budget would replace the current mechanism for establishing MA rates with a competitive system in which Medicare payments would be based upon an average of plans’ bids. The Administration estimates a savings of more than $175 billion over 10 years from this provision – approximately half of the health care savings in the budget proposal.
  • Reducing Drug PricesThe Administration proposes establishing a regulatory pathway for approval of follow-on biologicals. Additionally, brand biologic manufacturers would be prohibited from reformulating existing products into new products to restart the exclusivity process. The Administration also would prevent drug companies from blocking generic drugs from consumers by prohibiting anticompetitive agreements between brand name and generic drug manufacturers intended to keep generic drugs off the market. The budget also would increase the Medicaid drug rebate for brand-name drugs from 15.1% to 22.1% of the average manufacturer price (AMP), apply the additional rebate to new drug formulations, and allow states to collect rebates on drugs provided through Medicaid managed care organizations. The budget also supports the Food and Drug Administration’s (FDA) efforts to allow Americans to buy drugs from other countries.
  • Medicare and Medicaid Payment Accuracy/Program Integrity. The budget would expand CMS’s capacity to identify excessive payments and correct problems, such as through use of National Correct Coding Initiative edits for Medicaid claims. The budget also proposes to dedicate additional resources for oversight and program integrity activities related to the Medicare prescription drug program, MA, and Medicaid.
  • Hospital/Post-Acute Care Bundling, Reduced Hospital Readmission Rates. The budget calls for bundling payments to hospitals and certain post-acute providers for services provided within 30 days after discharge from the hospital. In addition, hospitals with high rates of readmission would be paid less if patients are re-admitted to the hospital within the same 30-day period.
  • Hospital Quality Improvement. The budget would link a portion of Medicare payments for acute inpatient hospital services to hospital performance on specific quality measures.
  • Physician Payment System Reforms. The Administration supports “comprehensive, but fiscally responsible” reforms to the physician fee schedule formula.
  • Cancer Research.  The budget includes over $6 billion in funding for the National Institutes of Health (NIH) to support cancer research.

Other Medicare/Medicaid health policy line-items identified in the budget charts include the following, among others: 

  • Establishing survey and certification revisit and recertification user fees;
  • Enabling physicians to form voluntary groups that coordinate care for Medicare beneficiaries and to receive performance-based payments for coordinated care;
  • Addressing financial conflicts of interest in physician-owned specialty hospitals;
  • Requiring the use of radiology benefit managers for Medicare imaging services;
  • Aligning Medicare home health payments with costs; and
  • Imposing higher Medicare drug benefit premiums on certain higher-income beneficiaries.

Note that many provisions of the proposed budget would require Congressional approval to implement. To that end, a number of Congressional committees have scheduled hearings on the budget proposal, including a March 10 Senate Finance Committee hearing focusing on the budget’s health care provisions.

2009 HCPCS Meeting Dates Announced

On February 27, 2009, CMS published a notice announcing the dates for the 2009 Healthcare Common Procedure Coding System (HCPCS) public meetings to discuss CMS’s preliminary coding and payment determinations for public requests for revisions to the HCPCS, including dates to consider new drug code requests.  The meeting dates are as follows: 

April 28, 2009: Drugs/Biologicals/Radiopharmaceuticals/Radiologic Imaging Agents (CMS notes that the April 29 date is tentative and may not be needed)

May 12 - 13, 2009: Supplies and Other Items

May 27, 2009: Orthotics and Prosthetics

May 28, 2009: Durable Medical Equipment (DME) and Accessories

July 9, 2009: DME and Accessories, including Negative Pressure Wound Therapy (NPWT) devices.

The notice outlines deadlines for primary speakers and other attendees. Draft agendas, including a summary of each request and CMS’s preliminary decision, will be posted on the CMS website at least 4 weeks before each meeting.

Preliminary Outpatient Imaging Efficiency Measures

CMS (through The Lewin Group and its subcontractors) is developing a preliminary set of outpatient imaging efficiency measures. CMS is soliciting comments on these measures until December 14, 2008.   

Medicare Physician Fee Schedule Final CY 2009 Rule

On October 30, 2008, the Centers for Medicare & Medicaid Services (CMS) released the text of its final rule updating the Medicare physician fee schedule (MPFS) for calendar year (CY) 2009.  As required under the “Medicare Improvements for Patients and Providers Act of 2008” (MIPPA), the rule increases physician payments by 1.1% in 2009, rather than the 5.4% cut CMS anticipated would result from the Sustainable Growth Rate (SGR) formula when it issued the July 7, 2008 proposed rule. Note that MIPPA did not amend the underlying SGR formula or modify payments for years after 2009; the Congressional Budget Office estimates that physician payment rates will be cut by 21% in 2010 unless Congress takes further action. In addition to making changes to physician payment rates, the sweeping rule includes many other policy changes, include the following.

  • CMS has adopted changes to the antimarkup rule for diagnostic tests billed by an ordering physician. In the proposed rule, CMS had offered two alternative approaches to reforming the anti-markup rules. Under the first approach, the anti-markup provision would apply if the professional component (PC) or technical component (TC) of a diagnostic test is ordered by a billing physician and is either: (i) purchased from an outside supplier, or (ii) performed or supervised by a physician who does not share a practice with the billing physician or physician organization. A supervising or interpreting physician could "share" a practice as an employee or contractor of the single physician or physician group billing the test; otherwise the anti-markup restriction would apply. Under the second alternative approach, CMS would maintain the current regulatory text that applies the anti-markup provisions to the technical and professional components of diagnostic tests performed outside the “office of the billing physician or other supplier,” but CMS would more broadly define the “office of the billing physician or other supplier” to include space in which diagnostic testing is performed provided that it is located in the same building in which the billing physician or other supplier regularly furnishes patient care. In the final rule, CMS provides that a billing physician or other supplier can avoid application of the anti-markup provisions by meeting either alternative 1 or, on a case-by-case basis, the “site-of-service” approach of alternative 2, both of which were subject to certain modification in the final rule. Specifically, under alternative 1, a performing physician "shares a practice" with the billing physician group if he or she provides at least 75% of his or her professional services through the billing physician group-- even if the physician works for one or more billing physician groups or other health care entities. There are no restrictions on the location where the services can be performed under alternative 1. If the performing physician does not meet the 75% test, the billing physician may avoid the anti-markup rule if the performing physician is an owner, employee or independent contractor and the services are performed in the billing physician’s office. The “office” means any medical office space (regardless of the number of locations) in which the ordering physician regularly furnishes patient care and includes space where the billing physician furnishes diagnostic testing if the space is located in the same building where the ordering physician regularly furnishes patient care. 
  • CMS did not adopt its proposal to require any physician or nonphysician practitioners organization furnishing diagnostic testing services (except diagnostic mammography services) to enroll as an independent diagnostic testing facility (IDTF) and meet most IDTF performance standards. Instead, CMS cites a MIPPA provision requiring accreditation of entities furnishing certain advanced diagnostic testing procedures by January 1, 2012. CMS states that it may reconsider finalizing the IDTF standard in a future rulemaking. CMS did, however, adopt its proposal to require entities providing mobile diagnostic testing services to enroll in Medicare, comply with IDTF performance standards and bill Medicare directly for their services (although CMS is not requiring mobile testing entities to bill directly for the services they furnish when such services are furnished “under arrangement” with hospitals). 
  • CMS did not finalize in the rule its proposed exception to the physician self-referral rule that would have protected remuneration provided by a hospital to physicians on its medical staff under incentive payment or shared savings programs under certain conditions. Instead, in order to finalize the exception(s) CMS is reopening the comment period and soliciting detailed information on 55 specific questions related to such issues as the definition of key terms, safeguards against patient or program abuses, and various aspects of program design. 
  • The final rule expands the quality measures that eligible professionals may report to qualify for incentive payments under the Physician Quality Reporting Initiative in 2009thatequal to 2% of their total Medicare allowed charges.  It also provides new PQRI reporting periods and provides for certain PQRI data to be submitted via clinical registries. In addition, as authorized by MIPPA, physicians and other eligible professionals who use a qualified electronic prescribing (e-prescribing) system to transmit prescriptions to pharmacies and submit required information on the claim may earn an incentive payment of 2% of their total Medicare allowed charges during 2009 (in addition to any PQRI incentive payment). 
  • In the final rule, CMS is refining relative value units (RVUs), continuing the transition to a new “bottom up” methodology for practice expense RVUs, and applying the budget neutrality adjustment factor to the overall conversion factor (rather than applying the adjustment only to the physician work RVUs).
  • CMS is codifying changes to the Part B drug average sales price payment methodology resulting from the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) that went into effect April 1, 2008, including the use of a volume-weighted methodology and revised payment rules for certain inhalation drugs. CMS had proposed several changes to the competitive acquisition program (CAP), which offers physicians the option to acquire certain injectable and infused Part B drugs from an approved CAP vendor rather than buying and billing the drugs directly. On September 10, 2008, CMS announced it was postponing the 2009 CAP indefinitely. In light of this postponement, CMS is not adopting changes in the CAP at this time, but the agency continues to solicit public feedback on a range of CAP issues.
  • The final rule updates the End Stage Renal Disease (ESRD) facility wage index, implements a MIPPA provision providing a 1% increase to the ESRD composite rate and establishing a site-neutral base composite rate for hospital-based and independent dialysis facilities, and provides no update to the drug add-on payment.
  • CMS has adopted a series of enrollment and documentation-related changes. Currently, newly enrolled physicians and non-physician practitioners may retroactively bill Medicare for up to 27 months prior to the effective date of their enrollment. The new enrollment rules will significantly limit retroactive billing by physicians and non-physician practitioners to no more than 30 days prior to the effective date of enrollment. In addition, the rule requires physicians and nonphysician practitioners to report to their carrier any changes of ownership, adverse legal actions, or change in practice location within 30 days (versus the current 90 days) or face revocation of Medicare billing privileges and the recoupment of Medicare payments from the date of the reportable change. Physicians and non-physician practitioners are barred from billing for services furnished after certain adverse actions. The final rule also requires providers and suppliers to maintain ordering and referring documentation (including the referring physician’s National Provider Identifier) for 7 years (rather than the proposed 10 years) years from the date of service, and it requires physicians and nonphysician practitioners to maintain written ordering and referring documentation for 7 years (rather than 10 years) from the date of service. CMS also clarifies the effective date of Medicare billing privileges.
  • The final rule implements a MIPPA provision related to Medicare coverage of oxygen equipment. Specifically, MIPPA repeals a requirement that a supplier of oxygen equipment transfer title of the equipment to the beneficiary at the end of a 36-month rental period. Medicare payment for oxygen equipment will continue to be capped at 36 months (although payment will continue to be made for the oxygen contents). MIPPA requires the supplier that furnishes oxygen equipment during the 36-month rental period continue to furnish the equipment after the rental period ends for any period of medical need for the remainder of the “reasonable useful lifetime” of the equipment, even if the beneficiary moves out of the supplier’s normal service area. In addition, if a break in medical need occurs following the 36-month rental period, the supplier must resume furnishing the oxygen equipment when the beneficiary once again has a medical need for the oxygen equipment.  While MIPPA authorizes CMS to make maintenance and servicing payments for non-routine maintenance and servicing of supplier-owned oxygen equipment, CMS has determined that it is not reasonable and necessary to make such payments. However, for CY 2009 only, CMS will make payments when the supplier performs a routine maintenance and servicing visit (but not replacement parts) for oxygen concentrators and transfilling equipment following each period of continuous use of 6 months after the 36-month rental period ends. CMS welcomes comments on this issue, especially regarding whether these payments should continue past CY 2009.
  • The final rule includes numerous other policy and payment changes, including provisions to address: potentially misvalued services; an expansion of the procedures subject to the multiple imaging procedure payment reduction; updates to the telehealth policy; potential refinements to geographic practice cost indices; revisions to the conditions of participation and other requirements affecting comprehensive outpatient rehabilitation facilities; changes to rehabilitation agency requirements, including provisions related to extension locations and emergency care; a prohibition on payment to suppliers of a continuous positive air pressure device when the supplier or its affiliate is directly or indirectly the provider of the sleep test that is used to diagnose a Medicare beneficiary with obstructive sleep apnea (although in the final rule CMS provides an exception for attended facility-based polysomnography); a new payment methodology for therapeutic shoes; and codification of other MIPPA self-implementing provisions, including an extension of the therapy cap exceptions process and changes to payments for clinical laboratory and ambulance services, among others. 

CMS has released the advanced text of the rule, and the official version is scheduled to be published in the Federal Register on November 19, 2008.  CMS is accepting comments on a limited number of provisions until December 29, 2008, including the exception for incentive payment and shared savings programs; certain MIPPA provisions, interim RVUs and pricing information for selected codes; and physician self-referral designated health services codes.

MedPAC Meeting

On November 6 and 7, 2008, the Medicare Payment Advisory Commission (MedPAC) is meeting to discuss a number of health care policy issues, including reporting of physicians’ financial relationships, medical imaging services, the Medicare Part D and Medicare Advantage programs, hospice payments, and physician resource use. 

Trends in Medicare Imaging Services

A new Government Accountability Office (GAO) report reviews the impact of a Deficit Reduction Act of 2005 (DRA) provision capping Medicare fees for certain imaging services covered by the physician fee schedule at the rate for these services under Medicare’s hospital outpatient prospective payment system (OPPS). The GAO found that the OPPS cap reduced the fee for the performance of about one in four physician imaging tests overall in 2007, and fees for advanced tests were more likely than other imaging tests to be paid at the OPPS rate. Moreover, the GAO found that from 2000 through 2006 both expenditures for and utilization of Medicare physician imaging services increased, but in 2007 expenditures declined while per-beneficiary utilization continued to rise.  

Medicare Payment for Imaging Services

The Government Accountability Office (GAO) has issued a report entitled "Medicare Part B Imaging Services: Rapid Spending Growth and Shift to Physician Offices Indicate Need for CMS to Consider Additional Management Practices." The GAO found that from 2000 through 2006, Medicare spending for imaging services paid for under the physician fee schedule more than doubled, with spending rising particularly fast for advanced imaging services. The GAO recommends that CMS consider adding prior authorization requirements and other payment safeguards for imaging services.