Health Law Advisory Bulletin

The 2003 Medicare Prescription Drug, “Improvement” and Modernization Act Provides Increased Revenue Opportunities

By Lisa Rediger Hayward and Susan L. Fine
[December 2003]

Signed into law on Dec. 8, 2003, the Medicare Prescription Drug, Improvement and Modernization Act, P.L. 108-173 (the “Act”), with close to 200 major sections, has been called the largest overhaul to the Medicare Program since its inception. The Act not only creates a historic prescription drug benefit, but makes significant payment changes to Medicare Part A and Part B, and Medicaid. Congress has hailed the Act as correcting existing payment “inequities.” Although rural providers and teaching hospitals are among the big winners, and durable medical equipment (DME) and drug suppliers potentially among those expected to suffer the most losses, the payment provisions contain increased revenue opportunities for hospitals, physicians, and other providers. For hospitals, increased revenue opportunities exist in the following:

  • inpatient PPS update;
  • short-term bump in IME reimbursement through 2006;
  • GME FTE opportunities for geriatric and family practice programs;
  • one-time moratorium on the financial arrangement requirement for supervision of residents at non-hospital settings;
  • ability to apply for an increased GME FTE limit;
  • expanded coverage of device trials;
  • reduction in thresholds to qualify for the new technology add-on payment; and
  • expanded opportunities for wage index reclassifications.

Hospitals may experience reductions in reimbursement for certain covered outpatient drugs, while other drugs may more easily qualify for separate outpatient ambulatory payment classification (APC) payment. For rural providers, the Act provides for numerous protections and opportunities for revenue enhancements, including extensions to hospital outpatient prospective payment system (OPPS) hold harmless, wage index reclassifications, increased disproportionate share (DSH) payments, and increased reimbursement for Critical Access Hospitals. Skilled nursing facilities (SNF) will see significant increases in payments for services to patients with AIDS.

For physicians, increased revenue opportunities include:

  • update to the physician fee schedule;
  • coverage of initial physical examinations;
  • coverage of certain screening tests for cardiovascular disease and diabetes; and
  • physician scarcity 5 percent bonus payments for 2005-2007.

Increased reimbursement is also available for screening mammography services, and beginning in 2005 for diagnostic mammography services, furnished in a hospital outpatient department. Outpatient physical and occupational therapy providers benefit from the two-year moratorium on the therapy cap.

DME suppliers will see their reimbursement rates frozen through 2008 for most items and services. In addition, reimbursement will decrease for selected items such as oxygen, oxygen equipment, wheelchairs, nebulizers, diabetic supplies, hospital beds, and air mattresses. Ambulatory Surgical Center (ASC) facilities will also see a reduction in payments beginning in April 2004, with rates then frozen while the General Accounting Office (GAO) conducts a study to determine how to re-vamp the ASC reimbursement system.

To determine whether the changes help or hurt the bottom line, providers are scrambling to make sense of the rules. While some Congressional mandates are quite clear, others remain subject to the Centers for Medicare and Medicaid Services (CMS) guidance and implementation. Ambitiously, and quite unrealistically, Congress has set implementation dates for many provisions in 2004, some as early as January. Congress has already imposed a deadline of Feb. 15, 2004 for providers to apply for one of the wage index opportunities. We expect to see a flood of CMS program issuances in the first quarter of 2004.

To help our clients evaluate how they fare under the new rules and how to take advantage of the available revenue enhancement opportunities, we have summarized the key payment provisions below, organized by issue and divided into sections for Medicare Part A and Part B. We have indicated the changes likely to result in significantly increased reimbursement, as well as those likely to have significant negative reimbursement impacts.


SUMMARY OF KEY PAYMENT CHANGES RESULTING FROM THE 2003 MEDICARE BILL

ISSUE LEGISLATIVE CHANGE
PART A
Inpatient PPS Payment The hospital inpatient prospective payment (IPPS) to acute care hospitals is a payment per discharge based on a specific diagnosis and assignment to a Diagnostic Related Group (DRG). The Act extends the full market basket update to the PPS payment for all hospitals, but for 2005-2007, there is a 0.4 percent reduction for hospitals that do not provide quality reporting data pursuant to CMS’s Hospital Quality Initiative in a given year. The required data is based on a set of 10 quality indicators established by the Secretary as of Nov. 1, 2003. The reduction in one year does not carry over to the next year. (§501)

For non-urban hospitals, the Act permanently maintains the increase in the “standardized amount” previously applied only to large urban hospitals. (§401) The PPS payment is determined by the following formula: DRG weight X Standardized Amount. The “standardized amount” is a dollar amount that represents the average allowable operating cost per discharge, and consists of two components: labor and non-labor. Section 401 of the Act serves to reduce the disparity in payments between rural and urban hospitals. (Above change is expected to have a significant positive reimbursement impact.)

IPP Wage Index Adjustments The Act reduces the labor share portion of the standardized amount from 71 percent to 62 percent for hospitals with a wage index of less than 1.0 for discharges on or after Oct. 1, 2004. (§403) The labor share of the standardized amount is adjusted by the “wage index,” which accounts for variations in area hospital labor costs. The reduction in the labor share will reduce the impact of the wage index, thus increase the PPS payment for hospitals in low wage areas.

The Act creates further opportunities for low wage area hospitals to increase their PPS payments by expanding availability of wage index geographic classifications to hospitals if a certain number of hospital employees migrate out of the county to work in a neighboring county with a higher wage index, referred to as the “commuting” adjustment. The Secretary has discretion to determine criteria for the out-migrating county and the minimum out-migration threshold (which cannot be less than 10 percent). The increase in the wage index shall be based on the percentage of the hospital employees residing in the qualifying county who are employed in any higher wage index area. The increase shall be effective for 3 years, unless waived by the hospital. A hospital with this wage index adjustment may not be eligible for other reclassifications. (§505)

The Act calls for the creation of a one-time opportunity for a wage index reclassification for those hospitals unable to qualify under existing criteria (CMS to determine criteria by Jan. 1, 2004, and hospital must apply by Feb. 15, 2004). (§§505, 508)
(Above changes are expected to have significant positive reimbursement impacts.)

IME/GME Effective for discharges occurring on or after April 1, 2004, the act increases the current IME education adjustment factor (a component of the IME payment formula) from 1.35 to 1.47 for the last half of fiscal year 2004, 1.42 for 2005, 1.37 for 2006, 1.32 for 2007, and 1.35 thereafter. (§502) (Above change is expected to have a significant positive reimbursement impact.)

For family practice residents in programs in existence as of Jan. 1, 2002, the Act provides for a 1-year moratorium (for 2004) on a portion of the requirement that hospitals incur all or substantially all of the costs of training in a non-hospital site. The Act provides that the “Secretary shall allow all hospitals to count residents in osteopathic and allopathic family practice programs … who are training at non-hospital sites, without regard to the financial arrangement between the hospital and the teaching physician practicing in the non-hospital site to which the resident has been assigned.” (§713); this appears primarily intended to permit hospitals to count FTEs at non-hospitals sites where the supervisors are volunteering their time.

For geriatric specialty residents or fellows, the Act provides for an exception to the GME rule that reduces an FTE by 50 percent for the years the resident/fellow exceeds the minimum number of years required for board eligibility (or five years, which ever is less) for programs that require two years of training to become board eligible in a geriatric specialty. (§712)

The Act provides for a “redistribution” of FTEs and adjustment of 1996 FTE limits, which essentially reduces the resident limit for hospitals with FTE counts below their limits and redistributes those FTE slots to other hospitals for the purpose of increasing the resident limit. If a hospital’s “reference resident level,” which is defined as the total number of FTEs before the application of the weighting factor in the fields of allopathic and osteopathic medicine (for the most recent cost reporting period ending on or before Sept. 30, 2002) is less than the resident limit, then, effective July 1, 2005, the applicable resident limit shall be reduced by 75 percent of the difference between the applicable resident limit and the reference resident level. At the same time, other hospitals may apply to increase their resident limits, but the aggregate increase in residents may not exceed the Secretary’s “estimate of the aggregate reduction” in the limits. The Act does not specify criteria to qualify for the increase, so it is not clear which hospitals are eligible to increase their limits, but the Act requires the Secretary to take into account “the demonstrated likelihood of the hospital filling the positions within the first three cost reporting periods beginning on or after July 1, 2005” and to give priority first to hospitals located in rural areas, then to hospitals in urban areas that are not large urban areas, then to residency training programs in a specialty for which there are no other programs in the state. No one hospital may increase their limit by more than 25 FTEs. (§422)

The Act Eliminates the GME FTE per resident amount update of CPI minus two for hospitals with high-cost residency programs (140 percent above the geographically adjusted national average) through 2013. (§711)

DSH The Act equalizes DSH payments among hospitals by applying the payment adjustment formula applicable to urban hospitals to all 100-bed or larger hospitals for discharges occurring on and after April 1, 2004. (§402) To determine whether this helps or hurts hospitals, they should perform their computations under the current formula and under the new formula.

For rural hospitals (except rural referral centers) and urban hospitals with less than 100 beds, the payment adjustment percentage is capped at 12 percent, up from 5.25 percent; this could double DSH payments for small hospitals that have high DSH patient percentages that were penalized under the old cap. (§402)
(Above changes are expected to have significant positive reimbursement impacts.)

Research & Technology The Act extends coverage of routine costs associated with “qualifying” clinical trials to trial of Category A (experimental/investigational) devices if certain conditions are met. (§731) One of the criteria for a qualifying clinical trial is that the device “has been determined by The Secretary” to be “intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.”

Establishes a lower formula threshold for determining whether the DRG rate for a new technology is “inadequate” before a supplemental payment is available. (§503)

Critical Access Hospitals The Act eases the qualifying bed limitation by permitting a hospital to qualify as a Critical Access Hospital (CAH) if it has up to 25 acute care beds (up from 15); in addition, CAHs may operate up to 10 distinct part psychiatric and rehabilitation unit beds without counting the beds toward the bed limit (not clear whether the psych and rehab unit bed limit is a total of 10, or 10 for each kind of distinct unit). This change will likely make it easier for hospitals to qualify and will allow them to operate psych and rehab beds without concern that it will jeopardize their CAH status. (§405)

The Act increases reimbursement rates for inpatient, outpatient, and skilled nursing facility services furnished by CAHs up to 101 percent of reasonable costs, effective for services furnished during cost reporting periods beginning on or after Jan. 1, 2004. (§405)

The Act expands reimbursement of costs incurred for on-call emergency room services to such services furnished by physician assistants, nurse practitioners, and clinical nurse specialists, as well as physicians, beginning for costs incurred on or after Jan. 1, 2005. (§405)
(Above changes are expected to have significant positive reimbursement impacts.)

Low-Volume Hospital Supplemental Payment The Act makes a supplemental payment available (amount to be determined by the Secretary) for PPS hospitals with less than 800 discharges in a given fiscal year (beginning with 2005) and located more than 25 miles from another PPS hospital. The Act defines “discharge” as “an inpatient acute care discharge … regardless of whether the individual is entitled to benefits under Part A.” (§406)
SNF Services to Residents with AIDS Effective for services furnished on or after 10/1/04, the act increases the per diem payment rate by 128 percent for any SNF providing Part A covered services to AIDS residents. (§511) (Above changes are expected to have significant positive reimbursement impacts.)
SNF Services Provided by RHCs & FQHCs Rural Health Clinics and Federally Qualified Health Center Services providing skilled nursing facility services are excluded from the PPS payment system for skilled nursing facilities for services furnished on or after Jan. 1, 2005. (§410)
PART B
Physician Fee Schedule The conversion factor (the dollar amount that when multiplied by the relative value unit (RVU) for a given service yields the Medicare payment amount) for the physician fee schedule will increase by 1.5 percent for calendar years 2004 and 2005. Thus, the 4.5 percent cut that was scheduled to take effect in 2004 and the additional cut scheduled to take place in 2005 have been blocked. (§ 601)

For physician services furnished in Alaska between Jan. 1, 2004 and Dec. 31, 2005, the Act establishes a floor of 1.67 percent for practice expense, malpractice and work geographic indices.

Increases drug administration portion of fee schedule payments. (§303) (This offsets the reduction in payments to physicians for drugs furnished to beneficiaries.)

Rural Physicians Establishes a floor at 1.0 for the work geographic index for services furnished between January 1, 2004 and January 1, 2007. This provision will provide some relief for those physicians, not just rural physicians, whose work component is below the national average.
(§ 412)

Provides a 5 percent bonus payment for physician services furnished between January 1, 2005 and December 31, 2007 by a primary care physician in a primary care scarcity county or by a specialist physician in a specialist scarcity county. The Secretary is authorized to designate those rural areas where physicians can qualify for the bonus payment. (§ 413)

E&M Documentation The Secretary is required to amend the documentation guidelines for evaluation and management (E&M) services to reduce paperwork burdens on physicians. In connection with developing revised documentation guidelines, the Secretary must accept input from practicing physicians of various specialties in teaching and non-teaching settings and conduct a pilot program to test the guidelines. This provides physicians with a great opportunity to express their concerns over the current E&M documentation guidelines. (§ 941)
Preventative Cases Effective Jan. 1, 2005, Medicare will cover certain screening tests for cardiovascular disease, such as blood tests for cholesterol level and other lipid or triglyceride levels. Beneficiaries may not be tested more than once every two years. (§ 612)

Also effective Jan. 1, 2005, Medicare will cover certain laboratory screening tests (such as fasting plasma glucose tests or other tests approved by the Secretary) for individuals with risk factors for diabetes. (§ 613)

Physicians and other practitioners may be reimbursed for an initial routine physical (including an EKG) for beneficiaries who become eligible for Part B coverage on or after Jan. 1, 2005, provided the examination occurs within the first six months of the beneficiary's eligibility. (§ 611)

Ambulance Services For ground ambulance payments, the Act provides a phase-in floor using a blend of the fee schedule and regional fee schedule plus a 1 percent increase across the board for trips originating in urban areas and a 2 percent increase across the board for trips originating in rural areas for trips between July 1, 2004 and Jan. 1, 2007. In 2010, ambulance suppliers will be paid entirely on the national fee schedule. (§ 414)

For ground ambulance trips between July 1, 2004 and Jan. 1, 2009, suppliers will receive an increase on the mileage on trips in excess of 50 miles. (§414)

Effective Jan. 1, 2005, the Act provides coverage of rural air ambulance services. The Secretary is to establish equipment and crew requirements that must be met in order for air ambulance services to be covered. The Act prohibits reimbursement for air ambulance services if there is a financial or employment relationship between the person requesting the rural air ambulance service and the entity furnishing the ambulance service, or an entity under common ownership with the entity furnishing the air ambulance service, or a financial relationship between an immediate family member of such requester and such an entity. There is an exception to the prohibition, however, if a hospital and the entity furnishing rural air ambulance services are under common ownership and the remuneration paid by the hospital to the air ambulance service is for provider-based physician services furnished in a hospital that are reimbursed under part A and the amount of the remuneration is unrelated directly or indirectly to the provision of rural air ambulance services. (§415)

DME Freezes payments through 2008 at current rates for most items/services.

Reduces payment rates for selected items, which include oxygen, oxygen equipment, wheelchairs, nebulizers, diabetic supplies, hospital beds, and air mattresses, to be consistent with rates paid under the Federal Employees Health Benefits Program, which are generally lower than the Medicare rates.

Beginning in 2007, and starting with the largest statistical metropolitan areas and high cost items, establishes competitive bidding acquisition process to replace current fee schedules for most items except inhalation drugs, parenteral nutrients (and equipment and supplies), and Class III medical devices; the Secretary has discretion to exempt rural or noncompetitive areas and items for which competitive acquisition “is not likely to result in significant savings.” In addition, the Secretary must establish a process to continue certain rental agreements and oxygen arrangements. (§302)

(Note that §302 requires the secretary to establish “clinical conditions” for DME payment, including face-to-face patient examinations and prescriptions, before Medicare will pay for power wheelchairs and certain DMEs determined by the Secretary to be prone to abusive practices.)
(THE ABOVE CHANGES ARE EXPECTED TO HAVE SIGNIFICANT NEGATIVE REIMBURSEMENT IMPACTS FOR DME SUPPLIERS.)

Covered Outpatient Drugs (§§303-305) Beginning 2004, reduces reimbursement from 95 percent of the average wholesale price (AWP) to 85 percent of AWP, with infusion drugs excluded from the reduction.

Beginning in 2005, non-self administered drugs furnished in connection with other Medicare covered services will be set at 106 percent of the average sales price (ASP). (ASP will be determined quarterly and will be based on average sales prices for each drug, taking into account discounts, rebates, free goods, and chargebacks.)

Beginning in 2006, a competitive acquisition process will be phased in as an alternative to ASP reimbursement. Under the competitive acquisition program, a single payment amount for each drug in an area will be based upon bids submitted and accepted. On an annual basis, physicians and other providers will have to option to obtain covered drugs and biologicals and seek Medicare reimbursement under ASP, or to select a contractor responsible for delivering covered drugs and biologicals to the physician. The contractor supplying the physician will submit the claim for the drug after it is administered, with Medicare payment and beneficiary cost sharing amounts made directly to the contractor.
(THE ABOVE CHANGES ARE EXPECTED TO HAVE SIGNIFICANT NEGATIVE REIMBURSEMENT IMPACTS)

Hospital Outpatient PPS Drugs (§§621, 622) Ties payment rates to AWP for 2004-2006 that range anywhere from 46 percent to 95 percent of AWP depending on whether the drug is a sole-source, multi-source, or innovator drug; in 2006, payment rates will be tied to the ASP.
(THE ABOVE CHANGE IS EXPECTED TO HAVE A SIGNIFICANT NEGATIVE REIMBURSEMENT IMPACT)

Reduces the threshold for separate APC payment from $150 to $50 to allow unbundling of more drugs.

Physician Services in CAHs Removes requirement that physicians and other health care providers assign billing rights to a CAH. However, the CAH will receive payment based on 115 percent of the Medicare Physician Fee Schedule for these providers’ services if they reassign their billing rights to the CAH. (§405).
Outpatient PPS Extends hold harmless protection to small rural hospitals (less than 100 beds) and sole community hospitals through 2005 from payment reductions resulting from the hospital OPPS reimbursement system. (§411)
ESRD Services Increases composite rate for renal dialysis facilities by 1.6 percent in 2005. (§623)

Restores composite rate exception for facilities that treat primarily pediatric dialysis patients.

Moratorium on Therapy Cap The Act reinstitutes a two-year moratorium on the annual payment limits for physical, occupational and speech therapy services provided by non-hospital providers. The cap, originally set at $1,500 per calendar year, does not apply to services furnished from the date of the Act through calendar year 2005. (§ 624)
Mammography Services Screening mammography services furnished in hospital outpatient departments are excluded from the outpatient department fee schedule and paid under the higher rates in the physician fee schedule. (§614)

Diagnostic mammography services furnished in hospital outpatient departments are similarly excluded from the OPD fee schedule beginning Jan. 1, 2005.

ASC Payments Beginning April 2004, there is a 1 percent reduction in payments for services furnished in ASCs. Then, from the last quarter 2005 through 2009, ASC payments are frozen at the then-current rate. (§ 626)

The Act requires that the GAO conduct a study that compares the relative costs of procedures furnished in ambulatory surgical centers to the relative costs of procedures furnished in hospital outpatient departments and that examines how accurately ambulatory payment categories reflect procedures furnished in ambulatory surgical centers. This study is to be conducted in 2004, with the GAO's report due to Congress by Jan. 1, 2005.

Between Jan. 1, 2006 and Jan. 1, 2008, the Secretary is to implement a revised payment system for payment of surgical services furnished in ambulatory surgical centers after taking into account recommendations from the GAO study.

Laboratory Fee Schedule Freezes payment updates to the CPI under the clinical laboratory fee schedule between 2004 and 2008. (§ 628)
Home Health Rural Add-On Extends add-on payment for services furnished to rural area residents from April 1, 2004 to March 31, 2005, but reduces the add-on percentage from 10 percent to 5 percent. (§421) (Above change is expected to have a significant positive reimbursement impact.)
MEDICAID
Medicaid DSH Increases 2004 state allotments by 16 percent, and bumps up the allotment for low DSH states (that spend less than 3 percent of state Medicaid expenditures on DSH) annually through 2008.

Imposes stricter reporting requirements to ensure state compliance with payment formulas.

Emergency Services for Undocumented Aliens Beginning 2005 and through 2008, makes providers eligible for direct payment from the Secretary for emergency services furnished to undocumented aliens (§1011); this could serve to relieve hospitals from increasing uncompensated care resulting from EMTALA requirements.
MISCELLANEOUS
Criminal Background Checks for Long-Term Care Workers Section 307 of the Bill introduces a new “Pilot” program that will require certain prospective employees working for long-term care providers in participating states to undergo criminal background checks. The requirement applies to long-term care workers who directly assist nursing home residents or patients. The Medicare Bill defines “direct patient access employee” to include “any individual (other than a volunteer) that has access to a patient or resident of a long-term care facility or provider through employment or through a contract with such facility or provider.” The definition of “long-term care facility” includes: (1) skilled nursing facilities, (2) nursing facilities, (3) home health agencies, (4) providers of hospice care, (5) long-term care hospitals, (6) providers of personal care services, (7) residential care providers that arrange for or directly provide long-term care services, and (8) intermediate care facilities for the mentally disabled. Employers who deny employment to applicants after reasonably relying on the information in the background check “shall not be liable in any action brought by the individual based on the employment determination resulting from the information.”

Providers with questions about how these payment provisions and forthcoming CMS guidance may affect their facilities, or how to comply with the associated regulatory requirements, can contact Susan Fine and Lisa Hayward in the Health Law Group of the Seattle office of Davis Wright Tremaine.

Questions concerning the employee criminal background provision in the Act, and other health care employment matters, should be directed to Amy Koziak in the firm’s Labor and Employment Group.


For further information, please contact:

Lisa Rediger Hayward, Seattle, (206) 628-7666, lisahayward@dwt.com


This Health Law Advisory is a publication of the Health Law Group of Davis Wright Tremaine LLP. Our purpose in publishing this Advisory is to inform our clients and friends of developments in health care law. It is not intended, nor should it be used, as a substitute for specific legal advice as legal counsel may only be given in response to inquiries regarding particular situations.

Copyright © 2003, Davis Wright Tremaine LLP.

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