Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

The Centers for Medicare & Medicaid Services (CMS) has issued its “Advance Notice” of changes to payment methodologies for Medicare Advantage (MA) organizations and Medicare Part D prescription drug plans for calendar year 2011. This year CMS is combining the Advance Notice with the annual “Call Letter” to health plans outlining upcoming non-payment policy changes. Among other thing, the Advance Notice includes: a preliminary estimate of a 1.38% change in the national per capita MA growth percentage; changes in risk adjustment payment methodologies; a 3.41% risk adjustment to reflect differences in coding patterns between MA plans and fee-for-service providers; and an update to the standard Part D benefit parameters. Other issues addressed in the Call Letter include practices to curb waste of unused drugs, reassignment, release of data, and drug coverage for beneficiaries with ESRD. Comments will be accepted until March 5, 2010. 

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This post was written by Jacqueline B. Penrod.

The Government Accountability Office has outlined the results of a study it conducted regarding how CMS has handled violations of the marketing rules applicable to Medicare Advantage Organizations (MAOs). The study found that between January 2006 and February 2009, CMS took action against 73 MAOs. The most frequent violation cited was noncompliance with regulations limiting commissions to agents; CMS responded that it has established stronger rules for governing these commissions in order to curtail these behaviors. Consequences for MAOs ranged from initial notices of noncompliance to punitive measures, such as civil money penalties. Although GAO was generally complimentary of the compliance efforts, it recommended better tracking of the number of beneficiaries affected by these violations. CMS concurred with this recommendation.

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An OIG report on Medicare Advantage Organization (MAO) beneficiary appeals found that MAOs make the vast majority of “organization determinations” (expedited reviews of benefit determinations) in favor of beneficiaries, with very few denials. Of the few denials that were appealed by beneficiaries, more than half were overturned by the MAO. At the second level of appeal, Independent Review Entities (IRE) overturned about one in five adverse MAO decisions. The OIG noted potential concerns regarding the low rate of beneficiary appeals, problems with timeliness in processing adverse expedited determinations, and the higher IRE overturn rate of expedited cases. 

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On October 9, 2009, the Centers for Medicare & Medicaid Services (CMS) released a proposed rule that would make numerous changes to the requirements for sponsors of Medicare Advantage (MA) and Medicare Part D drug plans intended to strengthen beneficiary protections, improve plan payment rules, and clarify various program participation requirements. Among many other things, the rule would: enhance CMS’s ability to identify and approve qualified drug and health plans and remove consistently-poor performers; clarify plan requirements relating to beneficiary cost-sharing; eliminate duplication in drug and health plan bids submitted by the same organization by requiring a meaningful difference between an organization’s product offerings; expand the collection of prescription drug event data elements; clarify Part D protected drug categories and classes; and make other refinements and technical changes to the Part C and Part D regulations. CMS will accept comments on the proposed rule until December 8, 2009. The official version of the rule is scheduled to be published in the Federal Register on October 22, 2009. CMS also has released information on 2010 Medicare Part D and MA plan options and premium and copayment amounts.

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The Congressional Budget Office (CBO) has released its preliminary score of the Senate Finance Committee health reform bill, as amended in committee.   In brief, the CBO concludes that the bill would cost $829 billion gross over 10 years, but result in a net savings of $81 billion over 10 years.  CBO estimates that the bill would would reduce direct spending on Medicare, Medicaid, and CHIP by $404 billion over the 2010–2019 period, and the Medicare and Medicaid provisions would increase federal revenues by approximately $16 billion over this period.  Program savings include $162 billion in reductions to annual updates to Medicare fee-for-service rates (other than physicians’ services), and a $117 billion cut in payments to Medicare Advantage plans.  The number of uninsured nonelderly individuals would be reduced by about 29 million, leaving about 25 million nonelderly residents uninsured (about one-third of whom would be unauthorized immigrants).  The Finance Committee is scheduled to vote on the bill on October 13, 2009.

 

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On August 13, 2009, CMS announced that the average monthly premium for standard Part D prescription drug coverage will be $30 in 2010, up $2 from the 2009 average premium. For 2010, CMS will be conducting a “Medicare Demonstration to Revise the Part D Low-Income Benchmark Calculation,” which will have the effect of decreasing the number of low-income beneficiary reassignments to plans with premiums below the 2010 subsidy amount. Nevertheless, CMS estimates that approximately 800,000 Medicare beneficiaries who are eligible for low-income subsidies will need to change plans in 2010 to remain in a zero-premium plan. CMS also released the 2010 national average monthly bid; the base beneficiary premium; the regional low-income subsidy premium amounts for 2010; and the 2010 Medicare Advantage regional preferred provider organization benchmarks. In addition, CMS has revised its Medicare Marketing Guidelines to reflect Medicare Improvements for Patients and Providers Act changes, effective August 7, 2009.

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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.

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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.

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On June 1, 2009, the Practicing Physicians Advisory Council (PPAC) is holding its quarterly meeting to discuss certain proposed changes in regulations and manual instructions related to physicians' services. Agenda topics include value-based purchasing, Recovery Audit Contractors (RAC), IPPS issues, DMEPOS surety bond, and various Medicare Part C and D issues. Registration is required. 

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On March 30, 2009, CMS issued its annual “Call Letter” for potential sponsors of Medicare Advantage (MA) and Part D Prescription Drug Plans (PDPs) in 2010. In announcing the Call Letter, CMS stated that it is taking steps to ensure that MA plan cost-sharing frameworks do not expose sicker beneficiaries to excessive out-of-pocket charges. MA organizations also are being directed to streamline their plan offerings to facilitate beneficiary plan selection. PDP sponsors also will be required to provide more information to beneficiaries on their utilization management criteria and their policies on drugs during the coverage gap. MA and PDP sponsors will be asked to conduct audits on the data provided to CMS about the operation of their plans, and existing program compliance audits will be more targeted, data-driven, and risk-based.  In addition, on April 6, 2009, CMS announced the 2010 Medicare Advantage growth trend and 2010 payment policies for MA and PDP organizations . CMS notes that for the first time, CMS will make a “coding pattern differences adjustment” to Medicare Advantage risk scores, reducing Medicare Advantage payment rates in 2010 to account for differences in disease coding patterns between MA organizations and the original Medicare program (Parts A and B). The adjustment will be applied as a uniform 3.41 percentage reduction to all Medicare Advantage plans’ Part C risk scores in 2010.

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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.

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The HHS Office of Inspector General (OIG) has issued a report on “Hospital Compliance With Medicare's Postacute Care Transfer Policy During Fiscal Years 2003 Through 2005.” Under the postacute care transfer policy, Medicare pays full prospective payments to hospitals that discharge inpatients to their homes, but for patients with certain diagnoses, payments to the hospital are reduced for discharges to certain post-acute care settings (such as skilled nursing facilities). The OIG estimated that hospitals improperly coded 15,051 claims as discharges to home rather than transfers to post-acute care, resulting in $24.8 million in overpayments. The OIG noted, however, that claims edits adopted by CMS in 2004 significantly decreased these types of overpayments. A separate OIG review examined “Medicare Payments to Managed Care Plans on Behalf of Deceased Enrollees.” The OIG found that CMS paid approximately $4.4 million to Medicare Advantage plans for coverage periods after the enrollees' months of death, although CMS had correctly stopped payments for the vast majority of the deceased enrollees.

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

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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 Prices. The 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.

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CMS has re-issued the draft 2010 MA, MA-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) Call Letter for public commen. CMS originally released a draft Call Letter for public comment on January 8, 2009 and withdrew it on January 22, 2009 pending further review. Comments on the letter should be submitted to CMS by March 6, 2009; comments previously submitted on the earlier version should be resubmitted if still relevant. In addition, on February 20, 2009, CMS issued its “Advance Notice” of changes in methods that will be used to calculate capitation rates for payments to Medicare Advantage organizations for 2010. The Advance Notice also announces policy and technical changes to the payment methodology for MA plans and PDPs. The final capitation rates for each county are scheduled to be announced on April 6, 2009. The Advance Notice also describes changes in risk adjustment of MA and PDP payments. Comments on the Advance Notice also are due March 6, 2009. 

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CMS has re-issued the draft 2010 Medicare Advantage (MA), Medicare Advantage-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) Call Letter for public comment. CMS originally released a draft Call Letter for public comment on January 8, 2009 and withdrew it on January 22, 2009 pending further review. Comments/concerns should be submitted to CMS by March 6, 2009; comments already submitted based on the January 8, 2009 version of the draft Call Letter, if they are still relevant to the revised document, should be resubmitted. 

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On February 27, 2009, MedPAC released its March 2009 Report to the Congress: Medicare Payment Policy. The report includes a series of recommendations for Medicare payments designed to assure beneficiaries’ access to care and preserve Medicare’s long-term sustainability, particularly through reductions in payment updates for 2010. The report also includes recommendations to increase transparency of physician financial relationships. A listing of key recommendations follows after the jump. 

Hospitals

• The Congress should increase payment rates for the acute inpatient and outpatient prospective payment systems in 2010 by the projected rate of increase in the hospital market basket index, concurrent with implementation of a quality incentive payment program.
• The Congress should reduce the indirect medical education adjustment (IME) in 2010 by 1 percentage point to 4.5 percent per 10 percent increment in the resident-to-bed ratio. The funds obtained by reducing the IME adjustment should be used to fund a quality incentive payment program.

Physicians and Ambulatory Surgical Centers

• The Congress should update payments for physician services in 2010 by 1.1 percent.
• The Congress should establish a budget-neutral payment adjustment for primary care services billed under the physician fee schedule and furnished by primary-care-focused practitioners. Primary-care-focused practitioners are those whose specialty designation is defined as primary care and/or those whose pattern of claims meets a minimum threshold of furnishing primary care services. The Secretary would use rulemaking to establish criteria for determining a primary-care-focused practitioner.
• The Congress should direct the Secretary to increase the equipment use standard for expensive imaging machines from 25 to 45 hours per week. This change should redistribute RVUs from expensive imaging to other physician services.
• The Congress should increase payments for ambulatory surgical centers (ASC) services in calendar year 2010 by 0.6 percent. In addition, the Congress should require ASCs to submit to the Secretary cost data and quality data that will allow for an effective evaluation of the adequacy of ASC payment rates.

Dialysis Services

• The Congress should maintain current law and update the composite rate in calendar year 2010 by 1 percent.

Skilled Nursing Facility Services

• The Congress should eliminate the update to payment rates for skilled nursing facility services for fiscal year 2010.
• The Congress should require the Secretary to revise the skilled nursing facility (SNF) prospective payment system by: adding a separate nontherapy ancillary (NTA) component, replacing the therapy component with one that establishes payments based on predicted patient care needs, and adopting an outlier policy.
• The Secretary should direct SNFs to report more accurate diagnostic and service-use information by requiring that: claims include detailed diagnosis information and dates of service, services furnished since admission to the SNF be recorded separately in the patient assessment, and SNFs report their nursing costs in the Medicare cost report.
• The Congress should establish a quality incentive payment policy for SNFs in Medicare and to improve quality measurement for SNFs, the Secretary should: add the risk-adjusted rates of potentially avoidable rehospitalizations and community discharge to its publicly reported post-acute care quality measures; revise the pain, pressure ulcer, and delirium measures currently reported on CMS’s Nursing Home Compare website; and require SNFs to conduct patient assessments at admission and discharge.

Home Health Services

• The Congress should eliminate the market basket increase for 2010 and advance the planned reductions for coding adjustments in 2011 to 2010, so that payments in 2010 are reduced by 5.5 percent from 2009 levels.
• The Congress should direct the Secretary to re-base rates for home health care services in 2011 to reflect the average cost of providing care.
• The Congress should direct the Secretary to assess payment measures that protect the quality of care and ensure incentives for the efficient delivery of home health care. The study should include alternative payment strategies such as blended payments and risk corridors and outcome-based quality incentives.

Inpatient Rehabilitation Facilities

• The update to the payment rates for inpatient rehabilitation services should be eliminated for fiscal year 2010.

Long-Term Care Hospitals

• The Secretary should update payment rates for long-term care hospitals for fiscal year 2010 by the projected rate of increase in the rehabilitation, psychiatric and long-term care hospital (RPL) market basket index less the Commission’s adjustment for productivity growth.

Recommendations on Medicare Advantage Payments

• The Congress should: Eliminate the stabilization fund for regional PPOs. Remove the effect of payments for indirect medical education from the MA plan benchmarks. Set the benchmarks that CMS uses to evaluate MA plan bids at 100 percent of FFS costs. Pay-for-performance should apply in MA to reward plans that provide higher quality care. Clarify that regional plans should submit bids that are standardized for the region’s MA-eligible population.
• The Secretary should calculate clinical measures for the FFS program that would permit CMS to compare the FFS program with MA plans.

Recommendations on Public Reporting of Physician Financial Relationships

• The Congress should require all manufacturers and distributors of drugs, biologicals, medical devices, and medical supplies (and their subsidiaries) to report to the Secretary their financial relationships with: physicians, physician groups, and other prescribers; pharmacies and pharmacists; health plans, pharmacy benefit managers, and their employees; hospitals and medical schools; organizations that sponsor continuing medical education; patient organizations; and professional organizations.
• The Congress should direct the Secretary to post the information submitted by manufacturers on a public website in a format that is searchable by: manufacturer; recipient’s name, location, and specialty (if applicable); type of payment; name of the related drug or device (if applicable); and year.
• The Congress should require manufacturers and distributors of drugs to report to the Secretary the following information about drug samples: each recipient’s name and business address; the name, dosage, and number of units of each sample; and the date of distribution. The Secretary should make this information available through data use agreements.
• The Congress should require all hospitals and other entities that bill Medicare for services to annually report the ownership share of each physician who directly or indirectly owns an interest in the entity (excluding publicly traded corporations). The Secretary should post this information on a searchable public website.
• The Congress should require the Secretary to submit a report, based on the Disclosure of Financial Relationships Report, of the types and prevalence of financial arrangements between hospitals and physicians.

Recommendations on Reforming the Hospice Benefit

• The Congress should direct the Secretary to change the Medicare payment system for hospice to: have relatively higher payments per day at the beginning of the episode and relatively lower payments per day as the length of the episode increases; include a relatively higher payment for the costs associated with patient death at the end of the episode; and implement the payment system changes in 2013, with a brief transitional period. These payment system changes should be implemented in a budget neutral manner in the first year.
• The Congress should direct the Secretary to: require that a hospice physician or advanced practice nurse visit the patient to determine continued eligibility prior to the 180th-day recertification and each subsequent recertification and attest that such visits took place, require that certifications and recertifications include a brief narrative describing the clinical basis for the patient’s prognosis, and require that all stays in excess of 180 days be medically reviewed for hospices for which stays exceeding 180 days make up 40 percent or more of their total cases.
• The Secretary should direct the Office of Inspector General to investigate: the prevalence of financial relationships between hospices and long-term care facilities such as nursing facilities and assisted living facilities that may represent a conflict of interest and influence admissions to hospice, differences in patterns of nursing home referrals to hospice, the appropriateness of enrollment practices for hospices with unusual utilization patterns (e.g., high frequency of very long stays, very short stays, or enrollment of patients discharged from other hospices), and the appropriateness of hospice marketing materials and other admissions practices and potential correlations between length of stay and deficiencies in marketing or admissions practices.
• The Secretary should collect additional data on hospice care and improve the quality of all data collected to facilitate the management of the hospice benefit. Additional data could be collected from claims as a condition of payment and from hospice cost reports.

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CMS has rescinded its draft 2010 Medicare Advantage (MA), Medicare Advantage-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) Call Letter so it can be further reviewed by the new Obama Administration. CMS will post a new version of the draft as soon as possible. 

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

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On January 12, 2009, CMS published a final rule that revises Medicare’s definition of Part D negotiated prices to require drug plan sponsors to use the amount paid to a pharmacy (rather than the sometimes lower "lock in price" paid to a pharmacy benefit manager) as the basis for determining cost sharing for beneficiaries and for reporting a plan’s drug costs to CMS. The rule also, among other things: requires new enrollees in special needs plans to be members of the population that the plan is designed to serve; permits CMS to impose on plans a civil money penalty of up to $25,000 for each enrollee adversely affected by a contract violation; codifies CMS policy regarding using the best available evidence to determine an enrollee’s eligibility for extra help through the Part D Low Income Subsidy program; prevents beneficiaries enrolled in Medicare Advantage and Part D plans who elect to have their premiums withheld from their Social Security payments from being double-billed for premiums; and requires Medicare Medical Savings Account plans to report cost and quality information to beneficiaries.  CMS also issued a related proposed rule providing CMS with the authority to "waive or modify" statutory requirements pertaining to the Retiree Drug Subsidy (RDS) program in order to facilitate the offering of a prescription drug plan covering employees or retirees has also been released. Comments on the proposed rule will be accepted until March 13, 2009.

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CMS has released draft 2010 Medicare Advantage (MA), Medicare Advantage-Prescription Drug (MA-PD), Cost-Based Plan, and Stand Alone Prescription Drug Plan (PDP) Call Letter. The 2010 Call Letter focuses on new regulatory requirements and other new policy clarifications and statutory requirements affecting MA and Part D programs in order help plans prepare their bids for the upcoming year. CMS will separately issue technical and procedural clarifications regarding bid and formulary submissions, benefits, HPMS data, CMS marketing models, and other operational issues of interest to sponsoring organizations. Comments on the draft will be accepted through January 30, 2009.

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The Medicare Payment Advisory Commission (MedPAC) is meeting January 8-9, 2009 to discuss a variety of Medicare payment and policy issues, including payments to hospitals, physicians, ambulatory surgical centers, dialysis providers, skilled nursing facilities, home health agencies, inpatient rehabilitation facilities, long-term care hospitals, hospices, and Medicare Advantage plans.  

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The OIG has issued a report entitled “Comparing Special Needs Plan Beneficiaries to Other Medicare Advantage Prescription Drug Plan Beneficiaries.” The OIG found that Special Needs Plan (SNP) beneficiaries filled an average of 11% more prescriptions than other Medicare Advantage Prescription Drug Plan (MA-PD) beneficiaries, and the average annual prescription cost per SNP beneficiary was 49% higher compared to that of other MA-PD beneficiaries. On the other hand, SNP and other MA-PD beneficiaries were similarly exposed to potentially inappropriate drug pairs that could lead to adverse drug events. The OIG recommends that CMS take steps to help physicians and pharmacists prevent inappropriate drug pairs. Separately, the Government Accountability Office (GAO) has issued a report entitled "Medicare Part D: Opportunities Exist for Improving Information Sent to Enrollees and Scheduling the Annual Election Period" Sponsors, pharmacists, beneficiary advocates, and counselors GAO interviewed expressed concern that CMS’s model Annual Notice of Change (ANOC) for the 2008 annual election period (AEP) did not effectively communicate drug plan changes to enrollees. In addition, although CMS and plan sponsors made improvements to the enrollment process, CMS data showed that about 15% of beneficiaries who chose to switch plans in the 2008 AEP were not fully enrolled in their new plan by January 1. To improve the AEP, the GAO recommends that CMS review alternative formats to communicate plan changes. Additionally, Congress should consider authorizing the HHS Secretary to amend the AEP schedule to include a processing interval between the end of the AEP and the effective date of new coverage. CMS concurred with the GAO recommendations.

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The GAO has released a report entitled "Medicare Advantage Organizations: Actual Expenses and Profits Compared to Projections for 2006." The GAO found that MA organizations reported earning average profits of 6.6% of total revenue in 2006, compared to projected profits of 4.1%, and they reported spending an average of 83.3% of total revenue on medical expenses compared to projections of 86.9%. The GAO points out that if MA organizations had more accurately projected both their revenues and expenses, they would have been able to provide beneficiaries with additional benefits or cost-sharing reductions, and still maintain the level of profits projected. In a separate report, "Medicare Advantage: Characteristics, Financial Risks, and Disenrollment Rates of Beneficiaries in Private Fee-for-Service Plans," the GAO found that beneficiaries in private fee-for-service (PFFS) plans in April 2007 tended to be healthier and generally younger than beneficiaries in other MA plans. Moreover, Medicare PFFS beneficiaries may have faced certain financial risks if they did not contact their plan before receiving services that generally were not assumed by beneficiaries in other MA plans and Medicare FFS.  The GAO also found that some PFFS plans were inappropriately using the term prior authorization in their informational materials when such plans were not permitted to deny service coverage due to lack of prior plan approval. The GAO observes that CMS guidance on this issue has been inconsistent and sometimes incorrect. Finally, the GAO found that from January through April 2007, beneficiaries in PFFS plans disenrolled at an average rate of 21% compared to 9% for other MA plans, and while CMS has not complied with statutory requirements to mail disenrollment rates to Medicare beneficiaries. GAO recommends that CMS (1) investigate the extent to which PFFS beneficiaries face unexpected costs for not contacting their plan before receiving care, (2) ensure that CMS guidance on prior authorization reflects CMS policy, and (3) mail MA plan disenrollment rates to beneficiaries, as required by statute, and update rates on Medicare’s web site.  

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

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

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

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On November 14, 2008, the Centers for Medicare & Medicaid Services (CMS) published an interim final rule with comment period revising marketing requirements for Medicare Advantage (MA) plans and Medicare Part D prescription drug plans (PDPs). Specifically, the rule amends requirements just issued on September 18, 2008 to further limit the compensation that can be paid to agents or brokers with respect to MA and Part D plans in order to limit incentives to switch beneficiaries between plans to generate commissions, as authorized by the Medicare Improvements for Patients and Providers Act (MIPPA). Under the September 18 rule, plans were required to pay compensation on a six-year cycle, comprised of an initial enrollment year and five renewal years, with compensation in the initial year capped at 200% of the amount paid for renewal years. CMS received complaints, however, that plans were misinterpreting the rule’s intent by proposing structures under which compensation in the initial year in the cycle was less than the renewal years and renewal compensation varied from year to year. Among other things, the November 14 rule modifies the marketing requirements by:

• Specifying that all compensation paid to agents and brokers reflect fair-market value based on the commissions paid in the past, adjusted for inflation for similar products in the same geographic area.
• Requiring that renewal compensation equal 50% of the compensation paid for that beneficiary in the initial year of the six-year compensation cycle.
• Applying similar limits on payments to organizations such as Field Marketing Organizations.
• Requiring plans to submit to CMS their compensation structures for the previous three years plus the compensation structure they are implementing for 2009, and preventing rates from being changed without prior CMS approval.
• Requiring plans to initially pay renewal rate compensation in 2009; upon CMS approval, plans will retrospectively pay agents/brokers an additional amount to total the initial compensation rate filed with CMS.

The rule is effective November 10, 2008; CMS is accepting comments on the rule until December 15, 2008. 

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On November 13, 2008, CMS announced the 15 chronic conditions certain Medicare Advantage special needs plans (SNPs) must use to identify the beneficiary populations eligible for enrollment, beginning in 2010. SNPs are a type of MA plan that serve only beneficiaries living in institutions, eligible for both Medicare and Medicaid, or living with severe or disabling chronic conditions. For SNP purposes, chronic conditions are defined as being medically complex, substantially disabling or life threatening, having a high risk of hospitalization or other adverse outcomes, and requiring a specialized delivery system across domains of care. The specific clinical conditions identified as meeting this definition are: chronic alcohol and other drug dependence; certain autoimmune disorders; cancer excluding pre-cancer conditions; certain cardiovascular disorders; chronic heart failure; dementia; diabetes mellitus; end-stage liver disease; end-stage renal disease requiring dialysis (all modes of dialysis); certain severe hematologic disorders; HIV/AIDS; certain chronic lung disorders; certain chronic and disabling mental health conditions; certain neurologic disorders; and stroke. 

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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. 

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On October 10, 2008, the Centers for Medicare & Medicaid Services (CMS) published a notice soliciting comments on the Medicare Part D/Medicare Advantage Calendar Year (CY) 2010 Bid Pricing Tool and the CY 2010 Plan Benefit Package software and formulary submission. CMS also has posted the forms and related documents regarding the information collections. CMS will accept comments on the forms through December 9, 2008.

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On October 10, 2008, CMS announced that beneficiaries may now review specific Medicare Part D prescription drug plan and Medicare Advantage health plan information for 2009 online through the Medicare Prescription Drug Plan Finder and Medicare Options Compare. 

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

• The first rule implements certain MA and PDP marketing provisions and a requirement related to the disclosure and dissemination of Part D information included in a May 16, 2008 proposed rule and subsequently enacted into statute by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Specifically, the rule: prohibits plans from providing meals to prospective enrollees at promotional events; prohibits unsolicited contact with potential enrollees (e.g., door-to-door solicitation); prohibits plans from cross-selling non-health care related products during Medicare marketing activities; restricts marketing activities in provider offices (except in certain common areas); prohibits plans from conducting marking activities at educational events; requires that only state-licensed representatives conduct marketing activities; requires plans to disclose certain beneficiary information at the time of enrollment and 15 days before the annual coordinated election period; and defines certain terms related to marketing activities. The rule is effective September 18, 2008 and applies to the 2009 benefit year marketing campaign, beginning October 1, 2008.  
  

• The second rule, which addresses a variety of other MIPPA MA and Part D provisions, is subject to a public comment period until November 17, 2008. With regard to Part D and MA marketing, the rule, among other things: codifies the $15 limit on nominal gifts to prospective enrollees; codifies restrictions on co-branding; limits marketing appointments to the scope of healthcare-related products agreed upon by the beneficiary in advance; restricts agent/broker compensation arrangements to reduce financial incentives to move a beneficiary from one plan to another; and establishes requirements for agent/broker training and testing and the reporting of terminated agents/brokers. The rule also includes provisions regarding special needs plans (SNP), including: an extension of the authority for SNPs through 2010; state contracting requirements for new and expanding dual eligible SNP applicants; model of care requirements covering scope of provider networks, individual assessments, outcomes measures, and interdisciplinary care management; cost-sharing limitations; disclosure requirements; and quality measure reporting. The rule also includes new access and quality improvement requirements for private fee-for-service plans, codifies the waiver of the late enrollment penalty for low-income subsidy enrollees; implements requirements regarding the prompt payment of clean claims; clarifies claims submission timeframes for long term care pharmacies; modifies cost plan contracts, phases out indirect costs for medical education from MA capitation rates; revises the use of certain Part D data; updates the prescription drug pricing standard; and makes exemptions to the income and resource requirements for Part D low-income subsidy eligibility determination.  The provisions of the rule generally apply beginning October 1, 2008, with certain exceptions.  CMS published a notice correcting technical and typographical errors identified in this rule on November 21, 2008. 

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

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CMS has announced the 2009 Medicare PDP and MA plan options. Details about the specific plans in each region will be available mid-October 2008. Open enrollment for 2009 prescription drug coverage begins November 15, 2008 and ends December 31, 2008.

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

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CMS has released the 2009 Part D national average monthly bid amount, the Medicare Part D base beneficiary premium, the Part D regional low-income premium subsidy amounts, and the Medicare Advantage regional benchmarks.  In addition, CMS has issued guidance to clarify its “best available evidence” (BAE) policy, which requires Part D drug plan sponsors to establish the appropriate cost-sharing for low-income beneficiaries when presented with evidence that the beneficiary's information is not accurate. 

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

• Physician Payments: MIPPA cancels a 10.6% Medicare physician fee schedule cut that was triggered on July 1, 2008 and provides a 1.1% increase for 2009 (rather than the forecasted 5.4% cut).  The law also expands the Physician Quality Reporting Initiative, promotes electronic prescribing, and requires non-hospital advanced imaging providers to be accredited by 2012.

 

• DMEPOS Competitive Bidding.  MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (CMS) competitive bidding program for certain categories of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS).  H.R. 6331 terminates contracts awarded under round one, rebids those areas in 2009, and delays round two bidding until 2011.  The delay is financed by cutting fee schedule payments for round one items by 9.5% nationwide beginning January 1, 2009.  MIPPA also includes a series of procedural improvements to the bidding process. A detailed Reed Smith analysis of the MIPPA DMEPOS bidding provisions is available on our website.
• Therapy Caps Exception Process.  MIPPA extends through December 31, 2009 the outpatient therapy service cap exceptions process.
• Clinical Laboratory Services.  The act repeals the clinical lab competitive bidding demonstration project and reduces the clinical lab fee schedule update by 0.5% in each of the next 5 years.
• Medicare Advantage (MA) Provisions.  MIPPA makes a series of MA payment and policy changes, including a $1.8 billion cut in the regional MA stabilization fund in 2012 and a phase-out of the adjustment for indirect medical education. 
• Medicare Part D Drug Plans.  MIPPA sets timeframes for plan payments to pharmacies and long-term care pharmacy submission of claims; mandates coverage of certain classes of drugs; clarifies the use of Part D drug data; limits certain sales and marketing activities; and makes other Part D reforms. 
• End-Stage Renal Disease (ESRD) Provisions.  The law updates the ESRD composite rate by 1.0% for 2009 and 2010, and mandates a fully-bundled ESRD payment system and quality incentive program by January 1, 2011.
• Medicaid Drug Reimbursement.  MIPPA delays the adoption of Medicaid payment based on average manufacturer price (AMP) for multiple source drugs and prevents publication of AMP data until October 1, 2009.

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

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On July 28, 2008, CMS published a final rule barring MA organizations from making midyear changes to non-prescription drug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. The rule also clarifies that MA organizations offering certain kinds of plans restricted to employer and union group health plan sponsors may continue to offer benefit enhancements through means other than midyear benefit enhancements. The rule does not apply to programs of all-inclusive care for elderly. The rule is effective August 27, 2008.

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

The following are highlights of the legislation:

• Physician Fee Schedule: MIPPA maintains physician payment rates for 2008 (rather than implement the 10.6% cut that was triggered on July 1, 2008), and provides a 1.1% increase for 2009 (rather than the forecasted 5.4% cut). The law also extends for two years the Physician Quality Reporting Initiative (PQRI), increases incentive payments for reporting by 2%, and makes other reforms to the program. The act promotes electronic prescribing (e-prescribing) by providing incentive payments for practitioners who use a qualified e-prescribing systems in 2009 through 2013, and reducing payments by 2% for providers practitioners who fail to e-prescribe beginning in 2011 (with limited exceptions). MIPPA also requires non-hospital advanced imaging providers to be accredited by 2012 and establishes a voluntary demonstration program to test the use of appropriateness criteria for advanced diagnostic imaging services.
• DMEPOS Competitive Bidding.  MIPPA delays and reforms the Centers for Medicare & Medicaid Services' (CMS) competitive bidding program for certain categories of durable medical equipment, prosthetics, orthotics and supplies (DMEPOS). The first round of the program went into effect in 10 geographic areas on July 1, 2008. H.R. 6331 terminates contracts awarded under round one and rebids those areas in 2009, with bidding for round two delayed until 2011. The delay is financed by cutting fee schedule payments for all items covered by round one bidding program by 9.5% nationwide beginning January 1, 2009, followed by a 2% increase in 2014 (with certain exceptions). MIPPA also includes a series of procedural improvements to the bidding process, and addresses quality by, among other things, requiring subcontractor accreditation, excluding complex rehabilitation wheelchairs and negative pressure wound therapy from bidding, and exempting of certain rural and low-population areas from bidding. Separately, MIPPA repeals current oxygen equipment transfer of ownership requirements.
• Therapy Caps Exception Process.  MIPPA extends through December 31, 2009 the exceptions process relative to the annual per-beneficiary limitations on outpatient therapy services.
• Clinical Laboratory Services. The act repeals the competitive bidding demonstration project for clinical laboratory services and instead reduces the fee schedule update for clinical lab services by 0.5% in each of the next 5 years.
• Medicare Advantage (MA) Provisions. MIPPA makes a series of payment and policy changes affecting Medicare Advantage plans, including a $1.8 billion cut in the MA stabilization fund for regional preferred provider organizations in 2012 and a phase-out of the adjustment for indirect medical education. 
• Medicare Part D Drug Plans. MIPPA establishes timeframes for plan payments to pharmacies and long-term care pharmacy submission of claims; codifies current coverage of certain “protected classes” of drugs; clarifies the use of Part D drug data for research and other purposes; limits certain sales and marketing activities; and makes other Part D reforms. 
• End-Stage Renal Disease Provisions. The law provides a 1.0% update to the composite rate for renal dialysis services for 2009 and 2010, requires the Secretary to establish a fully bundled ESRD payment system by January 1, 2011, and establishes a quality incentive payment program for ESRD providers, effective January 1, 2011.
• Medicaid Drug Reimbursement. MIPPA delays the adoption of Medicaid payment based on average manufacturer price (AMP) for multiple source drugs and prevent publication of AMP data until October 1, 2009.

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

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On June 6, 2008, Senate Finance Committee Chairman Max Baucus introduced the “Medicare Improvements for Patients and Providers Act of 2008” (S. 3101).   Most notably, the legislation would block a scheduled cut in Medicare physician payments, extend certain expiring health care provisions, and make numerous other Medicare and Medicaid payment and coverage changes. 

The following are highlights of the bill:

• Physician Payments: In the absence of Congressional action, Medicare physician fee schedule payments will be subject to a more than 10 percent across-the-board cut effective July 1, 2008. The Baucus bill would delay the cut through December 31, 2009 and provide a 1.1% update for 2009. In addition, the bill would extend the physician quality reporting initiative (PQRI) through December 31, 2010, with an increase in the PQRI bonus to 2.0% for 2009 and 2010. The bill also would provide financial incentives for physicians to use e-prescribing, establish accreditation requirements for providers of the technical component of certain diagnostic imaging services, extend the current treatment of certain physician pathology services, and extend an increase in the geographic adjustment to payment for physician work in rural areas.
• Renal Dialysis Provisions:  The bill would increase the composite rate for end stage renal disease (ESRD) services by 1 percentage point for both 2009 and 2010, and require the Secretary to established a fully bundled payment system for ESRD services. In addition, dialysis providers would be subject to new quality standards.
• Other Part B Provisions:  Among other things, the bill would extend the outpatient therapy cap exceptions process; extend current payment rules covering brachytherapy and radiopharmaceuticals; extend the Medicare hold harmless provision under the hospital outpatient prospective payment system for certain small rural hospitals; repeal the clinical laboratory competitive bidding demonstration project (offset by a 0.5 percent reduction in lab payment updates for each of the next 5 years); improve payments for clinical lab tests performed by critical access hospitals; and modify payments for oxygen and power wheelchairs.
• Hospital Provisions: The legislation would extend the Medicare Rural Hospital Flexibility Program, rebase sole community hospital payments, and make other rural hospital improvements.
• Medicare Advantage Reforms: The proposal includes a series of changes to Medicare Advantage payment and other policies, including a phase-out of indirect medical education payments and a $1.8 billion cut in the Medicare Advantage Stabilization Fund.
• Medicare Part D Drug Plan Provisions: Among other things, the bill would set deadlines for drug plan payment to pharmacies; establish claims submission time-frames for long-term care pharmacies; require weekly updates on pricing standards used for pharmacy reimbursement; allow coverage of barbiturates and benzodiazepines; codify coverage of certain “protected classes” of drugs; clarify the use of compendia for the drug benefit; and clarify the use of Part B data for research and other purposes.
• Clinical Trials, Clinical Effectiveness: The bill would authorize alternative methods of payment for Medicare services provided to beneficiaries who participate in certain randomized control trials conducted by a Department of Health and Human Services (HHS) agency. It also would authorize Institute of Medicine studies on best practices in setting clinical decision-making protocols and on methodological standards for conducting systematic reviews of clinical effectiveness research.
• Medicaid Drug Payments:  The bill would delay the establishment of Medicaid payment limits using Average Manufacturer Price for multiple source drugs through September 30, 2009.
• Beneficiary Improvements: The bill would expand coverage of preventive services, reduce copayments for outpatient mental health services, expand access to certain low-income programs, and limit certain Medicare Advantage and Part D drug plan sales and marketing practices, among other things.

Additional details regarding the Baucus bill are available here. The full Senate is expected to consider the legislation later this month. If approved by the Senate, attention would then shift to reaching an agreement with the House, which passed a much different Medicare bill last summer (H.R. 3162). Prospects for enactment are uncertain, given the Administration’s strong opposition to reductions in Medicare Advantage funding. Note that Senator Chuck Grassley, Ranking Republican on the Finance Committee, also has outlined an alternative Medicare proposal that does not include managed care cuts, which could serve as the basis of a compromise agreement.

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On May 16, 2008, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule that would revise Medicare Advantage (MA) program and Part D prescription drug program rules. Among many other things, the rule would codify recent marketing guidance documents and impose new requirements, including bans on door-to-door marketing and cold-calling, restrictions on broker/agent commissions, and limits on sales activities at educational events. The proposal also would streamline eligibility determinations under the low-income subsidy (LIS) program and provide new protections for beneficiaries enrolled in special needs plans, including clarified delivery-of-care standards. Moreover, CMS proposes new safeguards to protect beneficiaries from excessive cost-sharing, including refined definitions related to the drug costs Part D sponsors may use as the basis for calculating beneficiary cost sharing, reporting drug costs to CMS for reinsurance reconciliation and risk sharing, and submitting bids to CMS.  CMS also proposes a new definition for administrative costs to further clarify costs excluded from Part D drug costs. CMS will accept comments on the proposal until July 15.

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