CMS extends temporary moratoriums for some HHAs and ambulance suppliers

CMS has released a notice that its temporary moratorium on the enrollment of ambulance suppliers and home health agencies (HHAs) in designated geographic locations is being extended to combat fraud, waste, and abuse. CMS made the announcement in an advance release that covers metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey.

ACA

Section 6401(a) of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) provided the HHS Secretary with the authority to impose a temporary moratorium on providers and suppliers in Medicare, Medicaid, or CHIP if it is determined that a moratorium is necessary to “prevent or combat fraud, waste, or abuse” in the programs.

Moratoriums

In 2013, CMS imposed moratoriums on the enrollment of new HHAs in Miami-Dade County, Florida and in Cook County, Illinois and their surrounding counties. It also imposed moratoria on Part B ambulance suppliers in Harris County, Texas and its surrounding counties. The moratoriums were extended for another six months in 2014 and expanded to include HHAs located in Broward County, Florida; Dallas County, Texas; Harris County, Texas; and Wayne County, Michigan and their surrounding counties. The ambulance supplier moratoriums were also expanded to include Philadelphia, Pennsylvania and its surrounding counties.

Criteria

CMS consulted with the HHS Office of Inspector General (OIG) and the Department of Justice (DOJ) in identifying two types of providers and suppliers in nine geographic areas that warranted temporary moratoriums. CMS also consulted with appropriate state Medicaid agencies and state departments of emergency medical services and determined that the moratoriums would not create access care issues for Medicaid or CHIP beneficiaries.

Duration

Under 42 C.F.R. Sec. 424.570(b), temporary moratoriums will remain in effect for six months, and may be extended in six-month increments. CMS consulted with HHS OIG and determined that there remains a significant potential for fraud, waste, and abuse in the identified geographic areas and the circumstances that warranted the moratoriums have not abated. Additionally, CMS has determined that the moratoriums are needed to allow it to continue to monitor and proceed with administrative actions against providers and suppliers. As a result, CMS is extending the temporary moratoriums for the enrollment of HHAs and ground ambulance suppliers in Medicare, Medicaid, and CHIP.

Part D could save billions if CMS had negotiating power

Medicare Part D pays more for name-brand drugs than many other countries and even other U.S. government programs, such as Medicaid and the Veterans Health Administration (VHA). The Carlton University School of Public Policy and Administration found that, because brand-name drug prices are so high, many beneficiaries fail to fill prescriptions due to financial constraints. Reducing the prices would reduce premiums and co-pays, as well as taxpayer contributions used to fund Part D.

Part D

Part D is the largest federal drug program, with $69.3 billion spent on prescription drugs in 2013 and over 39.1 million people covered. Part D represents about 7 percent of the global prescription drug market, and about 58 percent of Part D spending goes to brand-name manufacturers. Plan sponsors are able to obtain rebates from manufacturers and pharmacies, but the HHS Office of Inspector General (OIG) has previously expressed doubts that these savings are passed on to beneficiaries in the form of lower premiums. Medicare itself is prohibited from interfering with these negotiations and therefore cannot leverage its purchasing power. Without congressional approval, CMS cannot reduce drug prices by securing rebates or discounts.

Comparisons

According to the study, due to CMS’ constraints, the Part D program pays 73 percent more than Medicaid and 80 percent more than the VHA for drugs. If Part D could secure the same prices as these other programs, it would save between $15.2 billion and $16 billion per year. However, even Medicaid and VHA pay higher prices than many countries in the Organization for Economic Co-operation and Development (OECD). The majority (21) of OECD countries cover 100 percent of their populations with a public drug plan, while the U.S. and Canada rely on private plans and have higher drug costs. Studies show that U.S. costs per capita for drugs are $1,010, while the OECD average is $498. Further, 19 percent of Americans chose not to fill prescriptions due to cost in 2014, which is a high ratio of cost related non-adherence (CRNA). Although the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) reduced the CRNA from 26 percent in 2010, other countries have ratios from 2 percent to 13 percent.

In 2014, Part D provided no coverage for the first $310 a beneficiary spent on drugs per year without a rebate, then covered 75 percent of spending between $310 and $2,850 with a rebate average of 17 percent. Between this amount and the catastrophic limit on out-of-pocket costs of $4,550, the study notes, there is limited coverage for generic and brand-name drugs although there is a mandatory discount of 50 percent for brand name drugs. The report notes that discounts and rebates are different, as rebates are reimbursed by manufacturers after the drug is purchased at full price and discounts are price reductions at the point of sale. Sponsor rebates lowered Part D payments to an average of 83 percent of official manufacturer prices.

Medicaid receives a mandatory rebate of at least 23.1 percent of the average manufacturer’s price for brand-name drugs. An inflation rebate is imposed if the average price rises faster than general inflation, and represents more than half of brand-name drug rebates. The VHA has four different options for receiving lower prices on drugs, and by utilizing the option that offers the lowest price, VHA paid on average about 46 percent of official manufacturer prices.

Policy

Proponents of the current system argue that public interference would undermine the competitive system used by plan sponsors. The report’s authors argue that Switzerland and the Netherlands also have managed competition models, like Part D, and that lower drug prices do not undermine competition among insurers and beneficiaries in these countries are subject to lower premiums. The authors also dispute the argument that reducing prices would also reduce research and development spending with by arguing that the Part D system offers few incentives for innovation, and manufacturers are more likely to produce new drugs that are extremely similar to existing drugs, but more expensive. They recommend that Part D should reduce brand name drug prices to at least match the levels of Medicaid or VHA, introduce mandatory discounts similar to VHA’s inflation discount, require generic substitution, and use these price reductions to reduce copays and deductibles.

Kusserow on Compliance: CMS moves to ease Stark rules for providers and for CMS

In the face of the landmark Tuomey case decisions that have added teeth to the enforcement of the Stark laws, CMS has learned what providers have known for years: vagueness in the law requires more interpretation. CMS has been overwhelmed by the number of self-disclosures that require interpretation, especially those involving technical violations. Previously, the agency may not have been sympathetic to calls from providers about the burden, but once the Office of Inspector General (OIG) announced that it would not handle any Stark referrals not implicating the Anti-Kickback Statute (AKS), CMS was forced to accept all the self-disclosures. Once that occurred, need for some clarifications in the regulations became dramatically clear. In response to this problem, CMS published a Proposed rule, which, if implemented, would update the Stark law regulations to account for recent changes relating to health care reform and advancements in patient care and payment methodologies (Proposed rule, 80 FR 41686, July 15, 2015). CMS is requesting information from the health care community on whether “additional guidance or rulemaking is needed to relax or remove barriers to health reform initiatives without compromising fraud and abuse prevention.”

The focus of the Proposed rule is on some of the technical requirements, which should not rise to enforcement levels. These changes were included in the 2016 Medicare physician fee schedule regulation and address many potential modifications to the Stark law, including the creation of new exceptions and guidance on CMS’ interpretation of existing Stark law exceptions. The most significant changes would involve: (1) new exceptions under the law for time-sharing arrangements with physicians; (2) recruitment incentives for non-physician practitioners; and (3) recognition that certain technical violations, such as expired agreements, would not necessarily arise to a fraud or abuse enforcement action.

Time-sharing agreements

CMS proposed a new Stark exception for time-share arrangements recognizing that it is a common practice for hospitals to rent space to physicians for a small amount of time during a defined period of time to permit patient visits at a location other than their primary office, for the convenience of the patients, the physician, or both. Under the Proposed rule, this would be permitted if physicians pay their hospital-landlord on a prorated basis for the time they occupy the space, and for the staff and equipment they use. However, such rentals would have to comply with Stark exception requirements (e.g., leases, equipment rentals), the agreement would have to be in writing, and it would have to reflect payment at fair-market value (FMV).

Non-physician practitioners

CMS has taken note of the fact that there is a looming shortage of primary care physicians and has proposed a limited exception for hospitals, federally qualified health centers (FQHCs), and rural health clinics (RHCs) to provide remuneration to physicians to assist with recruitment and employment of non-physician practitioners who receive remuneration from the hospital. This could add more non-physician practitioners to fill the gap. The exception would include many of the standard Stark safeguards, such as a written agreement signed by the hospital and the physician as well as remuneration that does not take into account the volume and value of referrals. Comments are also being sought as to whether this exception should also apply to non-physician practitioners who are recruited as independent contractors.

Technical issues

CMS also noted receiving numerous self-referral disclosures that are procedural in nature with providers saying they are unclear whether an arrangement has to be memorialized in a single document that covers all aspects of the arrangement. CMS reported that while a single document provides “the surest and most straightforward means” of compliance, “a collection of documents evidencing the course of conduct between the parties may satisfy the writing requirement.” This could extend to a variety of arrangements.

Comments

CMS is requesting comments from the industry to assist them with these changes. The agency can expect nothing but support from the industry for these proposed changes. For those interested in reviewing the entire draft rule and provide comments, such must be done by September 8, 2015. This is also an opportune time for hospitals to have their physician arrangements reviewed for current compliance and to understand the implications of the Proposed rule changes. This should not be done by anyone involved in development of them, but by independent experts under direction of legal counsel.

 

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

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Copyright © 2015 Strategic Management Services, LLC. Published with permission.

 

MedPAC proposes cure for what’s ailing hospital payment policies

According to Mark Miller, Executive Director of the Medicare Payment Advisory Commission (MedPAC), as a result of health care reform and changing trends in care settings, several areas of the fee-for-service (FFS) hospital payment policies need to be improved to ensure that payments are accurate. Miller provided testimony before the House of Representatives Committee on Ways and Means that summarized the MedPAC’s findings relating to hospital payment trends and its recommendations for improving the accuracy of FFS payment rates.

Trends

Inpatient discharges for Medicare patients declined 4.4 percent between 2012 and 2013. Notably, the use of outpatient services increased 33 percent for Medicare FFS Part B beneficiaries over the past seven years, which according to MedPAC, represents an increasing trend in providing care in outpatient settings. It also reflects the increasing number of hospitals that are purchasing and converting freestanding physician practices into hospital outpatient departments (HOPDs). This has resulted in a market shift away from freestanding practices and higher Medicare spending because the program pays higher rates in such settings than in freestanding offices.

Payment adequacy

Private insurers pay at higher rates, which allow hospitals to have higher costs that make Medicare payments appear inadequate. Hospital consolidation has allowed hospitals to gain a greater market power than private insurers. Therefore, hospitals do not receive pressure from private insurers to contain their costs.

Recommended payment changes

MedPAC recommended a number of changes to hospital payment policies, including outpatient rates should be equal or made closer to physician office rates for similar set of services. Similarly, standard payment rates for long-term care hospitals (LTCHs) should be paid only for patients who are truly chronically, critically ill (CCI). Services provided to LTCH patients who are not CCI should be paid based on inpatient prospective payment system (IPPS) rates.

IME and DSH payments

MedPAC has determined that only 40 to 45 percent of indirect medical education (IME) payments can be justified as covering the higher costs of Medicare inpatient care, which leaves $3.5 billion paid to teaching hospitals with little accountability.

Additionally, the disproportionate share hospital (DSH) payment policy does not relate to the cost of treating low-income patients. Section 2551 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) revised the DSH system by requiring that Medicare payments be divided between one pool for traditional DSH and another pool for non-Medicare uncompensated care costs. While MedPAC has raised concerns about how the uncompensated payments are allocated, the amount of such payments will decline as the uninsured rate decreases.

GME

According to MedPAC, the graduate medical education (GME) system is not aligned with delivery system reforms. Medicare payments for GME should be decoupled from the inpatient FFS payment system and GME resources should be devoted solely to programs that meet high educational standards. Medicare payments to teaching hospitals should be more transparent, and there should be studies of workforce needs, specialty residency programs, and medical school diversity.

Readmissions penalty

MedPAC recommends that the hospital readmissions penalty established by Section 3025 of the ACA should be continued, but recommends expanding the penalty to cover certain post-acute care providers. It recommended setting a fixed target for readmission rates and the readmission rates of hospitals that treat a large share of low-income patients should be compared based on peers serving a similar amount of Medicare beneficiaries.

Two-Midnight Rule

In response to the highly controversial, “Two-Midnight Rule,” MedPAC recommended that Recovery Audit Contractor (RAC) audits be focused on hospitals with the highest inpatient stay rates. The RAC contingency fees should be adjusted to make them more accountable for claims denials, and the RAC look-back period and rebilling window should be better aligned. MedPAC recommended withdrawing the Two-Midnight Rule completely because it will eliminate RAC oversight of a large number of inpatient claims.

Eliminate beneficiary liability

In order to address issues of beneficiary liability for short hospital stays, legislators should revise the three-inpatient-day hospital eligibility requirements for SNF care coverage so as to allow up to two outpatient observation days to count toward the requirement. Acute care hospitals should also be required to timely notify beneficiaries that they are in observation status and that it may affect their financial responsibility.

Lastly, MedPAC suggested that Medicare should create severity diagnosis-related groups that are specifically designed for one-day hospital stays. Alternatively, Medicare could adopt a site neutral payment policy that makes payments equal for similar short inpatient and outpatient stays.