CMS has announced that it has awarded the Region 5 Recovery Audit contract to Connolly, LLC (although the General Accounting Office subsequently reported that a bid protest has been filed regarding this award). The purpose of this contract will be to identify improper Medicare payments for durable medical equipment (DME), orthotics, prosthetics, and supplies and home health/hospice (HH/H) claims and work with CMS and the DME and HH/H MACs to adjust claims to recoup overpayments and pay underpayments. CMS observes that this award marks the beginning of the new Recovery Audit contracts, and it is the first contract to incorporate a series of changes intended to reduce the provider burden and increase program transparency (e.g., ADR limits, RAC accuracy threshold).
Today the HHS Officeof Inspector General (OIG) published its annual solicitation of recommendations for new or modified safe harbor provisions under the federal anti-kickback statute, as well as potential topics for new OIG Special Fraud Alerts. Comments will be accepted until March 2, 2015.
In a separate report, the OIG discusses three safe harbor proposals received in response to its 2013 solicitation:
- A new safe harbor protecting free continuing medical education programs offered by hospitals to physicians – The OIG is not adopting this suggestion, stating that the concept of free programs could vary greatly and should be addressed on a case-by-case basis, such as under the advisory opinion process.
- A new safe harbor that would permit health care providers and suppliers in certain circumstances to compensate individuals in clinical trials and to provide services related to the clinical trials at no cost, including the waiver of cost-sharing obligations – The OIG is considering the adoption of a safe harbor that would protect the waiver of cost-sharing obligations and possibly other incentives to participants in clinical trials sponsored by certain federal government entities.
- A new safe harbor protecting clinically integrated networks’ entry into contracts with commercial third party payors for value-based payments, including pay-for-performance bonuses and shared savings awards for high quality and cost-effective health care – The OIG believes the issues raised in the proposal require further study.
In preparation for legislative activity early next year, various lawmakers have issued open requests for feedback on several health policy initiatives. For instance:
- The House Ways and Means Health Subcommittee chairman and ranking member have released a bipartisan bill including a variety of Medicare fraud/abuse provisions, covering such issues as recovery audit contractors, prevention of Medicare Part D prescription drug abuse, elimination of civil monetary penalties for inducements to physicians to limit services that are not medically necessary, and others.
- The House Energy and Commerce Committee is seeking feedback on the regulation of in vitro diagnostic test kits and laboratory developed tests (LTDs); comments are due by January 5, 2015.
- The Energy and Commerce Committee also is requesting comments on graduate medical education (GME) financing, federal program governance and structure, and how it might be improved or restructured. Feedback is due by January 16.
The OIG has issued its Semiannual Report to Congress for the period of April 1 – September 30, 2014, in which it highlights significant investigation, audit, and enforcement activities and achievements across HHS programs during the six-month period and for all of FY 2014. The OIG reports expected recoveries exceeding $4.9 billion during FY 2014, consisting of almost $834.7 million in audit receivables and about $4.1 billion in investigative receivables (including about $1.1 billion in non-HHS investigative receivables, such as states’ shares of Medicaid restitution). In FY 2014, the OIG also reported: exclusions of 4,017 individuals and entities from participation in federal health care programs; 971 criminal actions against individuals or entities; and 533 civil actions (including false claims and unjust-enrichment lawsuits filed in federal district court, CMP settlements, and administrative recoveries related to provider self-disclosure matters). In addition to discussing legal and investigative activities, the report recaps various reports issued by the OIG over the 6–month period. It also responds to public suggestions for new anti-kickback safe harbors related to hospital continuing medical education programs, clinical trial participant compensation, and contracts between clinically integrated networks (CINs) and commercial third party payors for value-based payments.
Based on a review of Prescription Drug Event (PDE) records for human immunodeficiency virus (HIV) drugs and other beneficiary records, the OIG determined that Medicare Part D paid for HIV drugs for over 150 deceased beneficiaries in 2012, most of which were dispensed by retail pharmacies. The OIG identified shortcomings in CMS claims edits that reject PDE records for drugs with dates of service more than 32 days after death that allowed payment for drugs that do not meet Medicare Part D coverage requirements. The OIG recommends that CMS eliminate or, if necessary for administrative processing, shorten the window in which it accepts PDE records for drugs dispensed after a beneficiary's death; CMS concurred. The OIG also observes that while its report focuses on HIV drugs, the issues raised are relevant to all Part D drugs.
CMS Finalizes Rule to Strengthen Medicare Provider Enrollment Regulations and Permit Revocations for Patterns/Practices of Improper Claims Submissions; Defers Expanded Awards for Medicare Fraud Tipsters
On December 5, 2014, the Centers for Medicare & Medicaid Services (CMS) published a final rule that expands the circumstances under which it may deny or revoke the Medicare enrollment of entities and individuals on program integrity grounds, effective February 3, 2015.
- Allows CMS to deny the new enrollment of providers, suppliers, and owners that previously were affiliated with an entity with unpaid Medicare debt that existed when the entity’s enrollment was voluntarily terminated, involuntarily terminated, or revoked. This provision applies when (1) the owner left the provider or supplier that had the Medicare debt within one year of that provider or supplier’s voluntary termination, involuntary termination, or revocation; (2) the Medicare debt has not been fully repaid; and (3) CMS determines that the uncollected debt poses an undue risk of fraud, waste, or abuse (based on factors set forth is the final rule). A denial under this provision can be averted if the enrolling provider, supplier, or owner (1) satisfies the criteria set forth in 42 CFR § 401.607 and agrees to a CMS-approved extended repayment schedule for the entire outstanding Medicare debt; or (2) repays the debt in full.
- Provides that a managing employee’s felony conviction can serve as a basis for denial or revocation of a provider or supplier's enrollment. Specifically, CMS could deny enrollment or revoke Medicare billing privileges if, within the preceding 10 years, the provider or supplier, or any owner or managing employee thereof, was convicted of a federal or state felony offense (including those enumerated in the rule) that CMS determines to be detrimental to the best interests of the Medicare program and its beneficiaries.
- Enables CMS to revoke Medicare billing privileges if it determines that the provider or supplier has a “pattern or practice” of submitting claims for services that fail to meet Medicare requirements. CMS enumerates the following five factors as ones it will consider prior to imposing a revocation under this authority: (1) the percentage of claims denied; (2) the reasons for the claims denials; (3) a history of final adverse actions; (4) the length of time the pattern has continued; and (5) the length of time the provider or supplier has been enrolled in Medicare. CMS also may consider any other information regarding the provider or supplier’s specific circumstances the agency deems relevant. Importantly, CMS clarifies that its contractors (e.g., Medicare Administrative Contractor, Recovery Audit Contractors) will not be authorized to make determinations under this authority; only CMS itself will make such a determination.
- Limits the ability of ambulance suppliers to “backbill” for services performed prior to enrollment.
- Requires all providers and suppliers subject to revocations to submit all of their remaining claims within 60 days after the effective date of such revocation, except that with regard to home health agencies (HHAs), this date will be 60 days after the later of: (1) the effective date of the revocation; or (2) the date that the HHA’s last payable episode ends.
- Limits the ability of revoked providers and suppliers to submit a corrective action plan (CAP) to situations in which the revocation was based on 42 CFR § 424.535(a)(1), which states in part that a provider or supplier’s billing privileges may be revoked if the provider or supplier is determined not to be in compliance with enrollment requirements. CMS notes that it believes “providers and suppliers generally should not be exonerated from failing to fully comply with Medicare enrollment requirements simply by furnishing a CAP.” Nevertheless, there are situations in which revocations under § 424.535(a)(1) could result when a provider or supplier “had only minimally failed to comply with our enrollment requirements,” and revoking billing privileges “when the problem can be quickly and easily corrected via a CAP could in some instances lead to unfair results.”
Notably, CMS is not finalizing its proposal that would have dramatically increased the potential reward to an individual who provides a tip leading to the recovery of Medicare funds under the Medicare Incentive Reward Program due to the complexity of the operational aspects of the proposed changes,” but CMS may finalize the proposal in future rulemaking.
CMS intends to conduct a three-year Medicare prior authorization model for non-emergent hyperbaric oxygen therapy services in Illinois, Michigan, and New Jersey, where CMS contends there have been high rates of improper payments for these services. Under this model, CMS will require that all relevant clinical or medical documentation requirements are met before services are rendered to beneficiaries and before claims are submitted for payment; no new clinical documentation requirements will be created. The model is scheduled to begin on March 1, 2015. CMS also recently announced a similar prior authorization model for repetitive scheduled nonemergent ambulance transports.
The U.S. Department of Justice (DOJ) has announced a record $5.69 billion in civil False Claims Act settlements and judgments for FY 2014, including almost $3 billion in recoveries related to qui tam lawsuits. The DOJ reports $2.3 billion in health care fraud recoveries in FY 2014, primarily involving the Medicare and Medicaid programs.
The OIG has released its compilation of “2014 Top Management & Performance Challenges,” highlighting the following 10 most significant management and performance challenges now facing HHS:
- Implementing, Operating, and Overseeing the Health Insurance Marketplaces
- Ensuring Appropriate Use of Prescription Drugs in Medicare and Medicaid
- Protecting an Expanding Medicaid Program from Fraud, Waste, and Abuse
- Fighting Waste and Fraud and Promoting Value in Medicare Parts A and B
- Ensuring Quality in Nursing Home, Hospice, and Home- and Community-Based Care
- The Meaningful and Secure Exchange and Use of Electronic Health Information
- Effectively Operating Public Health and Human Services Programs to Best Serve Program Beneficiaries
- Ensuring Effective Financial and Administrative Management
- Protecting HHS Grants and Contract Funds from Fraud, Waste, and Abuse
- Ensuring the Safety of Food, Drugs, and Medical Devices
CMS Announces 3-State Medicare Prior Authorization Model for Repetitive Nonemergent Ambulance Transport
In light of government reports finding high utilization and potential improper Medicare payments associated with repetitive scheduled nonemergent ambulance transports, CMS will test a prior authorization model program for these services in New Jersey, Pennsylvania, and South Carolina. CMS defines repetitive ambulance service as medically necessary ambulance transportation that is furnished in 3 round trips or more times during a 10-day period, or at least once per week for at least 3 weeks. CMS notes that such repetitive ambulance services are often needed by beneficiaries receiving dialysis, wound care, or cancer treatment. The use of prior authorization will not create new clinical documentation requirements for suppliers; instead information that is already required to support Medicare payment will be furnished earlier in the process, prior to rendering services. The prior authorization program is scheduled to begin December 1, 2014 and last three years.
The HHS OIG has posted its FY 2015 Work Plan, which summaries the audit, evaluation, and other legal and investigative initiatives that the OIG intends to conduct in the coming year. The OIG plans numerous reviews of CMS, FDA, and other HHS agency programs, with a particular focus on Medicare and Medicaid reimbursement and program integrity policies. The OIG also forecasts areas that may be the subject of review in future years, including emerging Affordable Care Act marketplace issues, Medicaid expansion, and new Medicare payment and delivery models, among others. The OIG also plans to expand its work on Medicare and Medicaid reimbursement (including Medicaid managed care) and quality of care. The OIG notes that other areas under consideration for new reviews include the integrity of the drug and medical device supply chains; the security of electronic data; the use and exchange of health information technology; and emergency preparedness and response efforts.
The OIG published a notice today announcing that it is extending the public comment period on its July 11, 2014 notice soliciting recommendations for revising OIG's non-binding criteria for implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. The OIG notes that due to a technical problem, the public may have been unable to submit comments during the original comment period. The new comment deadline is December 29, 2014.
CMS Fingerprint-Based Background Checks are Underway - Impacting "High-Risk" Providers and Suppliers
CMS's long-awaited fingerprint-based background check screening process is underway for certain “high-risk” providers and suppliers participating in federal health care programs (specifically, Medicare, Medicaid, and the Children’s Health Insurance Program). Under CMS regulations, individuals who maintain a 5 percent or greater direct or indirect ownership interest in a provider or supplier in the high risk category -- including newly-enrolling home health agencies (HHAs) and newly-enrolling durable medical equipment, orthotics, prosthetics, and supplies (DMEPOS) suppliers -- are subject to a fingerprint-based criminal history report check of the Federal Bureau of Investigations (FBI) Integrated Automated Fingerprint Identification System.
This week CMS announced that the fingerprint-based background check process was launched on August 6, 2014. CMS confirmed that not all providers and suppliers in the “high” screening category will be included in the first phase of the background checks. Fingerprint-based background checks eventually will be required, however, “for all individuals with a 5 percent or greater ownership interest in a provider or supplier that falls into the high risk category and is currently enrolled in Medicare or has submitted an initial enrollment application.”
Medicare Administrative Contractors will send letters to the applicable providers or suppliers listing all 5 percent or greater owners who are required to be fingerprinted, and applicable individuals will have 30 days from the date of the notification letter to be fingerprinted at one of at least three specified locations. Fingerprints will be forwarded to the FBI, which will compile the background history and share results with the Fingerprint-based Background Check (FBBC) contractor (Accurate Biometrics). The FBBC will provide CMS with a "fitness recommendation" for the individual indicating whether the criminal history record information contains enrollment violations or otherwise fails to meet CMS enrollment requirements; CMS will then make the final determination about the provider or supplier.
CMS has announced that it is extending for an additional 6 months its current enrollment moratoria for new ground ambulance suppliers and home health agencies (HHAs)within designated metropolitan areas. The moratoria, which affect enrollment in Medicare, Medicaid, and the Children’s Health Insurance Program, apply to new ground ambulances in the Houston and Philadelphia metropolitan areas and new HHAs in the metropolitan areas of Chicago, Fort Lauderdale, Detroit, Dallas, Houston, and Miami. CMS discusses its rationale for extending the enrollment moratoria, including the qualitative and quantitative factors suggesting a high risk of fraud, waste, or abuse, in an August 1, 2014 notice. The extension is effective July 30, 2014. CMS may lift the moratoria before the end of the 6-month period or announce extensions in the Federal Register notice.
The OIG has posted guidance on its contractor self-disclosure program, which provides a means for contractors to self-disclose potential violations of the False Claims Act and federal criminal laws involving fraud, conflict of interest, bribery, or gratuity. The Federal Acquisition Regulation (FAR) requires federal contractors with contracts valued over $5 million to disclose to the OIG when they have credible evidence of one of these violations. The guidance specifies that such self-disclosures are made with no advance agreement regarding possible OIG resolution and with no promises regarding potential Department of Justice action. The guidance, a disclosure form, and FAQs are available at the OIG web site.
The OIG attributes $32 million in Medicare Part D spending on HIV drugs in 2012 to claims associated with “questionable utilization patterns.” Specifically, nearly 1,600 Part D beneficiaries with HIV drug claims had no indication of HIV in their Medicare histories, received an excessive dose or supply of HIV drugs, received HIV drugs from a high number of pharmacies or prescribers, or received contraindicated drugs. The OIG observes that while some of this utilization may be legitimate, these patterns warrant further scrutiny, since they could indicate that a beneficiary is receiving inappropriate drugs or diverting drugs, a pharmacy is billing for drugs that the beneficiary did not receive, or a beneficiary’s identification number was stolen. The OIG recommend that CMS: expand sponsors’ drug utilization review programs and use of beneficiary-specific controls; expand the Overutilization Monitoring System to additional drugs; restrict certain beneficiaries to a limited number of pharmacies or prescribers and limit their ability to switch plans; increase monitoring of beneficiaries’ utilization patterns; and follow up on questionable utilization patterns.
The Chairman of the House Ways and Means Subcommittee on Health is seeking comments on a draft bill, the Protecting Integrity in Medicare Act of 2014, that is “aimed at combating fraud, waste and abuse in the Medicare program.” The bill covers a range of Medicare and Medicaid policies, from establishing new alternative sanctions for technical physician self-referral violations to providing more flexibility in meeting durable medical equipment (DME) documentation requirements. Among other things, the bill would:
- Establish an alternative fixed financial penalty for individuals and entities that voluntarily disclose a technical Stark violation (e.g., an arrangement that is not in writing or that is not signed by one or more parties) through the Self-Referral Disclosure Protocol; the per-arrangement penalty would be capped at $5,000 if submitted within the year of the noncompliance and $10,000 thereafter;
- Require a study on how to establish a permanent physician-hospital gainsharing program;
- Expand the professionals who can document DME face-to-face encounters beyond physicians to align with the professionals who can furnish such encounters;
- Establish claims processing edits to prevent Medicare payments for incarcerated, unlawfully present, and deceased individuals;
- Require Medicare administrative contractors (MACs) to establish improper payment outreach and education programs, and modify how MACs prioritize efforts to reduce improper payment or error rates;
- Allow Medicaid fraud control units to investigate abuse and neglect in home and community based facilities;
- Provide the HHS OIG with up to 1.5% of all amounts collected from Medicare false claim and fraud cases;
- Give the Secretary greater flexibility to protect Medicaid from fraud, waste, and abuse;
- Improve incentives for individuals to report Medicare fraud and abuse under the Senior Medicare Patrol;
- Require valid prescriber National Provider Identifiers to be included on pharmacy claims;
- Revise the process for renewing MAC contracts;
- Create a high-risk beneficiary drug management program under the supervision of a Part D plan sponsor;
- Require the Secretary to issue guidance on the application of the “Common Rule” to clinical data registries;
- Revoke eligibility for Medicare benefits for providers convicted of defrauding the Medicare program under certain circumstances;
- Require home health agencies to obtain a surety bond in the amount of at least $50,000 as a condition of Medicare participation;
- Require prior authorization (PA) for certain chiropractic visits, blepharoplasty, and browplasty surgeries and expand a PA demonstration for non-emergent ambulance services;
- Require Social Security numbers to be removed from beneficiary Medicare cards; and
- Require the Secretary to include vacuum erection systems in the DME competitive bidding program by 2016.
Subcommittee Chairman Kevin Brady (R-TX) will accept comments on the discussion draft until September 1, 2014.
According to an OIG report, “Questionable Billing for Medicare Part B Clinical Laboratory Services,” Medicare allowed $1.7 billion for clinical laboratory claims in 2010 associated with eight types of “questionable billing.” Such indicators of questionable billing identified by the OIG include: claims for beneficiaries with no associated Part B service with ordering physician; claims with beneficiaries living more than 150 miles from the ordering physician; duplicate lab tests; claims with ineligible or invalid ordering-physician numbers; claims with compromised beneficiary, ordering-physician, or lab provider number. More than 1,000 labs had unusually high billing for five or more measures of questionable billing for Medicare lab service, and almost half of these labs were located in California and Florida. The OIG notes that while “some of this billing may be legitimate, all labs that exceeded thresholds on five or more measures of questionable billing may warrant further scrutiny.” The OIG recommends that CMS: review the labs identified as having questionable billing and take appropriate action; review the effectiveness of existing program integrity strategies; and ensure that existing edits prevent claims with invalid and ineligible ordering-physician numbers from being paid. CMS concurred with these recommendations.
The Senate Aging Committee has released a staff report entitled “Improving Audits: How We Can Strengthen the Medicare Program for Future Generations.” The report describes the burden audits can impose on providers, and raises concerns that CMS’s current efforts are “aimed more at identifying and recovering improper payments that have already occurred, rather than a proactive strategy to ensure that those errors are not made in the first place.” For instance, the Recovery Audit Contractor (RAC) contingency fee structure “could be viewed as providing an incentive to keep improper payment rates high.” The report also notes that inconsistent local coverage determinations (LCDs) can increase the burden on providers and contractors, since different rules apply depending on the location of the service provided. Moreover LCDs have not been targeted to the most costly, highly-utilized services in a consistent way and may lead to discrepancies in access to care based on the beneficiary’s location. The report includes a series of recommendations for reforms of the audit and local coverage decision processes, including consolidating post-payment review activities; revising the RAC incentive structure to focus on reduced improper payment rates; assessing the effectiveness of pre-payment review processes; improving provider education; and ensuring that LCDs are targeted and do not create inconsistent access to care. The report was issued in connection with a hearing on improving the Medicare audit program.
Today the HHS OIG issued a Special Fraud Alert highlighting its concerns regarding two trends involving transfers of value from laboratories to physicians that the OIG believes “present a substantial risk of fraud and abuse under the anti-kickback statute.” Specifically, the OIG details risks involved with certain compensation paid by laboratories to referring physicians and physician group practices for (1) blood specimen collection, processing, and packaging, and (2) submitting patient data to a registry or database. The Special Fraud Alert reiterates the OIG’s “longstanding concerns” when payments from laboratories to physicians exceed the fair market value of the physicians’ services or reflect the volume or value of referrals of federal health care program business. Reed Smith is preparing an analysis of the Alert.