Category: Administrative & Regulatory

A Review of Centers for Medicare & Medicaid Services' (CMS) Approach to $125 Million Recoupment of Payments to Providers for Services to Incarcerated / Unlawfully Present Beneficiaries

Sheppard Mullin 2012

CMS seeks to recover from providers $125 million in alleged overpayments for services to beneficiaries who are belatedly identified as ineligible (incarcerated/unlawfully present). This post examines the recovery process CMS has put in place, noting CMS procedural shortcomings and reviewing some substantive defenses available to providers facing such demands.

In January 2013, CMS’ Office of Investigator General released two parallel reports, criticizing CMS for making improper payments to providers for services rendered to beneficiaries who, according to updated Social Security Administration records, were either incarcerated or unlawfully present in the United States at the time of such service.[1]

OIG concluded that between 2010-2012, CMS made more than $125 million in improper payments to providers (including hospitals, outpatient facilities, physicians, skilled nurses, DME suppliers, home health, and hospice). OIG recommended that CMS take steps to recover such funds and avoid such payments in future.

In response, CMS noted that it already had in place a system that checks, at the time a claim is submitted, the eligibility status of each beneficiary. If data indicates that a patient is not eligible, the claim is rejected. As a result, all overpayments identified by OIG resulted from changes to SSA data after claims were processed.

Apparently anticipating these OIG reports, in November 2012, CMS published two change requests[2] to implement an Informational Unsolicited Response Process (IUR). Through an IUR, the Common Working File system would automatically flag and report to the MACs any previously paid claims where subsequent data updates indicated that the beneficiary was not eligible at time of service due to incarceration or unlawfully present status. In Spring 2013, CMS began implementing the incarcerated patient IUR.

Although CMS has Regional Audit Contractors (RACs) in place to perform post payment technical bill review, CMS has bypassed the RAC process; instead, using the IUR, CMS has instructed the MACs to “initiate recoupment procedures” upon receipt of an IUR to recover these funds. MACs, acting upon this instruction, immediately initiated recoupment through remittance advice[3] based simply upon the subsequent SSA data change. By acting in this way, CMS:

Failed to provide any explanation of the reason for the overpayment redetermination;
Failed to provide the required 15 day opportunity for rebuttal;
Failed to defer recoupment pending the 15 day rebuttal period and through reconsideration;
Failed to address whether provider liability should be waived under section 1870 of the Social Security Act (no fault waiver); and
Failed to advise providers of their appeal rights.[4]

Providers reacted with surprise, placing many calls to the MACs and SSA (to address mistakes in data). In many cases, SSA data indicating incarceration of a patient was simply erroneous; even if valid, it appears that, like CMS, provider were generally unaware of ineligibility at the time of service.

CMS initially took the position that notice letters were not required and there would be no appeal rights; CMS at first indicated that any erroneous findings would be addressed by “data revisions” (presumably through a discretionary reopening by the MAC).

CMS has modified some of its positions based upon provider objection.

In recent FAQs,[5] CMS now concedes that providers do have appeal rights.

But CMS says most errors won’t be fixed until October 2013.

Critically, CMS has not yet addressed its failure to give providers proper notice, explanation of findings, rebuttal rights, its failure to consider no fault waiver. CMS also has so far failed to honor the post payment restrictions on recoupment pending rebuttal and appeal.

The SSA database is not perfect. In one case, a hospice was put on recoupment for months of service to a female beneficiary in 2010-2011 who was mistakenly identified in the SSA database with an unrelated incarcerated male patient. Notice and thoughtful consideration of rebuttal evidence would have prevented this error.

Perhaps more importantly for the general provider community, at the time each provider filed claims for services previously rendered, SSA data showed that the patient was eligible (or the claim would not have been paid). This fact presents a strong case for waiver of provider overpayment liability under the no fault provisions of section 1870 of the Social Security Act.

[1]http://oig.hhs.gov/oas/reports/region7/70203008.htm and https://oig.hhs.gov/oas/reports/region7/71201116.asp

[2] CR 8007 and CR 8009; eg: http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R1134OTN.pdf

[3] Incarcerated Patient shows ANSI Code 81G.

[4] Key Authorities Include: 42 USC §§ 1395ff, 1395gg, 1395ddd(f); 42 CFR §§ 405.373, 405.379, 405.982; and the Medicare Financial Management Manual, Ch. 34, § 90.

[5] http://www.cms.gov/Medicare/Medicare-Contracting/FFSProvCustSvcGen/Downloads/Incarcerated-Beneficiary-FAQs-8-1-13.pdf

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First Post-Supreme Court Defense of Marriage Act (DOMA) Case Rules in Favor of Same-Sex Spouse

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In one of the first post-Supreme Court DOMA cases, the Eastern District of Pennsylvania, applying Illinois state law, held that the surviving same-sex spouse of a deceased participant in an employer sponsored pension plan was entitled to the spousal death benefit offered under the plan. See Cozen O’Connor, P.C. v. Tobits, Civil Action No. 11-0045; 2013 WL 3878688 (E.D. Pa., July 29, 2013).

This case is significant because it is the first case after the Supreme Court’s June 26, 2013 decision in United States v. Windsor, 133 S. Ct. 2675 (2013) to grapple with choice of law in determining whether a marriage is valid for purposes of obtaining spousal benefits under an ERISA-covered plan. While Windsor ruled that Section 3 of DOMA defining marriage only as between persons of the opposite sex unconstitutional for purposes of applying federal law, it did not address or invalidate Section 2, which permits states to decline to recognize same-sex marriages performed in other states.

Case Background

In 2006, Sarah Farley and Jean Tobits were married in Canada. Shortly after they were married, Ms. Farley was diagnosed with cancer, and she died in 2010. At the time of her death, Ms. Farley was employed by the law firm of Cozen O’Connor and a participant in the firm’s profit sharing plan (the Plan). The Plan provided that a participant’s surviving spouse would receive a death benefit if the participant died before the participant’s retirement date. If the participant was not married or the participant’s spouse waived his or her right to the death benefit, the participant’s designated beneficiary would be entitled to the death benefits. The Plan defined “Spouse” as “the person to whom the Participant has been married throughout the one-year period ending on the earlier of (1) the Participant’s annuity starting date or (2) the date of the Participant’s death.”

Ms. Farley’s parents and Ms. Tobits both claimed a right to the Plan’s death benefits. Ms. Farley’s parents claimed that they had been designated as the beneficiaries, but it was undisputed that Ms. Tobits had not waived her rights to the death benefits. Cozen O’Connor filed an interpleader action in the Eastern District of Pennsylvania asking the court to determine who was entitled to the benefits. Therefore, the case focused on whether Ms. Tobits qualified as a “Spouse” under the Plan and thus was entitled to the death benefits.

The Court’s Ruling

The court noted that Windsor “makes clear that where a state has recognized a marriage as valid, the United States Constitution requires that the federal laws and regulations of this country acknowledge that marriage” irrespective of whether the marriage is between a same-sex couple or a heterosexual couple. With Windsor’s emphasis on states’ rights to define marriage, lower courts are left with the complicated task of deciding which state law applies when determining whether a same-sex spouse is entitled to benefits under federal law in those instances, as in Cozen, where multiple jurisdictions with different laws on same-sex marriage are implicated.

Apparently, because Cozen O’Connor is headquartered in Pennsylvania, the Plan is administered there, and the Plan’s choice of law provision references Pennsylvania law, the Farleys asked the court to apply Pennsylvania state law to determine the validity of the marriage. Pennsylvania’s mini-DOMA statute expressly defines marriage as between a man and a woman. The court concluded that ERISA preempted Pennsylvania law. It reasoned that if courts were required to look at the state in which the plans were drafted, plan administrators might be encouraged to forum shop for states with mini-DOMA laws to avoid paying benefits to same-sex couples. The court thought this kind of forum shopping would upset ERISA’s principle of maintaining national uniformity among benefit plans. Without further analysis, the court concluded Pennsylvania state law was not an option for determining Ms. Tobits’ status as a spouse within the meaning of the Plan.

Instead, the court applied Illinois law, the state where Ms. Farley and Ms. Tobits had jointly resided until Ms. Farley’s death. It was undisputed that Ms. Farley and Ms. Tobits had a valid Canadian marriage certificate. The court concluded that the marriage was valid in Illinois and that Ms. Tobits was Ms. Farley’s spouse within the Plan’s definition. Accordingly, the court held that Ms. Tobits was entitled to the Plan’s death benefit. Although not entirely clear, the court presumably came to this conclusion based on Illinois’ civil union statute (even though it was enacted after Ms. Farley’s death). The statute provides that (i) same-sex marriages and civil unions legally entered into in other jurisdictions will be recognized in Illinois as civil unions and (ii) persons entering into civil unions will be afforded the benefits recognized by Illinois law to spouses. See 750 Ill. Comp. Stat. An. 75/5 and 75/60 (West 2011).

Impact of Cozen on ERISA Benefit Plans

Cozen is the first ruling in the wake of Windsor to address which state law might apply when there are conflicting state laws as to whether a valid marriage is recognized for the purpose of being a “spouse,” and therefore whether the spouse is entitled to benefits under an ERISA-covered plan. In Cozen, Ms. Farley and Ms. Tobits were lawfully married in Canada, and the court ruled that Illinois’s civil union law recognizes lawful marriages performed in other jurisdictions. The court applied the law of the domicile state to support its holding that Ms. Tobits was a surviving spouse entitled to the Plan’s death benefit.

The Cozen decision may have little value outside of cases where a valid same-sex marriage is performed in one state (the “state of celebration”) and the state where the couple is domiciled recognizes same-sex marriages. In other situations, faced with a choice of law where the law of the state of domicile conflicts with the law of the state of celebration, the outcome could be different, because Section 2 of DOMA survives after the Windsor decision. Unless the federal government creates a uniform method of determining the choice of law question, ERISA cases raising benefit entitlement questions in the context of same-sex marriages are likely to continue to complicate plan administration, and ERISA’s goal of maintaining national uniformity in the administration of benefits will remain elusive.

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US Government Accountability Office (GAO) Advocates for Increased Attention on Adapting to the Effects of Climate Change

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The US Government Accountability Office (GAO), the federal government’s non-partisan internal auditor, has jumped into the climate change fray, arguing that the federal government must improve how it is addressing the effects of climate change, in addition to and irrespective of any actions taken to prevent or reverse it. In two reports issued earlier this year, the GAO describes shortcomings in federal efforts to address the “significant financial risks” from climate change and recommends both macro and micro level changes to address these risks.

The first of the two reports is the biennial update to GAO’s list of federal programs and operations at “high risk” for waste, fraud, abuse, and mismanagement or needing broad-based transformation (High Risk List).[1] The High Risk List was originally compiled in 1990 and is released at the start of each new Congress to help in setting oversight agendas. An issue is added to the High Risk List if it meets the following four criteria:

  • the issue is of national significance;
  • it is key to government performance and accountability;
  • the associated risk involves public health or safety, service delivery, national security, national defense, economic growth, or privacy or citizens’ rights; and
  • the issue could result in significant impaired service, program failure, injury or loss of life, or significantly reduced economy, efficiency, or effectiveness.

The 2013 High Risk List adds climate change to the list of now 30 issues that meet these “high risk” criteria.[2] According to the GAO, the federal government allocates greater sums of money each year to climate change adaptation activities, but it is “not well organized to address the fiscal exposure presented by climate change, partly because of the inherently complicated, crosscutting nature of the issue.” In particular, the GAO is concerned that the federal government is exposed to “significant financial risks” from climate change: (1) as a property owner of extensive infrastructure; (2) as an insurer through the National Flood Insurance Program; (3) as an investor in infrastructure projects that state and local governments prioritize and supervise; and (4) as a provider of emergency aid in response to natural disasters.

In determining the scope of its policy recommendations, the GAO considered whether to focus on responses to prevent or reverse climate change or responses to adapt to the effects of climate change. In choosing to focus on adaptation strategies, GAO cites research from the National Research Council (NRC) and the United States Global Change Research Program (USGCRP) concluding that greenhouse gases already in the atmosphere will irrevocably alter the climate system for many decades.[3] The resulting policy recommendations advocate for key entities within the Executive Office of the President, including the Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy, in consultation with federal, state, and local stakeholders, to develop “a government-wide strategic approach with strong leadership and the authority to manage climate change risks that encompasses the entire range of related federal activities and addresses all key elements of strategic planning.” The GAO anticipates that this centralized approach will increase efficiencies in these efforts and take advantage of economies of scale. Private entities that operate in the infrastructure sector, and in related industries, should monitor the executive and legislative responses to these broad-based recommendations.

The second report centers on one of the areas of concern from the climate change addition to the High Risk List — the federal government’s role in supporting state and local governments in their efforts to strengthen infrastructure vulnerable to the effects of climate change.[4] In it, the GAO examines (1) the impacts of climate change on infrastructure; (2) the extent to which climate change is incorporated into infrastructure planning; (3) factors that enabled some decision makers to implement adaptive measures; and (4) federal efforts to address local adaptation needs, as well as potential opportunities for improvement. Similar to the recommendations made in the climate change portion of the High Risk List, GAO advocates for a centralized system of information and data, as well as streamlined access to that data for local infrastructure decision makers, as one of the primary means to increasing and improving climate-related adaptions in infrastructure planning. Of the specific projects that GAO studied in order to prepare the report, those that had easy access to climate data and expertise to help interpret that data were more likely to incorporate adaptions to address the effects of climate change into their plans.

Furthermore, the GAO specifically recommends that CEQ finalize its 2010 guidance on how federal agencies should consider the effects of climate change in their evaluations of proposed federal actions under the National Environmental Policy Act (NEPA). Until the guidance is final, it is “unclear how, if at all, agencies are to consistently consider climate change in the NEPA process, creating the potential for inconsistent consideration of the effects of climate change in the NEPA process across the federal government.”[5] Therefore, entities involved in projects that fall under NEPA’s purview should monitor CEQ’s activities on this issue and consider submitting comments on any resulting guidance or regulation.

[1] GAO, High-Risk Series: An Update, Report No. GAO-13-283 (Feb. 2013)

[2] Id. at 61-76 (“Limiting the Federal Government’s Fiscal Exposure by Better Managing Climate Change Risks”).

[3] Id. at 63 (“[L]imiting the federal government’s fiscal exposure to climate change risks will present a challenge no matter the outcome of domestic and international efforts to reduce emissions”).

[4] GAO, Climate Change: Future Federal Adaptation Efforts Could Better Support Local Infrastructure Decision Makers, Report No. GAO-13-242 (Apr. 2013).

[5] Id. at 87. 

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U.S. Medical Oncology Practice Sentenced for Use and Medicare Billing of Cancer Drugs Intended for Foreign Markets

GT Law

In a June 28, 2013 news release by the Office of the United States Attorney for the Southern District of California, in San Diego, it was reported that a La Jolla, California medical oncology practice pleaded guilty and was sentenced to pay a $500,000 fine, forfeit $1.2 million in gross proceeds received from the Medicare program, and make restitution to Medicare in the amount of $1.7 million for purchasing unapproved foreign cancer drugs and billing the Medicare program as if the drugs were legitimate. Although the drugs contained the same active ingredients as drugs sold in the U.S. under the brand names Abraxane®, Alimta®, Aloxi®, Boniva®, Eloxatin®, Gemzar®, Neulasta®, Rituxan®, Taxotere®, Venofer® and Zometa®), the drugs purchased by the corporation were meant for markets outside the United States, and were not drugs approved by the FDA for use in the United States. Medicare provides reimbursement only for drugs approved by the Food and Drug Administration (FDA) for use in the United States. To conceal the scheme, the oncology practice fraudulently used and billed the Medicare program using reimbursement codes for FDA approved cancer drugs.

In pleading guilty, the practice admitted that from 2007 to 2011 it had purchased $3.4 million of foreign cancer drugs, knowing they had not been approved by the U.S. Food and Drug Administration for use in the United States. The practice admitted that it was aware that the drugs were intended for markets other than the United States and were not the drugs approved by the FDA for use in the United States because: (a) the packaging and shipping documents indicated that drugs were shipped to the office from outside the United States; (b) many of the invoices identified the origin of the drugs and intended markets for the drugs as countries other than the United States; (c) the labels did not bear the “Rx Only” language required by the FDA; (d) the labels did not bear the National Drug Code (NDC) numbers found on the versions of the drugs intended for the U.S. market; (e) many of the labels had information in foreign languages; (f) the drugs were purchased at a substantial discount; (g) the packing slips indicated that the drugs came from the United Kingdom; and (h) in October, 2008 the practice had received a notice from the FDA that a shipment of drugs had been detained because the drugs were unapproved.

In a related False Claims Act lawsuit filed by the United States, the physician and his medical practice corporation paid in excess of $2.2 million to settle allegations that they submitted false claims to the Medicare program. The corporation was allowed to apply that sum toward the amount owed in the criminal restitution to Medicare. The physician pleaded guilty to a misdemeanor charge of introducing unapproved drugs into interstate commerce, admitting that on July 8, 2010, he purchased the prescription drug MabThera (intended for market in Turkey and shipped from a source in Canada) and administered it to patients. Rituxan®, a product with the same active ingredient, is approved by the Food and Drug Administration for use in the United States.

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ALERT: Fraud Scheme Targets Foreign Nationals

GT Law

Foreign nationals are advised to be aware of a reported fraud scheme that is currently being perpetrated in the United States.

Individuals purporting to be officers of U.S. Citizenship and Immigration Services (USCIS) are reportedly telephoning foreign nationals to falsely claim a discrepancy or problem in such individuals’ immigration records and pressure victims to pay a “penalty” to rectify the issue. Victims are told to wire funds to an address the caller provides.

The perpetrators may possess personal information about the victim and may ask victims to provide or confirm immigration information, including an I-94 number, an alien registration number or a visa control number.

Foreign nationals who receive such calls should not forward any funds as instructed by the caller or disclose any personal information. Those targeted by the scheme should contact law enforcement, the Federal Trade Commission Bureau of Consumer Protection, and an attorney.

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Amendments to SEC Rules Regarding Broker Dealer Financial Responsibility and Reporting Requirements

Katten Muchin

The Securities and Exchange Commission adopted amendments to the financial responsibility requirements for broker dealers under the Securities Exchange Act of 1934 (Exchange Act) designed to safeguard customer securities and funds held by broker dealers. Such requirements include Exchange Act Rule 15c3-1 (Net Capital Rule), Rule 15c3-3 (Customer Protection Rule), Rules 17a-3 and 17a-4 (together, Books and Records Rules) and Rule 17a-11 (Notification Rule, and together with the Net Capital Rule, the Customer Protection Rule and the Books and Records Rules, the Financial Responsibility Rules).

The SEC amended the Customer Protection Rule to: (1) require “carrying broker dealers” that maintain customer securities and funds to maintain new segregated reserve accounts for account holders that are broker dealers; (2) place certain restrictions on cash bank deposits for purposes of the requirement to maintain a reserve to protect customer cash, by excluding cash deposits held at affiliated banks and limiting cash held at non-affiliated banks to an amount no greater than 15 percent of the bank’s equity capital, as reported by the bank in its most recent call report; and (3) establish customer disclosure, notice and affirmative consent requirements (for new accounts) for programs where customer cash in a securities account is “swept” to a money market or bank deposit product.

The SEC amended the Net Capital Rule to: (1) require a broker dealer when calculating net capital to include any liabilities that are assumed by a third party if the broker dealer cannot demonstrate that the third party has the resources to pay the liabilities; (2) require a broker dealer to treat as a liability any capital that is contributed under an agreement giving the investor the option to withdraw it; (3) require a broker dealer to treat as a liability any capital contribution that is withdrawn within a year of its contribution unless the broker dealer receives permission for the withdrawal in writing from its designated examining authority; (4) require a broker dealer to deduct from net capital (with regard to fidelity bonding requirements prescribed by a broker dealer’s self-regulatory organization (SRO)) the excess of any deductible amount over the amount permitted by the SRO’s rules; and (5) clarify that any broker dealer that becomes “insolvent” is required to cease conducting a securities business.

The SEC amended the Books and Records Rules to require large broker dealers (i.e., at least $1,000,000 in aggregate credits or $20,000,000 in capital) to document their market, credit and liquidity risk management controls. Under the amended Notification Rule there are new notification requirements for when a broker dealer’s repurchase and securities lending activities exceed 2,500 percent of tentative net capital (or, alternatively, a broker dealer may report monthly its stock loan and repurchase activity to its designated examining authority, in a form acceptable to such authority). In addition, the amended Notification Rule requires insolvent broker dealers to provide notice to regulatory authorities.

In a separate release, the SEC also amended Exchange Act Rule 17a-5 (Reporting Rule). Under the amended Reporting Rule, a broker dealer that has custody of the customers’ assets must file a “compliance report” with the SEC to verify that it is adhering to broker dealer capital requirements, protecting customer assets it holds and periodically sending account statements to customers. The broker dealer also must engage a Public Company Accounting Oversight Board (PCAOB)-registered independent public accountant to prepare a report based on an examination of certain statements in the broker dealer’s compliance report. A broker dealer that does not have custody of its customers’ assets must file an “exemption report” with the SEC citing its exemption from requirements applicable to carrying broker dealers. The broker dealer also must engage a PCAOB-registered independent public accountant to prepare a report based on a review of certain statements in the broker dealer’s exemption report. A broker dealer that is a member of the Securities Investor Protection Corporation (SIPC) also must file its annual reports with SIPC.

The rule amendments also require a broker dealer to file a new quarterly report, called Form Custody, that contains information about whether and how it maintains custody of its customers’ securities and cash. The SEC intends that examiners will use Form Custody as a starting point to focus their custody examinations. In addition, a broker dealer, regardless of whether it has custody of its clients’ assets, must agree to allow SEC or SRO staff to review the work papers of the independent public accountant if it is requested in writing for purposes of an examination of the broker dealer and must allow the accountant to discuss its findings with the examiners.

The effective date for the amendments to the Financial Responsibility Rules is 60 days after publication in the Federal Register. The effective date for the requirement to file Form Custody and the requirement to file annual reports with SIPC is Dec. 31, 2013. The effective date for the requirements relating to broker dealer annual reports is June 1, 2014.

Click here to read SEC Release No. 34-70072 (Financial Responsibility Rules for Broker Dealers).

Click here to read SEC Release No. 34-70073 (Broker Dealer Reports).

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Resale Price Maintenance in China: Enforcement Authorities Imposing Large Fines for Anti-Monopoly Law Violations

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Recently Shanghai High People’s Court reached a decision in the first lawsuit involving resale price maintenance (RPM) since China’s Anti-Monopoly Law (AML) came into effect five years ago.  Shortly thereafter, a key enforcement agency announced RPM-related fines against six milk powder companies, five of which are non-Chinese.  Both cases clearly show that RPM can be a violation of the AML, and that RPM is currently under much greater scrutiny by enforcement authorities.  It would be prudent for all foreign corporations active in China’s consumer markets to take heed of these changes in China and conduct an immediate review of any potential RPM violations.

On 1 August 2013 the Shanghai High People’s Court reached a decision in the first anti-monopoly lawsuit involving resale price maintenance (RPM) since China’s Anti-Monopoly Law (AML) came into effect in August 2008.  In addition to this judicial decision, on 7 August 2013 one of the key agencies in charge of enforcing the AML, the National Development and Reform Commission (NDRC), announced RPM-related fines of USD 109 million against six milk powder companies, five of which are non-Chinese.  Both the High People’s Court and the NDRC have been striving to clarify how they will treat RPM, and specifically have focused on the issue of whether RPM should be treated as a per se violation or should be evaluated according to a “rule of reason” analysis.

Judicial Decisions in Civil Lawsuits

According to the recent decision by the Shanghai High People’s Court, in order to hold that an RPM provision is a monopoly agreement, the court must find that the RPM provision has restricted or eliminated competition.  Furthermore, the burden of proof will be on the plaintiff to show a restriction or elimination of competition arising out of the RPM.  The High People’s Court explicitly stated that this burden is the opposite from the burden of proof for horizontal monopolies, such as a cartel, in which case the burden of proof falls on the defendant to show that the agreement does not have any effect of eliminating or restricting competition.  This burden for horizontal monopolies has been further examined and confirmed by the “Judicial Interpretation of Anti-Monopoly Disputes” that was issued by China’s Supreme People’s Court on 1 June 2012.

Administrative Decisions in Enforcement Actions—Liquor and Infant Milk Formula

There have been several key RPM enforcement actions in 2013.  In February, the NDRC imposed a fine of USD 80 million on the famous Chinese liquor brands Maotai and Wuliangye for requiring distributors to resell the products above a certain price, which is common in some sectors in China.  On 2 July, according to the Price Supervision and Anti-Monopoly Bureau of the NDRC, six milk powder companies came under investigation for RPM violations of the AML.  According to the NDRC’s statements on the case, “from the evidence obtained, the milk powder companies under investigation instituted price controls over distributors and retailers, which excluded and limited market competition and therefore are alleged to have violated the Anti-Monopoly Law”.  The NDRC later announced record fines in that case of USD 109 million, which were the equivalent of between 3 per cent and 6 per cent of the companies’ revenue in 2012.

According to media reports, in the Maotai and Wuliangye cases, the NDRC provided clear indications about some of the factors that it will consider when determining whether the RPM has “eliminated or restricted competition”.   Specifically, when assessing the relevant market and market power of the two companies, the NDRC analysed the market structure and the role played by the two companies in the liquor industry, as well as the degree to which the products are substitutable with similar products and the loyalty of consumers towards the two liquors.  Based on this analysis, the NDRC concluded that the RPM provisions in the agreements with distributors of the two liquor giants eliminated and restricted competition, and thus were vertical “monopoly agreements”.

According to recent media reports, the NDRC has indicated it will “severely crack down” on and sanction vertical monopoly agreements such as RPM if they are maintained by business operators dominant in the market.  If business operators are not dominant, the NDRC reportedly indicated that it would still investigate all vertical monopoly conduct and determine if there has been any elimination or restriction of competition.

Conclusions

These civil lawsuits and administrative cases clearly show that RPM can be a violation of the AML and that RPM is currently under much greater scrutiny by enforcement authorities.  If RPM is an issue in civil lawsuits, a plaintiff will have to prove that RPM eliminates or restricts competition.  However, there are some indications that this burden of proof may be easily met.  In administrative cases, the NDRC will have to be satisfied that it has sufficient proof to show there is an elimination or restriction of competition.  However, it is unclear what level of evidence would be required to show such a restriction and it may not be a very high level, especially if the accused business operator is dominant in the market.

RPM has been a common feature of distribution agreements and other contracts in many sectors in China.  However, the recent cases clearly show there is a serious compliance risk if RPM continues to be part of a corporation’s normal practices.  This is particularly true for business operators that have a dominant market position or a group of business operators that are regarded as jointly dominant under the AML (in China, in certain circumstances, dominance is presumed with a market share as low as 10 per cent).  Unless the RPM conduct clearly falls within an exception in Article 15 of the AML, a company using RPM may face serious fines and confiscation of illegal gains.  It would be prudent for all foreign corporations active in China’s consumer markets to take heed of these changes to the enforcement priorities of the competition/antitrust authorities in China and conduct an immediate review of any potential RPM violations.

Alex An and Jared Nelson also contributed to this article.

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Zappos and It's Effect On "Browswrap" Agreements

Lewis & Roca

Key Takeaways For An Enforceable Terms of Use Agreement

In light of the recent Nevada federal district court decision In re Zappos.com, Inc., ‎Customer Data Security Breach Litigation, companies should review and update their ‎implementation of browsewrap agreements to ensure users are bound to its terms. MDL No. ‎‎2357, 2012 WL 4466660 (D.Nev. Sept. 27, 2012).

A browsewrap agreement refers to the online Terms of Use agreement that binds a web ‎user merely by his continued browsing of the site, even when he is not aware of it. Any ‎somewhat experienced web user is no stranger to the Terms of Use link that leads to the ‎browsewrap agreement. Yet, the users tend to ignore the link’s existence, and rarely think of it ‎as a “contract” with any practical effects. In Zappos, the court questioned the browsewrap ‎agreement’s validity particularly because of this tendency among web users. The court ruled the ‎arbitration clause in Zappos’ browsewrap Terms of Use was unenforceable because the users did ‎not agree to it and Zappos had the right to modify the terms at any time. ‎

Background of the Case

Founded in 1999, Zappos.com is a subsidiary of Amazon.com and one of the nation’s ‎biggest online retailers for footwear and apparel. Currently headquartered in Henderson, ‎Nevada, the company has more than 24 million customer accounts. In mid-January 2012, its ‎computer system experienced a security breach in which hackers attempted to access the ‎company’s customer accounts and personal information.

After Zappos notified its customers about the incident, customers from across the country ‎filed lawsuits against Zappos, seeking relief for damages arising from the breach. The cases were ‎transferred to and consolidated in Nevada. Zappos then sought to enforce the arbitration clause ‎contained in its Terms of Use, which would stay the litigation in federal court and compel the ‎case for arbitration. The court denied Zappos’ motion on two grounds: there was no valid ‎agreement to arbitrate due to the lack of assent by the plaintiffs and the contract was ‎unenforceable because it reserved to Zappos the right to modify the terms at any time and ‎without notice to its users.

Lessons Learned from the Browsewrap

Mutual Assent Must Be Clear 

Arbitration provisions are a matter of contract law, and the traditional elements of a ‎contract must be met even though Zappos’ Terms of Use was presented in electronic, ‎browsewrap form on the website. An essential element of contract formation is mutual assent by ‎the parties to the contract, which the court found was missing in this case as there was no ‎evidence of the plaintiffs’ assent.

The court compared the browsewrap agreement with another popular form of online terms ‎of use agreement, the “clickwrap” agreement. Clickwrap agreements require users to take ‎affirmative actions, such as clicking on an “I Accept” button, to expressly manifest their assent to ‎the terms and conditions.‎

Since Zappos’ browsewrap agreement did not require its users to take similar affirmative ‎action to show their assent to the terms and conditions, there was no direct evidence showing ‎that the plaintiffs consented to or even had actual knowledge of the agreement, including the ‎arbitration clause.‎

Link It Front and Center 

Furthermore, the court found Zappos’ Terms of Use hyperlink was inconspicuous and ‎thus did not provide reasonable notice to its users. The link was a) “buried” in the middle or ‎bottom of each page and became visible when a user scrolls down, b) appeared “in the same size, ‎font, and color as most other non-significant links,” and c) the website did not “direct a user to ‎the Terms of Use when creating an account, logging in to an existing account, or making a ‎purchase.” The court concluded that under ordinary circumstances, users would have no reason ‎to click on the link.‎

Unilateral Right to Modify or Terminate Won’t Work

Another problem with Zappos’ browsewrap agreement was that it was illusory and thus ‎unenforceable. In the agreement, the company “retain[ed] the unilateral, unrestricted right to ‎terminate the arbitration agreement” and had “no obligation to receive consent from, or even ‎notify, the other parties to the contract.” Users would unsuspectingly agree to the changes by ‎continuing to use the site. Under this provision, Zappos could seek to enforce the arbitration ‎clause, as it did here, or not enforce it by modifying the clause without notice to its users when it ‎was no longer in its interest to arbitrate. In either circumstance, the users would still be bound to ‎the agreement.

Implications for Companies

As a result of this decision, companies should carefully reassess the display and content ‎of the online terms of use they adopt to ensure their enforceability. In a narrow sense, the ‎decision means an arbitration clause in a browsewrap agreement similar to Zappos’ may be ‎deemed unenforceable. More broadly, this decision threatens the validity and enforceability of ‎other terms and conditions contained in a browsewrap agreement, which may deprive the ‎company of the agreement’s protection and favorable terms. ‎

Clickwrap agreements seem to provide the solution to Zappos’ problem. The court ‎suggested a clickwrap agreement could obtain a user’s assent to the terms and conditions. A ‎company may implement the clickwrap agreement through account registration or purchase ‎check-out, tailored to the nature of the company’s business and user interaction. The system may ‎require a user to click “I Accept” to secure the user’s assent to be bound by the agreement before ‎he can proceed further on the website. ‎

On the other hand, the court did not conclude that browsewrap agreements are never ‎enforceable. Other courts have held that browsewrap agreements are generally enforceable. ‎Enforceability largely depends on how the company presents the link and terms to the users such ‎that the users would have reasonable notice of the information. Accordingly, a browsewrap ‎agreement may be enforceable if the hyperlink is conspicuously located and displayed. ‎

In addition, companies should communicate and secure a user’s assent to any ‎modification when the user has previously accepted the terms and conditions. The user may ‎consent through another clickwrap agreement showing the modified terms. With a browsewrap ‎agreement, notice of the changes should, at the minimum, be conspicuously displayed on the ‎webpage. ‎

What This Means 

The Zappos decision reflects a change in the public policy on web activities, and users ‎who do not affirmatively agree to the online Terms of Use may no longer be bound. Consumers ‎are increasingly turning to the web for goods and services. In reaction, courts are beginning to ‎look closer into the transactions and resulting issues that occur online. In this process, courts are ‎testing and requiring new standards for these Terms of Use agreements. Companies should be ‎aware of the court’s evolving attitude towards the different types of agreements. You are ‎encouraged to seek legal guidance to properly adapt your implementation of Terms of Use ‎agreements. Failure to update your Terms of Use agreements may leave you exposed to ‎unfavorable terms that the Terms of Use is designed to prevent.‎

Will Obesity Claims Be the Next Wave of Americans with Disabilities Act (ADA) Litigation?

Poyner SpruillIn a new federal lawsuit in the U.S. District Court for the Eastern District of Missouri, Whittaker v. America’s Car-Mart, Inc., the plaintiff is alleging his former employer violated the Americans with Disabilities Act (ADA) when it fired him for being obese.  Plaintiff Joseph Whittaker claims the company, a car dealership chain, fired him from his job as a general manager last November after seven years of employment even though he was able to perform all essential functions of his job, with or without accommodations.  He alleges “severe obesity … is a physical impairment within the meaning of the ADA,” and that the company regarded him as being substantially limited in the major life activity of walking.

The EEOC has also alleged morbid obesity is a disability protected under the ADA.  In a 2011 lawsuit filed on behalf of Ronald Katz, II against BAE Systems Tactical Vehicle Systems, LP (BAE Systems), the EEOC alleged the company regarded Mr. Katz as disabled because of his size and terminated Katz because he weighed over 600 lbs.  The suit alleged Mr. Katz was able to perform the essential functions of his job and had received good performance reviews.  The case was settled after BAE Systems agreed to pay $55,000 to Mr. Katz, provide him six months of outplacement services, and train its managers and human resources professionals on the ADA.  In a press release announcing the settlement, the EEOC said, “the law protects morbidly obese employees and applicants from being subjected to discrimination because of their obesity.”

Similarly, in 2010, the EEOC sued Resources for Human Development, Inc. (RHD) in the U.S. District Court for the Eastern District of Louisiana, for firing an employee because of her obesity in violation of the ADA. According to the suit, RHD fired Harrison in September of 2007 because of her severe obesity.  The EEOC alleged that, as a result of her obesity, RHD perceived Harrison as being substantially limited in a number of major life activities, including walking.  Ms. Harrison died of complications related to her morbid obesity before the case could proceed.

RHD moved for summary judgment, arguing obesity is not an impairment.  The court, having reviewed the EEOC’s Interpretive Guidance on obesity, ruled severe obesity (body weight more than 100% over normal) is an impairment.  The court held that if a plaintiff is severely obese, there is no requirement that the obesity be caused by some underlying physiological impairment to qualify as a disability under the ADA.  The parties settled the case before trial for $125,000, which was paid to Ms. Harrison’s estate.

In June 2013, the American Medical Association (AMA) declared that obesity is a disease.  Although the AMA’s decision does not, by itself, create any new legal claims for obese employees or applicants under the ADA, potential plaintiffs are likely to cite the new definition in support of ADA claims they bring.  In light of these recent developments, obesity related ADA claims will likely become more common.

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Centers for Medicare and Medicaid Services (CMS) Issues Revised Process for Making National Coverage Determinations

vonBriesen

Yesterday, the U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services (CMS) published its revised process for external requests and internal reviews for new national coverage determinations (NCDs) or for reconsideration of existing NCDs.  Today’s guidance supersedes CMS’s previous process issued in 2003.

Prior to formally requesting an NCD or reconsideration, CMS encourages requesters to contact CMS staff in the Coverage and Analysis Group (CAG).  The CAG staff may identify additional needed information and supporting documentation.  The requester may also find that a formal request is not needed.  For example, CAG staff could determine that coverage of the item or service is already available or that the item or service falls outside the scope of an NCD.

If the requester decides to move forward with requesting an NCD review, the requester must provide the following, which would constitute a “complete, formal request”:

  1. A final letter of request that is clearly identified as “A Formal Request for A National Coverage Determination.”
  2. A full and complete description of the item or service in the request.
  3. The scientific evidence supporting the clinical indications for the item or service, including the proposed use of the item or service, the target Medicare population, the medical indication(s) for which the item or service can be used, and whether the item or service is used by health care providers or beneficiaries.
  4. The Medicare Part A or B benefit category or categories in which the item or service falls.
  5. Additional information if the item or service is currently under FDA review.

Once CMS receives the complete formal request, it will add the request to its tracking sheet on the CMS website and permits public comments on the request.  CMS will also initiate a formal evidence review and will generally issue a proposed decision within six months of opening the NCD review.  CMS will accept public comments for 30 days after issuing the proposed decision.  CMS will then issue a final NCD within 60 days of the end of the public comment period.  These timeframes could be extended, however, if CMS commissions a third party technology assessment, convenes the Medicare Evidence Development and Coverage Advisory Committee, or requests a clinical trial.

Today’s guidance also provides the process for requesting reconsideration of an NCD.  The reconsideration must be in writing and clearly identified.  The requester must also provide documentation meeting one of the following:

  1. Additional scientific evidence not considered at the most recent review and a “sound premise” that the evidence may change the NCD decision.
  2. Arguments that CMS’s conclusion materially misinterpreted the existing evidence at the time the NCD was decided.

CMS will generally accept or reject an external NCD reconsideration request within 60 days of receiving the request.

In certain circumstances, CMS may internally initiate review of an NCD.  CMS will also periodically review NCDs that have not been reviewed in the past 10 years.  CMS will publish a list of NCDs proposed for removal and rationale for removal and provide a 30 day public comment period.  CMS anticipates that this process will reduce the timeframe for removal or amendment of an NCD.  Currently, removal or amendment takes 9 to 12 months.

For more information, please see the guidance at this link.

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