October 28, 2014

CMS Extends Fraud and Abuse Waivers for ACO Shared Savings Program

On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) extended its interim final rule regarding fraud and abuse waivers for accountable care organizations (ACOs) that participate in the Medicare Shared Savings Program. The Medicare Shared Savings Program was one of the initial steps taken under the Affordable Care Act to both increase quality and lower costs in the Medicare program. ACOs that participate in the Medicare Shared Savings Program can share in the savings generated to Medicare.

Originally, the interim final rule was published in the November 2, 2011 Federal Register, and had the typical three-year period before becoming a final rule. The continuation of the interim final rule extends the timeline for an additional year, establishing a new deadline of November 2, 2015. The interim final rule offers five waivers to ACOs, which allow healthcare entities to form and operate ACOs without fear of violating federal fraud and abuse laws. The ACO waivers include:

  • An ACO participation waiver;
  • An ACO pre-participation waiver;
  • A compliance with the Physician Self-Referral (Stark) law waiver for the Gainsharing Civil Monetary Penalties (CMP) and Anti-Kickback Statute (AKS);
  • A shared savings distribution waiver; and
  • A patient incentive waiver.

    CMS offered these exemptions to the Stark law, AKS, and Gainsharing CMP to encourage ACOs to participate in the Medicare Shared Savings Program. Noting the success of the waivers, CMS extended the deadline in an attempt to prevent disruptions in the ongoing operations of ACOs. Additionally, CMS was concerned that the expiration of the interim final rule would result in considerable legal uncertainty for ACOs and, in turn, place the success of the Medicare Shared Savings Program at risk. In its announcement, CMS adamantly affirmed its commitment to establishing ACO waivers.

    CMS's deadline extension also allows time for further comments from providers, policymakers, and others with a stake in the interim final rule. Specifically, CMS requested input regarding:

  • Whether the existing waivers serve the needs of ACOs and Medicare;
  • How and to what extent ACOs are using the waivers;
  • Whether the waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
  • Whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking.

    Wachler & Associates regularly counsels healthcare providers regarding compliance with ACO requirements, the Stark Law, AKS, and other fraud and abuse laws. If you have any questions regarding ACOs or how CMS's interim final rule and ACO waivers may impact your health care entity, or seek assistance in commenting on any of the provisions, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.

  • October 22, 2014

    IMPACT ACT to Standardize Data Collection for Post-Acute Care Facilities

    On October 6, 2014, the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) was signed into law. The bill moved swiftly through both houses due to its joint development by the House Ways and Means Committee and the Senate Finance Committee. The Post-Acute Care (PAC) community also voiced strong support for the IMPACT Act.

    Currently, PAC payments to Medicare are typically based on the setting of care. This payment system often results in PAC providers supplying comparable services, but receiving dramatically different reimbursement amounts due to their setting of care. Under the IMPACT Act, the US Department of Health and Human Services (HHS) is tasked with promulgating a reporting system for PAC providers, which includes long-term care hospitals, skilled nursing facilities, inpatient rehabilitation facilities, and home health agencies. PAC providers will be required to report standardized data regarding patient care assessment, resource use, and quality measures. This data collection will allow providers and policymakers to analyze and compare the cost, quality, and type of services offered across a range of PAC providers. It is important to note that the IMPACT Act does not apply to critical access hospitals.

    Specifically with regards to quality measures, PAC providers will be required to report on the following issues:

  • Functional status and Cognitive function and changes to either;
  • Skin integrity and changes in skin integrity;
  • Incidence of major falls;
  • Medication reconciliation; and
  • The existence of, and providing for, transfer of care preferences and health information.

    Additionally, the IMPACT Act will require PAC providers to report standardized patient care assessment data at admission and discharge regarding:

  • Mental status and cognitive function;
  • Functional status;
  • Treatments, interventions, and special services;
  • Impairments;
  • Medical conditions and comorbidities (the simultaneous presence of two conditions in a patient); and
  • Other domains that the Secretary of HHS may specify.

    With regard to resource use, the IMPACT Act mandates that PAC Providers report estimated Medicare spending per beneficiary, discharge to community, and any measures to demonstrate risk-adjusted, all-condition, potentially preventable hospital readmission rates.

    Implementation of these reporting requirements will be phased in over a three-year period starting in 2016. Once the Medicare Payment Advisory Commission (MedPAC) collects and analyzes the data, the IMPACT Act requires it to report the merits of the new system to Congress and recommend specific features of the character-based payment system, so that providers can transition away from the current, settings-based system. Eventually, MedPAC and HHS must report to Congress regarding recommendations on a PAC prospective payment system that applies to all PAC providers.

    If you have questions regarding the IMPACT Act or how it may affect your practice, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. We will continue to notify you of any new federal or state healthcare legislation. To remain updated on healthcare news, subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

  • October 13, 2014

    OIG Releases Proposed Rule Affecting Anti-Kickback Statute Safe Harbors

    The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published a proposed rule that affects providers and suppliers seeking to comply with the federal Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) provisions. The proposed rule alters existing safe harbors, codifies statutory changes, and adds new protections for arrangements that the OIG believes present low risk to federal health care programs.

    The AKS provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under Federal health care programs. The law prohibits all types of remuneration, including kickbacks, bribes, and rebates. Due to the extremely broad reach of the statute, Congress authorized the OIG to develop safe harbor regulations that protect industry payment and business practices that, if structured properly, would not be treated as criminal offenses under the AKS even though they may induce referrals of business under the Federal health care programs. In authorizing these safe harbors, Congress intended that the safe harbor regulations be updated periodically to reflect changes in business practices and technology in the health care industry. The proposed rule will also codify statutory changes emanating from the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Affordable Care Act of 2010.

    Specifically, the proposed rule applies to safe harbors or exceptions related to 1) referral services, 2) cost-sharing waivers, 3) agreements between Medicare Advantage (MA) plans and Federally Qualified Health Centers (FQHCs), 4) the Medicare Coverage Gap Discount Program, and 5) free or discounted local transportation services.

    Referral Services - The proposed rule makes a technical correction to the safe harbor for referral services. As currently written, the safe harbor's language resulted in an unintended ambiguity that some viewed to permit referral services to adjust their fees based on the volume of referrals made to a provider. The proposed rule alters the language to now prohibit payments based on the volume or value of referrals to, or other business generated by, either party for the other party. The rule clarifies that referral services cannot adjust fees based on the volume of business generated for a health care entity.

    Cost-Sharing Waivers - The OIG has longstanding guidance that demonstrates the potential abuse of cost-sharing waivers in the context of the AKS. Waivers of cost-sharing also implicate the CMP prohibition against beneficiary inducements. The proposed rule seeks to except from liability arrangements that meet requirements relating to (1) certain waivers or reductions by pharmacies of any cost-sharing imposed under Medicare Part D, and (2) emergency ambulance services owned and operated by a State, a political subdivision of a State, or a federally recognized Indian tribe. Accordingly, the emergency ambulance safe harbor will not apply to contracts with private outside ambulance providers or suppliers. Also, in order to meet the safe harbor for waivers or reductions of cost-sharing under Medicare Part D, a pharmacy must demonstrate that (1) the waiver is not advertised or part of a solicitation, (2) the pharmacy does not routinely waive the cost sharing, and (3) before waiving the cost sharing, the pharmacy determines in good faith that the beneficiary has a financial need or the pharmacy fails to collect the cost-sharing amount after making reasonable effort to do so. However, if the waiver is made on behalf of a subsidy-eligible individual, requirements (2) and (3) will not apply.

    FQHCs and MA Organizations - The Medicare Modernization Act amended the AKS to protect any remuneration between a Federally Qualified Health Center (FQHC) and an Medicare Advantage (MA) organization pursuant to a written agreement. The amended law requires that the written agreement between the two entities specifically provide that the MA organization will pay the contracting FQHC no less than the level and amount of payment that the plan would make for the same services if the services were furnished by another type of entity. The proposed rule would incorporate these changes by implementing this exception into the safe harbor regulations pursuant to a new section, 42 CFR 1001.952(z).

    Medicare Coverage Gap Discount Program - The proposed rule will protect discounts in the price of applicable drugs furnished to applicable beneficiaries under the Medicare Coverage Gap Discount Program, so long as the manufacturer participates in, and is in full compliance with, the Discount Program. The proposed rule would incorporate by reference certain definitions found in the Medicare Coverage Gap Discount Program law.

    Free or Discounted Local Transportation Services
    - The new rule proposes to establish a new safe harbor to protect free or discounted local transportation (within 25 miles) services provided to Federal health care program beneficiaries. The proposed rule requires that the transportation services only be offered to established patients, for medically necessary services, and be determined in a manner unrelated to the past or anticipated volume or value of Federal health care program business. The OIG proposes to limit the protection of the safe harbor to an "eligible entity," which may exclude DME suppliers, pharmaceutical companies, and laboratories. The OIG also expressed concerns and sought comments as to whether the safe harbor should be available to the home health industry. Additionally, the safe harbor will include several restrictions that limit providers' ability to offer free transportation based on the volume or value of a patient's anticipated federal health care program business. Further, the safe harbor will not apply to air, luxury, or ambulance level-transportation. Lastly, the transportation services cannot be marketed, cannot involve marketing, and cannot accept per-beneficiary payments for transportation.


    Please note that these changes are all a part of the OIG's "proposed rule," and therefore are open to provider input via the OIG comment solicitation process. Also, please be aware that the proposed rule includes changes to the OIG's CMP authorities regarding beneficiary inducements and "gainsharing" that are not addressed in this blog.

    Wachler & Associates PC counsels healthcare providers nationwide regarding compliance with the Anti-Kickback State and safe harbors. If you or your healthcare entity seek clarification as to how the OIG's proposed rule may impact your healthcare entity, or seek assistance in commenting on any of the provisions found in the proposed rule, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com

    October 6, 2014

    Office for Civil Rights Advisor Warns Providers on HIPAA Audits: "Get Your House In Order"

    On September 9, Linda Sanches, the Senior Advisor for the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) warned that Health Insurance Portability and Accountability Act (HIPAA) audits are forthcoming. Speaking at the HIMSS Privacy and Security Forum in Boston, Sanches cautioned attendees that the best defense to an audit is conducting periodic and comprehensive risk analyses focused on administrative and technical protections, as well as human error vulnerabilities. "The onus is on you to prove that you had the proper systems in place," Sanches warned, advising providers to proactively perform risk analyses in advance of a HIPAA audit.

    To attendees' disappointment, Sanches did not unveil a start date for the HIPAA audits. Instead, Sanches explained that the OCR has postponed initiating HIPAA auditing to implement new technology with increased auditing capacities. Originally, the OCR intended to conduct a total of 400 desk audits. However, Sanches confirmed that now the OCR will likely perform fewer than 200 targeted desk audits and an unconfirmed number of on-site audits. A variety of providers across practice area, size, and geographic location should expect to be audited. Audited entities will be responsible for compliance with both the HIPAA Privacy Rule and the HIPAA Security Rule. In addition, providers should have available an updated list of business associates with contact information and services provided. Sanches warned that the OCR will use a provider's business associate list to select business associates for HIPAA auditing.

    Providers with patterns in reported breaches are more likely to face HIPAA auditing. Sanches emphasized that providers who fail to demonstrate compliance with the HIPAA privacy rule and HIPAA security rule may face hefty settlement fines based on the amount of harm and provisions violated. When discussing fines, Sanches stated, "It's basic math. How many people were affected?"

    Since the inception of the HIPAA Privacy and Security Rules, Wachler & Associates has counseled providers and other covered entities in HIPAA compliance. In order to attain compliance, providers should update security policies and procedures, business associate agreements, privacy policies and procedures, and HIPAA privacy notices. Additionally, all employees should receive regular training in HIPAA compliance. If your entity does not already have these procedures in place Wachler & Associates can help you implement these important compliance measures. If you have any questions regarding HIPAA, HIPAA audits or require assistance developing a HIPAA compliance plan, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com.

    October 2, 2014

    CMS Open Door Forum Clarifies Key Points of 68% Settlement Offer to Hospitals

    On September 30, the Centers for Medicare & Medicaid Services (CMS) held a Hospital & Hospital Quality Open Door Forum on a variety of topics pertinent to hospitals. CMS opened the forum with an unexpected update on CMS' recently announced 68% settlement offer for patient status claim denials. As many providers are already aware, CMS has offered to pay 68% of the net payable value of eligible patient status claim denials in exchange for hospitals' withdrawal of all pending eligible appeals.

    While the September 30 Open Door Forum covered a variety of topics unrelated to the settlement offer, CMS clarified key points regarding the settlement offer and providers should take note.

    First and foremost, CMS clarified that Part A patient status denials submitted for re-billing under Part B are eligible for inclusion in the settlement so long as the hospital has not received payment on the rebilled claim. In response to a question, CMS specified that as long as the hospital has not received Part B payment on a rebilled claim on the date that the settlement request is submitted, the claim is eligible for inclusion in the settlement process. CMS indicated that this issue will be discussed in greater detail during the October 9 Open Door Forum. Additionally, CMS indicated that it is not contemplating an extension to the October 31, 2014 filing deadline.

    CMS announced that it will post additional Frequently Asked Questions on its Inpatient Hospital Reviews website later this week.

    Wachler & Associates healthcare attorneys will continue to monitor the ongoing developments regarding CMS' 68% settlement offer. If you have any questions regarding the settlement offer, its potential implications on your pending appeals, or if you need assistance in submitting a settlement request, please contact an experienced healthcare attorney at (248) 544-0888 or at wapc@wachler.com.

    October 1, 2014

    OCR Offers Guidance on HIPAA Privacy Rule and Same-sex Marriage

    In September 2014, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) released guidance to assist covered entities in understanding their obligations under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule in light of the Supreme Court's 2013 decision in United States v. Windsor. In Windsor, the Supreme Court struck down Section 3 of the Defense of Marriage Act (DOMA), which restricted interpretations of "spouse" and "marriage" in federal law to opposite-sex marriages, as a violation of the Due Process Clause of the Fifth Amendment. As a result, OCR opined that covered entities and applicable business associates must take into account lawfully married same-sex couples when applying federal law.

    OCR noted that the Privacy Rule's definition of "family members" includes the terms "spouse" and "marriage." Under the Privacy Rule, a spouse is defined as any individual who is in a legally valid marriage sanctioned by a state, territory, or foreign jurisdiction (assuming that the marriage performed in a foreign jurisdiction would be recognized by a U.S. jurisdiction). OCR clarified that "marriage" includes same-sex marriages, a family member includes dependents of that marriage, and that these terms apply to individuals who are legally married, "whether or not they live or receive services in a jurisdiction that recognizes their marriage."

    OCR also provided two examples how this clarified definition of a family member would be applied to specific provisions in the Privacy Rule. Specifically, §164.510(b) Standard: uses and disclosures for involvement in the individual's care and notification purposes allows protected health information to be shared with a patient's spouse and family members. OCR opined that in light of Windsor, covered entities must consider legally married same-sex spouses, regardless of where they live, to be family members.

    In addition, §164.502(a)(5)(i) Use and disclosure of genetic information for underwriting purposes prohibits health plans from disclosing or using genetic information for underwriting purposes. Applying Windsor, OCR stated that the genetic tests of a same-sex spouse of the individual, or the manifestation of a disease or disorder in the same-sex spouse of the individual would fall within this prohibition.

    OCR concluded by indicating that it planned to provide more written guidance or rulemaking that would address the topic of same-sex spouses acting as personal representatives under the Privacy Rule.

    Wachler & Associates continues to monitor and provide timely updates on important developments under HIPAA. If you have questions regarding OCR's guidance, how the Windsor decision may impact your practice, or a more general HIPAA inquiry, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. To stay updates on healthcare news, subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

    September 30, 2014

    Medicare to Introduce More Star Ratings to Compare Providers

    CMS recently announced that it will soon be adding additional star ratings to the Medicare.gov website by 2015. CMS has already implemented the star rating system to provide consumers quality and safety information regarding nursing homes and physician groups on a five-star scale. The system is supposed to allow consumers to make informed decisions about their provider, while giving providers something to strive for. CMS Deputy Administer for Innovation and Quality, Dr. Patrick Conway, stated that the star rating system is based on scientific standards of both accuracy and rigor. Because providers differ on the quality of care and services they offer to customers, CMS touts its star rating system as giving consumers a "snap-shot" of the care an individual provider offers. By 2015, CMS plans to add hospital groups and dialysis and homecare providers to the rating system.

    While advocates of the consumer-oriented star-rating system are excited about the inclusion of more provider types, many providers are speaking out against the system. According to a recent article on Modern Healthcare, after being notified of dialysis and homecare providers' inclusion, a spokesman for Kidney Care Partners--a coalition of dialysis providers--claimed that the star rating system compares apples and oranges. The spokesman argued that the inaccurate comparison results in confused patients not really understanding what the amount of stars mean. Proponents of the rating system try to rebut views like those expressed by Kidney Care Partners, by arguing that the health care community should stress transparency, rather than worry about the imperfections in the rating system. Echoing these sentiments, Dr. John Santa, the Medical Director for Consumer Reports, stated that no provider will score well on every rating system, but the abundance of ratings will eventually provide a clearer picture of providers' quality of care and safety.

    Although proponents of the star rating system continue to espouse its positive aspects, many providers remain concerned. Because providers can lose accreditation for scoring poorly on certain measures of safety and quality, and even face fines, these ratings are becoming more important. Several providers urge CMS to delay the inclusion of more provider types to the rating system until it can provide a more complete performance rating. They assert that the measurement differences may result in one provider scoring high in one program and low in another and, although the system does not have to be perfect, it must be reliable. Opponents say that to allow otherwise is to misguide patients and may potentially lead to unfair financial penalties on the entities.

    If you have questions regarding the Medicare five-star rating system or how the anticipated inclusion of provider-types to the rating system may impact your practice, please contact an experienced healthcare attorney at 248-544-0888 or via email at wapc@wachler.com. We will continue to monitor the rating system and notify you of any changes. To stay updated on healthcare news, subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

    September 29, 2014

    Federation of State Medical Boards Releases Model Legislation to Expedite Physician Licensure in Lieu of Telemedicine Push

    As the demand for telemedicine increases across the country, states continue to grapple with licensure issues arising from physicians working across state lines. In an effort to resolve the dilemma, the Federation of State Medical Boards (FSMB) published model legislation designed to assist in the implementation of a multistate compact, by which physicians from one state can be expeditiously licensed in another state to practice telemedicine.

    FSMB's model legislation requires a minimum of seven states to participate, with each state providing representatives for a governing commission. When at least seven states have joined, the commission would openly share disciplinary and credentialing information in a joint effort to quickly license physicians that are already licensed in one of the other participating states. This sharing of information would allow the participating states to license physicians without being saddled with the responsibility of independently collecting the large amount of paperwork required to license a physician. The governing commission of the compact would not have any licensing power itself, but rather would serve to facilitate the quick transfer of information between participating states. As an example, if Illinois, Michigan, and Indiana joined the multi-state compact, a physician licensed in Michigan, wishing to practice telemedicine in Illinois and Indiana, would have the compact commissioner obtain the necessary credentialing information and approval from the Michigan medical board, collect the licensing fees mandated in Illinois and Indiana, and then process an expedited license.

    Members of the FSMB are hopeful for support of their model legislation because it ensures that licensure remains a state right and avoids federal intervention. A multi-state compact will hopefully solve the licensure dilemma, allowing physicians, for example, to use telemedicine technologies to offer specialized care to rural communities. One such state is Wyoming, which relies on telemedicine to care for its residents. The Executive Director of the Wyoming State Board of Medicine, Kevin Bohnenblust, stated that Wyoming has approximately 3,000 licensed physicians, but only 1,200 physicians that actually live in the state. As a prominent "importer" of telemedicine, Wyoming is hopeful that the FSMB policy takes effect. Bohnenblust also notes that states with renowned hospitals like Michigan, Minnesota, and Ohio, could benefit as "exporters" of telemedicine.

    Although there are few opponents of the FSMB model legislation, some are leery of establishing new governmental organizations. However, FSMB has considerable support from the American Medical Association, which recently stated that the multi-state compact legislation aligns with their efforts to modernize state licensure frameworks.

    As previously addressed on this blog, with the release of the model legislation, FSMB continues to be a strong supporter of integrating telemedicine practices across state lines. Providers interested in introducing telemedicine technologies into their practices should review state licensure laws, as well as any Fraud & Abuse issues that may arise from adding a new line of business to their practice. If you or your healthcare entity needs guidance regarding the practice of telemedicine, please contact a Wachler & Associates attorney by phone at 248-544-0888 or via email at wapc@wachler.com. Our firm will continue to keep you up to date on legislative developments applicable to telemedicine, as well as all other healthcare law news. If interested, please subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

    September 25, 2014

    CMS Final Rule Provides Greater Flexibility for Meeting EHR Meaningful Use Requirements

    On August 29, 2014, the Department of Health and Human Services (HHS) published a Centers for Medicare & Medicaid Services (CMS) final rule allowing providers more flexibility in meeting the meaningful-use requirements for the electronic health records (EHR) incentive program. The final rule, which was an adoption of the May 2014 proposed rule, aims to assist providers in utilizing Certified EHR Technology (CEHRT) by giving eligible providers another year to continue using the 2011 Edition CEHRT, or a combination of the 2011 and 2014 Edition CEHRT. However, providers should be aware that in 2015 they are required to use the 2014 Edition CEHRT software.

    Additionally, the final rule extends Stage 2 of meaningful use through 2016, thus delaying implementation of Stage 3. For those providers who first became meaningful users of EHR in 2011 or 2012, Stage 3 of meaningful use is now scheduled to begin in 2017. According to CMS, the updates in the final rule will better enable providers to participate and meet meaningful use objectives, including:

    • Electronic prescribing;
    • Checking for drug allergies and interactions;
    • Providing clinical summaries to patients;
    • Reporting on key public health data; and
    • Reporting on quality measures.

    Wachler & Associates will continue to monitor CMS rule-making and guidance related to EHR meaningful-use criteria, as well as other breaking health care news. If you need help understanding the meaningful-use requirements or assistance with negotiating EHR contracts, please contact an experienced healthcare attorney at Wachler & Associates via phone at 248-544-0888 or email at wapc@wachler.com.

    September 15, 2014

    CMS Holds Conference Call on 68% Settlement Offer

    On Tuesday, September 9, the Medicare Learning Network (MLN) hosted a Conference Call regarding the newly revealed 68% settlement offer from the Centers for Medicare & Medicaid Services (CMS) for short-stay inpatient status claims. In an effort to 'more quickly reduce the volume of inpatient status claims' pending in the appeals process, CMS offered an administrative agreement to any hospital willing to withdraw all of their pending short-stay inpatient status claim denial appeals in exchange for partial payment of 68% of the net allowable amount as long as the date of admission was prior to October 1, 2013 and the claim is either pending appeal or the appeal has been filed and is pending review. In its release, CMS further noted that only acute care hospitals and critical access hospitals are eligible to submit a settlement request; psychiatric hospitals, inpatient rehabilitation facilities, long-term care hospitals, cancer hospitals, and children's hospitals are not permitted to submit a settlement request.

    The purpose of the Conference Call was to provide interested stakeholders an opportunity to speak with CMS representatives in order to ask questions and obtain a better understanding of how this settlement process will work. Wachler & Associates healthcare attorneys participated in the Conference Call and came away with a deeper understanding of how this process works, but there are still unanswered questions. First and foremost, submissions for settlement are due by October 31, 2014. If your entity cannot meet this deadline, you may ask CMS for an extension. Additionally, short-stay inpatient status claims pending at any level of the appeals process are eligible to be submitted for settlement.

    In sum, eligible claims must also meet four requirements: (1) they must be pending in the appeals process or within the timeframe to appeal; (2) the date of admission for the claim must have been prior to October 1, 2013; (3) the denial must be based on a patient status review; and (4) the claim must not have been previously withdrawn or re-billed for payment under Part B. During the Conference Call participants requested clarification of whether the rebill for Part B must not have been submitted or whether it must not have been paid. CMS indicated that it would provider further clarification on this issue through the Frequently Asked Question (FAQ) page on CMS' website for hospitals. In agreeing to settle all claims for the 68%, the entity agrees to the dismissal of all associated claims (the entity may not pick and choose which ones to settle) and agrees that the settlement will serve as the final administrative and legal resolution of all eligible claims. However, this resolution does not resolve any potential False Claims Act reviews by the Department of Justice. Additionally, eligible claims include claims from any Medicare contractor so long as the denial was based on a patient status review.

    A final point of emphasis pertains to whether interest will be paid under Section 935 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) upon such claims if they are settled. Representatives from CMS indicated that Paragraph 3 of the settlement agreement indicates that payment in full by CMS would not include 935 interest on the claims. If a hospital paid interest on an overpayment (i.e. the hospital prevented recoupment at the earlier stages of appeal, but interested in favor of CMS accrued on the alleged overpayment) during subsequent recoupment of an alleged overpayment, that interest will be included in the net allowable amount that is used to calculate the settlement. If this same interest accrued on the alleged overpayment, but the hospital has not begun to repay any of that interest, then that interest balance will be waived. Finally, if CMS does not make payment on the settlement within 60 days of finalization, interest will accrue and be paid to the entity.

    The CMS settlement offer is an enticing offer for hospitals. By accepting the settlement, hospitals will receive reimbursement from the settlement in a much timelier manner than waiting for final adjudication of the appeals. Furthermore, hospitals will be able to conserve the resources required to challenge these denials. However, before choosing to settle, a hospital should weigh the costs and benefits, including calculating the amount of 935 interest the hospital could forego if it accepts CMS' settlement offer. For further information on this new settlement process please see our past blog post in addition to the CMS' FAQ Document on the topic and the PowerPoint presentation provided by CMS that accompanied the Conference Call.

    If you have any questions regarding this process, or require assistance in pursuing a settlement, do not hesitate to contact the healthcare attorneys at Wachler & Associates, P.C. at (248) 544-0888 or at wapc@wachler.com.

    September 8, 2014

    CMS Announces Settlement Offer to Hospitals

    In an effort to reduce the amount of cases currently pending appeal, specifically the backlog at the Administrative Law Judge (ALJ) level of appeal, the Centers for Medicare & Medicaid Services (CMS) announced an offer to hospital appellants to settle their patient status claim denials currently pending appeal. In exchange for hospitals' withdrawal of their pending appeals, CMS has offered to pay hospitals 68% of the net payable amount of the claims.

    In its announcement, CMS lists a number of conditions that must be met for a hospital to be eligible for settlement, including:

    1. The provider must be either (1) an Acute Care Hospital, including those paid via Prospective Payment System, Periodic Interim Payments, and Maryland waiver, or (2) Critical Access Hospitals (CAH). Those entities which are not eligible for the settlement include: psychiatric hospitals paid under the Inpatient Psychiatric Facilities Prospective Payment System, Inpatient Rehabilitation Facilities (IRFs), long-term care hospitals (LTCHs), cancer hospitals and children's hospitals.
    2. The claim was not provided to a Medicare Part C (i.e., Medicare Advantage) enrollee.
    3. The claim was denied upon review by a CMS audit contractor (e.g., Recovery Audit Contractor (RAC), Medicare Administrative Contractor (MAC), Zone Program Integrity Contractor (ZPIC) or Comprehensive Error Rate Testing Contractor (CERT)).
    4. The claim was denied was based on the CMS contractor's finding that the patient was inappropriately treated as an inpatient as opposed to outpatient.
    5. The first day of the inpatient admission was before October 1, 2013.
    6. The claim denial was timely appealed, or the provider has not yet exhausted their appeal rights.
    7. The provider did not subsequently rebill and receive payment for the claim under Medicare Part B.

    For those hospitals with eligible claims, CMS has provided instructions on its website detailing the process for hospitals to participate in the settlement offer. In order to take advantage of the settlement offer, hospitals must submit their settlement requests by October 31, 2014.

    According to the Administrative Agreement (i.e., settlement agreement), CMS will pay the agreed amount to the hospital within 60 days from the date in which the binding settlement agreement is executed. Once the binding settlement agreement is entered into, the pending appeals associated with the settled claims will be dismissed and the settlement will serve as the final administrative and legal resolution of those claims.

    This past July, the Department of Health and Human Services (HHS) introduced two new pilot programs - Settlement Conference Facilitation Pilot and Statistical Sampling Pilot - as alternative methods for eligible providers to resolve their appealed claim denials currently pending at the ALJ level of appeal. The recently announced settlement offer to hospitals is an added initiative implemented by HHS in an effort to reduce the ALJ backlog. CMS will be holding a national provider call on September 9, 2014, to further discuss the announced settlement offer. Wachler & Associates will be participating in that call. If you have any questions regarding the CMS settlement offer or pilot programs, or if you need assistance in the pursuing a settlement, please contact an experienced healthcare attorney at (248) 544-0888 or wapc@wachler.com.

    August 29, 2014

    Reports Show Increase in Individuals Participating in Employer-Based Health Plans

    Since the passage of the Patient Protection and Affordable Care Act (ACA) in 2010, much of the media focus has been on individuals who were previously denied coverage because of preexisting conditions or financial barriers. Now, studies are focusing on the large group of individuals who, prior to the ACA, simply chose not to purchase health insurance. The reports demonstrate that due to the Individual Mandate portion of the ACA, which requires individuals to purchase health insurance, many more individuals are choosing to participate in their employers' health plans.

    The increased participation in employer health plans will inevitably cost employers. Most recently, Wal-Mart announced that a dramatic increase in employees signing up for insurance through the company will cost its stockholders $500 million -- up from the company's previous estimate of $330 million. Although Wal-Mart is experiencing the employer-based insurance shift on a large scale, many employers nationwide are expected to see a jump in participation in their health plans. Recently, the National Business Group on Health announced that large employers should expect to see a 6.5% rise in healthcare costs in 2015.

    Although The New England Journal of Medicine and members of the Urban Institute both note a rise in individuals signing up for insurance through their employers, other analysts predict that employers' costs will be too high, and that the employers will simply "dump" these employees into their state's health insurance marketplace. Many experts, however, expect that if such dumping were to occur, it would come from small employers who merely cannot afford to offer adequate health plans.

    If you have questions regarding the ACA or how the anticipated increased participation in employer-based health plans may impact your practice, please contact an experienced healthcare attorney at 248-544-0888 or contact us here. To stay updated on healthcare news, subscribe to Wachler & Associates' health law blog by adding your email address and clicking "Subscribe" in the window on the top right of this page.

    August 26, 2014

    Community Health Systems to Pay $98.15 million to Settle False Claims Act Allegations

    On August 4, 2014, the United States Department of Justice (DOJ) announced that Community Health Systems (CHS) agreed to pay $98.15 million to settle False Claims Act (FCA) allegations that CHS knowingly billed Medicare, Medicaid and TRICARE for inpatient hospital services that should have been billed as outpatient or observation services. Seven actions were filed against CHS by whistleblowers under the qui tam provisions of the FCA, which allows individuals to file suit on behalf of the government and, in turn, obtain a portion of the recovery. These seven actions were filed in six different jurisdictions and alleged that, between 2005 and 2010, CHS engaged in a corporate scheme to increase admissions of Medicare, Medicaid, and TRICARE beneficiaries even though the admissions were not medically necessary at an inpatient level of care. Rather, the United States alleged that the patients could have been cared for in less costly outpatient or observation settings.

    In addition to the $98.15 million settlement payment, CHS agreed to enter into a five-year Corporate Integrity Agreement with the Office of Inspector General (OIG) in which CHS is required to implement significant compliance protocols, including retention of an independent review organization (IRO) to review CHS's inpatient admission claims. In exchange, CHS will be released from any civil or administrative monetary claims the United States has for the covered conduct under the FCA, Civil Monetary Penalties Law, or Program Fraud Civil Remedies Act.

    According to the DOJ, this settlement agreement is the largest FCA recovery in the Middle District of Tennessee. The DOJ touted the Health Care Fraud Prevention and Enforcement Action Team's (HEAT) coordinated nationwide effort for exposing the FCA noncompliance. Since the establishment of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) in 2009, the DOJ has recovered over $20.2 billion in FCA cases, of which $14 billion has come from cases involving fraud against government health care programs.

    Wachler & Associates regularly counsels providers regarding the FCA, Stark Law, Anti-Kickback Statute, and other federal and state fraud and abuse laws. If you or your healthcare entity have any questions regarding the FCA, Stark Law, Anti-Kickback Statute and/or other federal and state fraud and abuse laws, please contact an experienced healthcare attorney, at 248-544-0888 or wapc@wachler.com.

    August 22, 2014

    OCR Announces Start of HIPAA Audit Program Phase 2

    The U.S. Department of Health and Human Services' Office for Civil Rights ("OCR") recently announced that it will be initiating Phase 2 of the compliance audits mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH). The first phase of audits was carried out in 2011 and 2012, and targeted covered entities. While Phase 2 will expand the targeted entities to include business associates, it will utilize information gathered during Phase 1 to narrow the scope of audits in order to review the areas of greatest risk to protected health information (PHI).

    Following Phase 1, OCR's findings noted that, generally, the smaller the covered entity, the more compliance issues it had with all 3 Health Insurance Portability and Accountability Act (HIPAA) Standards: privacy, security, and electronic transactions. Furthermore, OCR observed that over 60% of the violations related to security standards. Additionally, nearly 40% of the findings related to privacy standards occurred simply due to lack of knowledge regarding the privacy standards.

    Applying this information, OCR will narrow the focus of their compliance audits in Phase 2. The audits will occur between October 2014 and June 2015, and will address:

    • Security risk analysis and management;
    • Breach content and effectiveness of notifications;
    • Privacy notices and access to records; and
    • Proper safeguards and adequate training.

    Phase 2 will begin with a random selection of 550-800 covered entities, chosen through America's Health Insurance Plans' databases of health plans, as well as the National Provider Identifier database. All covered entities that are randomly selected will be sent a link to an online pre-survey. OCR will use the pre-survey results to narrow-down the covered entities to 350 entities who will then be notified and sent data requests this fall. OCR will choose the business associates for Phase 2 from these data requests. 150 of the covered entities and 50 of the business associates will be audited for security standards compliance. Further, 100 of the 350 covered entities will be audited for compliance with breach notification standards and privacy standards.

    Once the covered entities and business associates are chosen, they will receive audit requests and have two weeks to respond. The requests will include a list of all the files needed, but OCR may request additional information at a later date. Audited entities are advised to respond to OCR in a timely fashion because failure to do so could lead to a more scrutinized compliance review by the OCR Regional Office. Once an audit is completed, OCR will provide a draft report and allow management to comment. OCR will take the comments into account before issuing a final report.

    Because covered entities and business associates are chosen at random, these entities should prepare for a potential Phase 2 compliance audit. Recommended steps include:

    • Undergoing a risk assessment to highlight any vulnerabilities;
    • Compiling a list of all business associates to fulfill date request;
    • Confirming that all employees are up to date on their HIPAA Standards training;
    • Checking that the entity is implementing all security, privacy, and breach standards and documentation is provided in the event that certain measures were not enacted.
    OCR's website will provide the Phase 2 Audit protocol for entities looking to prepare for a potential compliance audit. For more comprehensive preparation, covered entities and business associates can contact Wachler & Associates, P.C. Since the enactment of the HIPAA Privacy and Security Rules, Wachler & Associates has counseled healthcare entities in HIPAA compliance matters, which includes updating security policies and procedures, and ensuring employees undergo vital HIPAA compliance training. If you have any questions or require assistance developing a HIPAA compliance plan for your entity, please contact an experienced healthcare attorney at 248-544-0888 or contact us here.
    August 7, 2014

    FDA to Bolster its Regulation of Diagnostic Testing

    With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, Congress expanded the Food and Drug Administration's (FDA) authority to safeguard and advance public health. Exercising such authority, on July 31, 2014, the FDA notified Congress of its plan to publish a proposal to expand its oversight of laboratory developed tests (LDTs). LDTs are diagnostic tests, which are designed, manufactured, and used within a single laboratory. Previously, LDTs certified under the Clinical Laboratory Improvement Amendments (CLIA) could exist without FDA oversight. This exception existed because LDTs were primarily used for rare diseases. However, advances in molecular biology allowed laboratories to produce a broader range of LDTs, applicable to more common illnesses. The former exception has been touted by some as fostering laboratory independence, allowing for exponential innovation and accuracy in diagnostics. However, others like Senator Edward Markey (D-Mass.) claim that the newly implemented FDA oversight has been "long-overdue."

    As a result of support from individuals like Senator Markey, more than 11,000 LDTs, housed in 2,000 different laboratories, may fall into the FDA's expanded regulations. The FDA has cited LDTs for illnesses like Lyme disease and cancer, as justification for the new regulatory framework. By subjecting LDTs to such scrutiny, the FDA's stated goal is to eliminate faulty tests that produce inaccurate diagnoses and cause patients to seek unnecessary treatment, or delay vital treatment. However, opponents of the new regulation contend that the prior independence allowed laboratories to diagnose and measure disease with far greater accuracy than ever before.

    The FDA's regulatory expansion will take place over nine years and will first be applied to what are deemed the riskiest LDTs. However, some tests will remain excluded from FDA regulations. Such LDTs include those which treat rare diseases and those for which there is no FDA-approved test.

    In its announcement, the FDA stated its intent to publish guidelines detailing how laboratories can notify the FDA regarding their current manufacturing and use of LDTs. Once these guidelines are released, laboratories that currently utilize LDTs should notify the FDA about their tests in order to avoid legal repercussions. The FDA will allow currently available LDTs to continue during the reviewing process, in order to prevent any disruptions.

    If your laboratory utilizes LDTs or has any questions regarding the FDA's new regulations, please contact an experienced health care attorney at 248-544-0888 or email at wapc@wachler.com. Wachler & Associates will continue to keep you updated on breaking regulatory changes and other health care news.