The American Clinical Laboratory Association (“ACLA”) challenged the final rules promulgated by the Department for Health and Human Services (“HHS”) pertaining to how the Medicare Clinical Laboratory Fee Schedule (“CLFS”) payment rates are established for laboratory services (Am. Clinical Lab. Ass’n v. Azar, No. 17-2645 ABJ, 2018 U.S. Dist. LEXIS 161639, 2018 WL 4539681 (D.D.C. Sept. 21, 2018)). The U.S. District Court of the District of Columbia granted HHS’ motion for summary judgment to dismiss the complaint after concluding that the court lacked subject matter jurisdiction to hear the case. This is a significant set-back for the laboratory industry that has been fighting against the reductions in Medicare reimbursement under the new payment methodology, but it is not the end of the road.

In accordance with Section 216 of Protecting Access to Medicare Act of 2014 (“PAMA”), beginning January 1, 2018 the Medicare CLFS payment rate was established using a volume-weighted median of private payor rates for laboratory services as reported by applicable laboratories. What laboratories met the definition of an “applicable laboratory” and whether HHS had the authority to redefine the term was at the center of the challenge by the ACLA.

In December 2017, ACLA filed a lawsuit arguing that in the final rule HHS redefined the term “applicable laboratory” from the plain text of the statute and in doing so excluded almost 90% of hospital laboratories which reduced private-payment data reported and in turn resulted in lower CLFS payment rates. HHS argued that the terms “laboratory” and “revenue” relevant to determining an “applicable laboratory” were ambiguous and regardless PAMA includes a statutory bar to judicial review.

While ACLA presented multiple claims and arguments, the court focused on the threshold question: whether PAMA bars judicial review of HHS’ authority in “establishment of payment amounts under this section [of PAMA].” The court concluded that the statute did not permit judicial review; relying heavily on Florida Health, a D.C. Circuit case (Fla. Health Scis., Ctr., Inc. v. Sec’y of HHS, 830 F.3d 515 (D.C. Cir. 2016)). In Florida Health, the D.C. Circuit found that the statute gave HHS the power to make the choice as to what data should be used to calculate payment for hospitals’ uncompensated patient care. The reasoning in Florida Health is sound as it relates to the statutory authority granted under at issue in that case. Florida Health, however, seems to be easily distinguishable from the case brought by ACLA because, as the court itself recognized, “Florida Health did not involve a rule about how the Secretary would obtain the data needed … like this case does.” That is, Congress already defined under PAMA what data to be reported and who should report that data. In doing so, we believe the court conflated the breadth of the judicial review bar under PAMA and failed to differentiate between challenging the validity of HSS’ decisions made in the rulemaking process and contesting how and what data must be received and processed as per statutory procedure.

Here, ACLA argued that HHS overstepped its authority by redefining a clear statutory term; however, this was essentially ignored by the court by using the statutory judicial bar as a red-herring and conveniently limiting its analysis. Even though the court acknowledged that ACLA’s arguments “raise important questions,” the court refused to answer those very questions upon its determination that it could not hear the case. The court’s failure to address these issues likely gives ACLA grounds for appeal.

ACLA’s statement, released in response to the decision, reports that the association is exploring further legal options. The statement expresses concern that the decision “sets a harmful precedent that allows agencies to circumvent Congress’ express directions at the expense of patient care.” The association also urged Congress to take immediate action to resolve the issues raised in the lawsuit; specifically, the impact the reduction in Medicare CLFS payment rates will have on the laboratory industry. In the meantime, ACLA must seriously and carefully consider filing an appeal to request their central arguments be addressed and prepare to show the D.C. Circuit how this case can easily be distinguished from Florida Health and the underlying notion of judicial deference for an agency’s implementation of a complex statute.

Of course, even if successful, the ACLA must still address the other jurisdictional issues raised by HHS, such as whether ACLA had standing to bring suit on behalf of its members and if injury to labs or impact on Medicare rates had been proven.

 

Sydney Reed, a Law Clerk (not admitted to the practice of law) in the firm’s Houston office, contributed significantly to the preparation of this post.

The Department of Justice (DOJ) announced this week that it has entered into a settlement agreement with Davita Medical Holdings (Davita) for $270 million dollars to resolve certain False Claims Act liability related to Medicare Advantage risk adjustment payments.

As the settlement agreement describes, Davita acquired HealthCare Partners (HCP), a large California based independent physician association in 2012. HCP, subsequently Davita Medical Group (or Davita), operated as a medical service organization (MSO) who contracted with Medicare Advantage Organizations (MAOs) to provide services and manage the care of its beneficiaries. Davita would provide beneficiary diagnostic information to its MAOs which would be used by the Centers for Medicare and Medicaid (CMS) to calculate the MAO’s risk adjusted capitated payments under the program’s risk adjustment payment methodology. Payments would then be made by MAOs to DaVita under the terms of its risk sharing arrangements.

The settlement resolved allegations raised in the qui tam action filed in District Court for the Central District of California, United States ex rel. Swoben v. Secure Horizons, et al., by James Swoben, a former employee of a MAO that contracted with HCP. Swoben alleged that HCP hired coding companies to perform “one-way” retrospective reviews of member records, whereby the MAO would submit additional diagnosis codes to CMS but not validate previously submitted codes.

The settlement further resolves allegations related to incorrect coding guidance, unsupported but un-retraced codes identified during audits, in-home assessments, incorrect diagnosis mapping to appropriate ICD-9 codes in its electronic medical record, and acute condition codes in the primary care setting.  In its press release, the DOJ emphasized that the failure by Davita to delete unsupported or undocumented diagnosis codes caused the MAOs to retain payments from CMS that they were otherwise not entitled.

Importantly, Davita as downstream provider to MAOs, did not directly submit claims to the Centers for Medicare and Medicaid. Accordingly, this settlement is extremely significant to downstream entities such as MSOs, IPAs, physician practices and risk adjustment vendors who can themselves potentially be subject to “causes to be submitted” and other theories under the FCA.

Epstein Becker Green’s Jason Christ, Teresa Mason and Tom Hutchinson served as counsel and advisor to the Member Representative of the former owners of HCP. Epstein Becker Green was actively involved in co-defending this matter.

On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” (“Guidance”). The purpose of this Guidance is to explain FDA’s protocol in (1) determining how the centers will identify whether responsible parties failed to comply with submission and certification requirements to the ClinicalTrials.gov or submitted false or misleading documents to the data banks and (2) deciding when, why, and what civil monetary penalties will be assessed against the responsible parties or submitters. The new guidance seeks to address requirements of responsible parties involved in the performance of clinical research and submission of applications for marketing authorizations to register their trial, submit clinical results information and make certain certifications regarding their compliance with these requirements.  In order to mitigate their risk of civil money penalties in accordance with this guidance,  sponsors and researchers should (1) have policies and procedures that ensure correct clinical trial information is submitted to the ClinicalTrials.gov data bank, (2) have policies and procedures that ensure routine monitoring for missing or inaccurate clinical trial information in the data bank, (3) make timely submissions of the required information, and (4) remain responsive to any inquiries by FDA concerning clinical trial data and/or certifications to FDA.

Background

Under section 801 of the Food and Drug Administration Amendments Act of 2008 (the “FDAAA”), which amended section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)(5)(B)), responsible parties engaged in certain clinical research activities are required to submit registration and results information to the ClinicalTrials.gov data bank. Additionally, submitters of certain applications and other items to FDA regarding drug, biological, and medical device products are required to certify to FDA that all requirements of section 402(j) have been met. Similarly, the FDAAA amended section 301(jj) of the Food Drug and Cosmetics Act (the “FD&C Act”) to prohibit: (1) the failure of submitting or knowingly submitting a false certification to FDA, (2) the failure to submit required clinical trial information, and (3) submitting false or misleading clinical trial information to the ClinicalTrials.gov data bank. Further, the FDAAA amended section 303(f)(3) of the FD&C Act, authorizing FDA to assess civil monetary penalties against the person committing the prohibited acts.

Identifying Noncompliant Responsible Parties and Submitters

In this Guidance, FDA states its intention to utilize evidence collected during FDA’s Bioresearch Monitoring Program (“BIMO”) inspections to assess compliance with registration and results reporting requirements as described in Form FDA 2438 – Chapter 48 – Bioresearch Monitoring (Apr. 19, 2017). FDA also intends to identify violations as a result of complaints received by the Agency, which may entail reviewing public and non-public information, including, but not limited to information submitted to the ClinicalTrials.gov data bank and to FDA.

It is in the best interest of sponsors, researchers, and other parties subject to an obligation to submit clinical trial registration, information, results, and/or certifications to FDA to have policies and procedures in place to ensure correct information is submitted to ClinicalTrials.gov data bank. Policies and procedures should also include periodic review of the data bank to monitor for any missing or inaccurate clinical trial information. Developing and implementing these policies and procedures will mitigate the risk of enforcement for noncompliance with registration and clinical trial results reporting requirements, as outlined in the Guidance.

Determining When to Seek Civil Monetary Penalties

Under Guidance, FDA intends to provide the responsible parties with an opportunity to remedy any prohibited acts under section 301(jj) of the FD&C Act and corresponding regulations (42 CFR Part 11) before initiating an action to recover penalties. Pursuant to the procedures detailed in the Guidance, when FDA determines that when submissions are not timely filed or inaccurate, FDA will generally send the responsible party or submitter a Preliminary Notice of Noncompliance Letter describing the potential violation. The responsible party or submitter will have thirty (30) calendar days to remedy the violation. Should FDA conduct further review and find further or continued noncompliance with the applicable clinical trial requirements, the agency will then issue a Notice of Noncompliance, giving the responsible party or submitter another thirty (30) days to remedy noncompliance after receipt of the notice.

It is in the best interest of sponsors and researchers to promptly respond to any FDA inquiries and notices concerning registration, clinical trial information or certification issues related to the ClinicalTrials.org data bank. Failure to comply within the thirty (30) days of receipt of Notice of Noncompliance will result in FDA escalating regulatory action, including civil monetary penalties, of up to $10,000 for all violations adjudicated in a single proceeding.  Additional penalties of up to $10,000 each day may be included if the violation continues and if said violation is not corrected within thirty (30) days following notification. FDA may also pursue injunction and/or criminal prosecution.

In determining monetary penalties, the FDA will evaluate the circumstances, nature, extent, and gravity of the violation(s) with respect to the individual.  Other factors will include the violator’s ability to continue conducting business, any prior history of such violations, and the degree of culpability in the matter.

Responding To Civil Monetary Penalties by FDA

If FDA seeks civil monetary penalties, according to 21 CFR Part 17, the responsible party or submitter has the opportunity to either: (1) pay the penalty prescribed in the complaint or (2) file an Answer, contesting the allegations either in part or in whole, within thirty (30) days of date of service.

Should the responsible party or submitter contest the allegations by submitting an Answer, generally settlement discussions with FDA are entered into, providing the responsible party or submitter to present mitigating evidence to FDA for purposes of reducing the penalty amount. If a settlement is not reached before a decision on appeal, a presiding officer will make an initial decision, followed by the usual administrative appeal process (e.g., Department of Health and Human Services Departmental Appeal Board and then the U.S. Court of Appeals for the District of Columbia or any other circuit in which the responsible party or submitter resides or conducts business), should either party appeal the initial decision.

 

* * *

A recent BMJ article, “Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource,” reported that for approximately half of the clinical trials, the responsible person did not report results on the EU register while a 2015 New England Journal of Medicine article, “Compliance with Results Reporting at ClinicalTrials.gov,” reported that approximately 20% of industry trials did not report results when required to do so, and 50% of NIH-sponsored research went unreported. While the registration, reporting, certification requirements, and the penalties for noncompliance are not new, FDA’s release of this Guidance should be taken as a signal to sponsors and researchers of its plan to enforce those requirements more rigorously. Therefore, sponsors and researchers should take this opportunity to evaluate the sufficiency of their policies and procedures for compliance with registration and reporting requirements and audit their submissions to ensure they are up-to-date.  Comments are due by November 20, 2018.

Please join Epstein Becker Green attorneys for a fall webinar series—via five 45-minute sessions—that will address how proactive compliance initiatives are critical to a platform’s operations, expansion efforts, and eventual monetization upon exit.

Immediate Post-Closing Operational Fixes
When:  October 2, 2018 at 12:00pm – 12:45pm
People:  John Eriksen, Josh Freemire, Gary Herschman, and Marc Mandelman
Location:  Webinar (ET)

Add-On Diligence Strategy
When:  October 9, 2018 at 12:00pm – 12:45pm
People:  Josh Freemire, Anjana Patel, David Weiss
Location:  Webinar (ET)

Proactive Employment Compliance
When:  October 16, 2018 at 12:00pm – 12:45pm
People:  Denise Dadika, Paul DeCamp, Peter Steinmeyer
Location:  Webinar (ET)

Proactive Health Care Regulatory Compliance
When:  October 23, 2018 at 12:00pm – 12:45pm
People:  John Eriksen, Josh Freemire, Kevin Ryan
Location:  Webinar (ET)

Employee Benefits and Executive Compensation Compliance and Planning
When:  October 30, 2018 at 12:00pm – 12:45pm
People:  Christopher McMican, Kevin Ryan, Peter Steinmeyer
Location:  Webinar (ET)

Registration is complimentary click here.

If you have questions regarding this event, please contact David Stone.

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, D.C., on September 6-7, 2018. The purpose of this and other public meetings of MedPAC is for the commissioners to analyze existing challenges and issues within the Medicare program and to provide future policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. These meetings offer a comprehensive perspective on the current state of Medicare as well as future outlooks for the program.

As thought leaders in healthcare law, Epstein Becker Green monitors MedPAC developments to determine how regulations and policies will impact the health care marketplace. Here are our five biggest takeaways from the September meeting:

  1. MedPAC Discusses Trends in the Growth of Medicare and Total Healthcare Spending

MedPAC examined recent growth trends in Medicare and total healthcare spending in order to determine the budgetary impact of its recommendations. As part of their analysis, MedPAC reviewed the effects of healthcare spending on Medicare beneficiaries, households, and federal and state budgets as well as discussed evidence on ineffective spending and the opportunities it presents to lower health care spending without adversely impacting health outcomes.

MedPAC projects that the Medicare program will nearly double in size over the next decade, rising from “about $700 billion in total spending to 2017 to $1.3 trillion 2026.” At the same time, MedPAC expects that Medicare’s financing will become increasingly strained. Indeed, MedPAC projects that Medicare spending could rise from roughly 3 percent of our economy today to about 6 percent by 2048. The Commission estimates that Medicare, Medicaid, Social Security, and other major health program spending as well as net interest will reach nearly 20 percent of the economy and exceed total federal revenues by themselves.

Finally, the Commission found that Medicare may face a number of challenges in achieving savings down the road. The Commission points to Medicare’s fragmented payment systems across multiple health care settings, which the Commission believes contributes to a reduction in incentives to provide patient-centered coordinated care. Furthermore, Medicare’s benefit design is comprised of several parts, each of which cover different services and require different levels of cost sharing.

  1. MedPAC Provides Recommendations to Revise Statutory and Regulatory Requirements for PAC Providers

MedPAC presented recommendations for adopting a more unified payment system as well as ideas for creating common requirements for all Post-Acute Care (“PAC”) providers that would align the proposed system goals. The current system is comprised of four prospective payment systems (“PPS”). MedPAC’s concerns with the existing system is relative to differences in statutory and regulatory requirements for each. MedPAC found the requirements to be quite different across the four PPS settings while relatively similar in other cases. MedPAC also referenced other differences among PPSs relative to setting-specific and nursing requirements as well as Inpatient Rehabilitation Facilities (“IRF”) and Long-term Care Hospitals (“LTCH”). MedPAC’s theory rested on the idea that a unified PAC PPS would determine payments based “solely on patient characteristics and minimize the role of site of care in setting payments.”

MedPAC proposed establishing new requirements that could establish “separate categories to acknowledge that delivering care in the institution has some responsibilities that care in the home does not have . . . .” The proposed requirements were split into two tiers: (1) the first tier forming general requirements for services necessary to serve the majority of Medicare PAC patients and (2) the second tier for patients requiring more specialized care. Altogether, MedPAC believed that such a system could enhance the possibility of creating a more cohesive, unified payment system that could best determine patient payments.

  1. MedPAC Expresses Concerns Regarding Spending and Utilization of Long-term Care Hospitals

Congress mandated MedPAC to examine the effect of the LTCH dual-payment policy on the following issues:

  • The quality of care provided in long-term hospitals
  • The use of hospice care and post-acute-care settings
  • The effect on different types of LTCH, and
  • The growth in Medicare spending for services in LTCHs

MedPAC expressed concerns relative to LTCH spending and use over the past two decades as more than one LTCH would be located in one region of the country whereas some areas had none. Further concerns focused on research findings that failed to show a clear advantage in terms of outcomes or episode spending for LTCH users compared to those who used other PAC provider types. LTCHs are quite expensive—total Medicare spending totaled “just over $5.1 billion for about 126,000 cases in 2016.” Thus, due to the high expenses and unclear health outcome advantage of LTCHs, MedPAC suggested Medicare payers should better define the appropriate patients for LTCH care.

The Commission also expressed concerns relative to the growth of LTCHs. Though spending began to decrease after 2012, CMS never fully implemented policies to set limits on the share of cases being admitted to LTCHs from single referring acute-care hospitals. Thus, MedPAC is concerned as to whether the most appropriate patients are receiving care in LTCHs given that policymakers have failed to define this class of patients.

MedPAC plans to analyze new measures to determine quality of care in LTCHs, the use of hospice and other post-acute-care settings, use and spending data across different types of LTCHs, and the impact of the elimination of threshold policies in order to address these issues.

  1. MedPAC begins review of Medicare clinician payment updates under MACRA mandate

In 2015, the Medicare Access and CHIP Reauthorization Act (“MACRA”) repealed the sustainable growth rate formula for Medicare clinician fees and created permanent statutory updates for such fees. MACRA required MedPAC to conduct a report on clinician payment that reviews these updates and considers their impact on four indicators: (1) the efficiency and economy of care, (2) supply, (3) access, and (4) quality.

MedPAC first examined the efficiency and economy of care by analyzing Medicare spending trends. It identified the payment updates as affecting Medicare spending—the payment updates apply to Medicare’s conversion factor for the clinician services fee schedule used by Medicare. However, MedPAC also acknowledged that other factors might impact spending in addition to the payment updates, including policy adjustments (e.g., converting payment incentive programs to penalty programs), site-of-service shifts (i.e., moving services from “the physician office setting to the hospital outpatient department” decreases Medicare physician fee schedule spending but still increases total Medicare spending), and clinician increases in volume and intensity of services provided.

MedPAC then reviewed the effect of the payment updates on supply, which it measured as the “number of clinicians billing Medicare.” It found that despite “relatively modest” payment updates (averaging about a half percent annually), supply has been steadily growing since 2009, from a 1.5% increase in specialty physicians billing Medicare per year to a robust 10.1% increase in advanced practice registered nurses and physician assistants billing per year.

In order to track access to care, MedPAC analyzed the results of its yearly telephone survey of Medicare beneficiaries and individuals with private insurance, closely tracking the ease of finding new primary care physicians as a key indicator of access to care. It found that “diverging payment rates” between Medicare and private insurance “have not appeared to have resulted in a difference in patient-reported access to care” based on MedPAC’s survey results.

Finally, MedPAC reviewed statutory updates and their impact on quality. MedPAC reported “little evidence” that higher payments translate to higher quality for clinician services. MedPAC also emphasized its recommendation to repeal Medicare’s current quality program for clinicians, the Merit-based Incentive Payment System (“MIPS”) since MIPS does not allow for comparison of quality performance across clinicians. Overall, MedPAC concluded that impact on quality is indeterminate.

MedPAC plans to revisit this review in the spring of 2019 with a presentation analyzing updated data and a “site-of-service adjusted volume analysis.”

  1. MedPAC reviews its new Hospital Value Incentive Program and requests feedback regarding quality measures and monitoring hospital-acquired conditions

MedPAC was tasked with the potential redesign of the hospital quality and value program, which currently involves four complex and overlapping quality payment and reporting programs. Based on quality incentive principles laid out by the Commission, MedPAC created the Hospital Value Incentive Program (“HVIP”). MedPAC reviewed the design of its new clear and focused HVIP:

Combined

  • Hospital Readmissions Reduction Program (“HRRP”) and
  • Hospital Value-based Purchasing Program (“VBP”)

Eliminated

  • Inpatient Quality Reporting Program (“IQRP”) and
  • Hospital-Acquired Condition Reduction Program (“HACRP”)

MedPAC described four outcome, patient experience, and cost measures of quality in the HVIP: (1) readmissions, (2) mortality, (3) spending, and (4) patient experience. MedPAC also asserted the following characteristics of its HVIP:

  • Translation of quality measure performance into payment by adhering to clear performance standards.
  • “Peer grouping” to account for provider population differences (“Peers” are those providers that “treat a similar share of fully dual-eligible beneficiaries”)
  • Redistribution of a budgeted amount based on the hospitals’ performance
  • Public reporting of quality results

MedPAC explained that its model of the HVIP projected a 50:50 reward-penalty ratio. The model weighted each of the four measures of quality equally when determining a HVIP “score” for the hospital, but MedPAC reasoned that policymakers could prioritize certain measures to appropriately balance the interests of Medicare and its beneficiaries. MedPAC then offered suggestions for changing the withhold amount to align to the budget neutral goal of the HVIP, instead of the current maximum 3% reward and 6% penalty assessed to hospitals. MedPAC discussed the “patient experience” measure, which it stated would be based on the Hospital Consumer Assessment of Healthcare Providers and Systems (“HCAHPS”) national survey, which consists of ten core measures. MedPAC explained two alternatives for incorporating this survey data: (1) using the overall HCAHPS score or (2) scoring multiple select individual HCAHPS measures. MedPAC did caution that several hospital quality leaders favored the single overall HCAHPS rating due to better avoidance of bias. MedPAC subsequently requested the Commission’s thoughts on patient experience data to be used in the HVIP.

Finally, MedPAC expressed hospital quality leaders’ concern over Medicare’s hospital-acquired conditions (“HAC”) reduction program and its connection to payment. MedPAC suggested removing these financial incentives associated with limiting HACs and instead continue public reporting of results and allow financial incentives indirectly through HVIP’s readmissions measure. MedPAC requested feedback from the Commission on this issue.

Earlier this year, Florida Governor Rick Scott signed into law HB7099 and SPB7028 (collectively referred to as the “Bills”), ratifying emergency rules that require nursing homes and assisted living facilities to acquire alternative power sources- such as generators- and fuel in preparation of the upcoming hurricane season. See Rule 59A-4.1265 and Rule 58A-5.036. These rules were enacted after 14 residents died from heat-related illnesses and complications during Hurricane Irma last year when a Florida nursing home lost power to its air conditioning units for three days.

The Bills went into effect on March 28, 2018, and required qualifying facilities to come into compliance by June 1, 2018, unless granted an extension by the Governor whereby compliance is expected by January 2019. Facilities that can show delays caused by necessary construction, delivery of ordered equipment, zoning, or other regulatory approval processes are eligible for an extension if the facility can provide residents an area that meets the ambient temperature requirements for 96 hours. Extensions are granted on a case-by-case basis, although so far a majority of Florida facilities have been granted an extension. Indeed, it appears that over 77% of nursing homes received an extension in the first week of June. Additionally, facilities located in an evacuation zone pursuant to Chapter 252, F.S., must either evacuate its residents prior to the arrival of any emergency event, or have an alternative power source and no less than 96 hours of fuel stored onsite at least within 24 hours of the issuance of a state of emergency. Failure to comply with any provision may result in the revocation or suspension of a facility’s license and/or the imposition of administrative fines.

Nursing Homes and Assisted Living Facilities Must Develop Emergency Plans that Provide for Alternative Power Sources and Fuel Capable of Maintaining an Ambient Temperature of No Greater Than 81 Degrees Fahrenheit for At Least 96 Hours.

Nursing Homes and Assisted Living Facilities must prepare a detailed plan (“Plan”) that provides for the acquisition and maintenance of alternative power sources- such as generators- and fuel. The Plan will supplement a facility’s Comprehensive Emergency Management Plan and must be submitted to and approved by the requisite agency. While the Bills do not require facilities to maintain a specific type of power system or equipment; the alternative power sources utilized by a facility must be capable of maintaining an ambient temperature of no greater than 81 degrees Fahrenheit for at least 96 hours after the loss of primary electrical power. This temperature must be maintained in areas of sufficient size to shelter residents safely. Alternative power sources and fuel should be maintained in accordance with local zoning restrictions and the Florida Building Code.

Moreover, the Bills set forth additional requirements for nursing homes and assisted living facilities in evacuation zones, as well as for single campus and multistory facilities.

  • Facilities in Evacuation Zones – A facility in an evacuation zone pursuant to Chapter 252, F.S. must provide in their Plan for the maintenance of an alternative power source and fuel at all times when the facility is occupied but may utilize mobile generators to facilitate evacuation.
  • Single Campus – Single campus facilities under common ownership may share alternative power sources and fuel space if such resources are sufficient to maintain the ambient temperature required under the rules.
  •  Multistory Facilities – Multistory facilities, whose Comprehensive Emergency Management Plan comprises of moving residents to a higher floor during flood or surge events, must place their alternative power source and all additional equipment in a location protected from flooding or storm surge damage.

Fuel Storage Requirements Vary by Facility Size and Location.

The Bills require facilities to provide for storage of a certain amount of fuel based on their size and location. Assisted living facilities with 16 beds or less must store a minimum of 48 hours of fuel, while assisted living facilities with 17 beds or more a required to store a minimum of 72 hours of fuel. All nursing homes must store a minimum of 72 hours of fuel. Nursing homes and assisted living facilities located in a declared state of emergency area pursuant to Section 252.36, F.S., that may impact primary power delivery, must secure 96 hours of fuel; these facilities may utilize portable fuel storage containers for the remaining fuel necessary for 96 hours during the period of a declared state of emergency.

Emily Budicin, a 2018 Summer Associate in the firm’s Washington, DC office, contributed significantly to the preparation of this post.

A variety of traditional and non-traditional investors are starting to capitalize on the stability of the Medicare Advantage Program and expansion of the Medicare Advantage Health Plan Market.  These companies are leveraging sophisticated technological interfaces, data, and telemedicine to help improve the patient experience and to maximize the Triple Aim.

Why Medicare Advantage?

Medicare Advantage plans are offered by private insurance companies subject to certain standards established by the Centers for Medicare & Medicaid Services (“CMS”).  While the Medicare Advantage health plans are responsible for meeting specified levels of benefits and service standards and receive premium funding from the government, they have a high degree of autonomy on how they administer the plans to cover enrolled Medicare beneficiaries.  Medicare Advantage funding is risk adjusted for the health status of the enrollee and as a result, effective Medicare Advantage plans (“MA Plans”) are highly dependent upon real time data sharing.

Disfavored no more

Recent developments show that Medicare Advantage has more bipartisan support than the ACA Marketplace and is less susceptible to political intrigues.  However, this was not always the case. Not too long ago, Medicare Advantage was considered a “privatization of Medicare” and insurance companies were accused of making a profit off of the Medicare Program.  In February 2013, federal officials announced a 2.2% cut to Medicare Advantage reimbursement.  The political attacks on Medicare Advantage were not well received by the Medicare Advantage enrolled seniors who vocally began to defend their beleaguered program.  The patients began a campaign of communication to members of Congress, touting the benefits of engaged Medicare Advantage healthcare providers and health related initiatives such as fitness and nutrition counseling.  This caught the skeptics between a rock and a hard place.  Some Congressional Democrats have noted that they support killing the program but cannot because senior constituents love it.  After significant grassroots lobbying, coalition building, and industry efforts, the proposed 2.2% reduction was transformed into a minor increase by April 2013.  This turnaround was primarily due to patient and provider advocacy with thousands of seniors participating in letter writing campaigns to protect their Medicare Advantage Program.  Medicare Advantage went from a political pariah to a bipartisan tolerated program within a few years.

Medicare Advantage is here to stay

Fast forward to 2018, Medicare Advantage is marketed as an innovative health care option that will provide more choices and lower premiums.  The Trump Administration is providing greater flexibility to companies offering benefits in Medicare Advantage plans.  Medicare Advantage is expanding beyond the retiree states of Florida, Arizona, and California with significant inroads in all fifty states.  The growth has caught the eye of innovative healthcare investors and market consolidation has produced larger plans with stronger infrastructure including captive staff-model delivery systems.  Medicare Advantage continues to grow with 33% of Medicare eligible beneficiaries currently enrolled in MA Plans.  Significant opportunities exist for companies which already possess sophisticated data analytics and coordinated care systems.  Notably, one such player, Clover Health, announced on August 27, 2018 that it is also launching Medicare Advantage plans in six new markets in 2019.  Clover Health is a San Francisco based startup that uses data analytics and artificial intelligence to deliver health care.  Currently, Clover Health provides services for 30,000 seniors and others eligible for Medicare in parts of Georgia, New Jersey, Pennsylvania and Texas.  Only time will tell how successful starts ups such as Clover Health will be in the Medicare Advantage marketplace.  However, this investment is one indicator that despite the rhetoric around health care in America, Medicare Advantage is here to stay.

Financial sponsors commit substantial capital in establishing or acquiring physician/professional management platforms in sectors such as dermatology, orthopedics, gastroenterology, urology, pain management, radiology, ophthalmology/optometry, dentistry, etc. Thereafter, sponsors seek to consolidate and make the platform more operationally efficient and pursue platform growth through add-on and tuck-in deals, as well as organic expansion.

This webinar series will address how proactive compliance initiatives are critical to a platform’s operations, expansion efforts, and eventual monetization upon exit.

12:00 p.m. – 12:45 p.m. ET

 

Immediate Post-Closing Operational Fixes

Tuesday, October 2, 2018

Add-On Diligence Strategy

Tuesday, October 9, 2018

 Proactive Employment Compliance

Tuesday, October 16, 2018

Proactive Health Care Regulatory Compliance

Tuesday, October 23, 2018

Employee Benefits and Executive Compensation Compliance and Planning

Tuesday, October 30, 2018

 

Register for these complimentary webinars today!

In the tech world, blockchain technology appears to be the panacea to all problems.  As blockchain technology becomes increasingly popular, many industries are trying to determine the best way to use the new phenomenon. Healthcare is no different in this quest. Health care is an optimal candidate to benefit from development of innovative ways to solve its impending issues using transformational technology. Blockchain could be the technology that helps to alleviate some of health care’s problems, such as the incredibly fragmented delivery of care and the painstakingly slow reaction to technological advances.

What is Blockchain Technology?

An over-simplified explanation of blockchain is an online database that stores information on a network of computers. Information also known as “a record” is stored in a block. For example, a record of you paying Mr. Smith 10 dollars is stored in a block. Traditionally, that information is saved in a database at a data center. However, blockchain technology stores that record on an individual computer with a time stamp (the “block”).  Any change to that information is then stored on another individual computer with a time stamp.  Each individual computer holds a block of information that is chronologically time stamped, which creates the blockchain. Thus, information cannot be edited or changed without the verification from all parties who have access to a block in the blockchain.  Blockchain technology distributes and decentralizes information.  There is no central company or one person that holds the information. This makes it extremely difficult for any one person to take down or corrupt the network. Traditionally, blockchain technology is used as a public transaction ledger for bitcoin. Bitcoin users utilized the technology to mitigate the issue of double spending, spending the same single digital coin more than once, without the need of one trusted authorizer or central server. 

Blockchain and Health Care

Blockchain technology could play a role in the industry’s goal to improve the quality of care through care coordination. Care coordination often involves the sharing of information between multiples providers. Blockchain technology could be used to facilitate this process in a more efficient manner by storing a variety of information, including provider and patient details, within electronic health records (EHR) on a network of computers. Blockchain would store the information on various computers, such that information entered into an EHR could be stored across a network of computers that includes providers and the patient. Providers and the patient would hold blocks of information, allowing each provider and each patient to validate the updates to that patient’s record with the consensus of all the providers and the patient. Using blockchain in this fashion would give patients control over their care while also encouraging care coordination because providers would have to interact with one another to update a patient’s file. In this sense, Blockchain could take the first step in facilitatating the improvement of patient care as a whole.

Blockchain could also reduce the health care industry’s susceptibility to privacy attacks or breaches because of its decentralized and distributed structure. Privacy attacks often involve a hacker entering a system or a database, but, with blocks held in multiple locations instead of one database, blockchain technology would help to minimize hacker infiltration.

However, as with any heavily regulated industry, implementing blockchain will not be easy. There are state and legal roadblocks that hinder blockchain’s viability. Health Insurance Portability and Accountability Act (“HIPAA”), for example, could hinder the ability of sharing health information technology between a network of computers due to restrictions on sharing of Personal Health Information (PHI). Furthermore, state and federal laws would have to be updated to facilitate this technological advance. Despite these hurdles, there may be a glimmer of hope. The Centers for Medicare & Medicaid Services is dedicated to improving interoperability and patients’ access to health information through its Promoting Interoperability program. The agency’s push for moving health towards EHR has the potential to be pivotal if the industry uses blockchain or a similar technology to improve patient access to health information.

Blockchain may not be a today solution—it will take time to change state and federal laws regarding health information to facilitate such technology. However the promotion of initiatives encouraging use of EHR, may be priming the industry’s palate to provide a place for blockchain in the future.

On Monday, August 12, 2018, the U.S. Department of Justice (“DOJ”) announced a new addition to its regional Medicare Fraud Strike Forces: a Newark/Philadelphia Regional Medicare Strike Force that will target both healthcare fraud and opioid overprescription.[1] The newly-formed Newark/Philadelphia Strike Force joins nine existing regional Medicare Strike Forces, all of which are focused in geographical areas of high healthcare fraud risk: Miami, Florida; Los Angeles, California; Detroit, Michigan; Southern Texas; Southern Louisiana; Brooklyn, New York; Tampa, Florida; Chicago, Illinois; and Dallas, Texas.[2] The Newark/Philadelphia Strike Force will be supported by the resources of several federal agencies, including the Health Care Fraud Unit of the Justice Department’s Criminal Division’s Fraud Section, the U.S. Attorney’s Offices for the District of New Jersey and the Eastern District of Pennsylvania, the FBI, U.S. Department of Health and Human Services Office of the Inspector General (“OIG”), and the U.S. Drug Enforcement Administration.[3]

The creation of the regional Newark/Philadelphia Strike Force comes as little surprise as this heavily populated region is home to many major players in the healthcare industry, including pharmaceutical companies and healthcare facilities. Significantly, earlier this year, Maureen Dixon, the Special Agent in Charge of OIG’s Philadelphia Regional Office testified before the U.S. Senate Committee on Finance’s Health Care Subcommittee and highlighted many cases in the New Jersey/Philadelphia region as prototypical examples of patient harm and prescription and treatment fraud and addressed efforts to prevent opioid overutilization and misuse.

Enforcement in the Region: Expect More Enforcement Against Providers and Home Health Care Agencies

The new Newark/Philadelphia Strike Force is expected to usher in quickly a new wave of fraud enforcement to the region. Historically, DOJ’s Strike Forces have targeted provider activity, with enforcement often aimed at clinicians and home health care agencies. The new Strike Force’s dedicated focus on opioid overutilization is in line with the priorities of the District of New Jersey’s U.S. Attorney Craig Carpenito, who has made the abuse of opioid prescriptions a target for his district.  In February of this year, the District of New Jersey’s U.S. Attorney’s Office reorganized and announced the formation of an Opioid Abuse Prevention and Enforcement Unit to complement the existing Healthcare and Government Fraud Unit within that Office’s Criminal Division.

Notably, the addition of the new Newark/Philadelphia Strike Force demonstrates DOJ’s continued belief that behavior – both on the provider and the patient sides – can be changed through enforcement. The Strike Forces’ data-driven model of health care enforcement eschews reliance on qui tam filings and whistleblowers for investigative leads in favor of identifying and targeting health care fraud through data analytics.  Nationwide, the Strike Forces have brought a significant increase in healthcare fraud prosecutions since the concept was first introduced in 2007. Indeed, since their creation in 2007, the Strike Forces have been instrumental in obtaining nearly 2,500 indictments related to over $3 billion in fraudulent health care payments.[4]Most recently, DOJ’s Medicare Strike Forces were in part responsible for the DOJ’s July 2018 health care fraud takedown, the nation’s largest to date, resulting in 601 arrests in connection with over $2 billion of fraudulent billings.[5] 162 defendants, including 32 doctors, were charged for their roles in prescribing and distributing opioids and other narcotics.[6]

Impact on Provider Exclusion Actions

It is likely that the number of exclusion actions pursued by OIG will increase in the region because of the Newark/Philadelphia Strike Force. In the intervening year between DOJ’s June 2017 and July 2018 health care fraud takedowns, the OIG issued nearly 600 exclusion notices to individuals and entities whose conduct “contributed to opioid diversion and abuse.”[7] Among those issued exclusion notices were 67 doctors, 402 nurses, and 40 pharmacy services.[8]

Opioid Overutilization Enforcement

The Newark/Philadelphia Strike Force is the first of its kind to have a specific focus on targeting opioid overutilization. Identifying and targeting the opioid epidemic is a top priority of both DOJ and the OIG; according to Assistant Attorney General Brian A. Benczkowski of the Justice Department’s Criminal Division, CDC data found that over 40 percent of all U.S. opioid overdose deaths involved a prescription opioid in 2016.[9][10] A 2018 OIG report on opioid abuse in the Medicare Part D program found that about 460,000 beneficiaries received high amounts of opioids in 2017, and about 71,000 beneficiaries are at serious risk of opioid misuse or overdose.[11]

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Both the Eastern District of Pennsylvania and the District of New Jersey have developed novel, cutting-edge healthcare fraud cases time and time again over the past decade.  The addition of expertise and resources provided by the new Strike Force in these two districts demonstrate a clear intent to continue this trend. However, it remains to be seen if the new Strike Force and its opioid focus will divert resource away from other more long-term, complex investigations these Districts have traditionally concentrated on.

[1] https://www.justice.gov/opa/pr/assistant-attorney-general-benczkowski-announces-newarkphiladelphia-medicare-fraud-strike

[2] https://www.justice.gov/opa/pr/assistant-attorney-general-benczkowski-announces-newarkphiladelphia-medicare-fraud-strike

[3] Id.

[4] https://oig.hhs.gov/fraud/strike-force/

[5] https://www.justice.gov/opa/pr/national-health-care-fraud-takedown-results-charges-against-601-individuals-responsible-over

[6] https://www.fda.gov/ICECI/CriminalInvestigations/ucm612183.htm; https://oig.hhs.gov/newsroom/media-materials/2018/takedown/2018HealthCareTakedown_FactSheet.pdf; https://www.law360.com/articles/1064720/doj-s-health-care-enforcement-initiative-is-still-going-strong.

[7] https://oig.hhs.gov/newsroom/media-materials/2018/takedown/2018HealthCareTakedown_FactSheet.pdf

[8] Id.

[9] https://oig.hhs.gov/oei/reports/oei-02-18-00220.pdf; https://oig.hhs.gov/reports-and-publications/featured-topics/opioids/

[10] https://www.justice.gov/opa/pr/assistant-attorney-general-benczkowski-announces-newarkphiladelphia-medicare-fraud-strike

[11] https://oig.hhs.gov/oei/reports/oei-02-18-00220.pdf