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]

* * *

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

The Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 18-03 in support of an arrangement where a federally qualified health center look-alike (the “Provider”) would donate free information technology-related equipment and services to a county health clinic (the “County Clinic”) to facilitate telemedicine encounters with the County Clinic’s patients (the “Proposed Arrangement”).  The OIG concluded that although the Proposed Arrangement could potentially generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) and Civil Monetary Penalties Law (“CMPL”) with the requisite intent to induce or reward referrals of federal health care programs, the OIG would exercise its discretion and not sanction the Provider or the County Clinic (collectively the “Requestors”).

The OIG’s analysis and conclusion of the Proposed Arrangement provides new insight into the government’s position on these type of donations that facilitate telemedicine encounters.  Specifically, how the government views these type of donations with the continued expansion of coverage and reimbursement of telemedicine services under federal health care programs.  The Advisory Opinion indicates support for the development of collaborative telemedicine affiliations and that the potential remuneration from the future referrals can be outweighed by the access to health care services and benefits actually received by rural or remote communities.

Proposed Arrangement

The County Clinic is a division of the County Department of Health that furnishes certain confidential sexually transmitted infection testing, treatment and counseling. The Provider has an existing referral relationship with the County Clinic but the facilities are separated by about 80 miles making it difficult for patients to access the Provider.  Under the Proposed Arrangement, the Provider would donate information technology-related equipment and services to the County Clinic to facilitate telemedicine encounters between the Provider and the County Clinic’s patients for certain HIV prevention and treatment services.  The Provider would cover the costs of the equipment, its set up, and maintenance through grant-funding from the State Department of Health.  The Provider would bill the Medicare program for the professional services delivered in the telemedicine encounters.  The County Clinic would house the equipment and bill the state Medicaid program an originating site fee related to the telemedicine encounters. The originating site is not required to provide any personnel or equipment in order to bill for the facility fee (Q3014) (which is only a coverage requirement to provide the telehealth consult).

OIG Analysis

AKS makes it a criminal offense to knowingly and willfully offer or receive remuneration in an effort to induce or reward referrals of items or services reimbursable by federal health care programs. CMP provides for penalties against any person who offers or transfers remuneration to a Medicaid or Medicare beneficiary that the benefactor knows or should know is likely to influence the beneficiary’s selection of a specific provider, service, or item that will be paid, in whole or part, by Medicaid or Medicare.

Under the Proposed Arrangement, the County Clinic would receive remuneration of the free equipment and services and the Provider would have the opportunity to bill for the telehealth consultation referred by the County Clinic.  As such, the OIG acknowledged that the Proposed Arrangement could potentially generate prohibited remuneration under the federal AKS with the requisite intent to induce or reward referrals of services payable by a federal health care program.  However, the OIG identified the following factors as minimizing the potential risk of fraud and abuse:

  • There are safeguards in place to prevent patient steering to the Provider for treatment; namely use of technology with any other provider is not restricted and patients are given the option to have either a virtual or in-person consultation
  • Not likely to result in patient steering for prescriptions to any pharmacy operated by the Provider or County Clinic
  • There would be no increased cost to any federal health care program
  • Patients would benefit by having increased access to treatment; making it more likely that patients will seek out and receive such services

It is important to keep in mind that under the Proposed Arrangement the County Clinic would not obtain ownership of the equipment, as the Provider would use grant funds awarded by the State Department of Health to cover the costs of the equipment and services and the state agency would retain title and have the authority to recover the equipment at any time.  This could prove to be an important distinction concerning whether and how donating providers can provide information technology-related equipment and services to referring facilities in the other arrangements.

Notes and Comments

In prior Advisory Opinions (99-14, 04-07 and 11-12) concerning donations of information technology-related equipment and supplies, the OIG similarly concluded that it would not pursue sanctions; however, those proposed arrangements would not have directly resulted in a service payable by a federal health care program, but rather would only potentially result in other items or services to the patient by the donating provider. Under the Proposed Arrangement, both the County Clinic and the Provider would be in a positon to submit claims to a federal health care program as a result of the telemedicine encounter and follow-up services.  Nevertheless, the OIG concluded that there would be no increased cost to any federal health care program because the County Clinic would have performed the preliminary tests and referred clinically appropriate patients for in-person consultations and, potentially, follow-up items and services regardless of the Proposed Arrangement.

While the analysis acknowledges the additional reimbursement the County Clinic would receive for serving as the originating site (i.e., the location of the Medicaid beneficiary when the service furnished via a telecommunications system occurs), there is no actual analysis of this facility fee and why it is not considered an increased cost.  To be clear, the County Clinic does not provide the HIV preventative services to be delivered by the Provider via the telemedicine consultation, and therefore, would not have previously received any payments if and when the patient was referred to the Provider for an in-person consultation.

Again, it appears that the OIG is willing to prioritize the health benefits to patients over any secondary or tertiary benefits to the referring provider; especially when such subsequent benefits are unlikely to result in overutilization and have the potential to decrease costs to federal health care programs.

On June 28, 2018, California legislated into law A.B. 375, otherwise known as the California Consumer Privacy Act of 2018 (“California Privacy Act”).  Effective January 1, 2020, among other requirements, the law will expand privacy rights of California consumers as well as require businesses to disclose the what, why, and how consumers’ personal information are being used.  Failure to comply with these new laws could be costly to businesses with civil penalties resulting from an action by the state attorney general of up to $7,500 per violation.  In addition, in the event of a breach of personal information, the California Privacy Act provides consumers with statutory damages of no less than $100 and no more than $750 per consumer per incident, or actual damages, whichever is greater.  Therefore, the California Privacy Act will have a significant impact on businesses, including the healthcare sector.

Business Types Affected.

Generally, the California Privacy Act will affect business entities that are for-profit business entities that collect consumers’ personal information and that meet one or more of the following criteria: (1) have annual gross revenues greater than twenty-five million dollars ($25,000,000); (2) buy, receive, sell, or share personal information of 50,000 or more consumers annually; or (3) derive 50 percent or more of its annual revenues from selling consumers’ personal information.  The law applies to businesses who collect, use, or share personal information of California residents, including those who are outside the state for temporary or transitory purposes (e.g., travelers).  California’s privacy law does not apply to protected health information regulated by California’s Confidentiality of Medical Information Act or by HIPAA’s privacy, security, and notification rules, but, it does apply to the other personal information held by an organization that meets the criteria above and doing business in California. 

Consumer Rights Expanded.

Additionally, the California Privacy Act will provide California residents more control over their personal information.  For example, consumers will have the right to know the type of personal information collected by the business, the purpose for which the information is being collected, and with whom the information is being shared with.  Also, consumers will have the “right to be forgotten” by requesting the deletion of their personal information from the businesses’ systems (with certain exceptions that may apply).  Under the new law, consumers will have the right to prohibit businesses from selling their personal information.  Furthermore, the California Privacy Act will also provide consumers protection from discriminatory action by businesses for exercising these privacy rights.  Overall, the expansion of consumers’ rights to their personal information are similar to the requirements set forth in the European Union’s General Data Protection Regulation (“GDPR”) policies.  Therefore, in this regard, the good news is that the work businesses have been doing to be GDPR compliant will most likely comport with the California Privacy Act.

Business Response Required.

Also, the California Privacy Act will mandate businesses, affected by the law, to comply with several requirements that will ensure consumers’ awareness of their privacy rights.  For example, the law will require businesses to make available at least two methods for consumers to make requests for information required to be disclosed (at a minimum a toll-free telephone number and, if applicable, a Web site address).  Businesses will be required to disclose and deliver the requested information, free of charge to the consumer within 45 days of the request (although businesses will not have to provide such information more than twice a year to a single consumer).  Furthermore, businesses will be required to ensure that all individuals handling consumer inquiries about the business’s privacy practices or the business’s compliance with the law understand all the requirements under the California Privacy Law.  Therefore, businesses will need to make sure that its online privacy policies and/or California-specific consumers’ privacy rights are updated to include these new rights.

* * *

As mentioned above, the California Privacy Act reaches businesses beyond the borders of the state.  According to the International Association of Privacy Professionals (“IAPP”), more than 500,000 U.S. businesses (most being small- to medium-sized enterprises) will be affected by the privacy law.  Because the California Privacy Act follows in the footsteps of the GDPR, the work businesses have done to be in compliance with the GDPR will most likely comport with California’s privacy law.  But those businesses who have not, should begin making changes to their policies and procedures to ensure they are in compliance by the end of 2019.

On June 25, 2018, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) published Advisory Opinion 18-05, allowing a nonprofit medical center to provide or arrange for certain support services for individuals who care for adults with chronic medical conditions (the “Opinion”).  The Opinion is significant because it helps to define the limits of recently enacted exceptions to the Civil Monetary Penalties Law (“CMP Law”).  In addition, the Opinion follows other recent guidance and regulations promulgated by OIG and the Centers for Medicare and Medicaid Services that demonstrate a trend toward permitting providers to offer various forms of caregiver assistance, including Advisory Opinion 09-01 (regarding complimentary local transportation provided by a skilled nursing facility to friends and family of residents of the facility) and Advisory Opinion 11-16 (regarding a hospital’s provision of free transportation, lodging, meals and other items and services to patients and their family members).

As described in the Opinion, the requestor is a nonprofit hospital that established a center to provide various forms of assistance to caregivers (the “Center”).  The Center is funded by a foundation affiliated with the hospital and primarily staffed with unpaid volunteers.  The Center provides, either directly or via collaborations with other local nonprofit organizations, a variety of free and fee-based services, for example:

Free Services

  • Resource library,
  • Educational sessions,
  • Support groups,
  • Respite care during Center-sponsored activities attended by caregivers, and
  • Equipment lending program.

Fee-Based Services

  • Massage therapy,
  • Low-cost ride-share programs, and
  • Additional respite care resources.

If caregivers require financial assistance for the Fee-Based Services, then volunteers of the Center connect the caregivers to financial assistance resources in the community.  If additional financial assistance is required, then volunteers provide the caregivers with the hospital’s application for financial assistance.

OIG indicated that the services provided by the Center implicated both: (1) the Anti-kickback Statute (“AKS”) – which prohibits offering “remuneration” to induce the referral of items or services reimbursable by a federal healthcare program, and (2) the CMP Law – which prohibits offering “remuneration” to a Medicare or State health care program beneficiary that is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier.  With respect to the CMP Law, OIG discussed the potential applicability of two exceptions that were created under the Affordable Care Act and further clarified by OIG in regulations promulgated in 2016 – the “Promotes Access to Care Exception” and the “Financial Need-Based Exception.”

The “Promotes Access to Care Exception”[1] permits the provision of remuneration that promotes access to care and poses a low risk of harm to patients and federal health care programs.  OIG has interpreted this exception to apply to items or services that improve a beneficiary’s ability to obtain items and services payable by Medicare or Medicaid, and pose a low risk of harm to Medicare and Medicaid beneficiaries and the Medicare and Medicaid programs by –

  1. being unlikely to interfere with, or skew, clinical decision making,
  2. being unlikely to increase costs to federal health care programs or beneficiaries through overutilization or inappropriate utilization, and
  3. not raising patient safety or quality-of-care concerns.

The “Financial Need-Based Exception”[2] permits the provision of items or services for free or less than fair market value if the items or services:

  1. are not advertised,
  2. are not tied to the provision of other reimbursable items or services,
  3. are reasonably connected to the medical care of the individual, and
  4. are provided only after a good faith determination that the recipient is in financial need.

OIG ultimately determined that the services provided by the Center did not satisfy the requirements of either CMP exception.  For purposes of the Promotes Access to Care Exception, OIG reasoned that the services did not improve a beneficiary’s ability to obtain items and services payable by Medicare or Medicaid.  For purposes of the Financial Need-Based Exception, OIG reasoned that the services were not reasonably connected to the caregivers’ medical care, even though OIG conceded that the Arrangement related to the caregivers’ general health and well-being. For similar reasons, the OIG found that none of the AKS safe harbors would apply to protect the services provided by the Center.

Although no CMP exceptions or AKS safe harbors applied, OIG nonetheless concluded that it would not impose administrative sanctions on the hospital because the following safeguards were present:

  1. The services provided by the Center are not tied to federally reimbursable services, and the Center does not recommend any particular service providers. Therefore, there is a low risk that the Free or Fee-Based Services would influence a caregiver (or the care recipient) to choose the hospital for federally reimbursable services.
  2. The services are available to all caregivers regardless of insurance or health care provider.
  3. Financial assistance is awarded on the basis of objective, standardized financial criteria.
  4. The hospital does not actively market the services or the Center in the community or in the media – all promotion is done through the hospital’s own websites and brochures.
  5. Center volunteers direct caregivers to their own providers for any medical services and provide caregivers with a list of all known providers of non-medical services in the area.
  6. The Center’s operations are unlikely to increase costs to federal health care programs because the Center’s staff is comprised of unpaid volunteers, and all of the Center’s operating costs are funded by private donations.

Advisory Opinions 18-05, 09-01, and 11-16 each demonstrate that there is a growing need for various forms of caregiver support.  In fact, in its request for the Opinion, the hospital cited to a report from the National Alliance for Caregiving and AARP Public Policy Institute called Caregiving in the U.S. 2015, which found that many caregivers suffer from physical and financial strain as a result of caring for individuals with chronic conditions, and such caregivers could benefit from various educational and support services.  Thus, providers are beginning to develop programs to address the needs of caregivers, in addition to patients.

Although this Opinion acknowledges that there are limitations to the safe harbors and exceptions that may be used to protect caregiver arrangements from regulatory scrutiny, the Opinion nevertheless demonstrates that providers may still offer certain benefits to caregivers without violating AKS and the CMP Law if appropriate safeguards are in place.

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[1] 42 U.S.C. 1320a–7a(i)(6)(F) and 42 C.F.R. 1003.110(6)

[2] 42 U.S.C. 1320a–7a(i)(6)(H) and 42 C.F.R. 1003.110(8).

Since the inauguration of President Trump, the Affordable Care Act (ACA) has taken quite a few significant jabs and blows. When Congress failed to repeal the ACA, Congress instead eliminated the individual mandate penalty through the GOP tax bill. The individual mandate penalty was one of the main pillars of the ACA because it effectively widened the pool of participants who buy health insurance in order to keep costs down. While removal of this penalty hit the ACA where it hurt, the true threat to the stability of the ACA arose when the Trump Administration announced that it would no longer defend the ACA against a challenge filed by twenty states that believe the individual mandate itself is unconstitutional and that key parts of the act are invalid. What is the outlook for the ACA?

Congressional Efforts to Repeal

The House has voted to repeal or amend the ACA at least 50 times, but their efforts have never made it past the Senate. Despite this history of failure, there are still Republicans pushing for the repeal of the ACA.  On June 19, 2018, a coalition of conservatives released the outline of a new plan for repealing and replacing the ACA. The plan emphasizes the use of block grants, implementing risk pools, removing essential health benefits, and minimum loss ratio requirements.  As it stands, the plan will likely succumb to the fate of its predecessors.  Even if the bill passed the House, there are fewer Republicans in the Senate than the last time the repeal went to a vote. However, if after the upcoming mid-term elections the Republicans win Senate seats in Montana and Missouri and keep the majority in the House, the ACA could truly be in jeopardy.

Lawsuits

Meanwhile, twenty states have filed a lawsuit against the ACA’s individual mandate arguing that the elimination of the tax penalty without the elimination of the mandate is unconstitutional because it leaves the mandate without the exercise of Congress’s taxing power. The Supreme Court’s 2012 ruling may come back to haunt ACA proponents. The Supreme Court held that the individual mandate is constitutional because it constitutes a tax and that the ACA could not function without the mandate in place. Those filing suit argue that because the tax penalty is eliminated it is a tax-less mandate and thus unconstitutional because Congress cannot exercise its taxing power. As such, the mandate is such a key provision that the whole ACA should be thrown out if the provision cannot be severed.  In other words, the whole cannot exist without the entirety of its parts.

States Embrace Medicaid Expansion

Amid the slew of blows taken by the ACA, there is one provision left unscathed—Medicaid expansion.  The number of states expanding Medicaid continues to grow. For example, Virginia recently passed an expansion of Medicaid, and the Governor of Utah signed a Medicaid expansion bill.  Interestingly, some Republican-leaning states have embraced the expansion due in part to the current Administration’s support of work requirements. In fact, Maine is currently in a dispute with its Governor about the implementation of the expansion of Medicaid that was approved by Maine voters.

The Outlook

With the ACA constantly under attack from multiple vantage points, it is safe to say that the Act will have to fight to survive. Although heavily dependent on the November elections, it is possible that the ACA will survive additional congressional efforts to repeal the bill.  Further, the popularity of Medicaid expansion would make it difficult to repeal the bill in its entirety. More states are embracing Medicaid Expansion, and there is evidence available of the positive effects expansion has on access to care. The survival of the ACA really hinges on how U.S. District Judge Reed O’Connor interprets the law as he presides over the twenty-state suit, especially considering that the Trump Administration has already stated that it does not intend to defend the ACA. Stakeholders will have wait patiently to see how the outcome of the upcoming elections and the pending lawsuit will affect the ACA’s future.