Capital Thinking: Health Care Legislative Update

House to Consider Overriding President’s Veto of Reconciliation Legislation

Following a postponement due to weather last week, House Majority Leader Kevin McCarthy (R-CA) has announced that on Tuesday, February 2, the House will consider the President’s veto message on H.R. 3762, the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015. The legislation seeks to repeal major portions of the Affordable Care Act; it passed the Senate on a 52-47 vote and the House on a 240-181 vote. The President issued his veto on January 8.

This Week’s Hearings:

  • Tuesday, February 2: The House Committee on Veterans’ Affairs Subcommittee on Health will hold a hearing titled “Choice Consolidation: Evaluating Eligibility Requirements for Care in the Community.”
  • Tuesday, February 2: The Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy, and Consumer Rights will hold a hearing titled “License to Compete: Occupational Licensing and the State Action Doctrine.”
  • Wednesday, February 3: The House Committee on Oversight and Government Reform will hold a hearing titled “Examining Federal Administration of the Safe Drinking Water Act in Flint, Michigan.”
  • Wednesday, February 3: The House Committee on Agriculture Subcommittee on Nutrition will hold a hearing titled “To Review Incentive Programs Aimed at Increasing Low-Income Families’ Purchasing Power for Fruits and Vegetables.”
  • Wednesday, February 3: The House Committee on Armed Services Subcommittee on Military Personnel will hold a hearing titled “Military Treatment Facilities.”
  • Wednesday, February 3: The House Committee on Armed Services Subcommittee on Emerging Threats and Capabilities will hold a hearing titled “Outside Views on Biodefense for the Department of Defense.”
  • Wednesday, February 3: The Senate Committee on Indian Affairs will hold a hearing titled “Reexamining the Substandard Quality of Indian Health Care in the Great Plains.”
  • Thursday, February 4: The House Committee on Oversight and Government Reform will hold a hearing titled “Developments in the Prescription Drug Market: Oversight.”
  • Thursday, February 4: The House Committee on Energy and Commerce will hold a hearing titled “Examining Implementation of the Biologics Price Competition and Innovation Act.”
  • Thursday, February 4: The Senate Committee on Finance will hold a hearing on the nominations of Mary Wakefield to be Deputy Secretary of Health And Human Services, Andrew Eanes to be Deputy Commissioner of Social Security, and Elizabeth Copeland and Vik Stoll to be judges of the U.S. Tax Court.

Capital Thinking: Health Care Legislative Update

Blizzard Postpones House Consideration of Veto Message on Reconciliation Legislation

Due to the winter storm in Washington, the House will no longer be in session this week. Previously, House Majority Leader Kevin McCarthy (R-CA) had announced that on Tuesday, January 26, the House would consider the President’s veto message on H.R. 3762, the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015. The legislation, which passed the Senate on a 52-47 vote and the House on a 240-181 vote, seeks to repeal major portions of the Affordable Care Act. Of note, the legislation blocks federal funding for Planned Parenthood for one year; repeals the individual and employer mandates, various tax subsidies, and Medicaid expansion; and seeks to eliminate the medical device tax and Cadillac tax on high-cost employer-sponsored health coverage. The President issued his veto on January 8.

With the inclement weather, the hearing schedules for the House and Senate are also subject to change.

This Week’s Hearings:

  • Tuesday, January 26: The House Committee on Oversight and Government Reform will hold a hearing titled “Developments in the Prescription Drug Market: Oversight.”
  • Tuesday, January 26: The Senate Committee on the Judiciary will hold a hearing titled “Breaking the Cycle: Mental Health and the Justice System.”
  • Wednesday, January 27: The House Committee on Veterans’ Affairs will hold a markup to consider legislation, including: H.R. 4063, the Jason Simcakoski PROMISE Act, which seeks to improve the use by the Secretary of Veterans Affairs of opioids in treating veterans, enhance patient advocacy by the Secretary, and increase the availability of complementary and integrative health; and H.R. 1769, the Toxic Exposure Research Act of 2015, which establishes in the Department of Veterans Affairs a national center for research on health conditions of the descendants of veterans exposed to toxic substances.
  • Wednesday, January 27: The House Committee on Foreign Affairs Subcommittee on Africa, Global Human Rights, and International Organizations will hold a hearing titled “The Growing Threat of Cholera and Other Diseases in the Middle East.”
  • Wednesday, January 27: The Senate Committee on Indian Affairs will hold an oversight hearing titled “Reexamining the Substandard Quality of Indian Health Care in the Great Plains.”
  • Wednesday, January 27: The Senate Committee on the Judiciary will hold a hearing titled “Attacking America’s Epidemic of Heroin and Prescription Drug Abuse.”
  • Thursday, January 28: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing titled “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.”
  • Thursday, January 28: The Senate Committee on the Judiciary will hold an Executive Business Meeting to consider nominations and legislation, including S. 483, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015, which seeks to improve enforcement efforts related to prescription drug diversion and abuse.

HHS OIG Opines on Charity Financial Assistance and Kickbacks

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) posted two similar advisory opinions on January 4, 2016, regarding nonprofit, tax-exempt organizations and the financial assistance they give to the needy for their healthcare.  Specifically, the organizations asked OIG if (1) accepting donations for, and (2) disbursing financial assistance to federal health care program beneficiaries for their specific health care expenditures would constitute illegal kickbacks and result in civil monetary penalties.  OIG’s opinions state that because of the safeguards the organizations use, the donations and disbursements would not be grounds for imposition of civil monetary penalties under § 1128A(a)(5) of the Social Security Act (“Act”), and while the programs could violate the anti-kickback statute if the requisite intent were present, the OIG would not impose administrative sanctions under §§ 1128(b)(7) or 1128A(a)(7) of the Act.

Advisory Opinion 15-16

A non-profit, tax-exempt charitable organization proposed a program in which it would provide financial assistance to federal health care program beneficiaries for their out-of-pocket expenses related to prescription drugs used to treat two specific diseases, a type of cancer and a type of chronic kidney disease.  The organization would administer two separate funds, one each for the disease.  A patient’s eligibility for assistance would be determined by financial need, based on the federal poverty guidelines.  Assistance would be given on a first-come, first-served basis.  Patients would need to have already chosen their treatment and providers before applying for assistance, but they would be able to change treatments and providers while receiving assistance.  The organization expects to solicit donations from many parties, including the drug manufacturers who manufacture the patient’s treatment.  While donors may specify that their donations go to a specific disease fund, they may not specify that their donations go towards helping someone with a specific course of treatment.  Likewise, donors could receive aggregate information about the total amount of donations received and disbursed, but they would not be able to receive information about the specific treatments or patients that were helped through the programs.  In addition, the organization’s conflicts of interest rules maintain that no one from a donor would be able to serve on its Board of Directors.

Advisory Opinion 15-17

A non-profit, tax-exempt charitable organization proposed a program in which it would provide financial assistance to federal health care program beneficiaries with their insurance co-payments, premiums, and deductibles related to a specific disease.  Patients in stages three or four of the disease, and those who meet the financial eligibility criteria based on federal poverty guidelines would be able to apply for assistance.  Assistance would be given on a first-come, first-served basis.  Patients would need to have already chosen their treatment and providers before applying for assistance, but they would be able to change treatments and providers while receiving assistance.  Similar to the organization in Opinion 15-16, this organization expects to solicit and receive donations from many sources, including the manufacturers who make the different treatments the beneficiaries may take.  However, donors would not be able to receive information about the specific treatments or patients that were helped through the programs.  In addition, the organization’s conflict of interest rules maintain that no one from a donor would be able to serve on its Board of Directors.

Analysis

In both cases, the OIG examined the programs by first evaluating the donor contributions and their risk of influencing referrals, and then looking at the organization’s assistance to patients and its probability of fraud and abuse in light of the Act.  With respect to the donor’s contributions, OIG found that there was a minimal risk of influencing referrals to patients who receive assistance under the programs.  First, the donors would not be able to control the organization or the programs themselves, patients would have already chosen their course of treatment before applying, and finally, that donors would only receive aggregate data.  With respect to Advisory Opinion 15-17, OIG further opined that no donor would be able to influence the symptoms or disease states for eligible patients more specifically than stages 3 or 4 of the disease.  Given these facts, OIG stated that the donor’s contributions would not be payments for influencing referrals.

OIG next examined the programs’ probability of fraud and abuse in light of the Act.   A patient’s eligibility for the assistance programs is determined only on financial need, without considering the patient’s treatment or providers, and that the assistance is given out on a first-come, first-served basis.   Given these facts, OIG stated that there is a low risk of fraud and abuse, and the programs are not likely to influence a beneficiary’s selection of a specific treatment or provider.

Capital Thinking: Health Care Legislative Update

President May Highlight Obamacare Successes in State of the Union Address

On Tuesday, January 12, President Barack Obama will give his final State of the Union address to Congress. While details of the speech have yet to be released, last week, the President vetoed Congress’s budget reconciliation bill, which aimed to dismantle the Affordable Care Act (ACA) and defund Planned Parenthood. The President is thus expected to utilize Tuesday’s address to highlight successes of his signature health care reform law.

This Week’s Hearings:

  • Tuesday, January 12: The House Committee on the Judiciary will hold a markup of several bills, including H.R. 1854, the Comprehensive Justice and Mental Health Act of 2015, which seeks to foster collaboration among criminal justice, juvenile justice, veterans treatment services, mental health treatment, and substance abuse systems.
  • Tuesday, January 12: The House Committee on Agriculture Subcommittee on Nutrition will hold a hearing titled “Past, Present, and Future of SNAP: Addressing Special Populations.”
  • Tuesday, January 12: The Senate Committee on Armed Services will hold a hearing titled “Defense Health Care Reform.”
  • Tuesday, January 12: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a markup to vote on the nomination of Robert Califf to be commissioner of the Food and Drug Administration.

FDA Announces Commitment to MDSAP

The FDA announced on December 17 that it would participate in the operational phase of the Medical Device Single Audit Program (MDSAP), starting January 1, 2017.  The FDA currently participates in the ongoing MDSAP pilot program, scheduled to run until the end of 2016.

The MDSAP program was created by the International Medical Device Regulators Forum, a consortium of nine medical device regulators from around the world, in an attempt to streamline their inspection operations.  Five regulators currently participate in the MDSAP pilot program: the US FDA, Health Canada, Japan’s PMDA, Brazil’s ANVISA, and Australia’s TGA.  The MDSAP program is designed to harmonize the quality management system regulations and requirements for these five regulatory jurisdictions into one comprehensive audit, depending on the jurisdictions in which the audited establishment needs to be certified.  Used at full strength, the program allows an establishment to undergo one scheduled audit that covers the quality management system requirements for all five jurisdictions at once instead of many inspections from the different regulators.  If the establishment doesn’t send products to all five countries, then the MDSAP audit can be customized to only include the jurisdictions to which it does sell products.

The MDSAP program presents both pros and cons to the medical device industry, and an establishment should carefully weigh is options before submitting to an MDSAP audit.  First, combining audits is a clear money- and resource-saver for medical device manufacturers, especially larger ones and ones that sell products around the world and that undergo lengthy inspections as a result of their size and operations.  However, MDSAP’s requirement to include all jurisdictions in the audit in which the establishment’s products are sold brings questions of what exactly the different regulators will look at in the reports, especially if an establishment has different products for different countries.

One point that should make the decision easier for some establishments is Health Canada’s announcement that it will wind down its CMDCAS (Canadian Medical Devices Conformity Assessment System) program over the next couple years, and will only accept MDSAP certificates starting on January 1, 2019.  In its notice, Health Canada stated that its “ . . . transition to MDSAP is an attempt to align with the transition period for the revised version of ISO 13485 . . .” which may be published in early 2016.  As a result, product submissions and establishment registrations for Canada would have to be accompanied by an MDSAP certificate instead of a CMDCAS certificate.

Malicious Malware Brings On a Major HIPAA Headache

The United States Department of Health and Human Services (HHS) recently entered into a $750,000 resolution agreement with the University of Washington (UW) following an investigation.  The investigation was prompted by UW reporting a breach of about 90,000 people’s personal health information (PHI) after an employee unknowingly downloaded malicious malware from an email attachment.

Similar to other enforcement actions, HHS is heavily involved in UW’s corrections and corrective actions.  UW must not only conduct a risk analysis that addresses cybersecurity risks to ePHI, reviewable by HHS before it can be fully accepted, but also create a new risk management plan that addresses the risks found in the risk analysis.  UW must also review everything on an annual basis and update HHS accordingly.

In HHS’ press release announcing the resolution agreement, OCR Director Jocelyn Samuels stated, “All too often we see covered entities with a limited risk analysis that focuses on a specific system . . . [a]n effective risk analysis is one that is comprehensive in scope and is conducted across the organization . . . .”  It’s clear that no organization is too big or complex to ignore its HIPAA compliance responsibilities.  Having robust compliance procedures and policies, and reviewing them to ensure that they work as they are supposed to, is key for companies of all sizes to avoid expensive enforcement actions.

Triple S’ Violations Spark HHS’ Triple Enforcement Actions

HHS recently agreed to a $3.5 million resolution with business associates and covered entities for numerous violations of the Privacy, Breach Notification, and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA).  Triple S, as the parties are collectively known, seemed to miss the regulatory ball in a few ways, like protected health information being printed on marketing materials and mailing labels, former employees having access to the information, and people receiving the insurance ID cards of others in the mail.

As a result of these violations, HHS not only came to the resolution agreement with Triple S but is also holding its hand through what could be a lengthy and expensive (for Triple S) corrective action process.  Triple S has been ordered to conduct risk analyses, and develop processes and policies on a relatively tight deadline for HHS’ review and validation.  HHS retained the ability to make changes to these processes and policies before Triple S is able to train its workforce (the materials for which HHS will review) and implement the procedures.  Triple S also has to report on its progress annually to HHS.

HHS’ investigation and actions against Triple S are seen by many as the latest step by OCR in its continually stronger HIPAA enforcement.  Covered entities and business associates should carefully review their HIPAA policies and procedures to ensure that they exist and are compliant with the HIPAA rules.  Prudent organizations may also want to perform an internal audit to ensure that their workforce actually follows the directions, and to stress the importance of following these rules.

Capital Thinking: Health Care Legislative Update

House To Possibly Consider Amended Reconciliation Bill

Last week, the Senate passed an amended H.R. 3762, the Restoring Americans’ Healthcare Freedom Reconciliation Act of 2015, on a vote of 52-47. House Majority Leader Kevin McCarthy (R-CA) has stated that the House of Representatives could possibly consider the Senate-passed bill on the House floor this week. President Barack Obama is expected to veto the bill.

The Senate-passed bill includes provisions that repeal major provisions of the Affordable Care Act (ACA), including insurance subsidies, Medicaid expansion, federal operation of insurance exchanges, and the Cadillac and medical device taxes. The bill also defunds Planned Parenthood for one year and repeals provisions such as Obamacare’s reinsurance language and various taxes, such as the tanning tax.

House Committee To Hear Testimony From Acting Administrator Slavitt

On Tuesday, December 8, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “An Overdue Checkup Part II: Examining the ACA’s State Insurance Marketplaces.” Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services, is slated to testify. The hearing is expected to explore sustainability challenges that state insurance exchanges are facing, as well as how federal grant dollars were utilized.

This Week’s Hearings:

  • Tuesday, December 8: The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “An Overdue Checkup Part II: Examining the ACA’s State Insurance Marketplaces.”
  • Tuesday, December 8: The House Committee on Veterans’ Affairs Subcommittee on Health will hold a hearing titled “Legislative Hearing on: H.R. 3262; H.R. 3484; H.R. 4129; H.R. 4056; a Draft Bill to Amend the Veterans’ Benefits Programs Improvement Act of 1991 to Authorize VA to Sell Pershing Hall; and, VA’s Legislative Proposal Regarding Fiscal Year 2016 Construction Projects.”
  • Tuesday, December 8: The House Committee on Foreign Affairs Subcommittee on Africa, Global Health, Global Human Rights, and International Organizations will hold a hearing titled “Drug Resistant Tuberculosis: The Next Global Health Crisis?”
  • Tuesday, December 8: The Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold a hearing titled “Opioid Abuse in America: Facing the Epidemic and Examining Solutions.”
  • Wednesday, December 9: The House Committee on Energy and Commerce Subcommittee on Health will hold a hearing titled “Examining Legislation to Improve Health Care and Treatment.” The hearing is expected to cover the following pieces of legislation: H.R. 921, the Sports Medicine Licensure Clarity Act of 2015, which provides protections for sports medicine professionals who provide medical services in secondary states; H.R. 1209, the Improving Access to Maternity Care Act, which provides for the designation of maternity care health professional shortage areas; H.R. 2713, the Title VIII Nursing Workforce Reauthorization Act, which extends advanced education nursing grants to support clinical nurse specialist programs, among other provisions; H.R. 3441, the Accurate Education for Prenatal Screenings Act, which establishes education programs for patients and health care providers regarding cell-free DNA prenatal screening, among other provisions; H.R. 4152, the Cardiac Arrest Survival Act, which clarifies liability protections on the use of automated external defibrillators in an emergency; and H.R. 4153, the Educating to Prevent Eating Disorders Act of 2015, which establishes a pilot program to test the impact of early intervention on the prevention, management, and course of eating disorders.
  • Wednesday, December 9: The Senate Special Committee on Aging will hold a hearing titled “Sudden Price Spikes in Off-Patent Drugs: Perspectives from the Front Lines.”
  • Wednesday, December 9: The Senate Committee on Veterans’ Affairs will hold a markup of S. 290, the Increasing the Department of Veterans Affairs Accountability to Veterans Act of 2015, and S. 425, the vehicle for omnibus.

Reconsidering Certificate of Need Laws – Federal Antitrust Agencies Urge Reform of the Certificate of Public Need Program in Virginia

Weighing in on the growing debate around certificate of need (“CON”) laws, the Federal Trade Commission and the Antitrust Division of the U.S. Department of Justice (the “Agencies”) issued a joint statement on October 26, 2015, advocating the repeal or reform of Virginia’s Certificate of Public Need (“COPN”) laws, which regulate the construction of health care facilities and the provision of health care services.

The Virginia Department of Health describes the purpose of the COPN program as containing health care costs while ensuring access to health care for all residents at a reasonable price and the financial viability of the facilities providing such care.  Virginia’s COPN program requires certain health care facilities to secure a public need determination from the State Health Commissioner (“Commissioner”) prior to initiating certain projects, which include general acute care services, perinatal services, diagnostic imaging services, cardiac services, and nursing facility services.  The COPN program affects a variety of health care facilities such as hospitals, nursing homes, psychiatric facilities, and rehabilitation hospitals. To determine whether a public need exists, the Commissioner looks to certain factors, which can include the proposed project’s effects on existing barriers to access to care.  In addition, similar to a number of other states operating CON programs, the Commissioner can condition the issuance of a COPN on the provision of charity care in the Commonwealth.

The Virginia General Assembly, through the 2015 Appropriation Act, mandated the creation of a COPN Work Group to review the state’s COPN program and its impact on access to care.  In particular, the COPN Work Group is charged with developing specific recommendations for changes to the COPN process to address any problems or challenges it identified from its review by December 1, 2015.  Some of its recommendations will be introduced during the 2016 Session of the General Assembly.

In response to a request by Virginia state delegate Kathy Byron, the Agencies issued a joint statement to the COPN Work Group on October 26, 2015.  The Agencies state several reasons for the repeal or narrowing of the current COPN laws in their joint statement, including removing barriers to expansion, fostering innovation, and promoting consumer choice.  Further, the Agencies suggest that CON laws have not controlled health care costs, but instead have afforded existing providers the market power to increase health care costs.  The joint statement confirms the Agencies’ longstanding preference for market forces and increased competition in healthcare provider markets.

In a concurring statement to the Agencies’ joint statement, Commissioner Julie Brill cautions that the joint statement’s conclusion is based largely upon the application of the Agencies’ anti-competitive expertise to a complex and distinct market, not solid empirical support. Commissioner Brill also acknowledges that Virginia’s COPN program may serve as a vehicle for the state to achieve a range of health care goals, in addition to cost containment, such as the provision of charity care, establishing standards for providing services, preventing entities from providing certain services, and assessing quality by monitoring outcomes.

Virginia’s decision to review its COPN laws is not unique. Rather, it is indicative of similar discussions on the benefits of certificate of need laws occurring in a number of other CON state forums.  Several states have initiated studies and conducted hearings to evaluate the effectiveness of their CON programs, including Florida, New York and Pennsylvania.  This year, CON opponents in North Carolina used the legislative process to chip away at, but not repeal, the state’s CON laws.  In addition to market theories, Virginia’s public policies in regulating health care and ensuring charity care and access to care for medically underserved areas are likely to be equally considered as part of the December 1st recommendations, as well as echoed in similar discussions in other CON state forums.

CMS’s Top 7 Changes to the Stark Law

On November 16, 2015, the Department of Health and Human Services, Centers for Medicare and Medicaid Services, issued a final rule revising, clarifying, and adding exceptions to the Physician Self-referral Law (“Stark”) in order to (1) accommodate delivery and payment system reform; (2) reduce burdens; and (3) ensure and facilitate compliance. These changes include two new exceptions, clarifications adding additional explanations to existing policies, and revisions to existing definitions and exceptions.

Below are the top 7 changes providers and physicians should note:

  1. New “assistance to compensate a nonphysician practitioner (NPP)” exception: allows remuneration from a hospital, federally qualified health center, or rural health clinic to a physician to recruit a NPP, where substantially all (i.e., 75%) of the services furnished by the NPP to the patients of the physician’s practice are for primary care services or mental health care services. Please note this exception applies to the following NPPs: (1) physician assistants; (2) nurse practitioners; (3) clinical nurse specialists; (4) certified nurse midwives; (5) clinical social workers; and (6) clinical psychologists.
  2. New “timeshare arrangements” exception: this exception covers “use” arrangements only, which includes the use of premises, equipment (excluding advanced imaging equipment, radiation therapy equipment, and (most) clinical or pathology laboratory equipment), personnel, items, supplies, or services. Traditional office space leases and arrangements conveying a possessory leasehold interest in office space are not covered under this exception. Compensation for such arrangements must be carefully structured, as percentage compensation and per-unit services fees (i.e., “per-use” and “per-patient” rates) are prohibited but hourly or half day rates are acceptable.
  3. Clarification on the writing requirement: exceptions containing a writing requirement for certain compensation arrangements use “arrangement” and “agreement” interchangeably. The rule now clarifies that this requirement only requires an arrangement be set out in writing. Although CMS recommends having one signed written contract that satisfies every requirement of the exception, the preamble clarifies that this requirement may also be satisfied through a collection of documents that relate to one another and to the exact arrangement.
  4. Clarification on the 1-year term requirement for office space rental, equipment rental, and personal service arrangements exceptions: the final rule clarifies the arrangement itself must have a duration of at least one year, but a formal “term” provision in a contract is not required. Instead, the duration requirement can be shown through contemporaneous documents establishing the arrangement lasted for at least one year. However, if the arrangement was terminated during the first year, the parties must be able to show they did not enter into a new arrangement for the same space, equipment, or services during the first year.
  5. Clarification regarding “split bill” arrangements: “split bill” arrangements do not involve remuneration between physicians and designated health services (DHS) entities, for items or services such as examination rooms, nursing personnel, and supplies, “because the physician and DSH entity do not provide items, services, or other benefits to one another.” 80 Fed. Reg. 70,886, 71,321 (Nov. 16, 2015). However, outpatient departments billing a payor in one single bill will establish a compensation arrangement and must fit under an exception.
  6. Revision to “temporary noncompliance with signature” requirement: prior to this final rule, parties who inadvertently failed to comply with the signature requirement had 90 days to comply and others had 30 days. Now, there is a blanket 90 day period to comply with this requirement, regardless of whether the failure to obtain a signature was inadvertent or not.
  7. Indefinite holdover provisions: expired arrangements under the office space and equipment rental exceptions and the personal service arrangements exception can be “heldover” indefinitely rather than for only six months, provided the arrangement: (1) satisfies all of the requirements at the time of expiration; (2) continues on the same terms and conditions; and (3) continues to satisfy all of the requirements during the holdover. Current arrangements in a valid holdover under the current six month holdover provisions on January 1, 2016 may qualify for an indefinite holdover.
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