End of the Year Health Law Wrap-Up Webinar December 14, 2017 - - PowerPoint PPT Presentation

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Jenifer Brown (317) 236-2242 jenifer.brown@icemiller.com David Nie (317) 236-2300 david.nie@icemiller.com Christopher S. Sears (317) 236-5891 christopher.sears@icemiller.com Myra Selby (317) 236-5903 myra.selby@icemiller.com Kevin C. Woodhouse (317) 236-2154 kevin.woodhouse@icemiller.com

End of the Year Health Law Wrap-Up Webinar December 14, 2017

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Immigration Update (After Supreme Court Travel Ban Decision) 501(c)(3) and Advance Refunding Bonds under Tax Reform Bills Future of Medicare and Medicaid (View of Recent CMS Officials) Mental Health Update The Opioid Epidemic: Legal and Policy Considerations Results of Study on Value Based Purchasing Models Update on Status of Affordable Care Act

AGENDA

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Immigration Update

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Travel Bans – issued, revised, re-issued Buy American, Hire American Premium Processing Suspension DACA Rescission Other Shifts in Policy – USCIS and USCBP

Where are we?

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Country Immigrants Nonimmigrants Visitors Enhanced Screening Chad X X Iran X X* X X Iraq X Libya X X North Korea X X X Somalia X X Syria X X X Venezuela X* Yemen X X

Travel Ban 3.0

*For Iran, F, M and J nonimmigrants are not included but are subject to enhanced

• screening. For Venezuela, admission to the US is suspended for certain government
• fficials and their visiting families.

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Cap Exemptions

Institutions of Higher Education Affiliated Non-Profits Non-Profit or Governmental Research Institutions Certain J-1 Physicians Employed “at” cap exempt location Previously counted against annual quota Concurrent H-1B Employment

H-1B Cap Exemptions and Alternatives

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Analysis of U.S. immigration system and proposal of recommendations to address fraud and abuse (policy) Reform H-1B visa program to award most-skilled and highest paid beneficiaries (rulemaking/ legislation) Transition to merit/skills-based system Agency Discretion

Interpreting H-1B specialty occupations & cap exemptions Interpreting employer analysis of US candidates within PERM labor market testing

Hire American Executive Order

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New USCIS memo regarding computer programmers and other IT-related occupations

Definition of specialty occupation Compensation and prevailing wage selection Reconciling entry-level wage and complex job duties

How broadly applied? Reach of agency discretion? RFE’s on wage and complexity of positions

Hire American (example)

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Why?

Fraud, Abuse and Reverse Discrimination

What?

Fraud indicators, including wage, duties, experience and work location(s)

How?

Site Visits

USCIS cannot confirm basic business info H-1B dependent employers Third party worksites/responsibilities as end client

Investigations by DOL, DHS and DOJ Solicitation of Anonymous Tips to DOL, DHS and DOJ Consider Changes to H-1B Program (DOL and DHS)

H-1B Enforcement

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Advance parole denials Employment based green card interviews Delays in adjudication Medical examinations Experiences at Ports of Entry – Agent Discretion Termination of H-4 EADs

Other Shifts in Policy

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IRCA’s anti-discrimination provisions

Pre-offer questioning Effect of travel ban when condition of employment

Possible e-verify expansion If DACA ends EAD automatic renewals

I-9 Compliance

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Make thoughtful hiring decisions Confirm passport validity and current I-94 admission record with CBP International and domestic travel Properly maintain immigration status – primary purpose, employment conditions, protect documents Check sources/ watch for rumors Monitor real and perceived changes in law, policy and agency discretion Contact members of Congress

What Can You Do?

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Ice Miller’s Immigration Team (icemiller.com/choosetalent) American Immigration Lawyers Association (www.aila.org) American Immigration Council (www.aic.org) National Immigration Law Center (www.nilc.org)

Resources

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501(c)(3) and Advance Refunding Bonds under Tax Reform Bills

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Only in the House version of Tax Cuts and Jobs Act:

Repeal of tax-exempt “private activity bonds” after 12/31/17 Private activity bonds are tax-exempt bonds permitted under current law to be issued to finance projects for section 501(c)(3) organizations like hospitals and senior living facilities (in addition to cultural institutions, private colleges and universities and multi-family housing)

Future of 501(c)(3) Bonds Uncertain

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In the House and Senate versions of the Tax Cuts and Job Acts:

Repeal of tax-exempt advance refunding bonds after 12/31/17. An advance refunding is one in which the refunding bonds remain outstanding for a period of more than 90 days after the issuance of the refunding bond issue.

Future of 501(c)(3) Bonds Uncertain (cont’d)

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Inconsistent treatment of private activity bonds currently being reconciled by a conference committee Advance refunding bonds to be eliminated on 12/31/17 Corporate tax rate adjustment impact on 501(c)(3) bonds

Future of 501(c)(3) Bonds Uncertain (cont’d)

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Future of Medicare and Medicaid (View of Recent CMS Officials)

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Presenters:

Jonathan Blum – Former Deputy Administrator of CMS Herb Kuhn – Former Deputy Administrator of CMS Mark McClellan – Former Administrator of CMS

Future of Medicare and Medicaid

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Common Themes:

Lack of clarity, uncertainty, chaos Very high premiums in the individual market as a hedge against the loss of cost-sharing subsidies Individual market continues, but it is not robust End of cost-sharing will lead to increased cost as subsidies increase

Future of Medicare and Medicaid (Cont’d)

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Impact of Repeal of the Individual Mandate:

In the Senate version of the tax bill This would eventually have an impact as more healthy people pull out, leading to very selective markets and higher premiums. Low income individuals will get higher subsidies Individual market: Not likely to completely implode – will limp along

Future of Medicare and Medicaid (cont’d)

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Personnel Set Policy:

Very complimentary of Alex Azar, choice to head HHS Knowledgeable and experienced and respects the agency “Scary smart” Likely to take steps on drug pricing – look more at paying for drugs on a value basis and negotiating drug prices Likely to tackle payment reform and opioids

Future of Medicare and Medicaid (Cont’d)

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Future of Medicare:

Center for Medicare and Medicaid Innovation – Still important

More voluntary than mandatory (cancelled mandatory hip fracture and cardiac bundled payment models; reduced mandatory geographic areas participating in comprehensive care for joint replacement from 67 areas to 34 areas) Focus on payment reform ideas

340B – cutting reimbursement

Future of Medicare and Medicaid (Cont’d)

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Strong emphasis on growing MA program with more flexibility on plan design Focus on DSH and similar payments to the States and how these funds are used Deregulation Preparing for the tsunami – 80 million in Medicare by 2030

Future of Medicare and Medicaid (Cont’d)

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Future of Medicaid:

More State flexibility Transparency More waivers approved quicker – predictability Beneficiary responsibility Continued look at block grants and/or per capita

Future of Medicare and Medicaid (Cont’d)

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Mental Health Update

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2.4 m (1%): Schizophrenia 6.1 m (2.6%): Bipolar disorder 16 m (6.9%): Depression 42 m (18%): Anxiety 6 m (2.6%): Dementia 2.6 m (1%): Substance Abuse

Incidence of Mental Health Disorders (NAMI)

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Incidence: 1 in 2 will develop mental illness in lifetime Relationship to heart disease, obesity, cancer, substance abuse Frequency of suicidal ideation (8.4 m), plans (2.2 m), attempts (1 m) Role of poverty; lack of access to care (1 in 6) Age of onset of symptoms (50% at 14; 75% at 24) Time from symptoms to treatment (8-10 years) Data from Centers for Disease Control & Prevention (CDC), Substance Abuse & Mental Health Services Administration (SAMHSA), National Alliance on Mental Illness (NAMI)

Unmet Mental Health Needs

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Untreated mental illness costs U.S. $100 billion per year in lost productivity Depression can be quadruple cost of care (e.g., diabetes), double sick days (e.g., back pain) Increased/inappropriate use of ER due to decreased

• r inadequate benefit.

Impact on Workforce, Lost Productivity and Increased Cost of Care

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Too many doctors; too many specialists Too many prescriptions: 6+ (and possibly 12-20) meds/day Poor medication management: primary care provider unwilling to challenge specialist Overuse of “anti-anxiety” or “sleep” meds causing more agitation, confusion, falls Drug reactions including aggression, anxiety, depression, wandering, not eating

Vulnerabilities: Overmedication; Adverse Drug Reactions (Seniors)

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Not tracked Can cause negative interaction with other meds Include anticholinergics (Tylenol PM, allergy pills, bladder pills); sleeping meds; alternative meds; herbs, Eastern meds, “as-see-on-TV” meds Increased risk of falls, fractures, head injuries, if sedated, hypotension, bleeding, agitation

OTC Medications (Seniors)

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“Central clearinghouse” for health care visits, diagnoses, prescriptions Can be useful tool in preventing or minimizing adverse effects of poly-pharmacy, but . . .

• - Do PCPs defer too much to specialists?
• - OTC meds may not be captured

21st Century Cures Act – goals include enhance personalized medicine; speed up drug development, health data for research; expand access to and better coordinate mental health and substance abuse disorder care; develop best practices and evidence-based protocols

Role of Electronic Medical Record

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Need for:

Education campaign, including Mental Health First Aid Better training of physicians re: mental health, cognitive issues De-stigmatization of mental health needs Improved benefits for mental health care, integrated care, follow-up care – start with Medicaid? Medicare? Adopt IDT model? Increased focus on adolescents, youth, early diagnosis

More Policy Implications

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The Opioid Epidemic: Legal and Policy Considerations

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Presenters

Daniel Blaney-Koen, Senior Legislative Counsel, American Medical Association

• T. Jeffrey Fitzgerald, Polsinelli PC

Arthur L. Burnett, Sr., VP of Administration – National Executive Director, National African-American Drug Policy Coalition, Inc.

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*Chart presented by Daniel Blaney-Koen, Senior Legislative Counsel, American Medical Association during presentation “Opioid Epidemic: Legal and Policy Consideration,” at the ABA Health Law Section’s 15th Annual Washington Health Law Summit, December 4-5, 2017.

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Opioid-Related Mortality, U.S. 2012-2016*

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*Chart presented by Daniel Blaney-Koen, Senior Legislative Counsel, American Medical Association during presentation “Opioid Epidemic: Legal and Policy Consideration,” at the ABA Health Law Section’s 15th Annual Washington Health Law Summit, December 4-5, 2017.

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PDMP Use Increasing; Opioid Supply Decreasing

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Change in MMEs Prescribed Per Capita 2010- 2015

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MMEs Prescribed Per Capita (2015)

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What guidelines do physicians follow: State laws, CDC, PBMs, Insurers? Some state laws limit what can be prescribed – 1 size fits all remedies do not fit

Can prescription interventions be successful without addressing additional issues?

Still need to address chronic pain When a physician is “shut down” what happens to the patients? Need non-opioid alternatives for pain that are covered by payors.

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Challenging Issues

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Increase registration and use of PDMPs Ensure, safe, evidence-based prescribing Support comprehensive pain care; reduce the stigma of pain Reduce the stigma of substance use disorder; increase access to treatment Increase access to naloxone to save lives from overdose; support broad Good Samaritan protections Promote safe storage and disposal of opioids and all medications www.end-opioid-epidemic.org

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AMA Opioid Task Force Recommendations

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Develop written policy on opioids to treat chronic pain

Concise and practical Significant discretion on standards

Review current high-risk patients and prescribing patterns

Identify high-risk patients Analyze for potential diversion Analyze for clinical care and documentation quality

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Suggestions from Speakers

• n Ways to Address Legal Risk

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Have a clear process to document basis for high dose prescriptions

Process should ease burden on providers Effective process can add significant risk reduction

Consider additional clinical education

Develop process to keep up with clinical and regulatory change Targeted CME, such as, prescribing refresher courses

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Suggestions from Speakers

• n Ways to Address Legal Risk (cont’d)

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Study of Impact on Cost of Care of Population-Based VBP Models and Other Factors

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Presenters

Jim Landman, Director, Healthcare Finance Policy, HFMA David Muhlestein, Chief Research Officer, Leavitt Partners, LLC

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Quantitative Study Results

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Study:

To be published next year Research funded by Commonwealth Fund

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Study Results (Cont’d)

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Quantitative Analysis:

Impact on cost of care from:

Penetration of population-based VBP models Other applicable factors

Qualitative Analysis

Review of 9 markets

Baton Rouge, Billings, Grand Rapids, Huntsville, Los Angeles, Minneapolis/St. Paul, Oklahoma City, Portland, ME and Portland, OR

Study Results (Cont’d)

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Quantitative Study Results

No association with growth in VBP models and cost growth for Medicare or commercial populations. An increase of VBP models – no significant impact on quality. Impact of other factors on Medicare costs: Hospital quality (impact of higher re-admissions); Demographics; Chronic conditions; Market concentration; and Climate

Study Results (Cont’d)

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Impact of other Factors on Commercial Costs

Hospital quality (impact of higher re-admissions) Demographics Chronic conditions (prevalence) Climate

Study Results (Cont’d)

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*Charts from presentation on “What is Driving Total Cost of Care?” Presented by Jim Landman and David Muhlestein at the ABA Health Law Section’s 15th Annual Washington Health Law Summit, December 4-5, 2017.

Qualitative Study: Cost Clusters*

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Lower Cost Markets:

Billings, MT Grand Rapids, MI Minneapolis/St. Paul, MN Portland, OR

Mid-Range Markets:

Huntsville, AL Portland, ME

Higher Cost Markets:

Baton Rouge, LA Los Angeles, CA Oklahoma City, OK

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*Charts from presentation on “What is Driving Total Cost of Care?” Presented by Jim Landman and David Muhlestein at the ABA Health Law Section’s 15th Annual Washington Health Law Summit, December 4-5, 2017.

Qualitative Study: Features of Cost Cluster*

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Lower Cost Markets:

Significant presence in one or more integrated delivery system Competition among a few well-

• rganized health systems with

geographic coverage High Physician Employment or alignment Information-sharing mechanisms for care purchasers & others Mid-Range Markets: The Portland, ME market had many of the same features as the lower-cost markets The Huntsville market had: Dominant presence of a single commercial payer, which depressed hospital rates Little utilization management of physician services Higher Cost Markets: Highly competitive (including competition between physician-

• wned hospitals/surgery centers

and health systems Indications of higher than average utilization rates Tendency to segment patients and providers by socioeconomic status

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Possible reasons why population-based VBP Models have not had a significant impact on total cost of care:

The period analyzed for the quantitative study (2012-2014) was too early: Models had not yet had time to gain traction. Where VBP models had penetration, the penetration was broad but not deep (i.e., little downside risk for providers). Incentives have not yet been aligned from the system level to the clinician level. The investments required to participate in population-based VBPs are delaying realization of positive ROI.

Study Results (Cont’d)

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Recommendations from Speakers

Continue movement toward models that increase financial incentives to manage total costs of care

Challenge – will employer-sponsored markets pursue

Balance benefits of competition w/benefits of integration Support sharing of information on healthcare cost and quality within markets

Study Results (Cont’d)

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Update on Status of Affordable Care Act

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IRS has begun notification to employers of potential employer shared responsibility penalties for 2015 Assessment Letter 226-J Must respond on Form 14764 Will include list of employees who received premium tax credits on Form 14765 30 days to respond Two potential penalties: “A” penalty or “B” penalty

Employer Shared Responsibility Penalties

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Discount that lowers the amount paid under Marketplace coverage for deductibles, copayments, and coinsurance under a Silver plan. Available to individuals at and below 250% of poverty level. Approximately $7 billion in 2017. President announced on October 12 he would halt CSR payments. Insurers required to design plan to reduce cost sharing, even if federal government suspends CSR payments. Insurers responded with higher premiums for Marketplace plans in 2018. Congressional Budget Office projected that eliminating the payments would increase taxpayer costs by $6 billion in 2018 and $21 billion in 2020 because federal tax credits in the Marketplace rise when premiums increase. Possibility of payments being reinstated in upcoming spending bill.

Not in House spending bill released on December 13.

Elimination of Cost-Sharing Reduction Payments

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Trump Administration reduced the open enrollment period, ending it on December 15, instead of January 31. Nearly 4.7 million people have enrolled in federal Marketplace coverage in first six weeks of open enrollment (700,000 more than last year at this time) with over 1 million signing up in the sixth week alone. Total enrollment last year was 9.2 million.

Marketplace Open Enrollment for 2018

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Tax bill repeals individual mandate. Senator Collins has indicated she will vote for it if Senate Republicans allow a vote on two other bills to shore up Marketplaces and insurance companies:

Reinstate CSR payments for two more years; and Temporary funding for reinsurance pools to help insurers pay for high-cost claims in an effort to bring down premiums.

Will the deal survive House/Senate negotiations?

Collins’ wish list is not in House spending bill released on December 13.

CBO estimates that 13 million people would give up coverage by 2027.

Repeal of Individual Mandate

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On December 13, Republicans on the House Ways and Means Committee introduced the following five bills:

H.R. 4617 [Paulsen (R-MN) and Walorski (R-IN)] delays the ACA medical device tax for 5 years (through 2022). H.R. 4618 [Jenkins (R-KS)] provides for a two-year moratorium

• n the ACA tax on over-the-counter medications.

H.R. 4620 [Noem (R-SD)] for 2018, suspends the ACA health insurance tax for insurers choosing to provide premium rebates to plan holders and suspends the tax in 2019 for all insurers. H.R. 4619 [Curbelo (R-FL)] suspends the ACA health insurance tax for 2018 and 2019 for health care plans regulated by Puerto Rico. H.R. 4616 [Nunes (R-CA) and Kelly (R-PA)] suspends the ACA employer mandate retroactively to 2015 and prospectively through 2018; further delays the Cadillac tax until 2021.

Other Bills Related to ACA Taxes

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Conclusion

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