On his first day in office, President Trump issued an Executive Order entitled “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal.” The Executive Order is, in effect, a policy statement by the new administration that it intends to repeal the Patient Protection and Affordable Care Act (the “ACA” or the “Act”) as promptly as possible. The Executive Order also directs the Secretary of Health and Human Services and the heads of all other executive departments and agencies that, pending repeal of the ACA, they are to exercise the full extent of their authority and discretion to “take all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the Act, and prepare to afford the States more flexibility and control to create a more free and open healthcare market.”

Impact on the Individual Mandate

The Executive Order does not explicitly name provisions of the ACA to be targeted by executive agency and department heads. However, Section 2 appears to be aimed at the ACA’s “individual mandate,” which requires that individuals obtain health care insurance or pay a fine, and one potential effect of the Executive Order may be limited enforcement of the individual mandate:

To the maximum extent permitted by law, the Secretary of Health and Human Services (Secretary) and the heads of all other executive departments and agencies (agencies) with authorities and responsibilities under the Act shall exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the Act that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, healthcare providers, health insurers, patients, recipients of healthcare services, purchasers of health insurance, or makers of medical devices, products, or medications.

Impact on the Insurance Marketplace

The Executive Order also mandates that executive agency and department heads “provide greater flexibility to States and cooperate with them in implementing healthcare programs,” and “encourage the development of a free and open market in interstate commerce for the offering of healthcare services and health insurance, with the goal of achieving and preserving maximum options for patients and consumers.”

Regulatory Freeze

Also on January 20, 2017, the White House issued a memorandum to the heads of executive departments and agencies entitled “Regulatory Freeze Pending Review.” The memorandum directs that, except for certain emergency situations, no regulation be sent to the “Office of Federal Register (the “OFR”) until a department or agency head appointed or designated by the President after noon on January 20, 2017, reviews and approves the regulation.” “[W]ith respect to regulations that have been published in the OFR but have not yet taken effect,” the memorandum directs agency and department heads to postpone the effective date for 60 days from the date of the memorandum, as permitted by law and subject to exceptions for emergency situations. The memo also instructs executive agency and department heads to consider delaying effective dates beyond the 60-day period to address substantial questions of law or policy.

So, What Does This Mean…..From the Counselor to the President 

On Sunday, January 22, 2017, Kellyanne Conway, Counselor to the President, said that President Trump “wants to get rid of that Obamacare penalty almost immediately, because that is something that is really strangling a lot of Americans…”[1]

When asked if Trump would stop enforcing the individual mandate, she replied, “He may.” Conway also stated that the Trump Administration planned to end ACA’s requirement that employers with more than 50 full-time workers offer affordable coverage to their workers. “We’re doing away with this Obamacare penalty,” she said. “This tax has been… a burden on many small business owners…”[2]

Conway also noted that the Trump Administration does not intend to eliminate ACA entirely: “For the 20 million who rely upon the Affordable Care Act in some form, they will not be without coverage during his transition time.”[3] Conway noted that the President is “going to replace this with a plan that allows you to buy insurance across state lines, that is much more centered around the patient, and access to health care. . .”[4]

What’s Next And What To Watch?

Earlier today, Republican Senators Susan Collins of Maine and Bill Cassidy of Louisiana unveiled a bill intended to be an “Obamacare replacement plan,” “The Patient Freedom Act of 2017.” The Senators’ proposal, which is based upon a proposal originally put forward by the Senators in 2015, is intended to provide more power to the states on health care policy, to increase access to affordable insurance, and to help cover those who are currently uninsured.[5] For instance, states who like Obamacare will be able to keep it. Senator Cassidy explained as follows: “So, California and New York, you love Obamcare? You can keep it.”

In sum, uncertainty remains as to the extent that ACA will be changed, replaced, or otherwise amended, whether the changes will be administrative or legislative, and how much the changes to the Act will disrupt the health care marketplace. A flurry of further activity by the President, agency administrators, and members of Congress is expected over the coming days and weeks. Health care entities should closely follow these developments to ensure that they have sufficient time to react and adapt to the changing health care environment.

___

[1] ‘This Week’ Transcript 1-22-17: Kellyanne Conway, Sen. John McCain, and Sen. Chuck Schumer, http://abcnews.go.com/Politics/week-transcript-22-17-kellyanne-conway-sen-john/story?id=44954948 (last accessed Jan. 23, 2017).

[2] Trump’s ACA executive order heightens insurance market jitters, Modern Healthcare, Jan. 22, 2017, http://www.modernhealthcare.com/article/20170122/NEWS/170129985/breaking-trumps-aca-executive-order-heightens-insurance-market (last accessed Jan. 23, 2017).

[3] Emily Schultheis, Top Trump Aide: 20M on Obamacare “Will Not Be Without Coverage” in Transition to New Plan, http://www.cbsnews.com/news/top-trump-aide-20m-on-obamacare-will-not-be-without-coverage-in-transition-to-new-plan/ (last accessed Jan. 23, 2017).

[4] ‘This Week’ Transcript 1-22-17: Kellyanne Conway, Sen. John McCain, and Sen. Chuck Schumer, http://abcnews.go.com/Politics/week-transcript-22-17-kellyanne-conway-sen-john/story?id=44954948 (last accessed Jan. 23, 2017).

[5] https://www.collins.senate.gov/newsroom/senators-collins-cassidy-introduce-aca-replacement-plan-expand-choices-lower-health-care (last accessed Jan. 23, 2017).

As the transition in Washington moves into high gear this month, it’s not just the new Administration and Congress that are putting in place plans for policy and legislation; stakeholders are busy creating agendas, too.

Many stakeholder agendas will seek to affect how government addresses such prominent health care issues as the Affordable Care Act, Medicare entitlements, fraud-and-abuse policies, FDA user fees, and drug pricing. There will be a myriad of stakeholder ideas, cutting a variety of directions, all framed with an eye to the new political terrain.

But whatever policies a stakeholder advocates, ideas must be translated into a form that that the political system can digest. For this to occur, an important technical conversion must take place; words must be conjured and organized so that desired policy can become legal reality.  This is no easy task, and stakeholders should proceed thoughtfully.

Here are five takeaways for making proposals concrete and workable:

1. Butterfly Effect

A “simple” contract (to buy a house, say) can end up getting pretty complicated, even when the stated rights and obligations apply to no more than two parties. In contrast, a policy proposal typically seeks to set arrangements for a broad array of parties (perhaps a whole economic sector) and thus will usually involve substantial complexity.

The large number of parties potentially affected means that even the most minor-seeming policy adjustment can have large, unintended, and unpredictable results – not dissimilar from how the proverbial flap of a butterfly’s wings can start the chain reaction that leads to a distant hurricane.

2. Pre-Drafting Steps

Taming the butterfly effect should begin before putting pen to paper. It starts with a clear view of the problem to be solved and the ways to solve it.  Notably, the legislative drafters available to Congress place some considerable emphasis on the steps that precede actual drafting.

For example, the House Legislative Counsel’s Office recommends use of a pre-drafting checklist that includes questions like these:  What is the planned policy’s scope (expressed as populations or subjects)?   Who will administer the policy?  Who will enforce it?  When should the policy take effect (and are transition rules needed)?  Each of these questions contains multiple sub-questions.

Similarly, the Senate Legislative Counsel’s Office points out that most legislated policies build on prior statutes. As such, it is important to know how new provisions will harmonize with — or will override — previously adopted language.  Making these judgments requires a solid grasp of existing legal authorities and ways these authorities have been interpreted.

3. Words on the Page

Translating concepts into words is a specialized task, for ultimately the words must be “right” – they must be technically sufficient to effectuate the policy intended.

It is not news that Congresses, Presidents, and courts sometimes have different views on the meaning of statutes, regulations, and other types of policy issuances. In theory, the drafting curative is to make the words so clear that only a single meaning is possible.  But realistically, legal contention often comes with the territory of a controversial policy, and so stakeholders should at a minimum avoid such unforced errors as these:

  • Obvious mistakes – e.g., purporting to amend a U.S. code title that has not been enacted into positive law;
  • Wrong law – e.g., confusing the statute that enacts new language with the statute that the new language amends;
  • Wrong time – e.g., getting the words right but putting them into effect for an unintended time period;
  • Imprecise labels – e.g., referring to concepts or parties via shorthand phrases similar to, but not identical to, defined terms; and
  • Vague references — e.g., omitting enough key details to confer unintended discretion on an agency or administrative official.

4. Document Silos

Today’s integrated world doesn’t look kindly on silos, but, in the specialized context of Washington policy development, they can be a helpful check on the temptation to combine technical drafting with political messaging.

The desire to combine these two forms of communication is understandable, for it is an appealing notion that policy proposals be “user friendly” so they can be quickly scanned for substantive gist. In fact, however, the practice is dilutive and dangerous; it can put the wrong words on the page and undermine policy intent.

A better course is for stakeholders to manage separately siloed sets of documents that, while consistent, operate at different levels of specificity. One silo should be reserved for the technically rigorous proposals that effect legal authority and a separate silo for “plain English” issue briefs, fact sheets, and other materials that summarize the authority.

5. Plug & Play

Washington policy debates are less often set battles, more often fast-moving skirmishes. Such places a premium on ability to adapt as new ideas emerge, political signals morph, and coalitions shift.  For the task of converting ideas into policies, there are at least two implications.

First, stakeholders should be prepared to think and draft in modules – in discrete chunks of policy that can be embedded in one or more larger proposals. In Congress, stakeholder-originated ideas are more likely to emerge as legislative amendments than as free-standing bills.

Second, stakeholders should be ready to iterate quickly as debate advances. Feedback from reviewers will often focus on proposal summaries because they are easier to read and understand.  But changes in response to comments must also be reflected in the technical proposals themselves.  Tight deadlines are the norm, so separately siloing the two types of documents (see above) will help speed an effective response when political opportunity strikes.

On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a Catholic medical group, a Christian medical association, and eight states in which the plaintiffs allege, among other allegations, that the Section 1557 regulations force them to provide gender transition services and abortion services against their religious beliefs and medical judgment in violation of the Religious Freedom Restoration Act (“RFRA”).

By way of background, the Section 1557 regulations prohibit discrimination on the basis of gender identify, which regulations define to mean “an internal sense of gender, which may be male, female, neither, or a combination of male and female, and which may be different from an individual’s sex assigned at birth.”[i] The regulations prohibit a categorical insurance coverage exclusion or limitation for all health services related to gender transition and requires providers to provide transition-related procedures if the provider performs an analogous service in a different context. The plaintiffs also alleged that because they perform certain procedures for miscarriages, the Section 1557 regulations will require them to perform such procedures for abortions to avoid discriminating on the basis of termination of pregnancy.

The court held that the Section 1557 regulations failed to incorporate the exceptions for religious institutions and abortions services that Congress provided in Title IX. The court also found that Title IX, which is incorporated by Section 1557 statute, only prohibits discrimination on the basis of biological sex. The court further noted that “the government’s own health insurance programs, Medicare and Medicaid, do not mandate coverage for transition surgeries; the military’s health insurance program, TRICARE, specifically excludes coverage for transition surgeries. . .”[ii]

Specifically, the court concluded that “the regulation violates the Administrative Procedure Act (“APA”) by contradicting existing law and exceeding statutory authority, and the regulation likely violates the [RFRA] as applied to Private Plaintiffs.” The court also agreed that the plaintiffs would likely suffer irreparable harm without the injunction as “one of the State Plaintiffs is already undergoing investigation by the HHS’s OCR, and entities similarly situated to Private Plaintiffs have already been sued under the Rule since it took partial effect on May 18, 2016″ (emphasis added). Conversely, the court found that HHS will not suffer any harm by delaying implementation of this portion of the Section 1557 regulations. It should be noted that this is a ruling granting a preliminary injunction and a final ruling on the merits of a permanent injunction is still to come.

While an HHS appeal of this order would normally be expected, the impending change of Administration—including new leadership at HHS and an expected early Congressional push to repeal and replace the Affordable Care Act—makes it very uncertain whether an appeal will be filed, or ruled upon, prior to any possible changes in the regulatory scheme or underlying statute.

Health care entities should take note, however, that the remaining provisions of the Section 1557 regulations, including those that prohibit discrimination on the basis of disability, race, color, age, national origin, or sex (other than gender identity), are not impacted by the nationwide injunction and HHS can still enforce such provisions. Indeed, HHS has issued a broadcast email specifically stating that:

“[OCR] will continue to enforce the law—including its important protections against discrimination on the basis of race, color, national origin, age, or disability and its provisions aimed at enhancing language assistance for people with limited English proficiency, as well as other sex discrimination provisions—to the full extent consistent with the Court’s order.”

Health care entities should closely monitor this area of law for further developments and ensure that their operations are compliant with the remaining provisions of the Section 1557 regulations.

Further information regarding Section 1557 and its accompanying regulations can be found in EBG Client Alerts and Webinars.

[i] 45 C.F.R. § 92.4

[ii] The court cited Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2780 (2014). The Supreme Court will consider whether Title IX covers gender identity in Gloucester Cty. School Bd. V. G.G., Sup. Ct. No. 16-273, during the current term.

Recently, the Federal Trade Commission (“FTC”) faced major losses in challenging hospital mergers.  However, it is clear that the FTC is not backing down, especially given its tendency to conclude that proposed efficiencies do not outweigh the chance of lessening competition.

In July of this year, the FTC abandoned a challenge to the proposed merger of St. Mary’s Medical Center and Cabell Huntington Hospital in West Virginia after state authorities had changed West Virginia law and approved the merger despite the FTC’s objections. This year as well, the FTC failed to enjoin the Penn State Hershey Medical Center and PinnacleHealth System (“Pennsylvania Hospital Merger”) and the Advocate Health Care and NorthShore University Health System (“Illinois Hospital Merger”) under a relevant geographic market theory in the federal district courts.  However, the FTC promptly appealed to the United States Courts of Appeals for the Third and Seventh Circuits, respectively.

Against many predictions to the contrary, the FTC prevailed when, on September 27, 2016, the Third Circuit reversed the District Court’s decision in the Pennsylvania Hospital Merger, concluding that the lower court erred when it disagreed with the FTC on the choice and use of the proper test to define the relevant geographic market. The Third Circuit concluded that the hypothetical monopolist test should determine the relevant geographic market, and that using patient flow data to show a relevant market is “particularly unhelpful in hospital merger cases.”[1]  This means that using data showing why one patient travels to a farther hospital for services does not have a constraining effect on the price charged by the nearby hospital that the patient does not choose.  Additionally, the Third Circuit expressed extreme skepticism about using an efficiencies defense.  While it recognized that other courts and the government’s Merger Guidelines themselves consider efficiencies in their antitrust analyses, it made clear that “efficiencies are not the same as equities”[2] needed to successfully overcome a Clayton Act Section 7 claim in considering whether an injunction is warranted.

The Third Circuit’s logic may have emboldened the FTC, which on September 30, 2016, formally urged Virginia state authorities to reject the proposed merger of Mountain States Health Alliance and Wellmont Health System, two large regional health systems, claiming that the merger would lessen competition and reduce the quality, availability, and price of health care services in the area.  The FTC is alleging, that if the merger were consummated, the new entity would control 71% of the geographic market for inpatient hospital services in the area that both systems serve, and proposed efficiencies (e.g., greater clinical service offerings, reductions in labor expenses, and reductions in purchasing) are not extraordinary enough to outweigh the anticompetitive harms created.  While Virginia does not require FTC consent to approve the merger, the FTC’s evaluation under the Merger Guidelines carries weight because its process is similar to Virginia’s antitrust review.

Going forward, potential merger partners in the health care space should recognize that the FTC has been energized in its opposition to consolidation and should be attentive to the careful definition of geographic markets with an eye towards the hypothetical monopolist test. As stakeholders begin crafting acquisition strategies to take advantage of the Affordable Care Act’s consolidation opportunities, they should recognize that the enforcement components of the government such as the FTC are in apparent contradiction with the policy arm of the administration and that the FTC won’t back down from its challenges to mergers.

[1] FTC v. Penn State Hershey Medical Center, et al., at 19, No. 16-2365 (3d Cir. 2016).

[2] Id.at 36.

The Medicare Payment Advisory Commission (“MedPAC”) met in Washington, DC, on September 8-9, 2016. The purpose of this and other public meetings of MedPAC is for the commissioners to review the issues and challenges facing the Medicare program and then make policy recommendations to Congress. MedPAC issues these recommendations in two annual reports, one in March and another in June. MedPAC’s meetings can provide valuable insight into the state of Medicare, the direction of the program moving forward, and the content of MedPAC’s next report to Congress.

As thought leaders in health law, Epstein Becker Green monitors MedPAC developments to gage the direction of the health care marketplace. Our five biggest takeaways from the September meeting are as follows:

  1. MedPAC expects Medicare spending growth to outpace GDP, with total Medicare spending to reach approximately $1 trillion by 2025
    MedPAC began its September meeting with a discussion of the projected growth in the Medicare program. Although the growth in both Medicare and overall health care spending slowed from 2009 to 2013, the Congressional Budget Office (“CBO”) and the Medicare Trustees (“Trustees”) project that total Medicare spending will return to growing at a rate that outpaces gross domestic product (“GDP”) growth. Driven by an increase in both enrollment and per beneficiary spending, the CBO and Trustees project that total Medicare spending will grow at an average rate of 7 percent annually through 2025; if these projections are accurate, the Medicare program will almost double in size—from $600 billion in 2015 to approximately $1 trillion 2025.
  2. MedPAC predicts the trends in Medicare to trigger action from the Independent Payment and Advisory Board in 2017
    MedPAC staff expects the growth in Medicare spending to trigger action from the Independent Payment and Advisory Board (“IPAB”) at some point in 2017. Created by the Affordable Care Act, IPAB is an independent board tasked with proposing Medicare policies designed to reduce spending growth. As of now, no one has been appointed to IPAB. If there are no members when Medicare growth triggers IPAB action, IPAB’s authority will transfer to the Secretary of Health and Human Services. The Secretary will then be required to fulfill IPAB’s role, and the Secretary’s savings proposals will automatically become law unless Congress affirmatively acts to block the proposals.
  3. Physician practice sizes continue to grow, and a greater number are affiliating with health systems and hospitals
    MedPAC staff, using the SK&A Office-based physician database (a commercial database file with information on almost 600,000 physicians), determined that the number of physicians who reported as affiliated with a health system or hospital rose from 34 percent in 2012 to 39 percent in 2014. Over that same time period, the percentage of physicians working in practices with more than 50 physicians grew from 16 percent to 22 percent. MedPAC plans to look deeper into the size and affiliation of physician practice groups, including the geographic distribution of practice groups, to more accurately understand the infrastructure needed to move towards alternative payment models.
  4. MedPAC will focus on recommending steps for adjusting the clinician fee schedule to address “misvalued” services
    MedPAC expressed concern that certain clinician services, mainly primary care, are undervalued and undercompensated as a part of the clinician fee schedule. Accordingly, MedPAC will continue to look at recommendations to improve the Relative Value Scale Update Committee (or “RUC”) process and make suggestions to increase payment for primary care services, including a potential partial capitation payment for primary care services.
  5. MedPAC is considering how to evaluate initiatives for reducing avoidable hospitalizations of long-stay nursing facility residents
    MedPAC staff gave an overview of provider initiatives to reduce avoidable hospitalizations of nursing facility residents. These initiatives included efforts made in conjunction with the Center for Medicare and Medicaid Innovation that feature a new three-part payment model. The new model will make payments to facilities for providing treatment for qualified conditions, increase payments to clinicians for providing treatment in nursing facilities, and establish a new payment to providers who conduct care coordination in nursing facilities. MedPAC is planning on developing measures to evaluate the success of these initiatives at reducing cost and improving beneficiary care.
Stuart Gerson
Stuart Gerson

Today, the U.S. Supreme Court decided (6-2, with Kennedy writing for the majority and  Ginsburg and Sotomayor dissenting) the case of Gobeille v. Liberty Mutual Insurance Co.  The matter before the Court involved Vermont law requiring certain entities, including health insurers, to report payments relating to health care claims and other information relating to health care services to a state agency for compilation in an all-inclusive health care database. 

In an important victory for pre-emption advocates, the Court held that this law was pre-empted by The Employee Retirement Income Security Act of 1974 (ERISA) which expressly pre-empts “any and all State laws insofar as they may now or hereafter relate to any employee benefit plan.” And that includes any  state law that has an impermissible “connection with” ERISA plans, i.e., a law that governs, or interferes with the uniformity of, plan administration.  

In the context of this case pre-emption is necessary in order to prevent multiple jurisdictions from imposing differing, or even parallel, regulations, creating wasteful administrative costs and threatening to subject plans to wide-ranging liability. ERISA’s uniform rule design also makes clear that it is the Secretary of Labor, not the separate States, that is authorized to decide whether to exempt plans from ERISA reporting requirements or to require ERISA plans to report data such as that sought by Vermont. The Court went on to reject Vermont’s arguments about the lack of economic loss by Liberty Mutual or its traditional power to regulate in the area of public health. 

Finally, the Court held that ERISA’s pre-existing reporting, disclosure, and recordkeeping provisions maintain their pre-emptive force regardless of whether the newer Affordable Care Act’s reporting obligations also pre-empt state law.  

Epstein-Becker-Green-ClientAlertHCLS_gif_pagespeed_ce_KdBznDCAW4In February 2012, two years after the passage of the Affordable Care Act (“ACA”), the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule, which was subject to significant public comment, concerning reporting and returning certain Medicare overpayments (“Proposed Rule”). On February 12, 2016, four years from the issuance of the Proposed Rule (and six years after passage of the ACA), CMS issued the final rule, which becomes effective on March 14, 2016 (“A and B Final Rule”).

The A and B Final Rule applies only to providers and suppliers under Medicare Parts A and B. The return of overpayments under Medicare Parts C and D are addressed in a final rule that was published by CMS in May 2014 (“C and D Final Rule”). To date, no final regulations have been adopted that address Medicaid requirements.

Among other things, the A and B Final Rule and its preamble provide:

  • a six-year lookback period;
  • that providers and suppliers must exercise “reasonable diligence” in connection with identifying potential overpayments;
  • that the time period to conduct “reasonable diligence” should be no more than six months, except in extraordinary circumstances; and
  • that “identification” includes quantifying the amount of the overpayment.

Kirsten M. Backstrom, George B. Breen, Anjali N.C. Downs, David E. Matyas, and Meghan F. Weinberg coauthored a Health Care and Life Sciences Client Alert that addresses a number of the significant provisions of the A and B Final Rule, describes an important difference between the two final rules, and sets forth a list of nine key “takeaways” that we believe all Medicare providers and suppliers should be aware of.

Click here to read the full Health Care and Life Sciences Client Alert.

2016 is poised to be a major year in network adequacy developments across public and private insurance markets.  Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges.  The developing standards and enforcement will vary significantly across these markets.

Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act’s insurance exchanges (“Exchanges”).  Others reported on enrollees’ frustration with receipt of unexpected charges from out-of-network practitioners when receiving treatment at in-network facilities (often referred to as “surprise bills”).  As a result, calls for improved network adequacy and transparency mounted.  A September 2014 HHS Office of Inspector General (OIG) report was critical of variation in state oversight of the Medicaid managed care market.  An August 2015 Government Accountability Office (GAO) report called for greater CMS network oversight in the Medicare Advantage market.  In response, a series of proposed rules and other changes have accumulated –

Medicare Advantage (MA) – In April 2015, CMS announced in a Call Letter that it will impose more stringent network adequacy requirements in the application process for MA plans.  To address surprise provider terminations, CMS will require 90 days notice of any significant mid-year changes.  Additionally, plans must establish and maintain a process to keep provider directories current in real-time.  CMS intends to monitor compliance and is considering a CY2017 requirement for standardized electronic submission for inclusion in a nationwide provider database.  CMS has also expressed its intent to review network adequacy as part of its regular program audits, as a pilot in 2016 and as a standard feature in 2017.

Medicaid Managed Care – In May 2015, CMS released the first proposed rule to make comprehensive changes to its Medicaid managed care rules in 12 years, including new quantitative network adequacy standards.  Once finalized, states would be required to establish time and distance standards for specific provider types, including primary care (adult and pediatric), OB/GYN, behavioral health, specialists (adult and pediatric), hospital, pharmacy, pediatric dental, and any “additional provider types when it promotes the objectives of the Medicaid program for the provider type to be subject to such time and distance standards.”[1]  Interestingly, CMS suggested in its proposed rule that states look to MA and state commercial standards as models.

Federal Exchanges – In December 2015, CMS, through its Center for Consumer Information and Insurance Oversight (CCIIO), released a proposed rule that featured more prescriptive network adequacy standards for Qualified Health Plans (QHPs) offered on the federal Exchange.  Where CCIIO is satisfied that a state uses “an acceptable quantifiable metric,” it will defer to their review of QHPs.  In other states, a default federal standard would apply.  Starting in 2017, CMS expects to take a similar approach as to MA and apply time and distance standards, with an emphasis on high-utilization specialties.  While CMS says it will not “prohibit certification of plans with narrow networks or otherwise impede innovation in plan design,”[2] it intends to set a floor with the federal Exchange default standards and it seeks greater network transparency.  Toward that end, ratings on QHP network coverage may be a future feature of HealthCare.gov.

State Regulated Group and Individual Markets – In November 2015, the National Association of Insurance Commissioners (NAIC) released a long-awaited network adequacy model act with more detailed requirements than federal and many state standards.  While the act would not impose quantitative standards such as provider number and type requirements, it does include reimbursement parity provisions for emergency and out-of-network facility-based providers.

Looking Ahead

With legislative sessions underway in all but four states this year, there are several important developments to watch for in 2016.  Some states will adopt the NAIC model act, in whole or in part, or use the act as a baseline from which to tailor its own standards.  Other states will decline to adopt it, leaving existing standards intact that range from minimal to highly detailed and prescriptive.  With increasing pressure from CMS across markets, some states may seek to aggressively increase the specificity of their network adequacy standards, adding number and type requirements or legislating that their insurance commissioners do so through an administrative process.  Some states may consider aligning standards across markets to ensure regulatory uniformity.  While there is nothing in the model act that suggests states increase oversight and enforcement activities, CMS is clearly increasing its own oversight and is pushing states to set a floor for state level access standards.  Changes to the landscape will come better into focus as CMS releases its final rules for all of the above proposed changes.

 

[1] 80 Fed. Reg. at 31145.

[2] 80 Fed. Reg. at 75550.

Epstein Becker Green’s Lynn Shapiro Snyder, Senior Member of the Firm, and Tanya Vanderbilt Cramer, Of Counsel, will present “Accountable Care Organizations and Other Provider Risk Sharing Arrangements — a Legal and Regulatory Overview,” a webinar hosted by Bloomberg BNA.

While the federal government has encouraged the growth of accountable care organizations (ACOs) through the Affordable Care Act, the regulation of ACOs and other provider risk sharing arrangements remains a patchwork of federal and state requirements that span many different areas of law. This webinar will explore some of the regulatory issues faced by ACOs, integrated delivery systems, and other provider organizations that assume some or all of the financial risk for providing covered health care benefits to patients through reimbursement arrangements such as capitation or shared savings.

Epstein Becker Green would like to offer you a 25% discount off the registration fees for this program.  To sign up at this discounted rate, please follow the steps below:

  1. Go to http://www.bna.com/accountable-care-organizations-m17179934019/
  2. Click on “add to cart.”
  3. Sign in to your bna.com account – if you do not have a bna.com account, please click “create an account & continue”
  4. On the checkout screen you will see a box on the right side labeled “promotion code”.  Please enter the code FIRMDISC25 in this box and click submit.  Then click proceed to checkout.

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are “low risk” and are intended to:

  1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
  2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy lifestyle may reduce the risk or impact of such a condition.

 

This is big news and paves the way for continued innovation, particularly in the wearable devices and mhealth markets where many of the products would fall within the guidance’s definition of low risk —  not invasive, not raising biocompatibility questions or novel usability issues and to involving features with inherent patient safety risks (e.g. lasers, radiation, implants).

There are some limitations to this guidance, however.  First, it only applies to Center for Device and Radiological Health (CDRH).  It does not apply to combination products or products regulated by other FDA Centers.  Second, manufacturers will need to closely manage their marketing claims to ensure they do not step over the line and make clinical outcome claims that would subject them to FDA oversight.  Lastly, developers should be aware that being considered a general wellness product, rather than a device, will affect their ability to be covered under traditional reimbursement and third party payment models. There may be opportunities as novel payment approaches emerge as a result of the Affordable Care Act and health reform but companies will need to carefully navigate this guidance with payor’s weariness about reimbursement without evidence of directly improving clinical outcomes.

There will, undoubtedly, be questions about how much evidence is needed to be considered “well accepted” and other issues as the draft guidance is further analyzed. But, overall, the wellness guidance provides much of the clarity industry has been seeking and is a positive development for patients who live with chronic conditions.