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Iowa Healthcare Law Blog

News & Updates on Legal, Policy, & Business Issues Facing the Health Care Industry in Iowa

Peeling Back the Apple Watch

Posted in Electronic Health Records, HIPAA
Apple Watch at Brick Gentry P.C.

Apple Watch at Brick Gentry P.C.

Apple Watch, HIPAA, and Mobile Healthcare Industry.

When one of our more tech savvy partners recently showed us his new Apple Watch, it instinctively raised questions as to how would HIPAA regulate its use. One possible answer is that the features of this new Apple Watch may be the linchpin to a whole new culture in the mobile health industry.

Time will determine the answer, but the new Apple Watch does possess interesting features that will impact the mobile health care industry. Along with the Apple Watch, the company offers the HealthKit app, which is an application that can be used by the Apple Watch and is designed to log one’s activity and health data, and the ResearchKit software, which launched in April 2015, Apple has also introduced interesting “tools” in the health care marketplace—for the consumer, the provider, and possibly, other vendors. So, in addition to changing the health care marketplace, the Apple Watch and other applications have opened the door to multiple legal issues that will need to be addressed.

We co-authored “Peeling Back the Apple Watch:  Do HIPAA and the Apple Watch Go Together?” which is published this fall in ABA Health eSource and in Chicago Medicine, We highlight the major role the Apple Watch could play in the development of the mobile healthcare industry, and its possible impact on the regulatory framework used to control patient privacy.

  • Opportunities for consumers
  • Opportunities for healthcare providers
  • Privacy, security and data vulnerability
  • Applicability of HIPAA
  • Applicability of the FTC
  • Patient Safety Concerns
  • Discoverability and evidentiary issues of e-data in court proceedings
  • Future Role of Wearable Devices in Mobile Health

View the full article:  Peeling Back the Apple Watch_ Health Law Section.

Medicare “Incident To” Billing – CY 2016 Clarifications

Posted in Centers for Medicare and Medicaid Services-CMS

The billing physician must be the supervising physician.

The final CY (calendar year) 2016 Medicare physician payment rule is out and published in the November 16, 2015 Federal Register. In that rule, CMS (Centers for Medicare & Medicaid Services) made two changes clarifying Medicare’s Part B “incident to” billing rule found at 42 CFR 410.26. The amended regulatory language becomes effective on January 1, 2016.

The first of the two incident to rule changes relates to auxiliary personnel. Physicians and certain “other practitioners” (clinical psychologists, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives) may bill incident to for services and supplies provided by auxiliary personnel under their supervision. “Auxiliary personnel” means any individual acting under the supervision of a physician (or other practitioner) and can be employees, leased employees, or independent contractors. 42 CFR 410.26(a)(1). Auxiliary personnel must meet state law requirements, including licensure, for providing the service or supply. The final CY 2016 Medicare payment rule adds language specifying that auxiliary personnel must not be excluded from Medicare, Medicaid or any other Federal health program or had enrollment revoked at the time the incident to service or supply is provided. This new language clarifies what already is a Medicare billing requirement.

The second incident to rule change relates to supervision of auxiliary personnel. Only the physician (or other practitioner) who directly supervises the auxiliary personnel providing the service or supply can bill incident to for that service or supply. The physician (or other practitioner) providing direct supervision to auxiliary personnel can be, and very well may be, different from the physician (or other practitioner) treating the patient “more broadly.” Nonetheless, only the supervising physician (or other practitioner) is permitted to bill incident to for services and supplies provided by auxiliary personnel. 42 CFR 410(b)(7).

This revised regulatory language clarifies CMS’ longstanding but sometimes misunderstood position. In its comments to the final rule, CMS explains: “[B]illing practitioners should have a personal role in, and responsibility for, furnishing services for which they are billing and receiving payment as an incident to their own professional service.” In cases, then, where a beneficiary’s treating physician refers the beneficiary to another physician and where auxiliary personnel provide services to that beneficiary under the supervision of the second physician, only the second physician, not the referring physician, is authorized to bill incident to. The second physician’s billing number is reported on the claim form. Although the referring physician has a connection to the services, “we believe the physician or other practitioner directly supervising the incident to service assumes responsibility and accountability for the care of the patient that is provided by auxiliary personnel.”

Medicare’s expectations for “direct supervision” sometimes cause misunderstandings of their own. For purposes of incident to billing, “direct supervision” requires physician (or other practitioner) to be present in the office suite and immediately available to furnish assistance and direction to auxiliary personnel when providing the service or supply; direct supervision does not require the supervising practitioner’s presence in the same room. 42 CFR 410.32(b)(3)(ii). By way of note, only general supervision is required when services or supplies are provided by clinical staff incident to transitional care or chronic care management. 42 CFR 410(b)(7), 42 CFR 410.32(b)(3)(i).

In closing, in comments to its incident to rule changes, CMS noted stakeholder suggestions that it clarify by way of a CPT code listing those services that can or cannot be billed incident to. Medicare law dictates that only services and supplies of the kind commonly furnished in physicians’ offices without charge or included in a physician’s charge may be billed incident to; regulations provide additional specificity but not a listing of services appropriate for incident to billing. 42 CFR 410.26(a)(7), 42 USC 410.26(b)(1-4). CMS said it would take this suggestion under advisement in issuing future guidance on Medicare incident to billing.

CMS REQUIRES MEDICAID PROGRAMS ACCESS MONITORING PLANS BY JULY 1, 2016

Posted in Centers for Medicare and Medicaid Services-CMS, Medicaid

State plans must consider impact of provider rates on beneficiary access

US Supreme Court says providers cannot challenge Medicaid payment rates in a court of law

Physicians under Iowa’s Medicaid program consistently provide quality medical care to our State’s 560,000 Medicaid beneficiaries despite payment rates that, according to the Iowa Medical Society, are nearly the same as rates paid to physicians in 2000. IA Health Link requires Medicaid’s four contracted managed care organizations (MCOs) to pay physicians no less than the Medicaid fee-for-service rates in effect on July 1, 2015; Medicaid-enrolled providers who do not sign with an MCO suffer a 10% out-of-network reduction in payment rates. In 2016, physicians again will petition the Iowa General Assembly for a Medicaid rate increase, an ask that may be at odds with the substantial cost-savings goal of IA Health Link.

Exasperation with sluggish state and federal responses to Medicaid payment inadequacy has led to provider lawsuits over the years. Provider claims focus on that section of federal Medicaid law referred to by regulators as the “access requirement.” Each state’s Medicaid program, as part of its state plan, must “assure that payments are consistent with efficiency, economy, and quality of care and are sufficient to enlist enough providers so that care and services are available under the plan at least to the extent that such care and services are available to the general population in the geographic area.” 42 USC 1396a(a)(30)(A) [Emphasis added].

In March of this year, the U.S. Supreme Court dealt a harsh blow to provider lawsuits, ruling in a close 5-4 decision that providers cannot seek remedy through the courts against a state Medicaid program for inadequate payment rates. In Armstrong v. Exceptional Child Center, et. al., 575 US ___ (No. 14-15, decided March 31, 2015), habilitation service providers alleged that Idaho’s Medicaid payment rates violated Medicaid’s “access requirement” law. Lower federal courts ruled in favor of the providers. The Supreme Court, however, held that no private right of action existed to support Medicaid payment rate challenges by providers through the courts. Instead, the majority argued, the only avenue of redress Congress gave to providers was through the secretary of Health and Human Services (HHS) who must assure that each state Medicaid plan satisfies federal requirements. The “sheer complexity” of this “judgment-laden” statutory payment requirement, the Court said, speaks volumes in favor of exclusive enforcement through federal regulators best suited to manage it in a consistent manner. The dissenting justices disagreed, arguing that if Congress had intended to deny providers access to the courts, Congress would have said so in the Medicaid law.

In a final rule published in the November 2, 2015 Federal Register, the Centers for Medicare & Medicaid Services (CMS) requires each state Medicaid program, as part of its state plan, to develop an access monitoring review plan no later than July 1, 2016, to assure compliance with the statutory access requirement. The rule, CMS says, sets forth a framework “to make better informed, data-driven decisions” on, among other things, service rate structures and provider payment methodologies impacting beneficiary access. Because the Armstrong decision places enforcement accountability with HHS for state plan compliance with Medicaid’s access requirement, CMS says it must be more transparent in exercising data-driven judgment calls on payment adequacy affecting beneficiary access.

The final rule, 42 CFR 447.203(b), requires access monitoring review plans to include an analysis specifying data sources, methodologies, baselines, assumptions, trends and factors, and thresholds regarding sufficient access, each of which may vary by geographic location within a state. Further, the plan must consider, among other things, the availability of care through enrolled providers to Medicaid beneficiaries in each geographic area by provider type and site of service as well as actual or estimated levels of provider payment available from other payers, public and private, by provider type and site of service. The review plan and analysis must specify measures used by the state to analyze beneficiary access, such as time and distance standards; providers participating in Medicaid; providers accepting new Medicaid beneficiaries; service utilization patterns; and telehealth availability.

States are required to submit an access monitoring review analysis to CMS with any state plan amendment reducing provider payment rates or restructuring provider payment methodologies that could result in diminished access. In the event of no state plan payment rate amendment but, rather, stagnant rates over the course of many years, state Medicaid programs, nonetheless, are required to complete access analyses at least once every 3 years for, among other things, primary care services and physician specialist services.  CMS calls for additional comments and information to improve upon data and metrics identified in this final rule.

Most Iowa physicians are touched by Medicaid. In many Iowa communities, Medicaid patients are a significant percentage of the physician’s practice base. Adequate Medicaid payment rates fairly reflecting physician costs are important in assuring physician participation in Medicaid and in avoiding tough restrictions on the number of Medicaid patients they see. CMS’ new rule evidences greater regulatory focus on adequate Medicaid payment rates based on uniform, objective, data-driven criteria, bearing in mind, however, that payment rates are important only as they affect beneficiary access. While instinct influenced by a long history of inaction may make physicians justifiably suspicious about the ultimate value of this new rule, CMS has set in motion an avenue of oversight and remedy that physicians and other Medicaid providers should not ignore.

Iowa Medicaid Modernization Bid Winners Announced

Posted in Medicaid

On Monday, August 17, 2015, the Iowa Department of Human Services (DHS) issued a Notice of Intent to Award contracts to four (4) bidders to serve as contractors under the Iowa Medicaid Modernization initiative. Those selected are: Amerigroup Iowa, Inc.; AmeriHealth Caritas Iowa, Inc.; UnitedHealthcare Plan of the River Valley, Inc.; and Wellcare of Iowa, Inc.  DHS’ announcement stated that these four entities demonstrated abilities to manage care provided to Medicaid beneficiaries under this risk-based approach to Iowa’s Medicaid program. This new initiative has been named IA Health Link and is slated for implementation effective January 1, 2016.

Iowa Medicaid currently serves approximately 560,000 Iowans. DHS states that Iowa Medicaid program costs have grown 73 percent since 2003. “Starting January 1, these experienced MCOs [managed care organizations] are positioned to help us achieve savings at a time when there is an ever growing demand on our state’s medical assistance program,” DHS Director Chuck Palmer stated.

Information about the Iowa Medicaid Modernization initiative is available from DHS at http://dhs.iowa.gov/ime/about/initiatives/MedicaidModernization. To help prepare its physician members for this major transition, the Iowa Medical Society has developed a webinar and other educational resources available through its website at www.iowamedical.org.

Iowa Behavioral Health Association Hosts Jeanine Freeman & Paul Drey to Give HIPAA Training

Posted in Brick Gentry P.C., HIPAA, Mental Health

Iowa Behavioral Health Association Hosts Jeanine Freeman & Paul Drey

HIPAA presentations for IBHA by Paul Drey, Jeanine Freeman

Paul Drey, Jeanine Freeman present HIPAA education to Iowa Behavioral Health Association.

 

On July 23rd the Iowa Behavioral Health Association (IBHA), Iowa’s statewide association of substance use disorder agencies, addiction treatment programs and community mental health centers, hosted prominent health care attorneys Paul Drey and Jeanine Freeman of the Brick Gentry Law Firm to provide training on the Health Insurance Portability and Accountability Act (HIPAA).

This educational session centered around HIPAA requirements and regulations, new updates to the law, and its intersection with 42 CFR, the regulation governing substance use related health information.

Ms. Freeman and Mr. Drey answered questions from the audience, presented information and resources on compliance and best practices, and offered valuable insights from their own experiences. Participants clarified issues through lively discussion. Attendees left the session feeling confident and empowered in their understanding of HIPAA and its implementation and enforcement in their own organizations.


Upon generously contributing this photograph and information, Kelsey Clark, Interim Executive Director of the Iowa Behavioral Health Association, added, “IBHA very much appreciates Mr. Drey and Ms. Freeman providing this session and looks forward to future endeavors with these top notch legal experts.”

If your association or practice group could benefit from a customized presentation on healthcare law topics, we invite you to contact Paul Drey to discuss your needs and scheduling.  We appreciate the efforts of the healthcare community and stand ready to assist.

CMS Releases Proposed CY 2016 Medicare Physician Payment Rule

Posted in Centers for Medicare and Medicaid Services-CMS

A Topical Rundown

On July 8, 2015, CMS released its calendar year (CY) 2016 proposed Medicare physician payment rule in prepublication form; the rule will be formally published in the July 15 Federal Register. Comments on the proposed rule are due on September 8, 2015.

The prepublication version of the proposed rule can be found at https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-16875.pdf.  A CMS fact sheet on the proposed rule is available at http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-07-08.html.

The proposed rule implements statutory requirements set forth in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the legislation that permanently repealed the sustainable growth rate (SGR) formula; the Protecting Access to Medicare Act of 2014 (PAMA); the Achieving Better Life Experience Act of 2014 (ABLE); and other statutory directives impacting upon the Medicare physician fee-for-service payment system (PFS). With this rulemaking, CMS proposes and builds upon several policies and programs that move toward implementation of MACRA’s Merit-based Incentive Payment System for Medicare physician payment in CY 2019.

As directed by MACRA, physician payment in CY 2016 will be increased by 0.5%. The proposed rule estimates a conversion factor of $36.1096; the estimated conversion factor for anesthesia services is $22.6296. The final CY 2016 conversion factors, however, likely will vary somewhat from these estimates.

Several changes are proposed for Medicare’s quality reporting initiatives, including the Physician Quality Reporting System (PQRS), the Physician-Value-Based Payment Modifier (Value Modifier), and the Medicare Electronic Health Record (EHR) Incentive Program. As proposed, there would be 300 PQRS measures in CY 2016 and a proposed reporting option would allow groups to report quality measures data through a qualified clinical data registry (QCDR). CMS also proposes several new policies affecting the Physician Compare public reporting program, including incorporation of a benchmark reporting methodology.

Considerable discussion in the proposed rule is dedicated to proposed adjustments to relative values in codes identified as “misvalued.” ABLE directs a CY 2016 1% target reduction in Medicare physician fee-for-service (PFS) expenditures through adjustments to relative values of misvalued codes; if CMS cannot achieve the full 1% reduction through adjustments to misvalued codes, then the balance in reductions must be spread out among all PFS codes. CMS estimates a net expenditure reduction of 0.25% if RVU misvalued code adjustments are made as proposed in this rule, noting, however, that it may make further misvalued codes adjustments in the final rule. As such, CMS did not incorporate this 0.25% target reduction into the proposed rule’s estimated CY 2016 conversion factors.

To help interested readers to walk through this massive rulemaking, the following is a listing of major topics and the pages in the prepublication version of the rule where those topics can be found. Note: the format and pagination of the proposed rule changes upon July 15 publication in the Federal Register but the content remains the same.

  • Determination of practice expense (PE) RVUs (pp.23-55)
  • Determination of malpractice RVUs (pp. 55-63)
  • Potentially misvalued services under PFS (pp.64-83)
  • Refinement panel (proposed elimination) (pp. 84-85)
  • Improving payment accuracy for primary care and care management services (pp.86-96)
  • Target for RVU adjustments for misvalued services (pp. 97-105)
  • Phase-in of significant RVU reductions (pp.106-111)
  • Changes for (CT) computerized tomography (CY 2016 only) (pp. 112-113)
  • Valuation of specific codes (pp. 114-276), including proposed codes for advance care planning services subject to local coverage decisions (pp. 246-247)
  • Medicare telehealth services, adding codes 99356-57 and 90933-36, rejecting others, including CRNAs as distant site providers who can furnish Medicare telehealth services) (pp. 277-288)
  • Incident-to proposals, including clarification that the billing physician also must be the supervising physician (pp. 289-294)
  • Portable x-ray: billing for transportation services (pp. 295-296)
  • Waiver of deductibles for anesthesia services furnished on the same day as a planned colorectal cancer test (pp.297-298)
  • Proposed provisions re: ambulance fee schedule (pp. 299-319)
  • Chronic care management (CCM) services for rural health clinics (RHC) and federally qualified health centers (FQHC) (pp. 319-334)
  • HCPS coding for RHCs (pp. 334-338)
  • Payment to grandfathered tribal FQHCs (338-346)
  • Part B drugs – biosimilars (pp. 346-350)
  • Productivity adjustments for ambulance, clinical laboratory, and DMEPOS fee schedules (pp. 350-351)
  • Appropriate use criteria for advance diagnostic imaging services (pp. 352-369)
  • Physician Compare Website (pp. 370-396)
  • Physician Quality Reporting System (PQRS) (pp. 397-504)
  • Electronic Clinical Quality Measures (ECQM) and certification criteria and EHR incentive program – comprehensive primary care (CPC) initiative and Medicare meaningful use (MU) aligned reporting (pp. 505-510)
  • Potential expansion of the comprehensive primary care (CPC) initiative (pp. 511-520)
  • Medicare Shared Savings Program (MSSP) (pp. 521-545)
  • Value-based payment modifier and physician feedback program (pp. 546-605)
  • Physician self-referral updates (pp. 606-679)
  • Private contracting opt-out (pp. 680-681)
  • CY 2016 PFS proposed estimated impact on total allowed charges by specialty (Table 45, pp. 711-712)
  • CY 2016 PFS proposed payment impact for selected procedures (facility and non-facility), Table 46 (pp. 715-716)

Several specific issues are addressed within each of these broad topics requiring review and impact analyses prior to the September 8 comment deadline.

US Supreme Court Upholds ACA Tax Credits for All Qualified Individuals

Posted in Affordable Care Act (ACA), Healthcare costs

US Supreme Court Upholds ACA Tax Credits for All Qualified Individuals Purchasing Health Insurance Through a Marketplace Exchanges

In King v. Burwell, the Court’s 6-justice majority concludes that denying ACA tax credits to individuals on federally-facilitated State exchanges is contrary to what Congress intended.

King v. Burwell, U.S. Supreme Court No. 14-114, decided June 25, 2015.

In another major challenge to the Patient Protection and Affordable Care Act (“ACA”), the federal health reform law, the U.S. Supreme Court, on a 6-3 vote, upheld the Internal Revenue Service’s regulation extending federal tax credit support provided under the ACA to all qualified individuals enrolled in a marketplace Exchange regardless of whether the State elected to operate its own Exchange or exercised its option to have the federal government do so.

The Court’s decision rests on its interpretation of the law’s language rather than on constitutional grounds. Chief Justice Roberts, writing for the majority, said the challenged language is ambiguous; however, reading that language within the context of the ACA’s overall statutory framework compels an interpretation extending availability of the law’s tax credits to all qualified individuals purchasing coverage through an Exchange whether state-operated or federally-facilitated. The limited reading furthered by the petitioners “would destabilize the individual insurance market in any State with a Federal Exchange, and likely create the very ‘death spirals’ that Congress intended the Act to avoid.”

The limited reading furthered by the petitioners “would destabilize the individual insurance market in any State with a Federal Exchange, and likely create the very ‘death spirals’ that Congress intended the Act to avoid.”

The petitioners in King v. Burwell specifically pointed to ACA language making tax credits available to low and moderate income individuals purchasing health insurance coverage through an “Exchange established by the State.” The government argued in response that each State is required by the ACA “to establish” a marketplace Exchange and may do so, as allowed by the ACA, by either operating its own Exchange or defaulting to operation by the federal government. Facts before the Court showed that in 2014, 16 states operated their own Exchanges while 34 were federally facilitated. Of the 7.3 million individuals who purchased health insurance coverage through an Exchange, 5.4 million did so through federally-facilitated Exchanges and approximately 87% of those individuals were eligible for tax credits.

Petitioners’ arguments about the plain meaning of the challenged language are strong, the Court said, when viewed in isolation, but other language in the law, as highlighted by the Court, supports tax credit availability to qualified individuals purchasing insurance coverage on an Exchange regardless of operational source. Its task is to establish meaning within context. “A fair reading of legislation demands a fair understanding of the legislative plan.”

The Court noted that Congress based the ACA on three major reforms:

1) guaranteed issue and community rating requirements; 2) mandated individual insurance coverage at the risk of tax penalty; and 3) tax credits for individuals with household incomes between 100%-400% of federal poverty. Denying tax credits, a fundamental aspect of the ACA’s reform strategy, to individuals in federally-facilitated Exchange states would lead to substantially different operations and outcomes under this law in some states than in others, an implausible reading of what Congress intended. The Court referenced a study predicting that denying tax credits in federally-facilitated Exchange states would result in premium increases of 47% and enrollment decreases of 70% while another study predicted premium increases of 35% and enrollment decreases of 69%; collateral impacts also would result in insurance markets outside an Exchange. “[Tax] credits are necessary for the Federal Exchanges to function like their State Exchange counterparts, and to avoid the type of calamitous result that Congress plainly meant to avoid.”

The Court’s ruling is important to Iowa.

Iowa’s Exchange is federally-facilitated. Technically, Iowa operates a partnership Exchange, relying upon the participant enrollment technology of the federal government while retaining plan management and consumer assistance functions through the Iowa Insurance Division. Of the 45,000 Iowans on Iowa’s marketplace exchange in 2015, more than 33,000 were eligible for tax credit support.

TELEMEDICINE ABORTION RULE FOUND UNCONSTITUTIONAL

Posted in Iowa Board of Medicine, Telemedicine

Iowa Supreme Court says portions of the Iowa Board of Medicine’s rule, not consistent with standards of medical practice, place an unconstitutional burden on a woman’s exercise of her constitutional rights to an abortion.

Planned Parenthood of the Heartland v. Iowa Board of Medicine, No. 14-1415, filed June 19, 2015

The Iowa Supreme Court, on a 6-0 vote, invalidated as unconstitutional those portions of the IBM’s telemedicine medication abortion rule prohibiting physicians from inducing an abortion by providing an abortion-inducing drug without first providing a physical examination of the woman, without being physically present with the woman at the time of abortion-inducing drug is provided, and without scheduling a follow-up appointment with the woman at the same facility where the abortion-inducing drug was provided. In that case, Planned Parenthood of the Heartland v. Iowa Board of Medicine, portions of the IBM rule defining “abortion-inducing drug” and requiring compliance with Iowa’s law on parental notification prior to performing an abortion on a minor were not challenged on appeal and, as such, the Court affirmed them.

The Court looked to the IBM’s stated purposes for adopting its medication abortion rule (found at Iowa Administrative Code (IAC) 653-13.10 but put on hold by the Court pending the outcome of this appeal). The IBM particularly emphasized the need to protect the health and safety of women seeking a drug-induced, or medication, abortion. The Court engaged in extensive discussion of each patient health and safety interest asserted by the IBM for its rule. In doing so, the Court also looked to the IBM’s more recently adopted general standards for telemedicine practice in Iowa (IAC 653-13.11, a rule now in effect and not affected by this decision). The Court noted that physicians are required by the IBM’s general telemedicine rule to “utilize evidence-based telemedicine practice guidelines and standards of practice, to the degree they are available, to ensure patient safety, quality of care, and positive outcomes” and to perform “a physical examination, when medically necessary, sufficient for the diagnosis and treatment of the patient.”

In examining standards of medical practice for medication-induced abortions, the Court looked to practice standards of the American College of Obstetricians and Gynecologists (ACOG) which provide that a physical examination by the physician prior to proceeding with a medication termination of pregnancy is not medically necessary. Rather, ACOG says, the medical information necessary to performing a medication abortion is contained in the patient’s history, blood work, vital signs, and ultrasound images which can be accessed by reviewing the patient’s records remotely or in person. The Court also found that the weight of the evidence indicates that a pelvic examination prior to administering the abortion-inducing medication does not provide any measurable gain in patient safety. The Court further looked to FDA protocol for administration of mifepristone and misoprostol to induce an abortion, noting that FDA approved protocol does not prohibit physicians from using drugs in a different, “off-label,” manner; that additional studies have led to the development of safer and more effective administration protocol; and it is that newer protocol the IBM’s rule is meant to preclude.

The Court found little medical practice or drug regulatory support for the IBM’s asserted interests in adopting its medication abortion rule but substantial challenges for a woman seeking an abortion under the rule’s physician examination and in-person requirements. “It is not disputed the rule would have the effect of prohibiting telemedicine abortions in Iowa.” In balancing the IBM’s purposes in adopting the rule, which are not supported by the medical record, in light of the burdens the rule places upon a woman seeking to exercise her constitutional rights, the resultant consequences for the woman unconstitutionally outweigh the IBM’s asserted interests.

“Most significantly,” the Court went on to say, “the Board has adopted a rule that generally approves the use of telemedicine.” Yet, in its medication abortion rule, “the Board appears to hold abortion to a different medical standard than other procedures.” As such, the Court also hinted at constitutional equal protection issues.

The IBM issued a release on June 19, the same day the Court filed its opinion, noting the Court’s decision and stating that the IBM would discuss ruling at its July 9-10, 2015 meeting.

Paul Drey Honored with Prestigious John F. Sanford Award at Iowa Medical Society Gala

Posted in Iowa Medical Society
IMS President Jeff Maire, D.O., FACOS, FACS presents  Paul Drey the 2015 John F. Sanford Award

Attorney Paul Drey Receives 2015 John F. Sanford Award from Iowa Medical Society President, Dr. Jeff Maire. Photo courtesy of Iowa Medical Society.

Attorney Paul A. Drey was honored with the John F. Sanford Award during the Dinner Gala at the Iowa Medical Society’s 165th Annual Conference, Saturday, May 2, 2015, at the DoubleTree by Hilton, Cedar Rapids Convention Complex.  The Gala serves as a time to network with peers, to celebrate the accomplishments of the Iowa Medical Society (IMS), and to set the course for the coming year with the induction of a new president.

The John F. Sanford Award is the only award presented by the Iowa Medical Society to a non-physician. It honors the memory of the Keokuk physician who was a pioneer in the field of medicine, a champion of organized medicine on behalf of the physicians in Iowa, and a founder of the Iowa Medical Society in 1850. The award recognizes a layperson who has made outstanding contributions to health care on behalf of both the Iowa Medical Society and the physicians in the State of Iowa.

In his introduction of the award, IMS President Jeff Maire, D.O., commended Paul Drey for his long service as parliamentarian to the IMS House of Delegates, for his invaluable outside legal counsel to the Iowa Medical Society, for his efforts on behalf of the Iowa Medical Society, and for his work with physicians and physician groups throughout the state. Dr. Maire announced,

“There is a reason Paul is the ‘go to’ attorney for medical groups and physicians in Iowa – he truly cares about Iowa physicians, and understands how complex our world can be.”

The Iowa Medical Society also presented a number of awards to physicians. Thomas Evans, M.D., received the Distinguished Service Award for creating the Iowa Healthcare Collaborative. Paul Mulhausen, M.D. received the Presidential Citation Award for his efforts as the chair of the Iowa Medical Society Ad Hoc Task Force for Policy and Governance.  Michael McCoy, M.D. received the Merit Award for his work on medical liability reform and his leadership of the Iowa Medical Society Tort Reform Task Force.  William E. Scott, M.D. received the Physician Community Service Award for his selfless dedication to the children of Iowa through his work with Iowa Kid Sight.  In addition, the presidency of the Iowa Medical Society passed from Dr. Jeffrey Maire to Dr. K. John Hartman.

K John Hartnan MD, PAD, Jeff Maire DO FACOS, FACS

New Iowa Medical Society President, K John Hartnan MD, Paul Drey and Past IMS President Jeff Maire, DO. Photo courtesy of Iowa Medical Society.

Is Health Plan Identifier (HPID) required for Self-Funded Medical Plan?

Posted in Centers for Medicare and Medicaid Services-CMS

Some time ago, we were asked by a reader, “Is an employer self-funded medical plan required to have a Health Plan Identifier (HPID)?”

We thought this general information might be helpful. Please remember this information and blog is NOT LEGAL ADVICE, and you should consult with your own attorney. The inquirer correctly notes that the underlying question is whether an employer-sponsored self-funded plan is a controlling health plan (CHP) required to obtain an HPID. CMS regulations and guidance indicate that employer-sponsored self-funded health plans are CHPs and must obtain a HPID.

Before providing support for this response, please note that on October 31, 2014, CMS issued an enforcement delay on its HPID rule “until further notice.” There is a reasonable chance that the HPID, as now defined, may be eliminated. CHPs need not obtain a HPID until further notice from CMS.

Here is the background re: regulatory need for an employer-sponsored self-funded health plan to obtain a HPID.

CMS published its final regulations setting forth requirements for health plan receipt of an HPID on September 5, 2012. CMS also developed frequently asked questions (FAQs) giving guidance on compliance with its HPID requirements. One FAQ specifically addresses whether a self-insured health plan must obtain an HPID.

To determine the answer, a self-insured health plan must ask if it meets the HIPAA regulatory definition of a “health plan.” A health plan is an individual or group health plan that provides or pays the cost of medical care. Assuming that the employer self-funded medical plan does so, the next question is whether that self-funded plan meets the regulatory definition for a “controlling health plan” (CHP). A CHP is a health plan that controls its own business activities, actions, or policies, or is controlled by an entity that is not a health plan. An employer’s self-funded medical plan generally would satisfy this definition of a CHP.

It can be confusing because most self-funded plans work with third party administrators (TPAs) which sometimes, themselves, are health plans. TPAs, however, are not CHPs when acting in their roles as TPAs (i.e., providing eligibility, claims administration, and other administrative services). The sponsor of the self-insured plan is responsible for obtaining the plan’s HPID. The sponsor could ask that its TPA obtain a HPID on the plan’s behalf, but the HPID would belong to the sponsored self-funded health plan.

Advisors to the industry also say that employer-sponsored health plans are HIPAA-covered entities and that employers with self-funded health plans are required under the final regulations to obtain an HPID.

HPID compliance deadlines set forth in the September 5, 2012 rule are as follows –

• CHPs are required under the regulation to obtain their HPIDs by November 7, 2014.
• Small CHPs, however, have until November 7, 2015, to obtain a HPID. A CHP is a “small” CHP if its annual receipts are $5 million or less. CMS advises CHPs on processes to utilize in determining whether its receipts are $5 million or less.
• HIPAA-covered entities are required to use HPIDs in HIPAA-covered transactions effective November 7, 2016.

Now, about the delay identified above.

As noted above, shortly before the first HPID regulatory deadline, CMS issued a “discretionary delay” in enforcement of the HPID rule “until further notice.” This delay has been read by the field as putting on hold not only enforcement actions CMS might have taken against health plans that failed to timely obtain their HPIDs, but also putting on hold the need for a health plan to obtain a HPID until further directed by CMS to do so. The HIPAA statute requires CMS, in adopting HPID regulations, to obtain and consider the advice of the National Committee on Vital and Health Statistics (NCVHS). CMS did so in finalizing its HPID rule and, further, in issuing this indefinite delay. NCVHS has advised CMS against use of the HPID in HIPAA standard transactions. It is possible, according to some industry commentators, that the HPID will be done away with in favor of some other form or processes of unique health plan identification.

One other HIPAA regulatory requirement for health plans to be aware of and to watch.

CMS issued regulations on January 2, 2014, requiring all HIPAA covered entity health plans to certify compliance with HIPAA standard transactions for eligibility, health claims status, and electronic payment/electronic remittance advice by December 31, 2015. In certifying compliance, this rule requires health plans to use their HPIDs. The rule’s certification deadline remains in effect. CMS will need to address the rule’s requirement for use of the HPID at some time.

We hope this response is helpful to the inquirer and to others.