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.
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.
Continue Reading Medicare “Incident To” Billing – CY 2016 Clarifications
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.
Continue Reading CMS REQUIRES MEDICAID PROGRAMS ACCESS MONITORING PLANS BY JULY 1, 2016
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.
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.
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.
Several specific issues are addressed within each of these broad topics requiring review and impact analyses prior to the September 8 comment deadline.
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.”
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.”
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.
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.
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.
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.
• 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.
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.
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.