Disclaimer
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
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Obama Administration Announces Fraud Prevention Partnership
/in Fraud and AbuseBy Bill Mercer
Last month, Secretary Sebelius and Attorney General Holder announced a new collaboration with health insurance companies to provide both government and private payer claims data to a third-party to detect overpayments and fraud.
http://www.hhs.gov/news/press/2012pres/07/20120726a.html
http://www.justice.gov/opa/pr/2012/July/12-ag-926.html
By pooling claims data and having the third-party analyst look for suspicious billing patterns, the federal government and participating insurers believe outliers would be readily identifiable. Claims data which appear to suggest the existence of fraud or overpayments would be referred to federal law enforcement for further investigation.
By commingling claims information from private insurers, Medicaid, and Medicare, the Administration believes it could detect, for example, a provider who bills all payers for more than 24 hours in a day or bills the same claims to multiple insurers. Attorney General Holder’s statement [http://www.justice.gov/iso/opa/ag/speeches/2012/ag-speech-120726.html] refers to the prospect of detecting claims made to multiple public and/or private insurance plans for the same patient on the same day in more than one city.
A number of private sector participants have volunteered to participate in the partnership, including:
America’s Health Insurance Plans
Amerigroup Corp.
Blue Cross and Blue Shield Association
Blue Cross and Blue Shield of Louisiana
Humana Inc.
Independence Blue Cross
Travelers
Tufts Health Plan
UnitedHealth Group
WellPoint Inc.
Significant details necessary to the creation of a functional partnership have yet to be resolved. According to the HHS press release, the Executive Board and two committees will meet for the first time next month. The initial work plan is also a work-in-progress.
The partnership received support from Senator Coburn and Senator Hatch, who wrote to the Acting Administrator of CMS that “this is an effort which is long overdue.” [http://www.coburn.senate.gov/public/index.cfm?a=Files.Serve&File_id=b3d5048d-a395-49af-b4ac-2c2b65b9a4a0] The lack of detail in the Administration’s rollout of the initiative generated a series of follow-up questions from Senators Coburn and Hatch. They have asked for responses on the following issues by the end of August:
“Specifics regarding exactly how this collaboration will work including what entities will be involved, whether HHS/CMS or another entity will be overseeing the effort and a timeline for expected key milestones of the effort.
A step-by-step explanation of how the information will be shared (e.g., what systems will be used to transmit the data), what authorities allow the exchange of information, what impediments exist to sharing information (e.g., statutory language) and where the information will be stored/analyzed.
A description of the third party who will be analyzing the data, as well as an explanation of how that entity will be selected and what their capabilities are to integrate and analyze such a large amount of information.
Specifics regarding what will happen when leads are identified, how that information will be disseminated, and what the process will be for following up on those leads.”
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
HIPAA Compliance: Security Rule Enforcement on the Rise
/in HIPAAMost healthcare providers are acutely aware of and generally comply with the HIPAA Privacy Rule; however, they and their business associates may be less familiar with and likely fail to satisfy HIPAA Security Rule requirements. The Privacy Rule generally prohibits covered entities from using or disclosing a patient’s protected health information (“PHI”) without authorization. (45 C.F.R. § 164.500 et seq.). In contrast, the Security Rule applies to electronic health information (“e-PHI”). It requires covered entities and their business associates to implement specific administrative, technical, and physical safeguards to protect the integrity, availability, and confidentiality of e-PHI, e.g., by ensuring that computers and other electronic devices satisfy regulatory standards pertaining to passwords, firewalls, backups, transmission security, etc. (45 C.F.R. § 164.300 et seq.).
In the past, the Office of Civil Rights (“OCR”) seemed not to actively enforce the Security Rule, but that is changing:
These actions sound a wake up call to all providers and business associates—large, small, or public—who have ignored or become lax with Security Rule compliance. As OCR Director Rodriguez stated, “We hope that health care providers pay careful attention to [these] resolution agreement[s] and understand that the HIPAA Privacy and Security Rules have been in place for many years, and OCR expects full compliance no matter the size of a covered entity.” The OCR is now required to impose mandatory penalties of $10,000 to $50,000 per violation if a provider is determined to have acted with willful neglect. Based on the recent cases, failing to implement safeguards required by the Security Rule may evidence willful neglect.
If they have not done so recently, providers and their business associates should review their Security Rule compliance. Among other things, they should conduct a security assessment to determine their system vulnerabilities, and implement the safeguards specified in the Security Rule regulations. To obtain a checklist for Security Rule compliance, please click here. In addition, the OCR has published several tools to help entities comply:
Putting in place the required policies and practices and documenting appropriate training will go a long way to avoiding Security Rule penalties. More importantly, they will help providers avoid potentially devastating consequences of a security failure, system crash, or the loss of electronic data which the Security Rule is designed to protect. In that regard, Security Rule compliance is not just a regulatory mandate; it is a prudent business practice.
For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
Affordable Care Act Upheld in a Nuanced Opinion
/in Health Care ReformIn a dramatic and narrowly reasoned 5-4 ruling yesterday, the Supreme Court upheld the Patient Protection and Affordable Care Act (ACA).
Chief Justice Roberts started his summary of the decision by announcing that the Constitution’s Commerce Clause could not support the law’s controversial provision that most individuals purchase health insurance or pay a penalty – the so-called “individual mandate.” To observers, this appeared to signal that a key piece of the President’s signature legislation would be struck down. However, Justice Roberts went on to explain that the individual mandate may be upheld on the basis of Congress’s authority under the Taxing Clause. The Court reasoned that the Commerce Clause allows Congress to regulate commerce, not compel it. On the other hand, the Court determined the individual mandate can be upheld as a tax for three main reasons: the payment is not so high that it leaves no real choice except to buy health insurance, the payment is not limited to willful violations (as penalties for unlawful acts are), and the payment is collected exclusively by the IRS through normal means of taxation.
In an unexpected turn, Justice Kennedy, widely considered to be the swing vote, joined the dissent in objecting to the individual mandate on any grounds. Chief Justice Roberts, appointed by President George W. Bush, ultimately swung the Court’s decision in holding that the individual mandate is constitutional under Congress’s taxing authority. Ironically, the Court ruled that the mandate was not a “tax” for purposes of being able to decide the case without violating the Anti-Injunction Act (which holds that a tax cannot be challenged in court until some time after the tax is due in the spring of 2015), but was a tax for purposes of upholding the law.
The other major provision of the law that had been challenged is the expansion of Medicaid. Again, the Court held that the Medicaid expansion violates the Constitution by threatening States with the loss of their existing Medicaid funding if they decline to comply with the expansion. The Court, however, provided careful guidance to remedy the violation by holding that the Medicaid expansion is constitutional so long as the Secretary of Health and Human Services is precluded from withdrawing existing Medicaid funds for failure to comply with the requirements set out in the expansion.
The result of today’s opinion is that the ACA is considered constitutional. Accordingly, those provisions of the ACA already in place will continue. These include:
Likewise, provisions of the ACA scheduled to be implemented in the future will go forward as planned, unless Congress moves to eliminate or delay those provisions. These include the major expansion and reform provisions of the ACA that will take effect in 2014, including:
The ACA contains numerous cost containment and financing provisions. While the ultimate cost of the ACA is the subject of much debate, the ACA is designed to offset the costs associated with the expansion of coverage by slowing the rate of growth of federal health care spending and increasing revenues through taxes and penalties. The largest share of revenues will come from additional Medicare payroll taxes on those with incomes over $200,000 for single individuals and $250,000 for married couples. The ACA also creates an excise tax on high-cost plans, limits annual contributions to flexible spending accounts (FSAs) and excluding over-the-counter medications (with the exception of insulin) from reimbursement by FSAs and other health savings accounts.
The Congressional Budget Office (CBO) estimates that the direct spending and revenue effects of the ACA will reduce the federal deficits by $143 billion over a ten-year period (2010-2019) and that, by 2019, will result in 94% of the non-elderly, population of legal U.S. residents being insured. In actual numbers, this means that the ACA will reduce the number of uninsured by an estimated 32 million people, leaving approximately 23 million uninsured by 2019.
While the Supreme Court’s actions today resolve the constitutionality of the ACA, the controversy surrounding the law and challenges to it will continue. Mitt Romney has vowed, if elected, to repeal the ACA on the first day of his term by sending out waivers to all 50 states to keep them from having to pursue the law. With only 132 days to the election, the Supreme Court’s decision is only one volley in a greater debate. We at Holland & Hart LLP will continue to follow all health care issues that affect our clients and communities, and to provide timely updates as they develop.
For questions regarding this update, please contact
Kim C. Stanger
Holland & Hart, U.S. Bank Plaza, 101 S. Capitol Boulevard, Suite 1400, Boise, ID 83702-7714
email: kcstanger@hollandhart.com, phone: 208-383-3913
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
Medical Staff Member on Hospital Boards: Limits in New CoPs
/in Medical Staff, Credentialing, and Corrective Action, UncategorizedLast month, CMS issued new conditions of participation (“CoPs”) for hospitals and critical access hospitals (“CAHs”) to be effective July 16, 2012. (77 F.R. 29034, dated 5/16/12). Among others, 42 CFR § 481.12 will require that the hospital’s governing board “must include a member, or members, of the hospital’s medical staff.” We have confirmed with CMS, however, that there are limits to this new requirement.
1. Does Not Apply to CAHs. The new requirement only appears in the hospital CoPs, not in the corresponding CAH CoPs. (See 42 CFR 485.627). The new requirement for physician participation on the hospital’s governing body was not intended to apply to CAHs.
2. Does Not Apply Where State Law Establishes Board Membership. In some cases, state or local laws may control board membership. For example, state law may require that board members of county hospitals or hospital districts are elected or appointed by another government agency. The new CoPs were not intended to preempt such laws. In such cases, the CoPs regarding medical staff representation on the governing body would not apply, and CMS would expect the hospital to follow the laws of its particular locality.
3. The Physician May Serve in a Non-Voting Capacity. Even where they do apply, the new CoPs do not specify how hospitals should choose the medical staff representative, nor do they specify the particular role that the medical staff representative should fill on the governing body. CMS intends that hospitals have flexibility in addressing these issues. For example, the hospital may appoint the physician to the board in a non-voting or ex officio capacity. Limiting the physician board member’s voting rights may be appropriate given conflicts of interest that a physician board member may have since many board decisions will directly impact the physician’s practice.
We understand that CMS may be taking action to clarify these issues for providers.
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.
Changes to Idaho Health Care Consent Law
/in ConsentEffective July 1, 2012, amendments to Idaho’s health care consent statutes, Idaho Code § 39-4501 et seq., take effect. The changes resolve some concerns, but raise others. The following summarizes the more significant changes.
1. Application of consent statutes. The amended statute expressly confirms that it applies to all forms of health care, not just medical or dental care. (I.C. § 39-4503).
2. Capacity to consent. As amended, “any person who comprehends the need for, the nature of and the significant risks ordinarily inherent in” the contemplated health care may consent to or refuse their own care. (I.C. § 39-4503). The change removes the additional condition that the person must have “ordinary intelligence and awareness”, which created ambiguity and potentially unwarranted discrimination in applying the standard.
3. Surrogate decision makers. The amendment clarifies the authority of “surrogate decision makers” to make health care decisions for persons who lack capacity to make their own decisions. Surrogates may make decisions for minors and other persons who are not capable of giving consent. As amended, the statute establishes the following hierarchy for surrogates:
(I.C. § 39-4504(1)). Importantly, the amendment clarifies that the surrogate decision maker must themselves have sufficient capacity under § 39-4503 to make their own health care decisions before they can make decisions for others. In addition, the surrogate cannot trump the prior wishes of the patient expressed while the patient was competent, e.g., through a POST, advance directive, or other method. (I.C. § 39-4504(1)).
4. Responsibility for obtaining consent. The amendment confirms that the health care provider upon whose order or at whose direction the contemplated care is rendered is responsible for ensuring that sufficient consent is obtained, either by themselves or by their agents. (I.C. § 39-4508).
5. Advance directives. The old statute contemplated certain forms of advance directives, e.g., a living will, durable power of attorney for health care, or physician’s orders for scope of treatment (“POST”). Questions sometimes arose concerning other forms of advance directives, or the validity of a directive that did not contain the statutory elements required for a living will, durable power of attorney, or POST. The amended statute confirms that any advance directive ought to be honored, including any “document which represents a competent person’s authentic expression of [the] person’s wishes concerning his or her health care.” (I.C. § 39-4502(8); see also I.C. §§ 39-4509(3) and 39-4514(6)).
6. POSTs. The amended statute broadens the availability of POSTs. The former statute made POSTs “appropriate” if the patient had an incurable or irreversible injury, disease, illness or condition, or if such conditions were anticipated. The amended statute removes that condition, making POSTs possible for all patients. (See I.C. § 39-4512A). The amended statute also expands the persons who may execute a POST. In addition to physicians, the new statute allows advanced practice nurses or physician assistants to execute POSTs on behalf of the provider. (I.C. § 39-4512A). Similarly, in addition to the patient, the new statute allows surrogate decision makers to execute POSTs on behalf of the patient so long as the POST is not contrary to the patient’s last known expressed wishes. (I.C. § 39-4512A(1)). The amendment allows a provider or person to suspend a POST for a period of time, although such suspension is not automatic. (I.C. § 39-4512A(2)). For example, contrary to some providers’ belief, POSTs and other advance directives are not automatically suspended during surgery.
7. DNRs. When enacted, the former version of the statute removed the laws that authorized “do not resuscitate orders” (“DNRs”), apparently intending POSTs to replace DNRs. The amended statute expressly allows hospitals and other health care providers to continue to use DNRs, provided that if the patient presents a POST, they must accept the POST and not require a separate DNR to validate the POST. (I.C. §§ 39-4512B(3) and 39-4514).
8. Withdrawal or denial of treatment. A new section was added to limit a provider’s ability to withdraw or deny certain forms of treatment requested by the patient or surrogate. As amended, assisted feeding or artificial nutrition and hydration may not be withdrawn or denied if such care is requested by the patient or surrogate decision maker. Other forms of treatment cannot be withdrawn or denied if requested by the patient or surrogate decision maker unless the treatment that medically is inappropriate or futile. (I.C. § 39-4514(3)). Unfortunately and unlike other amendments, this section is poorly drafted and may inappropriately limit a provider’s professional judgment. For example, under both the former and amended law, the consent statute shall not be construed “to require medical treatment that is medically inappropriate or futile”; however, the new law expressly states that this limitation “does not authorize any violation” of the new withdrawal of care provisions described above, i.e., the requirement that requested treatment must be provided unless futile. (I.C. § 39-4514(3) and (6)). The limitation on withdrawal or denial of care does not reference medically inappropriate treatment. (I.C. § 39-4514(3)). The net effect appears to be that a provider may not withdraw or deny requested treatment even if medically inappropriate unless the treatment is also futile, which result defies logic and cannot be what was intended. At the very least, the amendment creates ambiguity concerning the proper response to treatment that is requested but is medically inappropriate.
9. Futile care. As amended, the statute only permits the withdrawal or denial of requested treatment if the treatment is futile. The statute now defines “futile care” as a course of treatment:
(I.C. § 39-4514(6)). This definition of “futility” only considers the length of a patient’s life without considering qualitative factors, including the pain or suffering that an incompetent patient may be forced to endure simply to preserve life or the fact that a patient may be in a permanent comatose state. It is inconsistent with Idaho’s “Baby Doe” regulations which also factor in the humanity of a patient’s care. (See IDAPA 16.06.05.004.10). In some cases, the provider may deem continued treatment to be unethical or unconscionable if not “futile” as defined in the statute, in which cases the provider’s alternative is to withdraw as the treating provider after making a good faith effort to transfer care to another provider pursuant to I.C. §§ 39-4513(2) or 18-611. That may be a viable alternative for a physician or other individual health care provider, but it is more difficult for a hospital or other health care facility. The practical effect is that it is even more important for providers and facility ethics committees to come to an agreement with patients or surrogate decision makers concerning the appropriate course of treatment or withdrawal thereof.
10. Minor consents. The amended statute does not explicitly resolve whether mature minors may consent to their own care. Section 39-4503 states that “any person” with sufficient comprehension may consent to their own care, not any “adult” person. Similarly, § 39-4509 was amended to define “competent person” to mean any person who meets the standard in § 39-4503, not just adults or emancipated minors. On the other hand, § 39-4504(1) states that surrogate decision makers may consent for minors. Until clarified by a court, the conservative approach would be to require surrogate consent for minors unless another statute grants the minor authority to make their own health care decisions or the minor is clearly deemed to be emancipated under Idaho law.
Conclusion. The amended consent statute resolves some of the concerns that have bothered providers in recent years; however, the new “withdrawal of treatment” provisions may prove problematic in some cases. Redlined copies of the amended statute may be accessed at http://www.legislature.idaho.gov/legislation/2012/S1294E1.pdf and http://www.legislature.idaho.gov/legislation/2012/S1348E1.pdf.
If you have questions concerning these or other legal issues, please contact Kim Stanger at kcstanger@hollandhart.com or (208) 383-3913, or visit Holland & Hart’s website at www.hollandhart.com
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.