Archive for February, 2020

Shift in Patient’s Right to Access Medical Records

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Shift in Patient’s Right to Access Medical Records

By: Kelli C. Fleming, Burr & Forman

The Office of Civil Rights (“OCR”), the government agency tasked with HIPAA compliance and enforcement, recently announced a change impacting a patient’s right to access his/her medical records—a change which is, given OCR’s history, surprisingly favorable to providers. 

One of the long-standing premises of HIPAA has been a patient’s right to access his/her medical records. For years, the HIPAA regulations have limited the fees that providers can charge patients when they request a copy of their medical records to a reasonable, cost-based fee (regardless of the permitted state law fees). HITECH expanded this right a few years ago by allowing patients to exercise their right to access medical records, but designate a third-party to whom the records should be sent (e.g., the patient’s attorney). These requests from patients to send their records to a designated third-party are oftentimes referred to in the industry as “HITECH” requests. 

Subsequent OCR guidance stated that the historical limitation on fees that applied when a patient exercised his/her right to access medical records would also apply to the situation where a patient requested that his/her records be sent to a designated third-party pursuant to a “HITECH” request. As a result, providers were limited in what they could charge third-parties, such as attorneys, seeking access to medical records by way of a “HITECH” request from a patient, as opposed to by way of a HIPAA authorization. 

However, based on a recent court order, such limitation on fees no longer applies to “HITECH” requests. As a result of the recent court decision, OCR has clarified that “the fee limitation set forth at 45 C.F.R. § 164.524(c)(4) will apply only to an individual’s request for access to their own records, and does not apply to an individual’s request to transmit records to a third party.” Thus, as a result of this recent court decision, providers, and their business associates, are no longer bound by the HIPAA-imposed limitation on fees when a patient requests that a copy of his/her medical records be sent to a designated third party (e.g., attorney). For these “HITECH” requests, providers can now charge fees acceptable under state law, without applying the HIPAA fee limitations. These state law fees are oftentimes higher than the HIPAA fees. Further, the court decision clarified that such “HITECH” requests are limited to requests for an electronic health record with respect to PHI maintained in an electronic format.

OCR has been clear that the  HIPAA limitation on fees, however, will continue to apply to patient requests to access their own medical records when the records are delivered directly to the patient. Nonetheless, this shift in guidance is favorable to providers and much welcomed by the healthcare industry.

Kelli Fleming is a Partner at Burr & Forman LLP practicing exclusively in the firm’s healthcare industry group.

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Medical Cannabis Passes Senate Committee

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Medical Cannabis Passes Senate Committee

Last Wednesday, the Alabama Senate Judiciary Committee advanced a bill allowing cannabis to be recommended for up to 15 conditions for medicinal purposes.

SB165, informally named the Compassion Act and sponsored by Sen. Tim Melson, M.D., would allow physicians to recommend medical cannabis for conditions such as cancer, anxiety and chronic pain. It would also let patients with state-issued cannabis cards to purchase cannabis products at licensed dispensaries. Cannabis products dispensed to patients would be under strict state regulation from seed to sale, including testing products for consistency and to ensure no contamination.

Under Melson’s bill, medical cannabis would available to anyone 19 years or older whom a physician certifies as having a qualifying medical condition. Patients 18 or younger would need a parent or guardian to administer cannabis. The patient would have to apply for a medical cannabis card, which would cost no more than $65.

Cannabis will only be available in encapsulated form or a topical agent. The bill would also establish a fund using tax proceedings for increased research on cannabis.

Having passed the Judiciary Committee 8-1, the legislation will now receive a vote before the entire Senate. Should it pass the Senate, it still must go to through a committee and floor vote in the House.

After surveying its members, the Medical Association found Alabama physicians believe if cannabis for medicinal use is legalized, then the growth, cultivation and sale of cannabis should be highly regulated by the state, and any physician involvement should be regulated not by some new state agency, but by the Board of Medical Examiners. Likewise, the survey found physicians believe any administration or use of legalized medical cannabis should be limited to encapsulated form and topical agents.

While there was no overwhelming consensus found regarding physicians’ support or opposition to the legalization of medicinal cannabis, the Medical Association has worked tirelessly with the bill sponsor to bring the legislation in line with the areas of broad agreement in our member survey. We appreciate the willingness of Sen. Melson in working with us and will continue monitoring the bill as it moves forward.

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Senate Committee Approves Collaborative Practice Ratio Increase

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Senate Committee Approves Collaborative Practice Ratio Increase

Last Wednesday, the Senate Health Committee approved an amended version of legislation dealing with the ratio of physicians to nurse practitioners in a collaborative practice.

Originally, the bill would have allowed physician collaboration with an “unlimited” number of full-time equivalent nurse practitioners or nurse-midwives. However, after significant input from the Medical Association, the legislation deletes “unlimited” and instead increases the number of nurse practitioners and physician assistants with whom a physician may collaborate.

Specifically, the amended legislation:

  • Deletes “unlimited” and instead increases the current ratio of FTEs from 1:4 to 1:9;
  • Adds physician assistants to the total collaborative ratio;
  • Maintains the collaborating physician’s autonomy and authority within the collaborative practice agreement;
  • Maintains the ability for exceptions to this new 1:9 ratio through regulation; and,
  • Maintains the current regulatory structure for physician assistants, nurse practitioners, nurse midwives, and collaborating physicians.

Collaborative practice is not “one-size-fits-all” and this newly-amended bill allows for flexibility in collaboration while also preserving physician authority. The compromise was a joint effort between the Medical Association, the Nurse Practitioners Alliance and the Alabama Physician Assistants’ Association. We now support this legislation.

The legislation (SB114) now moves to the Senate floor for a vote.

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Appropriate Use Criteria for Advanced Diagnostic Imaging

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Appropriate Use Criteria for Advanced Diagnostic Imaging

Contributed by: Gregg Everett, Gilpin Givhan

The Protecting Access to Medicare Act (PAMA) was passed in 2014.  PAMA required the Centers for Medicare and Medicaid Services (CMS) to establish a program that promotes “Appropriate Use Criteria” (AUC) for advanced diagnostic imaging. AUC’s are evidence-based criteria that assist professionals who order and furnish certain imaging services to make the most appropriate treatment decisions for specific clinical conditions. Once the AUC program is fully implemented (2021), payment will only be made for an advanced diagnostic imaging service if the Medicare claim indicates that the ordering professional consulted with a qualified Clinical Decision Support Mechanism (CDSM) about whether the ordered service meets an applicable AUC.  A CDSM is an interactive electronic tool for use by clinicians that communicates AUC information and assists in making appropriate treatment decisions during a patient’s workup.  An ordering professional is a physician or other licensed professional who orders an imaging service.  The settings covered include hospital outpatient departments (which includes the hospital’s ER), ambulatory surgery centers, physicians’ offices and IDTF’s.  

Advanced diagnostic imaging services include MRI’s, CT scans, PET scans and nuclear medicine. The CDSM must be reported on claims for payment using G-codes, modifiers and, eventually, the ordering physician’s NPI. For the period July 1, 2019, through December 31, 2019, only voluntary reporting was required.  Beginning January 1, 2020, an educational and operations testing period will be implemented, which is expected to run through December 31, 2020. For now, CMS will still pay a claim, whether or not the claim correctly includes AUC information. Eventually, CMS must develop outlier criteria (which will require some ordering professionals to obtain prior authorizations) and will not pay those claims that do not have AUC information, unless a specific exception is met. The exceptions include emergency services provided to individuals with emergency medical conditions (EMTALA definition), inpatient care where payment is made under Part A Medicare, or significant hardships, which includes insufficient internet access and EHR or CDSM vendor issues.  

Qualified CDSM’s (only national professional medical specialty societies or other organizations of providers who predominantly provide direct patient care may develop CDSM’s) must be approved by CMS and must meet other criteria, such as providing a certification or other documentation at the time of the order that a qualified CDSM was consulted, and whether or not the service ordered met the requirements of the specific referenced AUC. The regulations also list certain “priority clinical areas” that will be monitored to identify outlier ordering professionals as follows:  coronary artery disease (suspected or diagnosed), suspected pulmonary embolisms, headache (traumatic and non-traumatic), hip pain, low back pain, shoulder pain (including suspected rotator cuff injury), cancer of the lung (primary or metastasis, and suspected or diagnosed), and cervical and back pain. Ordering physicians and settings for these imaging services should begin the process of including AUC’s on Medicare claims in January 2020.

For more information see:

  1. “Protecting Access to Medicare Act of 2014,” Section 216, (Public Law 113-93), 42 U.S.C. Section 1395m(p) and (q).
  2. 42 CFR Section 414.94 – “Appropriate Use Criteria for Advanced Imaging Services.”
  3. “Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging – Educational and Operations Testing Period—Claims Processing Requirements”; MLN Matters Number MM11268 Revised December 6, 2019.
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Striking Your Best Deal: Things to Look at on the Front End of Negotiating an EHR Vendor Contract

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Striking Your Best Deal: Things to Look at on the Front End of Negotiating an EHR Vendor Contract

Article Contributed by Christopher L. Richard, Gilpin Givhan, PC

Backdrop

Imagine you’re selling your practice . . . or leaving your practice . . . or retiring. You want to continue to have access to the patient records you’ve maintained through the practice over the years, and in fact, you have an obligation to do so. Under Rule 540-X-9-.10(1) of the joint guidelines of the Alabama State Board of Medical Examiners and Medical Licensure Commission, physicians are required to retain medical records “for such period as may be necessary to treat the patient and for additional time as may be required for medical-legal purposes.”[1]In addition, you must provide patients notice and a reasonable opportunity to request their records or request that they be transferred to another practice. It used to be you would maintain physical copies of these records in your practice office, a secure storage area, or by some other means. However, your patient records are now stored in an electronic health record (“EHR”) system maintained by a third-party vendor. Your third party vendor is planning to charge you a regular monthly service fee for the entire duration of time you have to keep the records. The alternative is an exorbitant one-time fee for you to obtain a copy of the digital patient records maintained in the EHR system. Neither option is particularly good, but the scenario provides an important opportunity to examine key contractual provisions you and/or your counsel should pay attention to when negotiating EHR and other vendor contracts.

I Have the Need . . . for Legalese

Contracts, especially vendor contracts, can be filled with overly-complicated, legalese-ridden language that tends to earn attorneys their fair share of grief. However, a good portion of this language is born out of experience and necessity. For one, attorneys tend to loathe repeating (or allowing) the same mistakes more than once (“Fool me once, shame on you; fool me twice, shame on me,” as the saying goes). Unfortunately, attorneys cannot anticipate every possible scenario that might unfold, but we often attempt to ensure that contractual provisions at least provide clarity in situations where past ambiguities have turned into disputes.

Secondly, attorneys do their best to memorialize what are often extremely complicated arrangements between their clients. Complicated structures frequently require complicated descriptions. Otherwise, a contract may be lacking in meaningful standards and may be no more useful that the “handshake” agreement that started the contract negotiation process.

With the (perhaps) optimistic notion that attorneys craft documents out of necessity according to the principles above, consider the following contractual provisions that are worth the extra attention in the contract negotiation process.

Important Contract Provisions

Ownership of Records; Rights to Use.  It should go without saying that you and your patients are the owners of your patient records, regardless of whether they are stored in, or on, your vendor’s software and/or hardware. Be wary of any contractual language that seems to give ownership rights in your patient records to the EHR vendor. By that same token, consider what rights your EHR vendor reserves to use and/or disclose information stored on their system. When intense scrutiny of tech company privacy practices is layered on top of HIPAA and increasingly restrictive state, federal, and international privacy laws, it’s worth an extra look to ensure you’re not allowing your EHR vendor to take any actions that would impact your obligations under applicable privacy laws.

Indemnification/Hold Harmless/Limitation of Liability.  Experience tends to show that contracting parties will listen and respond to reasonable concerns, especially when they are trying to earn your business. The same principles apply to the remedies provisions of vendor contracts. For instance, the initial contract presented may require you to “indemnify, defend, and hold harmless” the vendor against a host of liabilities that may be incurred by you or the vendor. It is almost always a reasonable request to have the indemnification language be mirrored between the parties. In other words, if you are required to indemnify the vendor for your negligence, gross negligence, or willful misconduct, they should be willing to indemnify you for their similar conduct.

In addition, the contract may limit the amount of damages recoverable to the total amount of payments you make for the vendor’s services under the contract, or the number of payments in a given time period (e.g., one year or the term of the contract). These limitations are not uncommon, and they are not necessarily unreasonable. However, it’s not the kind of limitation you want to discover after you’ve encountered some significant financial harm and are expecting the other party to cover all the costs.  Similarly, it would be untenable to accept unlimited potential liability to your EHR vendor when they are putting fairly extensive limits on their liability to you.

Termination Provisions.   Now, back to where we started: what happens when you are attempting to terminate your practice or a relationship with an EHR vendor? As an initial matter, it’s worthwhile to consider your options to terminate the contract before the term is over. All too often, I’ve seen clients stuck in long-term contracts with little or no option to terminate. Obviously this is a matter of economics for the vendor. They have up-front investment costs that have to be recouped over the life of the contract, which hopefully (for them) is a long term. However, consider options to terminate the contract for “good cause.” It’s also worthwhile to consider including an illustrative list of items that constitute “good cause,” in an effort to avoid arguing about what “good cause” means when you elect to terminate the contract. In addition, consider a no-fault termination provision, which may be acceptable to both parties if there is a reasonable notice period before the contract can be terminated.

Lastly, consider what your options are to preserve the records or get them out of the EHR system upon termination of the contract. In the example above, you may be caught between a rock (continued EHR service fees for the required record retention period) and a hard place (a costly one-time fee to obtain a copy of the records). Again, these deal points can (and should) be negotiated on the front end of the arrangement with the EHR vendor, especially if you foresee a change in your practice (e.g., retirement) in the near future. An acceptable solution likely looks different for each individual physician or practice, and their respective vendors, and could vary based on the timing (early vs. end of contract term) and reasons (retiring vs. transferring to new vendor) for terminating services. Concepts like these should be considered to address this issue and other contractual issues on the front end of the agreement, rather than when the relationship has soured or ended.

Conclusion

The contracting process can be tedious, frustrating, and at times can seem unnecessary, especially if both parties “seem to be on the same page.” However, there are great benefits to a well-conceived contractual relationship. These may include robust and meaningful standards of performance. They may also include reasonable provisions and limitations on indemnification, liability, and damages, or even a plan for what happens when the relationship is terminated. At any rate, they should be tailored to meet the parties’ needs and should be a help, rather than a hindrance. They simply require some attention from the parties on the front end of the contract.Please note that the information provided in this article does not, and is not intended to, constitute legal advice; instead, all information, content, and materials contained herein are for general informational purposes only.  Readers are encouraged to contact their attorney to obtain advice with respect to contract negotiations or any other particular legal matter.

[1] Although there is no specific retention period, the Board of Medical Examiners suggests keeping patient records for at least 10 years or otherwise consulting with the malpractice liability carrier to determine an appropriate record retention period.

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Legislators: Just Apply Heat

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Legislators: Just Apply Heat

Through years of medical school, residency and fellowships, physicians earn not only more knowledge and expertise than any other health professional, they also earn the right and responsibility of leading the health team.  It is through physician-led care that we ensure continued quality and safety for patients.  But each year, “scope creep” proposals seek to “replace medical education with legislation” and to blur the lines between medicine and other health disciplines. 

Legislators, when confronted with such proposals, often ask how they can be expected to determine whether a particular piece of health legislation is in their constituents’ best interest.  After all, the extent of most legislators’ experience with health care is only on the patient side.  While muscle soreness can be alleviated by applying heat, legislators reviewing scope legislation would be well served by, as explained below, just applying H.E.A.T.  

What is HEAT?

Could the proposal harm patients and will its effects adhere to the Hippocratic Oath’s directive to “first, do no harm?”

Do the proponents of the proposal have the requisite education today to safely perform the tasks or functions they are seeking to amend the law to allow; and, have all members of the profession to whom the proposal would apply received the same levels of specified education to cover the subject of the proposal? 

Would the proposal expand access to additional quality care for patients or just additional care, perhaps of a lower standard? 

Do proponents of the proposal possess the requisite training at present to perform the tasks they are seeking to amend the law to allow?

What does it mean?

If the answers to any of the above questions is no, then the answer to the legislative proposal in question should likewise be a resounding “no.”   Medical education, residency and fellowships prepare physicians for the challenges of delivering quality care in today’s ever-changing health landscape.  While proponents of “scope creep” pitch their proposals as cure-alls for the state’s health delivery system, there are no shortcuts to addressing Alabama’s health challenges. 

To the contrary, removing physician supervision and reducing safety standards and protocols will only endanger patients and reduce quality.  By investing in and supporting programs, proposals and initiatives that recruit and retain physicians to this state, legislators can grow the physician workforce, maintain quality of care and boost Alabama’s economy. 

In the meantime, lawmakers utilizing the four-step HEAT process to analyze legislative proposals should find it helps them separate appropriate changes to Alabama’s health laws from the many dangerous “scope creep” bills that are on the increase. 

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