Access to Experimental Drugs and State “Right to Try” Laws

By on March 24, 2015

In November 2014, Colorado (Colo. Rev. Stat. §§ 25-45-101—108) became the first state to pass a “right to try” law giving terminally ill patients the right to try experimental drugs. Since Colorado’s law passed, several other states including Arizona (Ariz. Rev. Stat. §§ 36-1311—1314) , Michigan (Mich. Stat. § 16221), Missouri (Mo. Stat. § 191.480), and most recently Wyoming (to be codified at Wyo. Stat. §§ 35-7-1801—1806), have passed similar laws. Legislators in other states are considering similar bills to allow terminally ill patients access to experimental drugs.

HC Blog 3.24“Right to Try” legislation is controversial. Supporters argue that the laws will give dying patients faster access to potentially lifesaving treatment than the Food and Drug Administration’s (FDA) compassionate use program. Detractors argue that the laws give false hope because there is no guaranteed access to the experimental treatment, no financial support, the unstudied treatments could cause harm and hasten death, and drug companies may not want to risk providing unapproved drugs and treatment for fear of angering federal regulators.

The Colorado law, which is similar to laws in other states, allows an eligible patient access to investigational drugs, biological products, or medical devices by allowing (but not requiring) doctors to prescribe and companies to provide these experimental treatments. An investigational drug, biological product, or device is defined as a drug, biological product, or device that has successfully completed phase one of a clinical trial but has not yet been approved for general use by the FDA and remains under investigation in an FDA-approved clinical trial.

Colorado defines an “eligible patient” as a person who has documentation from his or her physician that he or she meets the following requirements:

  • Has a terminal illness, defined as a disease that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely, as attested to by the patient’s treating physician;
  • Considered all other treatment options currently approved by the FDA;
  • Has been unable to participate in a clinical trial for the terminal illness within 100 miles of the patient’s home or has not been accepted to the clinical trial within one week of completing the clinical trial application process;
  • Has received a recommendation from his or her physician for an investigational drug, biological product, or device; and
  • Has given written, informed consent or if a minor or lacks capacity, a parent or legal guardian has given written, informed consent.

Colorado has specific requirements for written, informed consent to receive investigational drugs, biological products, or devices. Informed consent must be contained in a written document signed by the patient and attested to by the patient’s physician and a witness. At a minimum, the informed consent must contain the following:

  • An explanation of the currently approved products and treatments for the disease or condition from which the patient suffers;
  • An attestation that the patient concurs with his or her physician that all currently approved and conventionally recognized treatments are unlikely to prolong the patient’s life;
  • A clear identification of the specific proposed investigational drug, biological product, or device that the patient want to use;
  • A description of the potentially best and worst outcomes of using the investigational drug, biological product, or device, including a realistic description of the most likely outcome and the possibility that new, unanticipated, different or worse symptoms might result and that death could be hastened, based on the physician’s knowledge of the proposed treatment in conjunction with an awareness of the patient’s condition;
  • A clear statement that the patient’s health insurer and provider are not obligated to pay for any care or treatments as a consequence of the investigational drug, biological product, or device;
  • A clear statement that the patient’s eligibility for hospice care may be withdrawn if the patient begins curative treatment but that hospice may be reinstated if the curative treatment ends and the patient meets hospice criteria;
  • A clear statement that in-home health care may be denied if treatment begins; and
  • A statement that the patient understands that he or she is liable for all expenses as a consequence of using the investigational drug, biological product or device, and that this liability extends to the patient’s estate, unless a contract between the patient and the manufacturer state otherwise.

Finally, there are several other interesting provisions in Colorado’s law. The law prohibits a licensing board from revoking, failing to renew, suspending, or taking any action against a health care provider’s license based solely on the provider’s recommendation to an eligible patient concerning access to or treatment with an investigational drug, biologic product, or device as long as the advice is consistent with medical standards of care. In addition, the law clarifies that the Colorado statute does not create a private cause of action unless there was a failure to exercise “reasonable care.” Thus, the statute does not grant immunity to a manufacturer or any person or entity involved in the care of an eligible patient from a negligence lawsuit.

While the “right to try” laws codify that the state will not interfere with a terminally ill patient’s access to experimental treatments, the laws cannot eliminate the FDA’s authority to regulate these treatments. To date, the FDA has not taken an official position on state right to try laws. However, the FDA recently decided to streamline the process for patients to obtain access to unapproved investigational drugs. On February 4, 2015, the FDA released a draft guidance that when finalized is intended to streamline the individual patient expanded access application process. In addition, there is a provision that would allow emergency expanded access for an individual patient by allowing an FDA official to give authorization for emergency use over the telephone.

It is likely that there will be new developments in right to try legislation as the year progresses. Health care providers and drug manufacturers should pay attention to these developments, particularly the FDA’s actions.

 

Image courtesy of Flickr by epsos .de

Filed under Experimental Drugs, State Right to Try Laws

CMS Announces Next Generation ACO Model

By on March 23, 2015

The Centers for Medicare and Medicaid Services (CMS) recently announced a new Accountable Care Organization (ACO) model called the Next Generation ACO Model.  The Next Generation ACO Model differs from current Medicare ACO initiatives by offering financial arrangements with higher levels of risk and reward than are available under the current ACO programs.  In addition, the Model has alternative payment mechanisms to enable a transition from fee-for-service to capitation.  According to CMS, the goal of the Next Generation ACO Model is to test whether strong financial incentives for ACOs can improve outcomes and reduce the amount spent on health care for Medicare fee-for-service beneficiaries.

The Next Generation ACO Model has several unique tools to improve engagement with beneficiaries.  These tools include the following:

  1. Enhanced access to home visits, telehealth services, and skilled nursing facilities
  2. Ability to receive a reward payment for receiving care from the ACO
  3. A process allowing beneficiaries a decision in their alignment with ACOs and
  4. Collaboration between CMS and ACOs to inform beneficiaries about the characteristics and potential benefits of ACOs in relation to their care.

CMS expects that 15 to 20 ACOs will participate in the Next Generation ACO Model.  CMS has issued a request for applications outlining specific eligibility criteria.  There will be two rounds of applications in 2015 and 2016.  The deadline to submit a letter of intent in round one is May 1, 2015, with applications due on June 1, 2015.  The round two deadlines are one year later.

Filed under Accountable Care Organization (ACO), Centers for Medicare and Medicaid Services

New Mexico Peer Review Case with Implications in Other States

By on March 16, 2015

In Yedidag v. Roswell Clinic Corp., a case of first impression with implications for hospital peer review in many other states, the New Mexico Supreme Court affirmed an appeals court ruling that a physician who spoke up against another physician at a peer review meeting could sue his hospital-employer for using confidential peer review information to justify his termination.  The court affirmed the jury’s award of compensatory and punitive damages based on its conclusion that the hospital violated New Mexico’s peer review statute, N.M. Code §§ 41-9-1 through 41-9-7, and breached its employment contract with the physician by terminating him based on his conduct at a peer review meeting.

Dr. Yedidag, a physician employed by the hospital, participated in a peer review meeting concerning another physician’s treatment of a patient.  A hospital administrator who was present at the meeting reported that Dr. Yedidag had “verbally attacked” the physician being reviewed.  The hospital subsequently fired Dr. Yedidag for unprofessional conduct.

The court concluded that the New Mexico peer review statute, which contains a provision protecting the confidentiality of peer review records, creates an implied private cause of action.  Because the acquisition and use of confidential peer review information for employee discipline is not a statutorily permissible use of peer review information and Dr. Yedidag’s confidentiality was violated, the court determined that Dr. Yedidag had an implied cause of action against the hospital.

Many states have peer review statutes that are similar to the New Mexico statute by providing for the confidentiality of peer review proceedings.  Thus, in light of the Yedidag decision, hospitals should examine their policies and practices concerning physician discipline in order to maintain the confidentiality of peer review proceedings.

Filed under New Mexico Peer Review Statute, Peer Review

Responding to Medical Record Requests: Changes in Colorado Law Affect Health Care Facilities

By on March 10, 2015

Last year Colorado, like many other states, passed new legislation that affects patient requests for medical records and the fees that may be charged for copies of the medical records.  House Bill 14-1186, codified at C.R.S. § 25-1-801, with related regulations at 6 CCR 1011-1, Ch. 1, Part 5.  The law changes the fees that may be charged for providing copies of records and adds provisions relating to the delivery of records in electronic format.  These provisions apply to medical records in the custody of a broad range of health care facilities (see C.R.S. § 25-1.5-103(1)) , including hospitals, nursing homes, assisted living residences, and hospice.

Colorado law requires that health care facilities make medical records available for inspection by a current patient or the patient’s personal representative at reasonable times and upon reasonable notice, except for certain records withheld in accordance with 45 § C.F.R. 164.524(a).  A reasonable time for inspection should normally not exceed 24 hours from the date of the request (excluding weekends and holidays) for an inpatient or current resident.  The patient or designated representative may not be charged for inspecting the records.

With regard to a discharged patient or resident, a health care facility must make a copy of the record available or make the record available for inspection within a reasonable time from the date of the signed request, normally not to exceed ten days, excluding weekends and holidays.  However, if the health care provider or designated representative is not available to acknowledge the request, the facility shall inform the patient of the situation and provide the records as soon as possible.  Discharged patients or their representatives cannot be charged for inspecting patient records.

Health care facilities should be aware of certain provisions of Colorado law relating to electronic records and films.  Medical records must be delivered in electronic format if the records are requested in electronic format, they are stored in electronic format, and are readily producible in electronic format.  Finally, a health care facility must release the original film if a licensed health care professional determines that a copy is not sufficient for diagnostic or other treatment purposes.

The amount that may be charged for medical records varies, depending upon the requesting party.  When a patient or a personal representative requests a copy of medical records, the fees are set in accordance with HIPAA.  Under HIPAA, a covered entity may charge a patient or a personal representative a reasonable, cost-based fee for providing a copy of medical records; this fee may encompass the cost of copying (including the cost of supplies for and labor of copying) and postage.  However, health care facilities may charge third parties fees that are established under state law.  Thus, the HIPAA fee limitations do not apply  when records are released under other HIPAA-compliant situations, such as requests that are based on an individual’s authorization.

Colorado law establishes the following reasonable fees that a health care facility may charge a third party.  The fees may not exceed the following:

  • For the first ten pages:  $18.53
  • For the next thirty pages (pages 11 through 40):  85 cents per page
  • Each additional page after page 40 :  57 cents per page (all records except those stored on microfilm) or $1.50 per page (records stored on microfilm)
  • Actual reproduction costs for each copy of a radiograph
  • Certification of medical records, if requested:  $10.00 fee
  • Actual postage and electronic media costs if applicable
  • Applicable taxes

Under certain circumstances, third parties may not be required to pay any fees or a different fee schedule may apply.  If a patient record is requested under the Laura Hershey Disability-Benefit Support Act, C.R.S. §§ 24-30-2201 through 2207, the third party may obtain one free copy of the record for the application process or for an appeal or reapplication when required by the disability benefits administrator.  Where a statute or rule for a state or local government entity establishes maximum rates, these rates prevail.  Finally, the statutory fee schedule does not apply to coroners requesting medical records.

Health care facilities should review their policies on releasing and charging for copies of medical records to ensure that they are in compliance with recent changes in Colorado law.

Filed under Health Care Facilities, HIPAA, Medical Record Requests

A Lot of Home Health Business? That’s a Lot of Home Health Claims for Medicare and Medicaid to Suspend

By on March 3, 2015

I’ve been thinking a good bit about home health care lately.  A lot of that is the concerted effort in the Affordable Care Act to promote home health in lieu of placement in a skilled nursing facility.  It seems like every other long term care provider out there – including most of the big ones – is trying to expand its home health presence as quickly as possible.  Some of that may be my recent experience with my grandmother’s end-of-life care over the past six or seven months, which was spent in a skilled nursing facility (first), an assisted living facility (second), and at her home receiving home-based hospice care (last).  Her last few weeks at home left me with a positive impression of home health care.

Anyway, I hate to be a stick in the mud, but one thing does concern me.  As this blog shows, I write a lot about Medicaid fraud-based temporary suspensions.  The same remedy (technically suspension, effectively termination) exists under Medicare.  As that regulation and Medicaid counterpart show, it’s a broad power.  The applicable federal or state agency need only show a “credible allegation of fraud,” at which point it can withhold all payments owed to the provider – including those that have nothing to do with the alleged fraud, and even when the provider can show that the vast majority of claims are legitimate.  Indeed, after the ACA, federal and state regulators are now told that they must have good cause to release any of the owed claims, and they can only do so under a limited set of circumstances.  As one colleague recently put it to me, “temporary suspension” is really code for “lazy man’s termination.”

So what does that have to do with home health care?  Regulators have long recognized that home health care carries an increased risk of fraud.  It makes sense, of course.  There is no direct supervision when a home health caregiver provides care in the home of a recipient.  Usually, the only way to know what the caregiver did, and for how long, is the say so of the caregiver and the recipient.  The opportunity for collusion is more-or-less unchecked.  Add in lower level managers responsible for scheduling and supervising the caregiver (inasmuch as supervision is possible), and it becomes very difficult to police fraud.  And indeed, from 2010 to 2014, OIG has identified over one billion dollars associated with fraudulent home health claims – and that’s without looking.  The real amount likely is a multiple of that.

That should cast the rapid expansion of the home health care industry in an ominous light.  The sorts of institutional providers looking to increase their home health presence quickly undoubtedly will be able to garner a large share of the market quickly.  And that’s a good thing for the most part.  But a lot of business means a lot of opportunities for fraud.  It’s a lot of caregivers, a lot of lower level managers, and a lot of recipients – which means a lot of risk that some small number of them might (for example) collude to record care for services not provided, and then split the proceeds.

And remember from above, if federal or state regulators believe that they have any credible allegation of fraud, they can suspend all payments owed to the company, not just those associated with the fraud.  Ouch.  Now, is it realistic that regulators would step in and turn the revenue spigot off entirely for a company providing home health services to thousands or even tens of thousands of recipients?  Probably not – at least not without a back-up provider lined up to step in.  But it’s certainly a lot of leverage on the part of Medicare and Medicaid, and there’s a strong likelihood that regulators might use that leverage to pressure institutional providers into favorable settlements (both financially and in terms of a going-forward corrective action plan).

So how should companies aspiring to a big share of the home health market protect themselves in such a perilous area?  That’s something I intend to address in the next few posts.

Filed under Affordable Care Act, Home Health Care, Medicaid, Medicare