Tag Archive for: health care

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NewsOK Q&A: E-players enter health market

Published: August 19, 2015
By Mary Holloway Richard

Q: Is Google becoming a provider of health services?

A: One new Google product, “Helpouts,” allows consumers to search for clinical experts and then to video chat with those doctors. This project is in its final stages, and Google is working with some existing medical groups who are verifying the credentials of the doctors who are participating in the trial. The trial is limited to symptoms related to common conditions or diagnoses and a wide range of pediatric concerns. One pediatrician, for example, is available for free consultations with the goal of eliminating gaps created by isolated visits in favor of applied multidisciplinary expertise. Not all of the offerings are related to health care and not all of them are free.

Q: What’s the impetus for this expansion by Google and presumably other technology companies?

A: A consulting company, PWC, has referred to this trend as a move toward “… building a new health economy centered around the consumer.” Stated another way, there are patient needs to be met and patient populations to be built by providers. This is likely to bring new players into local, state and regional health care communities who may position themselves to receive revenue from shrinking health care dollars. For example, Walmart is experimenting with health conglomerate Kaiser Permanente to access physicians via Skype in two of its California locations. Providers who’ve petitioned the Department of Health and Human Services to allow Affordable Care Organizations to be reimbursed for “connect care” argue that it will improve quality and reduce costs. Providers participating in the Medicare Shared Savings Program can’t currently bill for services provided using advanced technology.

Mary Holloway Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

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NewsOK Q&A: Sunshine Act applies to dentists, podiatrists, optometrists and chiropractors

Published: August 11, 2015
By Mary Holloway Richard

Q: The Physicians Payments Sunshine Act (“Sunshine Act”) was passed with the intent of limiting the affect of prescribing and treatment practices by payments to providers by manufacturers or groups involved with product selection known as group purchaser organizations. Does this mean that payments to physicians are actually listed on this website?

A: Yes, but the law doesn’t just apply to physicians. It also applies to dentists, podiatrists, optometrists and chiropractors. It doesn’t apply to medical or osteopathic residents, physician assistant or nurse practitioners. This information is reported annually by manufacturers and purchasing groups and is available to anyone on the Centers for Medicare and Medicaid Services (“CMS”) website https://openpaymentsdata.cms.gov/. The database is part of the Open Payments program created as a result of the Sunshine Act.

Q: What options does a provider have if he or she believes that information about a reported payment is inaccurate or misleading to the public?

A: There is a process by which physicians and other providers can seek to correct information they believe to be false. A dispute resolution process begins with a 45-day period during which a provider reviews and works with manufacturers or purchasing organizations to correct the information. During the following fifteen days, the reporting entity (manufacturer or group purchasing organization) can submit corrections to the Open Payments database. This combined 60-day period is the only time that corrections can be submitted by manufacturers and purchasing organizations. CMS will not mediate such disputes but encourages the parties to work together to resolve their dispute. You can see from this description that it is the physician’s or other provider’s responsibility to monitor this information on the website.  Providers can locate relevant data by their names.

Q: What kinds of payments are included in the CMS Open Payments database?

A: First, it applies to payments by manufacturers. That means manufacturers of prescription drugs, biologic agents and medical devices and supplies. Second, it also applies, as I have mentioned, to groups formed to help providers such as hospitals, home health agencies and nursing homes save money and time by purchasing in volume and obtaining manufacturers’ discounts. These are the group purchasing organizations. Third, it applies to payments such as consulting fees, honoraria, food, travel, entertainment, education, research support, charitable contributions, investment interests, grant, and any direct compensation. That’s not even a complete list.

Q: What is the impact of this database?

A: Many physicians, dentists, podiatrist, optometrists and chiropractors regularly disclose to their patients their participation as lecturers, researchers and consultants to such manufacturers and purchasing organizations. Where that is the case, there is likely to be minimal impact from such information appearing on the CMS website. There a great deal of criticism of the Open Payments program, however. For example, a listing of a specific payment or group of payments may be taken out of context and appear unexplained and create in inaccurate impression and a negative response that is not merited. It seems clear that there will be continued refinement of both the regulations and the manner in which the data is presented to the public in the future.

Mary Holloway Richard is recognized as one of pioneers in health care law in Oklahoma. She has represented institutional and non-institutional providers of health services, as well as patients and their families. She also has significant experience in representing providers in regulatory matters.

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Attorney Mary Holloway Richard sourced in CARE Act article

Attorney Mary Holloway Richard was featured as a source in a Journal Record article by Sarah Terry-Cobo.

The article, titled “Complex prognosis: Hospital group, AARP disagree on CARE Act,” focuses on the 2014 Oklahoma Caregiver Advise, Record, Enable Act and the protections it adds.

From the article:

Mary Holloway Richard, a health care attorney at Phillips Murrah, said the CARE Act doesn’t provide anything fundamentally different for elderly patients than laws in place before it was passed. Though the caregiver designation is different than a legal power of attorney, the patient still must sign a written release before the hospital can give out information to another person, she said.

“You could achieve the same thing if you got a release-from-patient for my best friend or my cousin, and in the discharge note you explain the care plan, and the patient gives you the release,” Richard said.

Read the rest of the Journal Record article here.

 

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NewsOK Q&A: Americans with Disabilities Act cites only dogs as service animals

Published: July 24, 2015

By Mary Holloway Richard

Q: Sunday is the 25th anniversary of the signing of the federal Americans with Disabilities Act (ADA). What animals are currently considered to be service animals?

A: The definition of “service animal” comes from the ADA and includes animals individually trained to perform tasks for individuals with disabilities. As of 2011, Titles II (state and local government services) and III (public accommodations and commercial facilities) of the ADA recognize only dogs as service animals, although there’s a separate provision about mini-horses. In addition to service dogs, there are sensory or social signal dogs, psychiatric service dogs and seizure response dogs.

Q: Is there a difference between a “service animal” and a “therapy animal?” 

A: Service dogs are trained to perform tasks or to do work for people with disabilities such as guiding the blind, alerting the deaf, pulling a wheelchair, reminding a person with a mental health diagnosis to take medications, or protecting a person who is having a seizure. The work must be directly related to the person’s disability. Therapy animals provide supports and comfort to people in many different types of situations.  There seems to be an impression among some members of the public that the service designation includes untrained animals providing comfort to owners of varying degrees of independence. It is generally true that a mental health provider may provide a letter indicating that a “regular” pet provides emotional support as needed by the owner who has a mental health condition or disability, and special training is not required. An  important distinction is that these are working animals and not pets. In my representation of hospitals over the years, I’ve been asked to advise concerning requests for visitation by a broad array of animals including burros, boutique cattle, and cats to serve specifically as therapy or emotional support animals. Some of the relevant case law from other jurisdictions involves monkeys and one involves a sugar glider, an Australian
opossum-like creature.

Q: Do these rules apply just to hospitals or do they also apply to other types of facilities and providers of health services?

A: The guidelines for service animals also apply to surgery centers, dental clinics, assisted living and long-term care facilities, and urgent care and outpatient clinics. The federal requirement is to allow service animals to accompany persons with disabilities in all areas of a facility or office where the public is normally allowed to go. It’s my experience that hospitals are better prepared than these other sites listed and physician offices to respond to these requests. Hospitals generally have policies and procedures that mirror state and federal laws and industry best practices.

Q: Are there limits to these ADA requirements?

A: When service dogs raise valid concerns about patient safety and quality of care, all providers in their distinct care settings will find it necessary to balance patient, staff, employee and public safety interests. Common valid concerns for institutional and non-institutional providers include infection control, allergies, animal control, safety of others, disruption of care or ability to safely provide quality services. An example of such a concern is a situation where a service dog’s presence is desired in a health care setting but there’s no one to provide the necessary care for the service dog. I also have encountered service animals with open wounds or otherwise in need of veterinary care that posed risks to patient care and to personnel that had to be considered. Another issue that has arisen is a service dog trained to be protective in a manner that impedes care by staff, such as a dog trained to place itself between the patient and others.

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Regulation focuses on financial ties between physicians and industry

Healthcare attorney, Mary Holloway Richard published an article about the Sunshine Act in the May/June 2015 issue of the Oklahoma County Medical Society publication, The Bulletin.

CMS seeks to mitigate potential impact on prescribing and treatment practices

Sunshine-Act-MHRThe Physicians Payments Sunshine Act (i) (“Sunshine Act”), despite its name, currently places no direct reporting requirements on physicians. Rather, the Sunshine Act requires that certain manufacturers of prescription drugs, biologic agents, medical devices and medical supplies (“Manufacturers”) and group purchasing organizations (“GPOs”) report to Centers for Medicare and Medicaid Services (“CMS”) payments in specified amounts (ii) and other transfers of value to physicians (iii) and to teaching hospitals (iv). In addition, ownership and investment interests in applicable Manufacturers and GPOs held by physicians (and immediate family members) must be reported annually by applicable Manufacturers and GPOs. Covered payments include cash (or cash equivalent, in-kind items or services), stock (including stock options or ownership interest dividend profit or other return on investment), and other forms of payment to be determined in the future by CMS. While it is not the physician’s duty to report, the reporting requirement directly impacts physicians who receive such payments as their names appear on a list on the CMS website accessible by patients and other consumers (v).

The purpose of the Sunshine Act is to identify potential biases in physician prescribing and treatment practices, to reveal conflicts of interest for clinical researchers and educators, and to identify transactions in which payments involving potential referrals by physicians exceed fair market value. The Sunshine Act creates the Open Payments Program for the actual reporting of the financial payments and transfers of value to physicians. Currently the burden is on the Manufacturers to report payments for consulting fees, contracted services, honoraria, gifts, entertainment, food, travel, education, research, charitable contributions, royalty or license, current or prospective ownership or investment interest, grants, direct compensation for serving as faculty or speaking at a medical education program, and any other nature of payment or transfer of value as defined by the Secretary of the Department of Health and Human Services (“HHS.”) The form of the payment and the nature of the payment must be reported. See Table 1 below. Data has been collected since August, 2013, and is due to CMS by March 31 of each year. The first report was available to the public on September 30, 2014, and the 2014 report is predicted to be available on June 30, 2015 (vi).

The regulations provide for a formal dispute resolution process whereby physicians can seek to correct inaccurate information. In September, 2014, representatives of pharmaceutical and biotechnology companies and organized medicine expressed concerns about the database and its presentation of data to the public in a potentially misleading manner. CMS shut down the Open Payments system for a period of time to address these issues. On October 30, 2014, CMS announced a procedure for Manufacturers and GPOs to report information not previously accepted by the system because of data errors, and CMS extended the reporting time accordingly. CMS has provided guides for Manufacturers to use to correct records and for covered recipients to correct information submitted in compliance with the regulations (vii).

Registration with CMS to receive notifications and information submitted by Manufacturers and GPOs is voluntary. This information is now available on the CMS website, to public and regulators alike, but the website itself continues to present issues of accuracy and ease of on-line accessibility. Physicians and teaching hospital representatives have the opportunity to review and, if appropriate, dispute information reported about them in the Open Payments System (viii).

open payments graph

Source: ttps://www.cms.gov/OpenPayments/About/How-Open-Payments-Works.html

It has been necessary to resolve a number of procedural and substantive issues with the reporting requirements including initial confusion about the information that had to be reported and by whom. Example of substantive issues to be resolved may be helpful is understanding the regulatory climate. Some confusion has surrounded the CMS treatment of payments related to continuing medical education. “Direct payments” have always been included in the Sunshine Act’s reporting requirements. “Indirect payments” refers to payments by a manufacturer to a continuing education organization where the Manufacturer directs that the third party provide the payment or transfer to a covered recipient. In the October, 2014, final regulations, CMS responded to widespread criticism of its treatment of the CME by requiring reporting in 2017 payments (direct and indirect) made to continuing education organizations in 2016 as long as the speaker can be identified (ix). Further, payments to physicians for speaking at CME programs need not be reported if the following conditions are met:

  • The CME program meets accreditation/certification standards of one of the following: (1) the Accreditation Council for Continuing Medical Education; (2) the American Academy of Family Physicians ; (3) the American Dental Association’s Continuing Education Recognition Program; (4) the American Medical Association; (5) the American Osteopathic Association; and
  • The Manufacturer or GPO does not pay the speaker directly; and
  • The Manufacturer or GPO does not select the speaker or provide the third party, such as the CME vendor, with a distinct, identifiable set of individuals to be considered as speakers for the CME program (x).

Other frequent questions concern Manufacturers providing meals and other event support and sponsorships to physicians. In this context the Open Payments program is very specific–e.g., where a Manufacturer’s sales representative brings a meal to a staff meeting or a community education event for a number of persons, the cost of the meal is divided by the number of persons who actually eat the meal and this benefit is reported only if it exceeds $10.00 per person. This does not include meals eaten by support staff. Financial support of buffet meals at large-scale medical conferences is not reportable. The “User Guide” for Open Payments published by CMS is over 350 pages long and provides additional guidance to those reporting and those reviewing reports. It is accessible on-line (xi).

The Open Payments System is expected to significantly impact historic financial support of provider, patient and community education by industry. Importantly, these regulations and reporting requirements echo federal policy designed to avoid improper payments and incentives and market influence. These are the same concerns that spawned the expansion of federal antitrust, Stark and Anti-kickback law within health care.

Ms. Richard is a health care lawyer at Phillips Murrah, P.C. in Oklahoma City and was formerly in house counsel with INTEGRIS Health, Inc.

The Natures of Payment that are of Interest to CMS

Nature of payment Definition Examples
Consulting fee Payments made to physicians for advice and expertise on a particular medical product or treatment, typically provided under a written agreement and in response to a particular business need. These payments often vary depending on the experience of the physician being consulted. Example 1: Company A has developed a drug to treat patients with a particular disease and wants advice from physicians on how to design a large study to test the drug on patients. Dr. J has a large number of patients with this disease and has experience doing research on how well medicines work for this condition. Company A asks Dr. J if he would spend about 10 hours per month to work with other physicians to create a new research study. Dr. J agrees and is paid for his time.Example 2: Company C has designed a new tool for surgeons to use when they are doing heart surgery. The company pays some physicians to give the new tool a “test drive” on a computer-simulated patient at the company headquarters. The physicians are paid an hourly fee for their time testing the tool and giving advice on how to make it work better. They are also paid for flights, hotel rooms and meals.
Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program. Payments made to physicians for speaking, training, and education engagements that are not for continuing education. A physician who frequently prescribes a particular drug is invited by the company that makes that drug to talk about the medicine to other physicians at a local restaurant.  The physician is paid for preparation time as well as the time spent giving the talk.
Honoraria Similar to consulting fees, but generally reserved for a one-time, short duration activity. Also distinguishable in that they are generally provided for services which custom prohibits a price from being set. A medical device manufacturer representative goes to a medical meeting and asks some physicians there for an hour of their time to talk about features they would like to see to improve a particular device. This representative pays each physician a one-time honorarium.

Footnotes:

(i) The Physician Payment Sunshine Act is Section 6002 of the Patient Protection and Affordable Care Act, 42 U.S.C.§18001. The regulations can be found at: http://www.cms.gov/OpenPayments/Downloads/Affordable-Care-Act-Section-6002-Final-Rule.pdf.

(ii) There are specific reporting thresholds for applicable manufacturers and GPOs. The Open Payments reporting thresholds are adjusted based on the consumer price index. This means that for 2015 (January 1 – December 31), if a payment or other transfer of value is less than $10.21 ($10.00 for 2013, $10.18 for 2014), unless the aggregate amount transferred to, requested by, or designated on behalf of a physician or teaching hospital exceeds $102.07 in a calendar year ($100.00 for 2013, $101.75 for 2014), it is excluded from the reporting requirements under Open Payments. http://www.cms.gov/OpenPayments/Program-Participants/Applicable-Manufacturers-and-GPOs/Data-Collection.html.

(iii) This law applies to physicians and other providers, but, for the purposes of this article, we will only reference physicians. The other providers as defined in Section 1861(r) of the Social Security Act to whom this law applies include medical and osteopathic physicians, dentists, podiatrists, optometrists and chiropractors. Providers exempted include medical and osteopathic residents, physician assistants, nurse practitioners and allied health practitioners. However, in some circumstances, payments to these types of providers may be imputed to physicians, thereby triggering the Manufacturers’ obligations to report payments.

(iv) Manufacturers and GPOs may also be referred to in this paper as “covered recipients.”

(v) https://openpaymentsdata.cms.gov/.

(vi) http://www.cms.gov/OpenPayments/About/Resources.html

(vii) The American Medical Association offers a toolkit for physicians to use in reviewing and dispute reports at: http://www.ama-assn.org/ama/pub/advocacy/topics/sunshine-act-and-physician-financial-transparency-reports/sunshine-act-toolkit.page?

(viii) See Flow Chart 1 in content.

(ix) 42 C.F.R. §403.902.

(x) 42 C.F.R. §403.904(g).

(xi) www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparenct-Program/Download/Open-Payments-User-Guide-%5BJuly-2014%5D.pdf.

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