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NewsOK Q&A: FBI warns against doctors, dentists using ‘anonymous mode’ computer servers

From NewsOK / by Paula Burkes
Published: April 12, 2017
Click to see full story – FBI warns against doctors, dentists using ‘anonymous mode’ computer servers

Click to see Mary Holloway Richard’s attorney profile

Mary 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.

Q: What attention has the FBI recently given to protect Protected Health Information (“PHI”) from cyber criminals?

A: Under a “Private Industry Notification” dated March 22, the FBI’s Cyber Division has provided guidance that’s applicable specifically to medical and dental providers and focuses on protection of sensitive, identifiable health information.

Q: What does the notice specifically recommend?

A: The notification recommends these health care providers request that their IT services personnel take steps to further secure the information from cyber threats by checking networks for File Transfer Protocol (“FTP”) servers running in anonymous mode. FTPs routinely are used to transport information between network hosts. This is the case, for example, when a covered entity such as a hospital or group practice transfers information to a business associate, such as a billing company or a third-party payer, for the purpose of submitting claims for services provided.

Q: What does “anonymous mode” mean and what threat does it represent?

A: “Anonymous mode” refers to the situation where an FTP server can be structured to permit users who are anonymous, doesn’t require a password to enter, and accepts common user names such as “anonymous” or “FTP.” The danger is that, in such circumstances, sensitive patient information stored on a server could be accessed with little or no security.

Q: Why does the FBI guidance focus specifically on health care?

A: Research conducted at the University of Michigan in 2015 resulted in a finding that more than one million FTP servers would allow such access. According to the FBI, some computer security researchers seek servers in anonymous mode as part of legitimate research, but others make such connections to facilitate nefarious activities such as launching cyber attacks, hacking, blackmailing, harassing and intimidating business owners. It’s the FBI’s purpose issuing this new guidance to both make health care business aware of the risks represented in their IT systems and to shore up weaknesses that pose cyber security risks. In addition to the precautions urged in the notice, the FBI has previously urged companies to buy and implement ransomware defense software.

Q: Should additional actions be taken by medical and dental health care entities to provide additional protections against cyber crime?

A: The FBI encourages medical and dental health care entities to report suspicious or criminal activity to the local FBI field office (locate via www.fbi.gov/contact-us/field) or the FBI’s 24/7 Cyber Watch, CyWatch 855-292-3937 or CyWatch@ic.fbi.gov. Submitted reports must include available information regarding the date, time, location, type of activity, number of people and type of equipment used for the activity, the name and contact person for the entity submitting the report. Victim complaints can be filed with the internet Crime Complaint Center at www.ic3.gov.

 

NewsOK Q&A: Advance directives provide care guidance for end of life

From NewsOK / by Paula Burkes
Published: April 28, 2016
Click to see full story – Advance directives provide care guidance for end of life

Click to see Mary Holloway Richard’s attorney profile

Mary 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.

Mary 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.

Q: What should we know about decision-making in the future to care for ourselves?

A: The mechanism for providing guidance to your health care professionals and to your family at the end of your life is a legal document known as an “advance directive.” The process of completing your advance directive is an important one because it makes you think about yourself in various end-of-life situations. You are telling your providers, in advance, what you will allow them to do, to the extent possible.

Q: Is there a specific form for an advance directive in Oklahoma?

A: Advance Directive forms are available at the Oklahoma Bar Association at www.okbar.org/Portals/14/PDF/Brochures/advance-directive-form.pdf. The advance directive statute requires that you must be 18 or older, of sound mind, and have two witnesses 18 or older and who aren’t beneficiaries of your will. The advance directive needn’t be notarized. It’s effective when your health state is such that your physician and another physician conclude that you no longer are able to make your own health care decisions.

Q: What kinds of provisions can I make for myself with an advance directive?

A: Advance directives provide treatment and care directions for three different conditions. You can provide directions to your providers when your condition is determined to be terminal. A terminal condition is one which, in your physician’s opinion, will result in your death within six months. You also can provide directions about your care when you’re persistently unconscious, which means that your condition is irreversible and you aren’t aware of your environment or of yourself. You also can provide your wishes for your care when you’re in an end-stage condition or an irreversible condition, and medical care would be ineffective. An advance directive also gives you the option of directing future artificially-administered food and water if you’re unable to take those by mouth in the three conditions described. You also can provide for organ donation in the advance directive.

Q: What else should I know about advance directives?

A: These decisions aren’t easy and it’s helpful if you involve your family in your decision-making so that they understand your wishes. Second, keep copies of your advance directives in a number of places and let your family members and loved ones know where they are so that guidance will be readily accessible when needed. Finally, under Oklahoma law, an advance directive for mental health also is available.

Q: Is there a specific form for the advance directive for mental health?

A: The Oklahoma Advance Directive for Mental Health form is found in our Oklahoma statutes, Title 43A Section 11-106. This advance directive allows you to provide for an alternate decision-maker for your mental health treatment. For the seriously mentally ill, this is important in terms of facilitating care when needed, at moments of crises. The advance directive on mental health becomes effective if the attending physician or psychologist determines that the ability to receive and evaluate information and to communicate decisions is impaired so that one lacks the capacity to refuse or consent to mental health treatment. “Capacity” is a determination made by the health care provider.

NewsOK Q&A: New health measures will require baseline screenings

From NewsOK / by Paula Burkes
Published: February 18, 2016
Click to see full story – New health measures will require baseline screenings, more data

Click to see Mary Holloway Richard’s attorney profile

Mary 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.

Mary 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.

Q: The Centers for Medicare and Medicaid Services (CMS) released core quality measures for physicians on Feb. 15. What does this mean for physicians and for patients?

A: Physicians currently are required to report multiple quality measures to a variety of entities, and this has been confusing for providers and difficult to report effectively. The quality measures, spearheaded for some time now by federal health care reimbursement programs and by commercial insurers, are being used to standardize care and to establish baseline performance for providers they reimburse for services provided to their beneficiaries. These measures are seen as a cost containment initiative and a way to facilitate provision of baseline quality services. It’s also envisioned as an opportunity to empower consumers to become informed decision-makers.

Q: How were these quality measures established?

A: CMS and America’s Health Insurance Plans came together, along with consumer groups, national physician organizations and employers, to form the Core Quality Measure Collaborative. The seven sets of core measures include: accountable care organizations, patient-centered medical homes and primary care; cardiology; gastroenterology; HIV and hepatitis C; medical oncology; obstetrics and gynecology; and orthopedics. CMS currently is using measures from each of these core sets. An example of a core measure for primary care (family practice) is control of high blood pressure by first obtaining a core set of data about the patient. Another primary care example for comprehensive diabetic care is performance of an eye exam.

Q: Does CMS intend to establish core measures for other medical practice “sets”?

A: The CMS news release of the Collaboration’s Core Quality Measures appears to be a single step in a process that will result in future proposed rules in additional clinical areas. Presumably CMS has stated that it will continue to engage in a multi-stakeholder collaboration including additional notice and public comment rulemaking. CMS isn’t newly committed to applying outcome metrics to payments for physicians and other providers. In fact, it’s not unusual for hospitals and other institutional providers to include baseline quality and performance metrics as a prerequisite to salary or bonus compensation in physician employment and other agreements.

Q: Are these additional regulations a win for Medicare, commercial insurers, physicians, patients?

A: The announcement of these regulations is thought to signal successful progress by Medicare and commercial insurers toward value-based purchasing. This is an effort to make the federal and private health care dollars go farther. Part of the federal health care agenda is based upon recouping financial savings by enabling a healthier population. For physicians, although this may initially seem like another layer of regulations tied to reimbursement, the standardized core measures are likely to simplify patient data the information that must be maintained and provided. For patients, although quality improvement is entirely positive, the logical extension of the efforts of the collaboration is to standardize care that will covered by these federal and commercial insurance programs. It’s possible that it will improve services provided to some patients while limiting that available to others.

Attorney Mary Holloway Richard moderates webcast for OBA

Mary 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.

Mary 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.

Phillips Murrah Health Care Attorney Mary Holloway Richard hosted a webcast October 28 for the Health Law Section of the Oklahoma Bar Association.

“The presentation is entitled ‘Representing Vulnerable Populations: Behavioral Health Patients and Families,’ Richard said. “The webcast covers psychiatric diagnoses, emergency detention and involuntary admissions, confidentiality of information and other topics which will be useful to attorneys across the state called upon to represent behavioral health patients and their families.”

Richard served as moderator and presenter along with Judge Don Andrews, District Judge Oklahoma County formerly assigned to the Mental Health docket; Dr. Britta Ostermeyer, chairman Department of Psychiatry at the University of Oklahoma College of Medicine; and Dewayne Moore, general counsel of the Oklahoma Department of Mental Health and Substance Abuse Services.

The presentation was offered for Continuing Legal Education credit and will be made available by the OBA here.

 

NewsOK Q&A: E-players enter health market

From NewsOK / by Paula Burkes
Published: August 19, 2015
Click to see full story – E-players enter health market

Click to see Mary Holloway Richard’s attorney profile

Consumers can search for doctors and clinical experts on a new product of Google called “Helpouts.” The trial is limited to symptoms related to common conditions or diagnoses and a wide range of pediatric concerns.

Mary 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.

Mary 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.

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.

 

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

From NewsOK / by Paula Burkes
Published: August 11, 2015
Click to see full story – Law also applies to dentists, podiatrists, optometrists and chiropractors

Click to see Mary Holloway Richard’s attorney profile

Physicians should review federal Open Payments database

Mary 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.

Mary 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.

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.

Attorney Mary Holloway Richard sourced in CARE Act article

Mary 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.

Mary 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.

Phillips Murrah 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.

 

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

From NewsOK / by Paula Burkes
Published: July 24, 2015
Click to see full story – Americans with Disabilities Act cites only dogs as service animals

Click to see Mary Holloway Richard’s attorney profile

Federal law has a narrow definition of what animals can be considered service animals under the Americans with Disabilities Act.

Mary 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.

Mary 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.

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.

NewsOK Q&A: Health care providers can use Oklahoma’s unclaimed property fund to collect on unpaid bills

From NewsOK / by Paula Burkes
Published: June 3, 2015
Click to see full story – Health care providers can use Oklahoma’s unclaimed property fund to collect on unpaid bills

Click to see Gretchen M. Latham’s attorney profile

Gretchen Latham, a litigator at Phillips Murrah law firm, talks about how physicians can recoup payment by making a claim to the state treasurer for unclaimed property.

Gretchen M. Latham’s practice focuses on representing creditors in foreclosure, bankruptcy, collection and replevin cases.

Gretchen M. Latham’s practice focuses on representing creditors in foreclosure, bankruptcy, collection and replevin cases.

Q: I understand it’s becoming increasingly difficult for health care providers to collect fees from patients and third-party payers for services rendered. What can they do?

A: Collection of these monies through the judicial system involves the filing of a lawsuit, and often times strict compliance with collection and privacy laws. And the time frame within which any significant collection activity takes place can be months or even years. Luckily, physicians, and nearly everyone, can make a claim with the state’s Unclaimed Property Fund to recoup funds in certain circumstances.

Q: What is unclaimed property?

A: Unclaimed property consists of obligations and liabilities for businesses which have been inactive, or have not been paid for a period of time. The funds may be in the form of a security deposit, an overpayment on an account, collateral pledged as security on a loan, payroll and wage obligations, or stocks and bonds.

Q: How does property attain unclaimed status?

A: When the rightful owner of the property fails to contact the holder of the property for a specified period of time, the property is considered unclaimed. A typical example is when an employee leaves his or her job prior to receiving the last paycheck, and there’s no forwarding address for the employer’s use in mailing final payment. Upon showing proof of ownership and making a valid claim, the state will relinquish the property to its rightful owner.

Q: How does the state come into possession of unclaimed property?

A: Holders of unclaimed property are required by law to make an annual report of the property being held. After the holder makes a diligent effort to contact the rightful owner both within and outside the state’s borders without success, the holder is then required to deliver the unclaimed property to the state treasurer.

Q: Can physicians and other providers rely on this claim process for more than clinic visit charges?

A: In the medical field, making a claim for unclaimed property can help physicians recover funds due them for a variety of reasons. Perhaps the practice has been sold and not all the funds due as part of the transaction have been paid. Although there’s no time limit on claiming the provider’s property, the sooner the claim is made, the sooner he or she will get paid.

Regulation focuses on financial ties between physicians and industry

Phillips Murrah 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.

NewsOK Q&A: Laptop losses, misdirected faxes and phishing scams can lead to health information breaches

From NewsOK / by Paula Burkes
Published: May 1, 2015
Click to see full story – Laptop losses, misdirected faxes and phishing scams can lead to health information breaches

Click to see Mary Holloway Richard’s attorney profile

Phillips Murrah’s Mary Holloway Richard provides medical providers tips for minimizing risk and damages related to health information breaches.

Mary 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.

Mary 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.

Q: What do you recommend to hospitals, physicians and other providers to minimize the risk of a breach of confidential patient information and to lessen the degree of harm in the event of a breach?

A: I recommend creation in advance of a response process to enable a rapid, sensible response. The goals in such a plan (“Incident Response Plan” or “IRP”) are to demonstrate compliance with HIPAA (Health Insurance Portability and Accountability Act) and HITECH (Health Information Technology for Economic and Clinical Health) regulations and to mitigate any harm that may result from the breach.

Q: What specific steps should be taken to prepare for a breach?

A: The first step is to create an IRP that includes all appropriate parties and to appoint someone in the practice or facility who is knowledgeable about HIPAA and HITECH requirements. The second step is to make certain that the process created is a quick, sensible one. In addition, information technology (IT) components, such as encryption throughout the process, are imperative. The safe harbor provision of the breach notification rule establishes a certain standard of encryption and relieves the provider from breach notification responsibilities if the protected patient information has been properly encrypted. Most breaches result from lost IT assets such as phones, laptops and iPads. Fourth, the IRP must be supported by sufficient employee and staff training. I also recommend that you adequately document that this training took place. Finally, insurance should be in place to provide for risk transfer as needed. Cyberliability is a continually developing area along with a range of products that foresee types of breaches and predict costs that may be incurred.

Q: How do such losses occur?

A: Along with loss of IT assets, misdirected faxes, disposal of nonshredded records, inappropriate disposal or destruction of paper, such as placing material in a dumpster without shredding and mailing patient information to incorrect address. Intentional loss or compromise of data can occur through a combination of IT and social engineering, such as where a person is tricked into clicking on a hyperlink or revealing a password. This occurs with Spear phishing or false emails inserting malware in a system and is very difficult to control. In the case of Cryptolocker, the perpetrator makes a threat and requires payment to restore prevention. This also is called ransomware and can make the system and information completely inaccessible to everyone in your organization, effectively stymieing patient care and business operations.

Affordable Care Act changes affect physicians

Gavel to Gavel, appears in The Journal Record.
Originally published in The Journal Record on Apr. 22, 2015.
View G. Calvin Sharpe’s attorney profile here.


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G. Calvin Sharpe is a trial attorney who represents a diverse list of business clients in matters relating to medical malpractice, medical devices, medical licensure boards,products liability, insurance and commercial litigation.

The Affordable Care Act brought fundamental changes to the American health care system.

One called evidenced-based care significantly affects how physicians are paid. I’ve represented many providers in malpractice actions and before professional licensure boards, but now I must also be as proficient in regulatory law.

The ACA’s value-based care replaces traditional fee for service. In the traditional model, a patient visit is followed by a bill paid by the patient or insurer, and providers are rewarded for a higher-volume practice. One of the stated goals of the ACA is to eliminate care and decision making that could be financially motivated.

The value-based pay-for-performance compensation model that reimburses physicians based upon achievement of measurable objectives or metrics is replacing that traditional model. Evidenced-based guidelines focus on outcomes and will seek to eliminate unnecessary procedures, and compensation will be based upon performance.

Examples would be patient readmission following hospital discharge and so-called never events, defined by the National Quality Form’s list of Serious Reportable Events as events that should never have happened.

Changes in evidenced-based care practice guidelines and how medical malpractice claims are brought generally attempt to measure a provider’s performance against a legal standard. This means the performance is evaluated according to that of a prudent professional in the same or similar circumstances.

Read the entire column here.

Resolution of the “sustainable growth rate” issue

By Mary Holloway Richard.  View her attorney profile here.


medicare

Senate Passes the bill repealing Medicare’s sustainable growth rate (“SGR”) formula just in time to avoid the looming cuts (21%) to physician payments.

(See HERE our ongoing coverage leading up to this.)

Congressional members are purportedly patting themselves on the back as the bill goes to the President who has given assurances that he will sign it.

In the past weeks we have discussed possible amendments, but none of the amendments are included in the final legislation approved by the Senate.  The bill extends the Children’s Health Insurance Program (“CHIP”) for two years.  The bill also provides physician incentives sure to impact both reimbursement and physician contracting include incentives to shift more patients to risk-based payment models.  For physicians who are successful in this effort, as interpreted by CMS, the reimbursement will increase in 2019.

Approximately one-third of the cost of this package is offset by financial cuts to providers and increased costs to wealthier Medicare patients.  The bill also includes additional funding for community health centers and a six-month delay in the enforcement of the payment policy for short inpatient stays known as the “two midnights” rule.

Mary Holloway Richard is recognized as one of the 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.

(UPDATE) What does all of the talk in the media about the “SGR” mean for physicians?

By Mary Holloway Richard. View her attorney profile here.


Mary 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.

Mary 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.

(Updated 4/14/15)

What does all of the talk in the media about the “SGR” mean for physicians?

One of the important issues identified in the health care industry “crisis” and reform is the cost of providing services.  Focus has been on shifting payment from charges for visits and procedures to reimbursement according to certain metrics such as outcome and quality.  In addition, a ceiling on physician reimbursement has been much debated.  The Affordable Care Act (“ACA”) included the Medicare sustainable growth rate (“SGR”) formula for doing just that, although the SGR was actually created as part of the 1997 deficit reduction law designed to contain federal spending  by tying physician payments to an economic metric or growth target.

On Tuesday, March 24, 2015, Democrats and Republicans revealed the result of their negotiation and cooperation to offer an alternative to Medicare’s SGR formula.  The proposal calls for repeal of the SGR formula.  House Speaker John Boehner (R-OH) and Minority Leader Nancy Pelosi (D-CA) have arrived at this compromise to strengthen the financial picture for Medicare and to end the continuing threat of payment cuts to physicians.  According to the Association of American Medical Colleges, although medical school applications are up slightly since 2011, the United States faces a physician shortage of between 46,000 and 90,000 by 2015.  www.aamc.org/newsroom/aamcstat/,a=427828.  The economic incentives to the professional are an integral component in stabilizing the health care system in this country.  The House overwhelmingly approved the proposal on Thursday, March 26, 2015.

What does the SGR mean to physicians?  There is still great divergence between the Boehner (repeal Washington’s most famous gimmick) and Pelosi (Medicare payments for doctor services to seniors facilitating continuation of physician-patient relationship) perspectives.

What does the bipartisan proposal mean to physicians?  This will halt the cut that was to be implemented on April 1, 2015.  When the ACA was signed five years ago, that seemed like a long time away but was nonetheless worrisome.  It puts in place a 21.2% reduction in Medicare payments making it virtually impossible for many providers to support the operations of their practices or clinics.

This proposal is very similar to the one proposed in 2014 , and it includes a system of rewarding physicians based upon quality standards rather than output or number of services provided and fosters a focus on coordination of care, prevention and quality and key cost containment strategies.  All of these elements are part of a new accountability that is the cornerstone for allowing payment increases for doctors for the next five years during this period of transition.  In addition, if approved by the Senate, the bipartisan proposal would extend the Children’s Health Insurance Program (“CHIP”) with full funding through September 30, 2017.  It also provides for $7.2 billion funding for community health centers.  The cost of the House package is $200 billion

On Friday, March 27, 2015, the Senate adjourned without approving the Doc fix.  It apparently will take up the issue upon its return in mid-April.  In the meantime, CMS is poised to delay processing provider claims as of April 1, 2015, when the 21.2% cut was to go into effect.  However, CMS is warning that the cut will go into effect if the Senate fails to pass an SGR fix by April 15.  One complication may exist in the form of legislation introduced by a bipartisan Senate team, Senators Cardin (D-MD) and Collins (R-ME), to permanently repeal the caps on how much the program spends on rehabilitation therapy.  This unresolved issue may arise as an amendment to the legislation to be considered after the break and provides a reminder of how single issues or senators can ultimately frustrate the passage of legislation that has support from both parties.  Others in the Senate are critical that spending cuts will offset only a portion of the costs.  Conservatives have characterized this element of the plan as irresponsible.  The AARP is focused on increased costs to Medicare beneficiaries and will continue to lobby for changes to lower these costs.

Democrats may want amendments to extend the CHIP program four years, to remove the Hyde Amendment (abortion-related language), and to repeal the Medicare therapy cap.  Any amendments would, of course, send the legislation back through the House, and this appears to be an unattractive alternative to all concerned because of the remarkable support for this resolution from both parties.  A perhaps more significant complication is presented by the report issued last week by the Office of the Actuary of the Centers for Medicare and Medicaid Services (CMS) indicating that physician payments in which the 0.5% increases in Medicare payments over the next four years would come to a halt in 2020.  In that year a two-tiered system is phased in which is designed to encourage physicians to shift greater numbers of patients into risk-based models.  For physicians continuing to work within the traditional payment system, but who are scoring well on the quality metrics, remuneration will be awarded from a separate appropriation.  After 2024, the alternative payment track would increase annually by 0.75% which will be three times greater than the rates of other physicians. CMS is predicting that 2024 is the time when there will be a shortfall and payments will lag behind inflation.

On the one hand, Congress is fed up with required annual intervention for the past seventeen years to avoid scheduled cuts to physicians.  On the other hand, Congress is forced to rely on estimates to predict costs which places the federal government at risk of future payments not keeping up with the either the chosen formulae or with inflation.

Best, worst states to be a doctor

South Carolina tops the list, Rhode Island finishes lastshutterstock_156022646

WalletHub released its list of the best and worst states for physicians based on several metrics, including wages and job opportunities.

For the report, all of the states and Washington, D.C., were rated on 12 metrics sorted into two categories:

  • Environment, or risks of the job, such as state medical board penalties, malpractice payouts, and costs of malpractice insurance; and
  • Job opportunity and competition.

Data for the report were taken from Citizen.org, Diederich Healthcare, HHS, the Missouri Economic Research & Information Center, the U.S. Bureau of Labor Statistics, and the U.S. Census Bureau.

Based on those categories, WalletHub identified the five best states for doctors as:

      1. South Carolina
      2. Minnesota
      3. Texas
      4. Mississippi
      5. Kansas

Meanwhile, the five worst states for doctors were:

      1. Rhode Island
      2. New Jersey
      3. Oregon
      4. New York
      5. Maine

View on Advisory.com.

 

SCOTUS reverses lower court decision, Medicaid providers can’t bring injunction against Idaho officials

scotus_shutterstock_104498510

United States Supreme Court Building

SCOTUS reverses a lower court decision in Armstrong v. Exceptional Child Center, Inc.:

Idaho residential care facilities sued the state for failure to implement higher reimbursement rates required by Medicaid which the Idaho legislature had not sufficiently funded.  The federal district court and the Ninth Circuit Court of Appeals sided with the facilities ruling that Idaho’s Medicaid rates were insufficient to support the federal requirements that payments had to be at such a level to provide for quality care and adequate access to services.  In Armstrong v. Exceptional Child Center Inc., the United States Supreme Court reversed the lower court ruling and held that the Supremacy Clause does not confer a private right of action and so Medicaid providers cannot sue for an injunction requiring the state to comply with the reimbursement rate provision of the federal Medicaid Act.  42 U.S.C. §1396a(a)(30)(A)

View on SCOTUSBLOG

NewsOK Q&A: Health care data hacking likely to require new state laws

From NewsOK / by Paula Burkes
Published: March 9, 2015
Click to see full story – Across the U.S., more state laws are likely for mandated encryption of health data

Phillips Murrah’s Joshua Edwards discusses health care data hacking

Hacking may bring more state laws, encryption of health data

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Josh Edwards is a Director at Phillips Murrah law firm.

Q: How serious of a problem are health care data hacks for insurance companies, employer health plans and others in the health care industry?

A: Last month Anthem Inc., the second-largest health insurer in the U.S., announced hackers had stolen personal information, including names, dates of birth, member ID/Social Security numbers, addresses, phone numbers, email addresses and employment information of up to 80 million individuals covered under its health plans. The Anthem breach alone affects one out of every four Americans. This data can be sold on the black market and then used by identity thieves to commit financial crimes, as well as fraudulently obtain medical services and prescriptions. The FBI previously warned insurers and other companies in the health care industry that their data security systems lagged behind those of the financial and retail sectors and that they were particularly susceptible to cyberattacks given the value of such data to cybercriminals.

Q: What federal and state laws govern the security of health care data and a company’s obligations after discovery of a breach?

A: The primary federal law is the Health Insurance Portability and Accountability Act (HIPAA), which was amended in 2009 by the Health Information Technology for Economic and Clinical Health Act specifically to address electronic transmission and storage of protected health information (PHI). HIPAA governs the privacy and security of an individual’s PHI and requires certain kinds of technological safeguards to protect against unauthorized use and disclosure. In addition to HIPAA, earlier this year New Jersey passed a law requiring health insurers to encrypt all electronically-stored personally identifiable information of New Jersey residents, and it seems likely we will see similar laws passed by other states as well. HIPAA also requires a company to notify affected individuals after discovering a breach of PHI. Forty-seven states also have their own breach notification laws, each of which have their own unique content and timing requirements.

Q: How does an insurer’s data breach impact employers who use the insurer for their health plans?

A: Events such as the Anthem breach affect not only the insurer, but also companies that partner with the insurer to provide health coverage to their employees. For companies with a fully-insured health plan, the insurer will be a “covered entity” under HIPAA and have primary responsibility for protection of PHI and compliance with the breach notification requirements. However, for self-insured health plans, an insurer serving as a third-party administrator will be considered a “business associate” under HIPAA, meaning primary responsibility for protecting PHI and notifying affected individuals and government agencies would fall to the employer. Regardless, employers should have a plan to address such concerns and keep employees informed.

Q: What should insurers and employers do upon discovery of a breach of health care data?

A: After a breach, both insurers and employers should review their contracts, including any business associate agreements, to determine their relative responsibilities as well as any indemnification rights and obligations. It’s also essential for both parties to know their duties under HIPAA and state breach notification laws so that compliant and timely notifications can be crafted and delivered to affected individuals and applicable federal and state agencies. Finally, a plan should be implemented for keeping affected individuals informed of the ongoing investigation, as well as strategies for protecting against identity theft and credit monitoring options that may be available.