What You Need to Know About the Physician Feedback/Value-Based Payment Modifier Program

Via CMS.gov

What?
The Physician Feedback/Value-Based Payment Modifier Program provides comparative performance information to physicians and medical practice groups, as part of Medicare’s efforts to improve the quality and efficiency of medical care.  By providing meaningful and actionable information to physicians so they can improve the care they deliver, CMS is moving toward physician reimbursement that rewards value rather than volume.

The Program (which is specific to Fee-For-Service Medicare—not Medicare Advantage) contains two primary components:

  • The Physician Quality and Resource Use Reports (QRURs, or sometimes referred to as “the Reports”) Select “QRUR Templates…” option from the menu on the left side of the page
  • Development and implementation of a Value-based Payment Modifier (value modifier)

Select “Value-based Payment Modifier” from the options on the left side of the page.

Why? 
This program supports the transformation of Medicare from a passive payer to an active purchaser of higher quality, more efficient health care through the value-based purchasing (VBP) initiative.  Physician feedback reporting was initiated under Section 131 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA), and was expanded by section 3003 of the Affordable Care Act of 2010. The Affordable Care Act directed CMS to provide information to physicians and medical practice groups about the resources used and quality of care provided to their Medicare Fee-For-Service patients, including quantification and comparisons of patterns of resource use/cost among physicians and medical practice groups. Most resource use and quality information in the QRURs is displayed as relative comparisons of performance among similar physicians or groups.  Section 3007 of the Affordable Care Act mandated that, by 2015, CMS begin applying a value modifier under the Medicare Physician Fee Schedule (MPFS).  Both cost and quality data are to be included in calculating payments for physicians. By 2017, the Value-based Payment Modifier is to be applied to all physicians who bill Medicare for services provided under the physician fee schedule.

READ ON

Physicians & Facilities Frustrated in Upcharging Lab Fees

Licensed healthcare providers and facilities (including many drug and alcohol recovery businesses) who enter into arrangements with clinical labs to provide services to their patients and who then wish to charge more for those lab services will be very disappointed to learn about the restrictions under Florida law.

Section 456.054, Florida Statutes prohibits “kickbacks” and reads—

(1) As used in this section, the term “kickback” means a remuneration or payment, by or on behalf of a provider of health care services or items, to any person as an incentive or inducement to refer patients for past or future services or items, when the payment is not tax deductible as an ordinary and necessary expense.

(2) It is unlawful for any health care provider or any provider of health care services to offer, pay, solicit, or receive a kickback, directly or indirectly, overtly or covertly, in cash or in kind, for referring or soliciting patients.

(3) Violations of this section shall be considered patient brokering and shall be punishable as provided in s. 817.505.

The issue involved in a provider or facility charging more for lab services than they were charged by the lab itself is that the prohibition above applies to healthcare providers and “any provider of healthcare services.”  Regulators may find any reduced fee by the lab to constitute a kickback in exchange for a volume of patient referrals.

A related issue has to do with Florida insurance laws that pertain to charging more for an item or service than the provider or facility was charged.  For instance, if Lab 1 charges the provider/facility $10 for lab work, and the provider/facility charges an insurer $20, that can be found to constitute insurance fraud.

The key Florida prohibition, however, is found in the Florida Administrative Code, which reads—

59A-7.037 Rebates Prohibited – Penalties.

(1) No owner, director, administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person either directly or indirectly, shall pay or receive any commission, bonus, kickback, rebate or gratuity or engage in any split fee arrangement in any form whatsoever for the referral of a patient. Any violation of Rule 59A-7.037, F.A.C., by a clinical laboratory or administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person acting on behalf of the clinical laboratory will result in action by the agency under Section 483.221, F.S., up to and including revocation of the license of the clinical laboratory. In the case of any party or individual not licensed by the agency acting in violation of this Rule, a fine not exceeding $1,000 shall be levied and, as applicable, the agency shall recommend that disciplinary action be taken by the entity responsible for licensure of such party or individual.

(2) No licensed practitioner of the healing arts or licensed facility is permitted to add to the price charged by any laboratory except for a service or handling charge representing a cost actually incurred as an item of expense. However, the licensed practitioner or licensed facility is entitled to fair compensation for all professional services rendered. The amount of the service or handling charge, if any, shall be set forth clearly in the bill to the patient.

(3) Each licensed laboratory shall develop a fee schedule for laboratory services which shall be available to the patient, the authorized person requesting the test or agency upon request and shall be subject to subsection 59A-7.037(2), F.A.C.

In this era where healthcare providers and facilities are struggling to hold onto dwindling profit margins, it is understandable why some are considering arrangements with clinical labs.  Still, Florida providers and facilities have to be extremely cautious when entering into such arrangements.

 

Sample Letter for Physicians – Medicare Open Enrollment

letter

Via Marilyn Tavenner,  Acting Administrator, Center for Medicare Services 

It’s picking season – pumpkins, apples, Halloween candy…and a Medicare health or drug plan. Today is the start of Medicare Open Enrollment!

In my work with Medicare, one of the questions people ask me often is which plan is the best one. That’s not something I can answer, because picking a plan is an important and personal decision. Each person has a unique set of priorities. How do you weigh your options? Now’s the time to think about what matters to you, and pick the Medicare plan that meets your needs.

When you sit down to review your Medicare health and drug plan choices this year, keep track of the things you may want in a plan, and pick one that’s right for you. Here are some things to keep in mind while you consider your choices:

Costs

You should look at your current health care costs to find coverage that works with your financial situation. How much are your premiums and deductibles? How much do you pay for hospital stays and doctor visits? Just like with everything else, the lowest-premium health plan option might not be the best choice for you.

Coverage

Are the services you need covered? We know future health care needs can be hard to predict, but changes happen. Maybe your doctor changed your prescriptions this year or you have different health concerns. Make sure you understand what services and benefits you’re likely to use in the coming year and find coverage that meets your needs.

Convenience

Your time is valuable. When comparing plans, make sure you check which doctors and hospitals you’ll be able to use. Where are they located and what are their hours? Check which pharmacies you can use. Can you get prescriptions by mail? Remember that even if you’re happy with your current plan, these answers might change from year to year.

Quality of care

Ask yourself whether you’re truly satisfied with your medical care. Not all health care is created equal, and the doctors, hospitals and facilities you choose can impact your health. Look for plans with a 5‑star performance rating — the right expertise and care may help speed your recovery and improve your outcomes.

It’s worth your time to take a look and compare coverage between now and when Open Enrollment ends on December 7. Use the Medicare Plan Finder to look at all of the health and drug plan options in your area. If you still need help comparing, call 1‑800‑MEDICARE (1‑800‑633‑4227).

Only you know what’s most important to you and your family – that’s why I want to make sure you have all the information you need to make the best decision. Before you consider your Medicare plan options, think about your personal priorities so you can be sure your plan meets your unique needs.

Stay up to date on the latest Medicare news and follow us on Twitter @Medicarego

Medicare Open Enrollment – What Physicians Need to Know

With special thanks to Dr. Brent Schillinger

The open enrollment period for Medicare Advantage plans runs from October 15 through December 7, 2012.  That is precisely the reason why every form of communication—– be it internet, television, radio or your mailbox is loaded with recruitment messages from the big and not so big companies.  Medicare Advantage Plans is the contemporary name given to the old Medicare HMO insurance programs.  The difference is that today the marketing is particularly intense and slick because under current federal legislation, passed several presidential administrations back, the profits for the commercial insurers is huge.  When the first Medicare HMOs appeared on the scene, they were providing care to seniors at an average cost savings (to the federal Medicare budget) of 5% less than traditional Medicare.  Today, they provide care at upwards of 115% of the average cost per patient per year for traditional Medicare.

The plans market themselves to seniors offering more services for less money than a person would have to pay under traditional Medicare.  In most cases there are savings in terms of reduced monthly out of pocket costs.  And there may be extra services I such as a gym membership or a low-priced pair of eyeglasses.  But there are many tradeoffs for patients tradeoffs that are not referenced in the marketing material.  Patients are limited to doctors who are specifically contracted with the plan, specialist referrals are generally rationed, and it may be difficult, should a person desire care in a specific hospital if that facility is not contracted.

Seniors have options. They can choose from many different Medicare Advantage Plans and probably save some money, but they  need to understand that they are giving up many of the choices they have with the other option, keeping traditional Medicare and adding supplemental medical and pharmaceutical insurance. Identified problems include:

  1. Care can cost more than  it would under original Medicare
  2. Private plans may not be stable and may suddenly cease coverage
  3. Members may experience difficulty in getting emergency care
  4. Continuity of care may be broken if the plan drops a provider
  5. Members have to follow plan rules to get covered,
  6. Members are restricted in their choices of doctors, hospitals, and other providers
  7. It can be difficult to get care away from home
  8. The extra benefits offered often turn out to be less than promised.

Physicians will be approached by patients about the confusion in the choice of the Medicare Advantage plans vs. traditional Medicare.  As your patients’ advocate you should become knowledgeable about the different plans so you can give reasonable guidance to your patients.   This would also be a good time to review your contracts and reimbursement schedules as well the ability to obtain authorizations for prescription drugs and specialist referrals.

From an economic point of view, most physicians, in our area who participate in these Medicare Advantage plans receive reimbursements that are substantially lower than traditional Medicare.   Take the United Health Care product for example.  While United is paid by the government upwards of 115% of the average traditional Medicare cost, many specialists receive less than 70% of the normal Medicare allowable.   Some of the Blue Cross plans work with a number of tightly restricted capitated networks so patients may not be able to see the doctor of their choice, individual physicians may not be able to join these restricted networks,  and the same time the reimbursements through the capitated networks are pathetically low, often less than half of the traditional Medicare allowable.

Doctors need to take all of these factors into consideration in order to give their patients good advice.  For additional information and patient resources you can visit www.pbcms.org or email Dr. Schillinger at [email protected].

 

 

Perceived Risk Outweighs Actual Harm in Assessing $1.5M HIPAA Fine

The Office of Civil Rights’ recent assessment of a $1.5 million fine for HIPAA violations should be a shrill wakeup call to all health care organizations that use (or allow their physicians to use) portable devices containing patient identifiable information.  The sanction stems from a physician’s lost laptop computer containing protected health information (ePHI).

Importantly, the OCR’s investigation could not establish whether ePHI was used or even accessed, partly because the device was lost in a foreign country.  However, it was not necessary to definitively conclude if any data had been compromised; the OCR was more concerned that the offending provider had not implemented appropriate measures mandated by the HIPAA Security Rule which could have reduced, mitigated or eliminated the risk altogether.  For the OCR, the heart of the matter was the fact that the covered entity failed to fully assess and evaluate the risk to the confidentiality and security of ePHI on portable devices used by its physicians in their personal activities, and failed to have a process to address when such devices are lost.  In this case, it was the incident itself that caused the organization to formalize and take responsive measures.  The barn door was closed after the horse got out.  To the OCR, the covered entity’s reactive, rather than proactive approach, was totally at odds with HIPAA Security Rule concerns and the mandated obligations of covered entities.

The facts are fairly simple.  A research physician from a Massachusetts specialty hospital facility was traveling to South Korea to give a lecture when he misplaced his backpack in a public area.  A personal laptop, containing health information of several thousand patients, was in the backpack.  The computer was eventually “detected” a few weeks later when it was connected to the internet, and its hard drive was later remotely “wiped”, however, the device was not recovered.  The incident was then reported to the OCR in accordance with the breach notification requirements of the HIPAA Security Rule.

This is an instructive case for a number of reasons.  For one, it is important to recognize that the OCR’s investigation was prompted by the obligatory “breach notification” it received from the provider.  The OCR’s inevitable investigation in turn revealed that there was significant noncompliance with multiple aspects of the Security Rule.  Notably, the OCR determined that the covered entity had lax control over, and little knowledge concerning its own physicians’ use of laptops issued to them by the organization.  Physicians were permitted unfettered access to the entity’s information, took their devices off-site where they were used for personal activities, and could remotely download information and install applications freely to these personal devices.  Further, while the laptop in question was password protected and had “LoJak” tracking and wiping software, encryption was not employed.  Further, many weeks passed before a hard drive wipe was effectuated and only after it was determined that the device had been connected to the internet.  In short, the OCR concluded that the entity had neither conducted an adequate security assessment nor established necessary policies or procedures addressing laptop use, and had not promulgated an appropriate response procedure.  Instead, it reacted to the lost laptop in a scramble of ad hoc activity and only instituted organization-wide changes as a result of this episode.

The most significant issue for the OCR in assessing a $1.5 million fine was not whether the incident caused actual harm to any patient, but the degree of risk of potential harm and whether reasonable steps and safeguards should have been in place to mitigate any data breach.  In short, the entity should have anticipated laptops would be lost and it should have addressed the attendant risks through a deliberate process and in a manner that is “situationally” appropriate for the organization.  Here, the organization abrogated such a duty, thus prompting a fine that may be disproportional to the perceived harm.  This outcome should prompt providers to seriously regard the HIPAA Security Rule, and the OCR’s enforcement efforts, and to abandon any “no harm, no foul” notions they might apply when security breaches occur and must be reported

The Florida Healthcare Law Firm Goes National

Email Announcement

Followers & Friends – BIG Announcement coming out today! If you haven’t seen our new NATIONAL platform, check it out here at www.nationalhealthcarelawfirm.com and stay tuned for our #healthcare #legal news at 2pm EST !!!

Supreme Court upholds Obama health care law

Via @USAToday

The Supreme Court upheld President Obama’s health care law today in a splintered, complex opinion that gives Obama a major election-year victory.

Basically. the justices said that the individual mandate — the requirement that most Americans buy health insurance or pay a fine — is constitutional as a tax.

Chief Justice John Roberts — a conservative appointed by President George W. Bush — provided the key vote to preserve the landmark health care law, which figures to be a major issue in Obama’s re-election bid against Republican opponent Mitt Romney.

The government had argued that Congress had the authority to pass the individual mandate as part of its power to regulate interstate commerce; the court disagreed with that analysis, but preserved the mandate because the fine amounts to a tax that is within Congress’ constitutional taxing powers.

The announcement will have a major impact on the nation’s health care system, the actions of both federal and state governments, and the course of the November presidential and congressional elections.

A key question for the high court: The law’s individual mandate, the requirement that nearly all Americans buy health insurance, or pay a penalty.

Critics call the requirement an unconstitutional overreach by Congress and the Obama administration; supporters say it is necessary to finance the health care plan, and well within the government’s powers under the Commerce Clause of the U.S. Constitution.

While the individual mandate remained 18 months away from implementation, many other provisions already have gone into effect, such as free wellness exams for seniors and allowing children up to age 26 to remain on their parents’ health insurance policies. Some of those provisions are likely to be retained by some insurance companies.

Other impacts will sort themselves out, once the court rules:

— Health care millions of Americans will be affected – coverage for some, premiums for others. Doctors, hospitals, drug makers, insurers, and employers large and small all will feel the impact.

— States — some of which have moved ahead with the health care overhaul while others have held back — now have decisions to make. A deeply divided Congress could decide to re-enter the debate with legislation.

— The presidential race between Obama and Republican challenger Mitt Romney is sure to feel the repercussions. Obama’s health care law has proven to be slightly more unpopular than popular among Americans.

Full Story Here: http://content.usatoday.com/communities/theoval/post/2012/06/Supreme-Court-rules-on-Obama-health-care-plan-718037/1#.T-xqPhd5F9E

June 30th Deadline to e-Prescribe to Avoid Medicare Adjustment Penalty

June 30, 2012 is the deadline for submitting ten (10) Part B Fee for Service (FFS) claims to Medicare to avoid the 2013 Adjustment (penalty) of 1.5% against 2013 reimbursements.

Exception: if a provider submitted 25 e-prescribing events successfully in 2011, they have already met the reporting requirement to avoid the 2013 penalty. Otherwise, this upcoming June 30, 2012 deadline will apply. If you’ve started e-prescribing and are continuing to do so, do not stop at just 10 for this year to avoid the reduced reimbursement for 2013. This should be continually noted on all Medicare claims regardless to avoid any future penalties into the coming years as they will continue to require this as there will be a 2% reduction for year 2014 as well.

The Florida Healthcare Law Firm Announces National Expansion

NHLFLogo
(Delray Beach, FL) June 21st, 2012 – The Florida Healthcare Law Firm, one of Florida’s leading healthcare law firms, today announced a major increase in their legal practice capabilities with the official launch of the National Healthcare Law Firm, a d/b/a and new portal of the firm. The expansion to a national platform providing healthcare legal services to physicians and healthcare businesses is one that significantly increases resources for clients who lack qualified local healthcare counsel. While the Florida Healthcare Law Firm has for years assisted clients outside the state of Florida*, this new development further cements the firm’s commitment to providing ethical legal counsel in the healthcare industry.

“We are very excited about it. The fact that we serve clients all over the country has been a small secret for a while but we realized there’s a huge demand and decided to just go for it,” said Jeffrey L. Cohen, Esq. Founder and President of Florida Healthcare Law Firm.

According to Cohen, “It’s just a strange area of the law.  Nearly everything in healthcare business is regulated; leases, employment agreements, compensation.  Things you wouldn’t think are regulated are strongly regulated.  And there are large fines and criminal penalties for getting it wrong!  Our clients understand that healthcare business of any kind has serious legal risks and that they need uniquely qualified help.”

To request a service list or for any other firm information, call Autumn Piccolo at 888-455-7702 or visit the firm’s website at www.nationalhealthcarelawfirm.com or www.floridahealthcarelawfirm.com

*     *     *

Acknowledged throughout the country for its service and excellence, Florida Healthcare Law Firm is one of the nation’s leading providers of healthcare legal services. Founded by Jeffrey L. Cohen, Esq and headquartered in South Florida, FHLF provides legal services to physicians and healthcare businesses with the right pricing responsiveness and ethics. From healthcare clinic regulation, home health agency representation and physician contracting to medical practice formation/representation and federal and state compliance matters, the Florida Healthcare Law Firm is committed to bringing knowledge and experience to a diverse group of clients.

CROs Must Know Patient Consent Requirements

Clinical Research Organizations (CROs) in Florida have to be careful about ensuring compliance with state and federal patient consent requirements.

To begin with, let’s agree on the following language.

  • Institutional Review Board (“IRB”): Empowered by FDA to oversee trials on human subjects.  IRB oversees informed consent process.
  • “Investigator” is person conducting the study.  Often a physician but not always.
  • “Article” is the drug, device or other item being tested.
  • “Subject” is the human upon which the test is conducted.

FEDERAL LAW

Federal law contains the following for effective informed consent:

  • •A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the Subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
  • •Description of any reasonably foreseeable risks or discomforts to the Subject.
  • •A description of any benefits to the Subject or to others which may reasonably be expected from the research.
  • •A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the Subject.
  • •A statement describing the extent, if any, to which confidentiality of records identifying the Subject will be maintained and that notes the possibility that the FDA may inspect the records.
  • •For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
  • •An explanation of whom to contact for answers to pertinent questions about the research and research Subjects’ rights, and whom to contact in the event of a research-related injury to the Subject.
  • •A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the Subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  • •A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or fetus, if the Subject is or may become pregnant) which are currently unforeseeable.
  • •Anticipated circumstances under which the Subject’s participation may be terminated by the Investigator without regard to the Subject’s consent.  Non-specific statement that Subject’s participation will be terminated for a failure to follow protocols is insufficient if Subject has not been apprised of all protocols.
  • •Any additional costs to the Subject that may result from participation in the research.
  • •The consequences, to the Subject’s health, of the Subject’s decision to withdraw from the research, and procedures for orderly termination of participation by the Subject.
  • •A statement that significant new findings developed during the course of the research which may relate to the Subject’s willingness to continue participation will be provided to the Subject.

Under federal law, informed consent is not required if, before the test is conducted, the Investigator and a physician who is not participating in the trial certify in writing:

i.    Subject is confronted by life-threatening condition necessitating use of the test article; AND

ii.    Informed consent is not possible due to inability to communicate with, or obtain legally effective consent from, the Subject; AND

iii.    There is not enough time to obtain consent from the Subject’s legal representative; AND

iv.    There is available no alternative method of approved or generally recognized therapy that provides at least as good of a chance of saving the Subject’s life.

If the Investigator feels that all items above are true, but the Investigator does not have time to obtain determination by an independent physician prior to administering the Article, the Investigator can obtain determination by an independent physician within five working days after administering the Article to the Subject.  Certifications must be submitted to the IRB within five working days after administering the Article to the Subject.

When informed consent is required, it must be documented.

  • •Via written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form.  A “long form” or a “short form” of documentation may be used
  • •A written “long form” embodies the elements of informed consent set forth above in section II.  This form may be read to the Subject or the Subject’s legally authorized representative.  The Investigator shall give either the Subject or the representative adequate opportunity to read the form before it is signed.
  • •A written “short form” states that the elements of informed consent set forth in section II have been presented orally to the Subject or the Subject’s legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the Subject or the representative. Only the short form itself is to be signed by the Subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining the consent shall sign a copy of the summary. A copy of the summary shall be given to the Subject or the representative in addition to a copy of the short form.

IRB will sometimes waive the requirement that informed consent be documented for some or all Subjects.  This waiver only concerns documentation.  Informed consent must still be obtained.  IRB itself can issue such a waiver if the trial presents a minimal risk of harm, and does not involve any procedures for which written consent customarily would be required in ordinary, non-trial, healthcare delivery, or if emergent circumstances justify such a waiver.  If documentation is waived, informed consent must still be obtained verbally.

FLORIDA LAW

Current Florida law does not regulate the clinical trials research process.  The investigational drug program and the Florida Drug Technical Review Panel were repealed by the Florida Legislature in 2000.  Instead, clinical trials research is regulated entirely by federal law.

That said, clinical trials in Florida are subject to applicable state law, including the Florida Medical Consent Law (Section 766.103) and the health care surrogate provisions (Section 765).

The seminal law in Florida regarding patient consent is Section 766.103, F.S., the Florida Medical Consent Law.  It precludes recovery in any court action based on a claim of failure to obtain informed consent, in essence, if:

  1. The physician, ARNP or PA obtains the consent “in accordance with an accepted standard of medical practice among members of the medical profession with similar training and experience in the same or similar medical community as that of the person treating, examining, or operating on the patient for whom the consent is obtained;” and
  2. A reasonable person, based on the information provided above, would have a general understanding of the procedure, medically acceptable alternatives and the substantial risks in the proposed treatment; or
  3. The patient would have reasonably undertaken the treatment had the patient been so advised; and
  4. The consent is signed by a mentally and physically competent patient or other authorized person.

The failure to meet the above does not violate any law.  Rather, meeting the above essentially precludes any successful lawsuit based on the claim that there was a failure to obtain informed consent.

Relatedly, Section 381.026, the Florida Patient’s Bill of Rights and Responsibilities state—“Every individual has the basic human right to be informed about the medical treatment or procedure that is being proposed to them.”  under this state law, the key principles that comprise Informed Consent are:

  • The proposed Treatment  
  • The purpose of the treatment to be provided
  • The common risks
  • Benefits
  • Side effects
  • The specific dosage range for the medication, when applicable
  • Alternative treatment modalities
  • The approximate length of care
  • The potential effects of stopping treatment
  • How treatment will be monitored
  • That any consent given for treatment may be revoked orally or in writing before or during the treatment period by the patient or by a person who is legally authorized to make health care decisions on behalf of the patient.  (Section 394.459)

CROs have a lot of ground to cover to ensure patients understand the risks and benefits associated with participating in clinical research.  They have to be particularly astute regarding not only federal law, but also the law of the state where the research is performed.