EHR

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Stark Law waived to facilitate COVID related medical services

by admin on April 17, 2020 No comments

stark law waiverBy: Jeff Cohen

The Secretary of Health and Human Services issued blanket waiver of the Stark Law on March 30th in order to facilitate COVID related medical services.  The waivers apply only to financial relationships and referrals related to COVID.  The circumstances and conditions under which the waivers apply are strictly and narrowly described.  Moreover, the waivers have no impact in the presence of fraud or abuse.  With respect to physicians wanting to provide designated health services (e.g. clinical lab services) related to COVID detection and treatment, for instance–

  1. the federal requirement that the DHS be provided in the same building as the physician office is waived; and
  2. the financial relationship limitations between the physician (or family member) and the DHS provider is waived.

The waiver also contains specific examples of waived interactions between providers and hospitals, including—

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Genetic Testing HIPAA Warning: Legal Considerations

by admin on January 14, 2019 No comments

genetic testing hipaaBy: Jacqueline Bain

You might have recently received a holiday gift of a direct-to-consumer genetic testing kit from Ancestry.com or 23andMe.com (or any other number of companies). So exciting! In our melting pot society, one can’t help but be curious about where they come from and if they are more likely than any other person to be subject to any number of ailments.

Not so fast though! Before you swab yourself and send away your genes for testing, you might consider what you’re exposing yourself to. Direct-to-consumer genetic testing companies, which provide genetic testing directly to consumers without any intervening healthcare provider, are not bound by HIPAA. They are not considered “covered entities”, and therefore not required to use the same protections for genetic information the way a hospital or your doctor would.

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Fall 2014 HIPAA Audits: Is Your Business Ready?

by admin on October 9, 2014 No comments

hipaa-audits-imageFile-3-a-7296By: Jackie Bain

Section 13411 of the HITECH Act authorizes and requires the Department of Health & Human Services Office for Civil Rights (“OCR”) to provide for periodic audits to ensure that covered entities and business associates comply with the HIPAA Privacy and Security Rules. OCR conducted its first round of those audits in 2011 and 2012, and has announced that it will begin a second phase.  Unlike the first phase of audits, which were limited to covered entities, both covered entities and business associates are intended to be audited during this second phase.

How will audited businesses be selected?

This fall, OCR will deliver pre-audit surveys to between 550 and 800 covered entities.  OCR is attempting to obtain a fair snapshot of all covered entities, so these pre-audit surveys will be sent to health care providers, health plans, and health clearinghouses. Moreover, the audits will span the gamut of business sizes, from large corporations to solo practitioners. After pre-audit surveys are returned, OCR will randomly select 350 of those covered entities for a full audit.  As a part of these full audits, covered entities will be asked to identify their business associates.  OCR will then select 50 business associates to participate.

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Board of Medicine: New Rule Regarding Adequacy of Medical Records for Compounded Medication

by admin on September 9, 2013 No comments
gavelThe Florida Board of Medicine reviewed Rule 64B8-9.003, Florida Administrative Code which provides standards for the adequacy of medical records.  The underlined portions below are the new standards required for medical records as it relates to compounded medications.  These standards are effective September 9, 2013.
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CMS Issues Final Rules Updating Medicaid & Medicare Payments For 2013 & 2014

by admin on November 20, 2012 No comments

Repost Via mondaq.com and Kristen A. Larremore & Sarah K. Baker — On November 1, 2012, the Centers for Medicare and Medicaid (“CMS”) issued three final rules, to be effective January 1, 2013, that implement a number of Medicare and Medicaid payment changes for 2013 and 2014.

Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Electronic Reporting Pilot; Inpatient Rehabilitation Facilities Quality Reporting Program; Revision to Quality Improvement Organization Regulations

The hospital outpatient prospective payment and ambulatory surgery center (“ASC”) final rule with comment period updates the payment policies and payment rates for services furnished to Medicare beneficiaries in hospital outpatient departments and ASCs. This final rule changes certain amounts and factors used to determine the payment rates for Medicare services paid under the Medicare hospital outpatient prospective payment system (“OPPS”) and the Medicare ASC payment system.

According to CMS estimates, payments to hospitals under the OPPS for 2013 will be approximately $48.1 billion (an increase of $4.6 billion compared to 2012) and payments to ASCs for 2013 will be approximately $4.07 billion.

OPPS payment rates are being increased for 2013 by an outpatient department fee schedule increase factor of 1.8 percent. Additionally, the final rule continues to implement the statutory 2.0 percent reduction in payments for hospitals failing to meet the hospital outpatient quality reporting requirements, by applying a reporting factor of 0.980 to the OPPS payments and copayments for all applicable services. The final rule further modifies OPPS payments by basing future determinations of relative payment weights on geometric mean costs rather than median costs (which has been utilized in determining OPPS payments since the inception of the OPPS).

Payment rates for ASCs are being increased for 2013 by 0.6 percent (less than the 1.3 percent update included in the proposed rule).

Additionally, this final rule updates and implements new requirements under the Hospital Outpatient Quality Reporting (“OQR”) Program, the ASC Quality Reporting (“ASCQR”) Program, and the Inpatient Rehabilitation Facility (“IRF”) Quality Reporting Program. The final rule also (1) continues the electronic reporting pilot for the Electronic Health Record (“EHR”) Incentive Program, as finalized for 2012 through 2013, and (2) revises the various regulations governing Quality Improvement Organizations (“QIOs”), including (a) granting QIOs the authority to send and receive secure transmissions of electronic versions of medical information, (b) providing more detailed and improved procedures for completing Medicare beneficiary complaint reviews and general quality-of-care reviews (including a new alternative dispute resolution process called “immediate advocacy”), (c) increasing information beneficiaries receive in response to QIO review activities, (d) conveying to beneficiaries the right to authorize the release of confidential information by QIOs, and (e) making other technical corrections.

In addition to the foregoing modifications and payment updates reflected in the final rule, the following briefly lists certain additional changes implemented therein:

  • Continuation of a 7.1 percent adjustment to OPPS payments to certain rural hospitals, including sole community hospitals and critical access hospitals (applicable to all services paid under the OPPS, excluding separately payable drugs and biological, devices paid under the pass-through payment policy, and items paid at charges reduced to cost);
  • Continuation of the cancer hospital payment adjustment with a target payment-to-cost ratio of 0.91 for determining the 2013 cancer hospital payment adjustment to be paid at cost report settlement (intended to cause cancer hospital payments to equal the weighted average payment-to-cost ratio for other OPPS hospitals);
  • Adjustment of payments to cover the marginal cost of hospital conversion to the use of non-highly enriched uranium (“non-HEU”) sources of radio-isotopes used in medical imaging (intended to reduce US reliance on reactors outside of the US);
  • Setting the payment for the acquisition and pharmacy overhead costs of separately payable drugs and biological that do not have pass-through status at the statutory default of average sales price plus 6 percent;
  • Clarification of the application of the supervision regulations to physical therapy, speech-language pathology, and occupational therapy services that are furnished in OPPS hospitals and critical access hospitals;
  • Updates to the Part A to Part B Rebilling Demonstration that is in effect for 2012 to extend it through 2014; this extension is designed to address increased length-of-stay times for outpatients receiving observation services as well as Medicare Part A to Part B rebilling policies when a hospital inpatient claim is denied because the inpatient admission was not medically necessary;
  • Revisions to regulations governing payments for new technology intraocular lenses (§§ 416.196(a0(2) and 416.195(a)(4)) with regard to labeling, requiring the inclusion of a claim of a specific clinical benefit therein and demonstration of evidence that the intraocular lenses result in a measurable, clinically meaningful, improved outcome; and
  • Adoption of measures for the Inpatient Rehabilitation Facility Quality Reporting Program that will affect annual prospective payment amounts for 2014 as well as the adoption of new pressure ulcer measures.

Medicaid Program; Payment for Services Furnished by Certain Primary Care Physicians and Charges for Vaccine Administration under the Vaccines for Children Program

The Medicaid final rule requires State Medicaid agencies to pay at least the Medicare rates in effect under the Medicare physician fee schedule rate in 2013 and 2014 or, if higher, the rate using the calendar year 2009 conversion factor for primary care services furnished by physicians practicing within the scope of practice of medicine or osteopathy with a specialty designation of family medicine, general internal medicine or pediatric medicine, or a subspecialty within those specialties (as recognized by the American Board of Medical Specialties, American Osteopathic Association, or the American Board of Physician Specialties). Physicians are required to self attest for purposes of inclusion as a “primary care physician” that they are either Board-certified in family medicine, general internal medicine, or pediatric medicine or a subspecialty related to those specialties; or that 60 percent of all Medicaid services billed by such physician or provided in a managed care environment are for the specified evaluation and management (“E&M”) and vaccine administration codes. This payment requirement applies to primary care services paid on a fee-for-service basis as well as those paid on a capitalized or other basis by Medicaid managed care plans.

However, the final rule also requires a 100 percent federal match for any increase in payment above the amounts due for such services under the applicable Medicaid State plan rate as of July 1, 2009, such that no additional costs accrue to states for payments above the rates in effect under the 2009 Medicaid State plan methodology. Accordingly, unless a state has reduced its Medicaid rates since 2009, it will be fully reimbursed by the federal government for any increased payments. In order to claim such enhanced federal match, states must be able to document the difference between the July 1, 2009, Medicaid rate and the applicable Medicare rate for specified providers that is claimable at the 100 percent matching rate. States are given flexibility in determining whether and how often to update rates to conform to changes in the Medicare Part B Fee Schedule, if the 2013 and 2014 rates are applicable, since such scheduled rates are subject to periodic adjustments or updates through the calendar year.

Primary care physicians are targeted by these payment changes in part due to their ability to perform the vital function of coordinating patient care, including specialty care, but also due to the need for a sufficient number of primary care physicians to be participating in the Medicaid program prior to the expansion of Medicaid eligibility in 2014. Primary care services are defined under the Patient Protection and Affordable Care Act (“ACA”) (Section 1902(jj)) to include certain specified procedure codes for E&M (codes 99201 through 99499, to the extent covered by the approved Medicaid State plan or included in a managed care contract) as well as certain vaccine administration codes. Additionally, the higher payment rates are applicable to services provided under the personal supervision of eligible physicians by all advanced practice clinicians. Physicians delivering primary care services in a Federally Qualified Health Center or Rural Health Clinic are not eligible for increased payments under this final rule due to the view that these physicians are already reimbursed at the appropriate rate under the Medicaid statute.

Additionally, the final rule updates the regional maximum fees that providers may charge for administration of pediatric vaccines to federally vaccine-eligible children under the Pediatric Immunization Distribution Program (more commonly known as the Vaccines for Children program) by adding 42 C.F.R. Part 441, Subpart L. Under this program, each state is required to establish a Vaccines for Children program under which certain specified groups of children are entitled to receive qualified pediatric immunizations without charge for the cost of the vaccine. This program permits providers to impose a fee for the administration of such a vaccine, as long as the fee does not exceed the costs of such administration, without permitting the provider the ability to deny administration of the vaccine due to the inability of the child’s parents or guardian to pay the administration fee.

The explicitly stated, expected, overall benefit from the Medicaid final rule is increased provider participation by primary care physicians, resulting in better access to primary and preventive health services by Medicaid beneficiaries. However, skeptics have questioned the ability of the final rule to generate such increased participation due to the fact that the increased rates are only in place for a 2-year period, 2013 and 2014. Currently under the final rule, states are required to collect and report data to CMS on the impact of the higher rates on physician participation. That data will assist Congress in determining whether or not to extend the provisions of the final rule beyond the end of 2014.

Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule, DME Face-to-Face Encounters, Elimination of the Requirement for Termination of Non-Random Prepayment Complex Medical Review and Other Revisions to Part B for CY 2013

In conjunction with implementing the foregoing Medicaid payment increases, CMS also released a Medicare final rule with comment period that includes a statutorily required 26.5 percent across-the-board reduction to Medicare payment rates for more than 1 million physicians and non-physician practitioners under the Balanced Budget Act of 1997’s Sustainable Growth Rate (“SGR”) methodology. While Congress has overridden the required reduction every year since 2003, currently no such action has been taken.

Additionally, the Medicare final rule establishes payment rates for 2013 for the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that the payment system is updated to reflect changes in medical practice and in the relative value of services. It also includes a new policy to pay a patient’s physician or practitioner to coordinate the patient’s care in the 30 days following a hospital or skilled-nursing-facility stay. The changes in care coordination payment and other changes in the rule are expected to increase payment to family practitioners by 7 percent, and other primary care practitioners between 3 and 5 percent, if Congress averts the statutorily required reduction in Medicare’s physician fee schedule.

The Medicare final rule also includes the implementation of the physician value-based payment modifier under the ACA. Under the ACA, this new system is required to apply to all doctors by the start of 2017, and is one of the trickiest and most politically loaded parts of Medicare’s effort to shift away from paying for the volume of services and toward the quality of care.

The value-based payment modifier is the percentage by which amounts paid to a physician group under the Medicare physician fee schedule are adjusted based upon a comparison of the quality of care furnished to cost of care. The payment modifier provides for differential payment starting in 2015, based on performance in the 2013 calendar year. CMS originally planned to apply the modifier to medical groups of 25 or more professionals; however, in the final rule CMS changed the plan to only include medical groups of 100 or more practitioners. This change was adopted to gain experience with the methodology and approach before expanding to smaller groups—which CMS emphasizes will occur in future rulemaking.

In general, physicians with higher quality and lower costs will be paid more, and those with lower quality and higher costs will be paid less. The final rule provides an option for these groups of physicians to choose how the value modifier is calculated based on whether they participate in the Physician Quality Reporting System (“PQRS”). The PQRS is a voluntary program that allows physicians and other healthcare professionals to report information to Medicare about the quality of care they provide to people with Medicare who have certain medical conditions. All of the quality measures for which groups of physicians are eligible to report under the PQRS starting in 2013 are used to calculate the value-based payment modifier to the extent the group submits such data. Note, however, that the final rule also makes minor changes to the PQRS. Additional quality measures for those not participating in the PQRS are composites of rates of potentially preventable hospital admissions or readmissions.

Among other changes, the final rule also implements provisions of the ACA by removing certain regulations regarding termination of non-random prepayment review. Medical review is the process performed by Medicare contractors to ensure that billed items or services are covered and are reasonable and necessary. As a result of this final rule, contractors are not required to terminate non-random prepayment medical review by a prescribed time, but instead must terminate each medical review when the provider or supplier has met all Medicare billing requirements as evidenced by an acceptable error rate as determined by the contractor.

Finally, the rule implements provisions of the ACA by establishing a face-to-face encounter with a beneficiary as a condition of payment for certain durable medical equipment items such as prosthetic devices, orthotics, and prosthetics. The encounter must occur during the six months prior to the written order for each item or during such reasonable timeframe as provided by the Secretary.

Overall, this Medicare final rule continues efforts by CMS to align quality reporting across programs to reduce burden and complexity, and emphasizes paying for the quality of care as opposed to volume of services provided.

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adminCMS Issues Final Rules Updating Medicaid & Medicare Payments For 2013 & 2014

From Intervention to Prevention

by admin on October 2, 2012 No comments

“Healthcare Reform,” “PPACA” and “ACOs” all have one certain thing in common:  cost-saving change.  Though debate swirls about politics, timing and the particulars of change, it seems clear that the changing demographics of our country (aging baby boomers) in our economic climate is not sustainable as is.  And it’s no surprise that a compensation system based on how much is done and how much it costs leads to greater expense.  An economic reward system that drives costs up as more and more people are set to join the ranks of the insured (through mandated health insurance and expanded Medicaid) simply underscores the timing of the change.  What does that mean for physicians?

Physicians are asking three key questions:

  1. Is there a future for small or solo practices?
  2. Is fee for service really gonna change?
  3. What can I do right now to adapt?

The Future of the Small Practice

The only solid answer is “less.”  It really depends on complex things like the demographics of where the doctor practices and the number of competitors close by.  That said, as change happens, the hardest hit will likely be the smaller practices, since they lack the personnel and financial resources to weather the change and to invest in adaptation.  Many small practices will likely experience change in such a way that the best they can hope for is to survive, rather than thrive.  Even worse, solo practitioners already know what it’s like to handle all the duties as a physician, keep track of business operations and keep the patients flowing into the practice.  Exhausting.  Without substantial support and resources, it’s just not realistic for most solos to expect to keep up.

Even larger practices are not often run like a business.  The professionals that generate the revenue often manage as well.  Moreover, most medical practices do not market or do any serious “back office” magic (revenue cycle management).  As such, change hits small practices especially hard.  Implementing even new EHR requirements can be consuming for a small practice.  How will it be as changes are made to reduce cost and improve quality?  How will it be when practices begin to see there is opportunity in change, that they may actually make more money in a risk based compensation environment?  Rougher.  Like a herd of buffalo when attacked, circling together is a good strategy.

That said, the vision has to be clear.  Why circle together?  Most medical practices are combining and growing to guard market share, not to manage costs or measure and demonstrate quality.  This is probably the biggest reason why we see larger practices in single specialties, not multi-specialty or primary/specialty based practices.  Most physicians that are adapting by joining larger practices are doing so for the same reason why buffalos circle together—the threat of change.  Though size alone is no panacea, larger practices are definitely in a better position to adapt.

Let’s face it:  few are running after change in healthcare right now.  Few see the opportunity and are leading the charge.  Most are waiting or are just setting the stage.  And most large practices are, at best, a good platform where change can be implemented and costs can be shared and spread among a larger pool.

Will There be a Change to Fee for Service Payment?

Yep.  Simple as that.  It’s already happening.  Bundled payments are in place, even in Florida.  Capitation is old hat for many now.

When?  Over time…  Not right away.  Even ACOs aspirants are selecting just one sided risk, testing the water as they see how well they do to reduce costs, improve quality and “earn” their right to bonus money.  Physicians that think fee for service will thrive for decades are kidding themselves, at least in the insured market.  Is there a basis for it in a “second tier” or concierge sort of environment?  Probably.

What Can I Do Right Now?

First, accept that we are approaching a new paradigm of healthcare delivery.  The current model of disease/injury crisis management has prepared no one for the move from intervention to prevention.  And yet, systems that are solidly based in wellness and prevention stand to profit most from the change we all face.

Second, look to shore up you business model.  That means:

  1. Look to join a larger practice that is committed to thriving in the future risk-based compensation scenario.  If the practice is there just to thrive in a fee for service environment and has no commitment to thriving in a risk based compensation model, keep looking;
  2. Market.  Most practices do not market at all, and yet consumers are selecting medical care in the most unlikely environment—the internet;
  3. Look at anything concierge-like.  Most of the public conversation centers around the insured market, mostly the Medicare Shared Savings Program (which has spawned the ACO concept).  What about the rest of the consumers?  As the insured market gets squeezed (remember that consumers are feeling the pressure too with heightened copays, deductibles and benefit limits), you can expect growth of the “second tier,” those who want more and are willing to pay for it;
  4. Build in wellness and prevention.  Not all practices lend themselves to wellness related services that can reduce healthcare costs, but those that do must look at ways to offer cost-saving, wellness and prevention-oriented services;
  5. Enlist the patients.  The concept of “partnering” with patients is strange, but consider the amount of savings and the enhancement of outcomes if physicians could incentivize healthy patient behavior.  Though absent from the public policy conversation, health care businesses that build in patient accountability stand to win big in a payment system that rewards clinical outcomes and cost savings.

Change is frightening.  Even “good” change is frightening.  Just look at all the upset stomach meds sold at airport kiosk counters.  Physicians have a terrific burden at this time.  They not only hold our health in their hands.  They are expected to have skills and time to help create a new environment in which care will be delivered.  Denying change in the healthcare sector is a waste of time and energy.  Looking for ways to thrive in it and even drive it is wise.

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Federally Funded Electronic Health Recordkeeping: Friend or Foe?

by admin on March 31, 2011 No comments

The Federal HITECH Act will provide over $20 billion to promote health care provider use of electronic health records.  Starting this year, “meaningful” EHR users can earn $44,000 under Medicare and $64,000 under Medicaid over 5 years.  Those who enroll early will benefit the most, because nearly 70% of the payments come in the program’s first 2 years.  Physicians who have engaged in PQRI and electronic prescribing in the past few years have put another $6,000 to $8,000 in their pockets.

The Federal push for electronic health records isn’t going away.  Over $7 billion has been released to fund state capacity for exchanging health information across the health care system both within and across states.  The Florida Agency for Health Care Administration received nearly $21 million to develop this state’s health information infrastructure.  The intent is to assure a fully connected national health care IT system to provide all health care providers and their patients seamless access to a patient’s medical information.

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adminFederally Funded Electronic Health Recordkeeping: Friend or Foe?