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Health care regulatory services

Providing advisory services across the health care ecosystem

By focusing on the differentiated needs of plans and providers, our US Health Care practice can help clients transform uncertainty into possibility, and rapid change into lasting progress. We look deeper at the biggest industry regulatory and compliance issues and provide cutting-edge research to give you the insights you need to see things differently.

Inflation Reduction Act of 2022

Signed into law on August 16, 2022, the Inflation Reduction Act of 2022 (IRA) establishes new measures and regulatory authorities to control drug costs across the Medicare program.

The IRA provisions, especially those regulating drug prices, will have broad-reaching impact on life sciences and health care stakeholders, including health plans, hospitals, biopharma manufacturers, the federal government, and employers. This new law marks the first significant changes to Medicare drug policy since the Medicare Modernization Act of 2003. It also includes important changes that directly impact consumers in two ways: it will drive down costs for Medicare beneficiaries, primarily through closure of the “donut hole,” and will extend the Affordable Care Act’s premium tax credits to help individuals who purchase health insurance coverage on the exchanges.

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Compliance challenges for the health care industry

Key issues and focus areas

Participation in the Medicare program, either as a health care provider or a health plan, presents both risks and opportunities to organizations. As the number of Medicare beneficiaries is expected to increase over the next decade, regulators are expected to continue to take a prominent role in shaping health care in the US. Deloitte’s Health Care Regulatory Support teams with health plans, health care providers, pharmacies and pharmacy benefit managers, and other organizations across the care continuum to help address emerging guidance and assist organizations with maintaining compliance with existing rules governing the Medicare Program.

The Medicaid program has experienced evolutionary change over the past decade of its existence. Given the expected increase in Medicaid enrollment predicted as a result of the current financial situation brought about by COVID-19, change is expected to continue. With change comes challenges to both health plans and health care providers. For plans, stringent contract requirements make operational and compliance excellence paramount. For providers, the diminished levels of reimbursement provided for Medicaid patients compel value-based portfolio strategies. As change continues, organizations will likely continue to contend with these challenges.

Pharmacy services go beyond just getting your prescriptions filled. Pharmacies work in close coordination with health care providers, health plans, pharmaceutical companies, group purchasing organizations (GPO), wholesalers, and other pharmacies to provide their communities with seamless and timely access to medications. Additionally, the traditional role of the pharmacist continues to evolve particularly as there is an increase in:

  • The role pharmacists play in clinical decision-making
  • The use of automation and technological advancements
  • High-cost specialty medications with plan-imposed restrictions and guardrails

As the roles of pharmacy and the pharmacist continue to evolve, it’s vital that organizations are well-informed and have adequate controls in place to comply with guidelines and rules from the multiple regulatory and other governing parties that oversee pharmacy operations. These controls help protect organizations against vulnerable areas ripe for noncompliance, including billing operations, documentation management, and controlled substance practices. Deloitte works with pharmacies and related entities across the end-to-end continuum of care to help them understand emerging guidance, assist organizations with maintaining compliance with existing governing rules, and find new sources of value to drive efficiency and growth in a competitive market.

The past decade has seen a convergence of regulatory disruption and macro technology forces. Emerging federal requirements have the potential to be a key catalyst to ignite multiple changes in the health industry that promote higher-quality, lower-cost care. As regulators increasingly focus on giving patients agency over their health care journey, Deloitte’s Health Care Regulatory Support team is assisting clients to capitalize on these opportunities in a way that aligns with and expands upon evolving federal requirements to create strategic differentiation.

Serving the entire ecosystem of health care players

Deloitte’s Health Care Regulatory Support practice can help clients across the ecosystem of health care. From health systems and health plans to specialized care settings, retail pharmacies, and emerging care providers and financers, we assist organizations in navigating emerging regulatory policy and maintaining compliance with federal rules, regulations, and leading practices.

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Seismic shifts: A future of health webcast series

PART 2: REGULATORY CHANGES IN THE FUTURE OF HEALTH

Interoperability and information blocking in health care

LATEST NEWS, RESOURCES, AND STRATEGIES ON INTEROPERABILITY FOR ELECTRONIC HEALTH RECORDS (EHR)

Health care risk leaders are keeping their heads above water for now

BUT A TIDAL WAVE OF NEW RISKS MAY FORCE THEM TO SINK OR SWIM

Meeting consumers’ changing needs: Moving towards the future of health

IMPROVING ENGAGEMENT IN A CONSUMER’S HEALTH CARE JOURNEY MAY HELP IMPROVE OUTCOMES AND REDUCE THE COST OF CARE

CMS proposes demonstration to reduce Part D plan risk from safe harbor changes

PLANS EXPECTED TO BID UNDER CURRENT REBATE RULES

The future of health

HOW INNOVATION WILL BLUR TRADITIONAL HEALTH CARE BOUNDARIES

Six months after CARES

PROVIDER RELIEF FUND (PRF) RECIPIENTS HAVE LONG AWAITED THE REPORTING REQUIREMENT DATA ELEMENTS THAT ARE MANDATED AS PART OF RECEIVING AND ATTESTING TO PRF PAYMENTS.

Health care compliance agenda: Relieve the pressure

FACING AN ONSLAUGHT OF CHALLENGES THAT HAVE BEEN MAGNIFIED BY COVID-19, COMPLIANCE LEADERS IN HEALTH CARE MAY BENEFIT FROM NEW STRATEGIES TO OPTIMIZE, STANDARDIZE, AND DIGITIZE.

How innovative staffing can improve compliance

HEALTH CARE COMPLIANCE DEPARTMENTS THAT ARE STRETCHED THIN MAY BE ABLE TO STRETCH THEIR CAPABILITIES A LITTLE FURTHER WITH ALTERNATIVE TALENT MODELS.

Greater transparency and interoperability in health care

UNCOVER STRATEGIC OPPORTUNITIES FOR HEALTH SYSTEMS

Hospital Price Transparency Regulation

MARKET RESPONSES ARE VARIED AND REFLECT THE MANY STRATEGIC IMPLICATIONS OF INCREASING INFORMATION TRANSPARENCY IN HEALTH CARE.

Transparency in Coverage Rule

HEALTH PLANS FACE BOTH MARKET DISRUPTION AND STRATEGIC OPPORTUNITIES AS THE UPCOMING RULE SEEKS TO PULL BACK THE CURTAIN ON INFORMATION THAT HAS LONG BEEN CONSIDERED A “TRADE SECRET”.

Gateway Health CCO Touts Collaborative Compliance

A FOCUS ON BUILDING RELATIONSHIPS CAN HELP FOSTER COMPLIANCE GROUNDED IN TRUST AND RESPECT.

Deloitte's Health Care Regulatory Support practice helps clients across the health care industry. Whether traditional organizations or those entering the competitive landscape, we assist organizations in navigating emerging regulatory policy and maintaining compliance with federal rules, regulations, and leading practices.